bluuebunny/crossref_metadata_2025 huggingface dataset:
Mediational E-values
Authors: Smith Louisa H. , VanderWeele Tyler J.
Published: July 2019

Background:

Mediation analysis is a powerful tool for understanding mechanisms, but conclusions about direct and indirect effects will be invalid if there is unmeasured confounding of the mediator–outcome relationship. Sensitivity analysis methods allow researchers to assess the extent of this bias but are not always used. One particularly straightforward technique that requires minimal assumptions is nonetheless difficult to interpret, and so would benefit from a more intuitive parameterization.

Methods:

We conducted an exhaustive numerical search over simulated mediation effects, calculating the proportion of scenarios in which a bound for unmeasured mediator–outcome confounding held under an alternative parameterization.

Results:

In over 99% of cases, the bound for the bias held when we described the strength of confounding directly via the confounder–mediator relationship instead of via the conditional exposure–confounder relationship.

Conclusions:

Researchers can conduct sensitivity analysis using a method that describes the strength of the confounder–outcome relationship and the approximate strength of the confounder–mediator relationship that, together, would be required to explain away a direct or indirect effect.
Renin–Angiotensin–Aldosterone System-based Antihypertensive Agents and the Risk of Colorectal Cancer Among Medicare Beneficiaries
Authors: Htoo Phyo T. , Stürmer Til , Jonsson-Funk Michele , Pate Virginia , Simpson Ross J. , Lund Jennifer L.
Published: July 2019

Background:

Biologic evidence suggests that angiotensin II may play a role in tumor progression or growth. We compared the short-term colorectal cancer (CRC) risk among initiators of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) versus guideline-recommended clinical alternatives (beta blockers, calcium channel blockers [CCB], and thiazides).

Methods:

We conducted a new-user cohort study on U.S. Medicare beneficiaries aged over 65 years, who initiated antihypertensive monotherapy during 2007–2013 and were free of cancer diagnosis before drug initiation. Follow-up began 6 months postinitiation to allow time for the diagnostic delay. We estimated hazard ratios (HR) with 95% confidence intervals (CI) using propensity score weighted Cox regression, overall and stratified by time since drug initiation, and 5-year cumulative risk differences (RD) using Kaplan–Meier estimator. We assessed the potential for unmeasured confounding using supplemental data from Medicare Current Beneficiary Survey.

Results:

For analyses without censoring for treatment changes, we observed 532 CRC events among 111,533 ACEI/ARB initiators. After a median follow-up of 2.2 years (interquartile range: 1.0–3.7), CRC risk was similar between ACEI/ARB and active comparators, with adjusted HRs of 1.0 (95% CI = 0.85, 1.1) for ACEI/ARB versus beta blockers, 1.2 (95% CI = 0.97, 1.4) for ACEI/ARB versus CCB and 1.0 (95% CI = 0.80, 1.3) for ACEI/ARB versus thiazide. Five-year RDs and as-treated analyses, which censored follow-up at medication changes, produced similar findings.

Conclusions:

Based on real-world antihypertensive utilization patterns in Medicare beneficiaries, our study suggests no association between ACEI/ARB initiation and the short-term CRC risk.
Simple and Rapid Quantification of the Multi-Enzyme Targeting Antifolate Pemetrexed in Human Plasma
Authors: van den Hombergh Erik , de Rouw Nikki , van den Heuvel Michel , Croes Sander , Burger David M. , Derijks Jeroen , van Erp Nielka P. , ter Heine Rob
Published: July 2019

Background:

Pemetrexed is an antifolate cytostatic drug that targets multiple enzymes involved in folate biosynthesis and is indicated for treatment of non–small-cell lung cancer and malignant pleural mesothelioma. As evidence for an exposure–response/toxicity relationship is accumulating, dose individualization using therapeutic drug monitoring may be a feasible strategy to optimize treatment. The purpose of this study was to develop a simple, sensitive, high-performance liquid chromatography method with UV detection for quantification of pemetrexed levels in human plasma.

Method:

The method involves a simple protein precipitation, followed by ultra-performance liquid chromatography with ultraviolet detection at a wavelength of 254 nm. Pemetrexed was separated using a mobile phase with a linear gradient and a run time of only 7 minutes.

Results:

The assay has been validated over the concentration range 0.25–500 mg/L of pemetrexed. Accuracy for this assay ranged from −4.50% to 1.78%, and the within- and between-run coefficients of variation were <3.57%. Pemetrexed in plasma was proven to be stable for 8 months at −40°C.

Conclusions:

The bioanalytical method we developed proved to be simple, accurate, precise, and fast. This analytical method is successfully in use for therapeutic drug monitoring and will be used for pharmacokinetic studies.
A Unifying Algorithm in Microvascular Reconstruction of Oral Cavity Defects Using the Trilaminar Concept
Authors: Butler Daniel P. , Dunne Jonathan A. , Wood Simon H. , Jallali Navid
Published: July 2019

Background:

Although many algorithms exist to classify oral cavity defects, they are limited by either considering a single subsite or failing to provide a concise reconstructive algorithm for the breadth of defects. Based upon our experience as a tertiary referral center, a unifying algorithm is presented that guides free flap selection in this heterogenous population.

Methods:

All intraoral defects requiring microvascular reconstruction from February 2012 to August 2018 were reviewed. Defects were classified according to their depth as unilaminar (type U = mucosa only), bilaminar (type B = mucosa and bone), or trilaminar (type T = mucosa, bone, and skin) and the number and side of mucosal zones involved (from 1 to 5). Hard palate defects were considered separately and excluded if part of a wider maxillectomy defect.

Results:

A total of 118 patients were eligible for inclusion in the study. Of type U defects involving 1 mucosal zone, 98% were reconstructed with a radial forearm free flap. Ninety-two percentage of type U defects involving ≥2 mucosal zones were reconstructed with an anterolateral thigh flap. Among type B defects, 86% were reconstructed with a fibula osseocutaneous free flap if less than 4 mucosal zones were involved and 100% reconstructed with an ALT if ≥4 mucosal zones were involved. The algorithm presented was accurate for 93% of the cases. Ninety-eight percentage of patients achieved intelligible speech and 72% returned to a normal diet. Flap success rate was 100%.

Conclusions:

The algorithm presented provides a simple system to guide the reconstruction of oral cavity defects.
High-efficiency Combination Treatment of Submental Neck Fullness
Authors: Cheng Carl K.L.
Published: July 2019

Background:

Fat accumulation, skin laxity, and muscle contraction cause aging cervical fullness. Combining botulinum toxin to treat muscle contraction, and technique-oriented microfocused ultrasound for skin laxity, can improve cervical fullness without requiring lipolysis. Gel-assisted depth adjustment (GADA) is a depth-targeting, image-guided approach using an appropriate gel volume to precisely heat tissue layers during real-time visualization.

Methods:

A 41-year-old woman presented with moderate submental neck fullness and saggy cheeks. An appropriate gel volume was applied as determined by the targeted tissue layer’s distance from the skin. The submental and submandibular areas received 112 lines of 0.9 J/cm2 microfocused ultrasound with visualization (MFU-V) from a 4.5-mm transducer and 0.3 J/cm2 from a 3-mm transducer to treat the SMAS and dermosubcutis, respectively. For concomitant jowling, these transducers delivered 111 MFU-V lines to the lower cheek. Six units of incobotulinumtoxinA was injected in 1 point at the mandible to modulate hyperactive mentalis muscles. The platysma received 10U of incobotulinumtoxinA per cheek, whereas downturned mouth corners received 4U of incobotulinumtoxinA.

Results:

One-month posttreatment, submentum improvements included changes of the vertical pogonion position, more mandible angularity, and a straighter mandibular line. Anterior chin projection was more pronounced and the pogonion had more inferior displacement, creating a younger appearance in the chin-neck complex. Patients followed-up for 3 months also demonstrated these changes.

Conclusions:

Delivering MFU-V using the GADA technique effectively tightens submental and submandibular soft tissues. When combined with incobotulinumtoxinA, muscles in the chin and perioral area are relaxed. Thus, GADA yields significant clinical improvement and patient satisfaction.
Varicose Vein Treatment by Suction-assisted Shaving Phlebectomy without the Use of Transillumination/Irrigation: A Simple, Quick and Effective Method
Authors: Hsu Honda , Lee Jiunn-Tat
Published: July 2019

Background:

Traditional management of saphenous vein incompetency is using high ligation and stripping with multiple stab incision phlebectomies for the varicose tributaries. A number of minimally invasive options have been described, each with their own advantages and disadvantages. We describe a new technique using suction-assisted shaving phlebectomy without transillumination and irrigation in the management of varicose veins.

Methods:

All patients that underwent combined conventional high ligation and stripping for saphenous vein insufficiency and suction-assisted shaving phlebectomy for varicose tributaries between 2011 and 2016 was included. They were evaluated with respect to surgical time, number of incisions, complications, and outcomes.

Results:

A total of 232 patients with mean age of 49 years old were included. The mean operation time for combined saphenous stripping and suction-assisted shaving phlebectomy was 29.5 minutes and for suction-assisted shaving phlebectomy was 7.4 minutes. The number of incisions excluding the groin incision was 3 incisions in 38 limbs, 2 incisions in 186 limbs, and 1 incision in 33 limbs. Postoperative complications included 2 (0.8%) skin perforation, 1 cellulitis (0.4%), 2 hematoma (0.8%), 3 saphenous neuropathy (1.2%), 4 skin pigmentation (1.6%), 4 skin depression or irregularities (1.6%), and 3 hypertrophic scarring (1.2%).

Conclusions:

Suction-assisted shaving phlebectomy has the advantage of decreased operating time, fewer surgical incisions, ad decreased scar formation. There is no need to purchase expensive medical equipment. It is a simple and effective procedure with comparable complication rates. This technique aims to replace traditional ambulatory phlebectomy and transilluminated powered phlebectomy.
To Post or Not to Post: Plastic Surgery Practice Marketing, Websites, and Social Media?
Authors: Mess Sarah A. , Bharti Gaurav , Newcott Ben , Chaffin Abigail E. , Van Natta Bruce W. , Momeni Reza , Swanson Scott
Published: July 2019

Social media is beginning to eclipse practice websites and other traditional electronic marketing utilized by plastic surgeons. First, highlights are presented from the relevant electronic marketing literature. Next, this article presents a new case study of how, why, when, and what social media is being used by ASPS members (n = 100). Results suggest a significant disconnect between plastic surgeons and the highest impact platforms reported in the literature such as Instagram, YouTube, Snapchat, and Facebook. Plastic surgeons currently prefer to focus electronic marketing efforts on practice websites over social media platforms. This study suggests that instead of relying on their practice websites to disseminate information, surgeons should be utilizing social media, posting promotions, before-and-after photos, and videos to develop their client base.
Comparing the Modified History, Electrocardiogram, Age, Risk Factors, and Troponin Score and Coronary Artery Disease Consortium Model for Predicting Obstructive Coronary Artery Disease and Cardiovascular Events in Patients With Acute Chest Pain
Authors: Teressa Getu , Bhasin Varun , Noack Pamela , Poon Michael
Published: July 2019

The objective of this study was to compare the History, Electrocardiogram, Age, Risk factors, and Troponin (HEART) score and clinical coronary artery disease (CAD) consortium (CADC) model for predicting obstructive CAD (≥50% stenosis on coronary computed tomographic angiography) and 30-day major adverse cardiovascular events (MACE, composite of acute myocardial infarction, revascularization, and mortality). We studied 1981 patients with no known CAD who presented with acute chest pain and had negative initial troponin and electrocardiogram. Chest pain was classified as typical, atypical, and nonanginal and used to score the history component of the modified HEART score. The C-statistic for predicting obstructive CAD was 0.747 [95% confidence interval (CI), 0.712–0.783] for the HEART score and 0.792 (95% CI, 0.762–0.823) for the CADC model (P = 0.0005). The C-statistic for predicting 30-day MACE was 0.820 (95% CI, 0.774–0.864) for the HEART score and 0.850 (95% CI, 0.800–0.891) for the CADC model (P = 0.11). Among the 48.3% of patients for whom the CADC model predicted ≤5% probability of obstructive CAD, the observed 30-day MACE was 0.6%; among the 48.9% of patients for whom the HEART score was ≤2, the 30-day MACE was 0.6%. In conclusion, the CADC model was more effective at predicting obstructive CAD compared to the HEART score. The HEART score and CADC model were equally effective to safely identify low-risk patients by achieving <1% missed 30-day MACE.
Adenosquamous Carcinoma Arising in Bulbar Conjunctiva
Authors: Kase Satoru , Ishida Susumu
Published: July 2019

Adenosquamous carcinoma is a highly aggressive tumor, which can rarely arise from the ocular surface. The authors herein report a patient who presented with a 5 mm mass on the temporal conjunctiva that was clinically diagnosed as squamous cell carcinoma. The lesion was surgically resected with cryopexy to the conjunctival wound edges. Histopathology and immunoractivity confirmed the diagnosis of adenosquamous carcinoma. Following topical interferon alpha 2b for 3 months, there has been no recurrence or distant metastsis during a follow-up of 12 months.
The electronic nose technology in clinical diagnosis: A systematic review
Authors: Farraia Mariana Valente , Cavaleiro Rufo João , Paciência Inês , Mendes Francisca , Delgado Luís , Moreira André
Published: July 2019

Background:

Volatile organic compounds (VOC) are end products of human metabolism (normal and disease-associated) that can be mainly excreted in breath, urine, and feces. Therefore, VOC can be very useful as markers of diseases and helpful for clinicians since its sampling is noninvasive, inexpensive, and painless. Electronic noses, or eNoses, provide an easy and inexpensive way to analyze gas samples. Thus, this device may be used for diagnosis, monitoring or phenotyping diseases according to specific breathprints (breath profile).

Objective:

In this review, we summarize data showing the ability of eNose to be used as a noninvasive tool to improve diagnosis in clinical settings.

Methods:

A PRISMA-oriented search was performed in PubMed and Cochrane Library. Only studies performed in humans and published since 2000 were included.

Results:

A total of 48 original articles, 21 reviews, and 7 other documents were eligible and fully analyzed. The quality assessment of the selected studies was conducted according to the Standards for Reporting of Diagnostic Accuracy. Airway obstructive diseases were the most studied and Cyranose 320 was the most used eNose.

Conclusions:

Several case–control studies were performed to test this technology in diverse fields. More than a half of the selected studies showed good accuracy. However, there are some limitations regarding sampling methodology, analysis, reproducibility, and external validation that need to be standardized. Additionally, it is urgent to test this technology in intend-to-treat populations. Thus, it is possible to think in the contribution of VOC analysis by eNoses in a clinical setting.
Pharmacogenomics in clinical care
Authors: Wysocki Kenneth , Seibert Diane
Published: July 2019

Health care designed specifically for a person based on their genetic makeup (“personalized” or “precision” medicine) is expanding rapidly, especially in the area of drug selection. Pharmacogenomic (PGx) testing, when drugs and doses are selected based on an individual's genetic profile, is increasingly being used to guide the selection of drugs or therapies to optimize outcomes and minimize side effects. Based on an individual's genetic blueprint, health care providers now have important information about how a drug is likely to behave in that individual's body. Pharmacogenomic information on drug labels is now available for nearly 250 drugs. Health care organizations are also increasingly making this information available to customers to reduce emergency department visits, improve outcomes (selecting the right chemotherapy doses), and reduce cost. This study reviews some of the challenges and benefits on using PGx testing to improve clinical outcomes.
Tax incentives for preceptors of nurse practitioner students in Massachusetts: A potential solution
Authors: Carelli Katherine Valorie , Gatiba Peris N. , Thompson Linda S.
Published: July 2019

With a growing population, there is an increasing need for nurse practitioners to improve access to health care. There is currently a shortage of nurse practitioner (NP) preceptors across Massachusetts, making clinical placements difficult and at times unachievable. The lack of NP preceptors has a direct impact on student outcomes, educational programs, and ultimately access to care. The authors explored lessons learned about the national scale of this problem and whether Massachusetts should entertain legislative initiatives similar to other states as a solution. Data were collected from the boards of nursing and the national and state chapters of the American Association of Nurse Practitioners regarding current and pending legislation. State and federal sources and the Massachusetts Association of Colleges of Nursing provided statistical and qualitative data on current and future needs for NP preceptors. States that have successfully passed legislation have awarded tax incentives to NP preceptors, although none of the existing regulations have assessed for their effectiveness in improving preceptor availability. Massachusetts may benefit from legislation to improve NP student access to preceptors; however, incentives related to geographical location may best serve both students and the greater population.
Research translation and the evolving PhD and DNP practice roles: A collaborative call for nurse practitioners
Authors: Falkenberg-Olson Ann C.
Published: July 2019

Doctoral prepared nurse practitioners (NPs) are uniquely positioned for responsible leadership as essential members of the health care system and have a professional responsibility to contribute to research and clinical inquiry initiatives that advance health care delivery and improve outcomes. Academic preparation of the Doctor of Philosophy (PhD) and Doctor of Nursing Practice (DNP), although different in focus, offers opportunities for effective collaborations that transcend and integrate the scientific and practice roles of generating data and translating evidence. As health care organizations evolve in managing complexities of providing high-quality care, roles for the PhD as research scientist and DNP as research translation specialist will also evolve to keep pace. Despite this professional calling and global opportunity for research and evidence-based practice (EBP), future NPs and nurses will be challenged with an imminent lack of experts who have the skills needed for data and research generation and evidence translation. This commentary introduces and discusses emerging roles and organizational models for doctoral prepared NPs in research, EBP, quality assurance, and quality improvement projects, offers suggestions for NPs interested in research and clinical inquiry, and seeks to ignite excitement for scientific discovery in NP-driven initiatives. Nurse practitioners are encouraged to take advantage of the many opportunities to shape and expand their careers by engaging in knowledge generation for improving health care outcomes.
Cochlear Implant Outcomes in Large Vestibular Aqueduct Syndrome—Should We Provide Cochlear Implants Earlier?
Authors: Hall Andrew C. , Kenway Bruno , Sanli Halit , Birman Catherine S.
Published: July 2019

Objective:

Examine postoperative speech perception outcomes in a large vestibular aqueduct syndrome (LVAS) patients at a major cochlear implantation center.

Study Design:

Retrospective analysis of the Sydney Cochlear Implant Centre (SCIC) database and medical records from January 1994 to December 2015 was performed.

Setting:

Tertiary referral center.

Patients:

Patients with a diagnosis of LVAS who received a cochlear implant (CI). Only those with speech perception outcomes recorded at least 12 months post implant were included in our analysis.

Intervention(s):

Therapeutic.

Main Outcome Measure(s):

: Postoperative speech perception scores.

Results:

Between 1994 and 2015, 176 adult and pediatric patients with a diagnosis of LVAS underwent cochlear implantation at SCIC. Postoperative Bamford-Kowal Bench (BKB) sentence test scores were obtained for 97 patients. The postoperative median BKB score was 93% with a lower quartile score of 85% and an upper quartile score of 98%. Smaller numbers were available for post-CI City University of New York (CUNY) and Consonant-Nucleus-Consonant (CNC) word scores yet similar excellent results were seen.

Conclusions:

Our study results suggest the CI should be considered when BKB scores have dropped to 85%. We suggest that rather than LVAS cases representing a challenge to cochlear implantation, they are amongst the best candidates for surgery, and should receive a CI at an earlier stage in hearing loss, when they have better speech perception. This allows stable hearing to be established earlier along with excellent speech perception outcomes.
Rationale and methods of a randomized clinical trial to compare specific exercise programs versus home exercises in patients with subacromial impingement syndrome
Authors: Gutiérrez-Espinoza Héctor , Araya-Quintanilla Felipe , Zavala-González Jonathan , Gana-Hervias Gonzalo , Martínez-Vizcaino Vicente , Álvarez-Bueno Celia , Cavero-Redondo Iván
Published: July 2019

Background

Subacromial impingement syndrome (SIS) is a common clinical condition with a multifactorial etiology. Currently, there is a great variety of therapeutic exercise modalities aimed at treating SIS. Based on alterations of the glenohumeral and/or dysfunctional scapular kinematics associated with SIS, we hypothesize that the implementation of a specific exercise program with special focus on the correction of muscle deficits should be more effective than nonspecific exercises performed at home. This article describes the rationale and methods of study aimed at testing the effectiveness of specific exercise programs versus home exercises in patients with SIS.

Method/Design

Ninety-four patients between the ages of 18 and 50 years referred to the Physical Therapy department of the Clinical Hospital San Borja Arriaran in Chile will be randomized to 2 treatment arms. The intervention group will receive a program of specific exercises with a duration of 12 weeks, taking as a reference the algorithm of clinical decision proposed by a panel of experts. The control group will receive a program of nonspecific exercises to perform at home. Three evaluations will be performed: before the initiation of treatment, and at the 12-week and 1-year follow-up. The primary outcome measure will be the shoulder function by the Constant-Murley questionnaire, and the secondary outcome measures will be the upper extremity function by the Disabilities of the Arm, Shoulder and Hand questionnaire, and pain by the visual analog scale.

Discussion

This article reports the design of a randomized clinical trial aimed at assessing the effectiveness of a specific exercise program versus home exercises in patients with SIS.

Trial registration

Brazilian registry of clinical trials UTN number U1111-1204-0268. Registered 27 September 2017.
Effective therapeutic options for elderly patients with hepatocellular carcinoma
Authors: Shin Jongbeom , Yu Jung Hwan , Jin Young-Joo , Suh Young Ju , Kim Deuck Hwa , Byun Seyoun , Lee Jin-Woo
Published: July 2019

We evaluated the post-treatment overall survival (OS) of elderly hepatocellular carcinoma (HCC) patients.

The archived records of 10,578 HCC patients registered at the Korean Central Cancer Registry from 2008 through 2014 were retrospectively analyzed. In this registry, we selected Barcelona Clinic Liver Cancer (BCLC) 0, A, or B staged HCC patients (n = 4744) treated by surgical resection (SR), local ablation therapy (LAT), or locoregional therapy (LRT). OSs in nonelderly (<70 years) and elderly (≥70 years) patients were compared after propensity score matching (PSM).

In BCLC 0-A staged HCC, the cumulative OS rates of elderly patients were poorer than those of nonelderly patients after PSM (P < .001), but not in those with BCLC stage B (P > .05). In BCLC 0-A staged elderly patients, OS after SR was significantly better than after LAT (P = .005) or LRT (P < .001). In BCLC B staged elderly patients, SR achieved better OS than LRT (P = .006). Multivariable analysis showed that LAT (hazard ratio [HR] 1.52, P = .048) or LRT (HR, 2.01, P < .001) as compared with SR, and large (>3 cm) tumor size (HR1.49, P = .018) were poor predictors of OS for elderly patients with BCLC stage 0-A, and that LRT (HR, 2.64, P = .042) was a poor predictor for those with BCLC stage B.

SR provided a better OS rate than LAT or LRT in elderly HCC patients with BCLC stage 0–A, than LRT in those with BCLC stage B. SR should be considered the first therapeutic option even in elderly HCC patients with these stages.
Effect of radiotherapy on the survival of cervical cancer patients
Authors: Yang Jian , Cai Haoyang , Xiao Zhi-Xiong , Wang Hangyu , Yang Ping
Published: July 2019

Cervical cancer is among the most frequent cancer types in women worldwide. Radiotherapy, including external beam radiation and brachytherapy, is one of the commonly used treatment options for cervical cancer. However, the adverse effects of radiation therapy on cervical cancer survival have been poorly investigated with inconclusive results. Therefore, the aim of this study was to determine the suitable radiotherapy modality according to patients’ characteristics. A retrospective survival analysis of 44,602 patients was performed using the Surveillance, Epidemiology, and End Results (SEER) database. Multivariate proportional hazard Cox model was used to evaluate the prognostic impact of different radiotherapy modalities, primary surgery, age, TNM stage, and tumor size. Our results indicated that patients without primary surgery, diagnosed at older age (≥45 years’ old), at advanced TNM stages (III/IV) or with larger tumor size (≥3 cm) could benefit from radiotherapy. However, radiotherapy was detrimental in patients with primary surgery, diagnosed at younger age (<45 years’ old), at earlier TNM stages (I/II) or with smaller tumor size (<3 cm). In addition, external beam radiation was in most cases less effective compared with combined external beam and brachytherapy. These results highlighted the necessity of realizing personalized radiotherapy treatments for patients with cervical cancer.
Evaluation of the efficacy and safety of herbal medicine for treating work-related chronic low back pain
Authors: Ko Youme , Jang Bo-Hyoung , Oh Min-Seok , Kim Sun Joong , Cha Yun-Yeop , Lee Eun Jung , Song Yun-Kyung , Ko Seung-Gyu
Published: July 2019

Introduction:

In Korea, low back pain (LBP) which is occupation-related symptom is one of the major health issues owing to rapid industrialization. Even traditional Korean medicine has the long history in pain treatment, there still has been lack of supporting evidence on herbal prescription itself. Sogyeonghwalhyeol-tang, a Korean herbal medicine prescription, has been suggested as a medication for treating chronic LBP as well as work-related pains.

Objective:

This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang on work-related chronic LBP patients.

Method:

This trial is designed as a multicenter, randomized, controlled, clinical trial. Seventy-two participants who have chief complaint of LBP in Korean medicine rehabilitation center will be randomly assigned to ether Sogyeonghwalhyeol-tang group or placebo group with a ratio of 1:1. They will receive assigned drugs in 4 weeks and follow-up for 2 weeks.

Discussion:

The result of this study will provide the valuable information for efficacy and safety of Sogyeonghwalhyeol-tang for patients with work-related chronic LBP.
Pralatrexate induced durable response in a relapsed/refractory peripheral T-cell lymphoma patient with a history of autologous stem cell transplantation
Authors: Merdin Alparslan , İskender Dicle , Ulu Bahar Uncu , Doğan Mehmet , Çakar Merih Kizil , Dal Mehmet Sinan , Altuntaş Fevzi
Published: July 2019

Rationale:

Relapsed or refractory peripheral T-cell lymphomas are aggressive diseases. Pralatrexate is an antimetabolite. Hereby, we are reporting a pralatrexate induced durable response in a relapsed/refractory peripheral T-Cell lymphoma patient with a history of autologous stem cell transplantation.

Patient concerns:

A male patient born in February 1947 was diagnosed with lymphoma based on his cervical lymph node excisional biopsy.

Diagnoses:

He was diagnosed with PTCL-NOS on February 19, 2013.

Interventions:

The patient received 6 cycles of CHOP (Cyclophosphamide, doxorubicine, vincristine, methylprednisolone) chemotherapy, which achieved a complete remission. The patient underwent autologous stem cell transplantation in December 2013. After relapse was detected in the third month of the transplantation, the patient was treated with 2 cycles of ViGePP (vinorelbine, gemcitabine, procarbazine, prednisone/ methylprednisolone) chemotherapy. The patient was considered refractory to treatment after the ViGePP chemotherapy, and he was given brentuximab vedotin. Once a full response to treatment was achieved after 2 cycles, the patient received 6 cycles of brentuximab vedotin treatment. After 6 cycles, a skin biopsy was performed and the patient was diagnosed with relapsed/refractory PTCL-NOS. Pralatrexate therapy was then started on February 1, 2016 at a dose of 30 mg/m2 once weekly for 6 weeks in 7-week cycles.

Outcomes:

The patient responded to pralatrexate treatment. And he has been under pralatrexate treatment over 3 years.

Lessons:

Pralatrexate should also be kept in mind as a treatment alternative in relapsed or refractory peripheral T-cell lymphoma patients.
A novel sequence variant in COL10A1 causing spondylometaphyseal dysplasia accompanied with coxa valga
Authors: Zhang Xianzuo , Liang Haiyi , Liu Weilu , Li Xu , Zhang Wenzhi , Shang Xifu
Published: July 2019

Rationale:

Spondylometaphyseal dysplasia (SMD) is an extremely rare disorder of irregular development of spine and metaphyses of long tubular bones. Mutations in the collagen type X alpha 1 gene were found to underlie this condition. Previously reported mutations in the N-terminal non-collagenous NC2 domain and C-terminal non-collagenous NC1 domain failed to be identified in some specific patients.

Patient concerns:

A 23-year-old male was referred to us for fixed, angular thoracolumbar kyphosis with semi-paralysis, numbness, and tremor on his left lower limb. Marked hypoplasia of thoracolumbar vertebra and spinal canal stenosis were observed on radiology.

Diagnoses:

He was diagnosed with spondylometaphyseal dysplasia (Type A4). Gene sequencing was performed using normalized targeted regions sequencing (TRS). A novel heterozygous missense variant p.Gly139Cys in the triple-helical region. Multiple lines of evidence imply this mutation to be pathogenic.

Interventions:

Posterior instrumentation and vertebral column resection were given to correct his fixed, angular thoracolumbar kyphosis.

Outcomes:

The correction was satisfying and the functional outcomes were good.

Lessons subsections as per style:

The findings corroborated that type X collagen plays a critical role in the formation of the human spine as well as the long bones, and further expanded the range of type X collagenopathy. Surgical procedure could be considered for patients with severe malformation and neurological impairments.
Rhabdomyolysis-induced acute kidney injury in a patient with undifferentiated connective tissue disease
Authors: Mai Hongxia , Zhao Yuliang , Salerno Stephen , Li Yi , Yang Letian , Fu Ping
Published: July 2019

Rationale:

Acute kidney injury (AKI) accounts for 8% to 16% of hospital admissions and can quadruple hospital mortality, placing a serious burden on the health economy. Acute kidney injury (AKI) is mainly caused by dehydration, shock, infection, sepsis, heart disease, or as a side-effect of nephrotoxic drugs. About 10% to 60% of patients with rhabdomyolysis develop AKI, and 10% of AKI is attributable to rhabdomyolysis. However, rhabdomyolysis-induced AKI secondary to undifferentiated connective tissue disease (UCTD) has rarely been reported before.

Patient concerns:

We report the case of a 50-year-old male of UCTD presented with dark brown urine, swelling and edema of the upper limbs, and decreased urine output.

Diagnosis:

The patient was diagnosed with rhabdomyolysis-induced AKI secondary to UCTD.

Interventions:

The patient was successfully treated with intravenous methylprednisolone with other supportive treatment.

Outcomes:

After 3 days of initiating treatment of medicinal charcoal tablets, sodium bicarbonate and intravenous fluids upon admission, the patient's serum creatinine changed mildly from 145.0 μmol/L to 156.0 μmol/L, but the urinary output increased from 1000 mL/24 h to 2400 mL/24 h, with his creatine kinase (CK) and myoglobin rose from 474 IU/L to 962 IU/L and from 641.5ng/mL to 1599 ng/mL, respectively. We then tried to empirically initiate UCTD therapy by giving corticosteroids. After the administration of the 40 mg of methylprednisolone daily, the serum creatinine level dropped to 97 μmol/L the second day, CK decreased to 85 IU/L within 1 week and myoglobin decreased to 65.05 ng/mL within 10 days. When maintenance dose of 4 mg daily was given, the patient showed no abnormalities in creatinine or CK levels.

Lessons:

There have been few reports on the association between rhabdomyolysis-induced AKI and UCTD and its mechanism remains unclear. Clinicians should be aware of UCTD as a possible cause to rhabdomyolysis-induced AKI.
Antiviral therapy for HCV in hemophilia A patients with HIV-1 co-infection
Authors: Xiao Hong , Chen Jun , Wang Jiangrong , Li Juhua , Yang Feia , Lu Hongzhou
Published: July 2019

Anti-hepatitis C virus (HCV) treatment for human immunodeficiency virus (HIV)/HCV co-positive patients with hemophilia A presents numerous problems in terms of safety and effectiveness. The emergence of direct-acting antiviral (DAA) regimens has led to tremendous changes in the management of HIV/HCV co-infection over the past few years, but the application of DAA in patients with hemophilia complicated with HIV/HCV co-infection has rarely been reported.

We retrospectively analyzed the clinical course and outcome of hemophilia A patients with HIV/HCV co-infection receiving DAA with a focus on the virological response, changes in cluster of differentiation 4 lymphocyte (CD4) count, side effects, and impact on bleeding before and after DAA therapy.

A total of 12 hemophilia A patients with HIV/HCV co-infection were included, 9 of which were severe. All the patients were in stable states with CD4 counts >200/mm3 and plasma HIV ribonucleic acid (RNA) suppressed (<40 IU/mL) while taking the antiretroviral regimen. Majority of the patients (n = 9, 75.0%) were infected with HCV genotype (GT) 1b, while 2 and 1 was infected with HCV GT 2i and HCV GT 3, respectively.

After 12 weeks of DAA treatment, 11 patients (91.7%) obtained sustained virologic response within 24 weeks of discontinuation of treatment (SVR24), except 1 patient who was treated with sofosbuvir (SOF) + pegylated interferon + ribavirin (PR), which was then switched to daclatasvir (DCV) + asunaprevir (ASV) for 12 weeks; this patient then achieved SVR24. During DAA treatment, HIV RNA in all the patients was constantly suppressed, while CD4 counts showed no obvious change.

The most common treatment-emergent adverse events were weakness and loss of appetite (generally mild). There was no evidence of an increased tendency of bleeding, and changes in response to replacement.

DAA therapy offered a safe and well-tolerated management strategy for HIV/HCV co-infected patients with hemophilia A. An awareness of the potential drug-drug interactions (DDI) between DAA and combination antiretroviral therapy (cART) by clinicians is important for optimal management of co-infected patients.
Total knee arthroplasty for treatment of rheumatoid arthritis
Authors: Hou Hai-bin , Cao Bo , Shi Sheng-mei , Huo Ai-xin , Liu Yu-hong
Published: July 2019

Background:

Rheumatoid arthritis (RA) is a very tricky orthopedic condition. If it can not be treated fairly well, it may greatly affect quality of life in patients with RA, and even can cause disability. Total knee arthroplasty (TKA) has reported to treat patients with RA effectively. However, no study has systematically explored its efficacy and complications for patients with RA.

Methods:

Seven databases will be searched from their inceptions to the present without any language restrictions: MEDICINE, EMBASE, Cochrane Library, Web of Science, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. Two authors will carry out all study selection, data extraction, and risk of bias assessment independently.

Results:

The primary outcome of joint pain will be measured by any pain scales, such as visual analogue scale. The secondary outcomes will include joint function, quality of life, and postoperative adverse events. The joint function will be measured by The Western Ontario and McMaster Universities Arthritis Index, Knee Injury and Osteoarthritis Outcome Score, or other relevant scales. The quality of life will be assessed by the 36-Item Short Form Health Survey or any related tools. In addition, postoperative adverse events will also be analyzed.

Conclusions:

The findings of this study will summarize the latest existing evidence on the efficacy and safety of TKA for patients with RA.

Ethics and dissemination:

This study does not need ethical approval, because it will not analyze individual data. The results of this study are expected to be disseminated at peer-reviewed journals.

PROSPERO registration number:

PROSPERO CRD42019133274.
Taxane-based chemotherapy and risk of breast cancer-related lymphedema
Authors: Zhang Zhenhua , Zhang Xiwen , Chen Shuntai , Jiang Juling , Qi Runzhi , Zhang Xing , Xi Yupeng , Li Meng , Zheng Honggang , Hua Baojin
Published: July 2019

Background:

Many studies were performed to explore the correlation between taxane-based chemotherapy and the risk of breast cancer-related lymphedema (BCRL), however, with inconsistent results. Hence, the purpose of this study is to evaluate whether taxane-based chemotherapy is a risk factor for BCRL.

Methods:

A comprehensive systematic search of clinical trials published in the PubMed, Embase and the Cochrane Library databases will be conducted to identify eligible studies up to the date of December 31, 2018. We will employ risk ratios with 95% confidence intervals (95% CIs) to estimate the correlations between taxane-based chemotherapy and BCRL. Meta-analysis will be performed using Stata SE version 12.0 software.

Results:

The results of this systematic review and meta-analysis will provide a high-quality synthesis of existing evidence of the correlations between taxane-based chemotherapy and the risk of BCRL.

Conclusion:

The protocol will provide updated evidence for the use of taxane-based chemotherapy in postoperative breast cancer patients.

Ethics and dissemination:

It is not necessary for ethical approval because it is based on published studies. The protocol will be disseminated in a peer-reviewed journal or presented at a topic-related conference.

Trial registration:

This systematic review protocol has been registered with a number of CRD42019123989.
Primary thoracic neuroblastoma in an adult
Authors: Tan Yan-Bin , Li Jin-Fan , Li Wen-Shan , Yang Run-Lin
Published: July 2019

Rationale:

Neuroblastoma is one of the most common malignant tumors in childhood, which mainly occurs in adrenal glands and peripheral sympathetic nerve system. Neuroblastoma occurring in adulthood is rare, and adults with neuroblastoma arising from thorax are exceedingly rare. A case of neuroblastoma that originated from thorax was reported, and was treated by resection operation.

Patient concerns:

A 46-year-old woman was admitted to our hospital with left side chest pain for 5 days. Laboratory examinations were all normal. Chest computerized tomogram (CT) showed a lesion with clear boundary that was located at the left dorsal pleura. The nature of the mass was heterogeneous, showing slight heterogeneous enhancement after contrast and there was no obvious necrosis.

Diagnoses:

Based on the morphologic and immunohistochemical features, the tumor diagnosis was favorable for neuroblastoma.

Interventions:

A resection operation was carried out.

Outcomes:

Three years postoperative, no sign of recurrence or metastasis has been observed.

Lessons:

Primary neuroblastoma in adulthood is rare and has poor prognosis. Resection can be an important treatment option, and combining with other methods like chemotherapy, stem cell transplantation, the survival rate may be improved.
The predictive values of serum dickkopf-1 and circulating tumor cells in evaluating the efficacy of transcatheter arterial chemoembolization treatment on hepatocellular carcinoma
Authors: Wu Xiaoxia , Yang Chao , Yu Hao , Cao Fei , Shan Yongfeng , Zhao Weifeng
Published: July 2019

In this study, we aim to explore the values of serum dickkopf-1 (DKK1) and circulating tumor cells (CTCs) in predicting the efficacy and prognosis of transcatheter arterial chemoembolization (TACE) treatment on patients with hepatocellular carcinoma (HCC). We did a retrospective analysis on 155 HCC patients who underwent TACE treatment. The patients were divided into response group (complete response and partial response) and nonresponse group (stable disease and progressive disease), and their changes in serum DKK1 and CTCs after TACE were recorded. Receiver operating characteristic curve and survival analysis were used to assess the predictive values of DKK1 and CTCs for TACE efficacy and long-term prognosis of HCC. We found that the levels of preoperative DKK1 and CTCs in patients with HCC had a moderate positive correlation (r = 0.54). After TACE treatment, the serum DKK1 and CTCs in the response group were significantly decreased compared to pretreatment levels (P < .05), whereas the nonresponse group showed significantly increased serum DKK1 and CTCs levels (P < .05). The largest area under the curve (AUC) was achieved when using >0.02 μg/L reduction in DKK1 level after 4 weeks of TACE to predict the efficacy of TACE treatment (AUC = 0.913, 95% confidence interval: 0.856–0.952, P < .001), with the sensitivity of 78.26% and the specificity of 88.07%. The overall survival, disease-free survival, and 5-year survival rates were all significantly lower in the patients with positive preoperative levels of serum DKK1 and CTCs. COX multivariate regression analysis showed that Eastern Cooperative Oncology Group score, and preoperative levels of serum DKK1 and CTCs are independent influencing factors for the prognosis of patients with HCC. Overall, our results demonstrated that serum DKK1 and CTCs levels were good biomarkers for predicting the efficacy and prognosis of TACE treatment in patients with HCC. Moreover, these parameters exhibited different characteristics, and might have different potential applications.
Surgical treatment of pyloric stenosis caused by glyphosate poisoning
Authors: Luo Wenjun , Lu Tingting , Li Fugen , Qian Chuan , Zhang Liuping , Sun Meng , Xu Zhengwen , Jia Yingdong
Published: July 2019

Rationale:

Oral ingestion of glyphosate can induce gastrointestinal symptoms such as vomiting, abdominal pain, and hematochezia. Timely and effective treatment of pyloric stenosis caused by glyphosate poisoning is important.

Patient concerns:

The patient had a poor appetite, accompanied by nausea and vomiting of a small amount of dark brown material that resembled blood clots several times a day. Gastroscopy revealed gastric ulcer, a large pyloric antrum ulcer, and a deformed stomach cavity.

Diagnosis:

Pyloric stenosis due to glyphosate poisoning in a 36-year-old man.

Interventions:

The patients received distal gastrectomy and subsequently transferred to the ICU for further treatment. A mechanical ventilator was used to assist breathing. Outcomes: Follow-up was conducted 3 years after surgery. The patient had no problem with food ingestion and experienced no discomfort, such as vomiting, nausea, coughing, or expectoration.

Lessons:

Gastrectomy is necessary to treat pyloric stenosis caused by glyphosate poisoning.
Evaluation of hippocampal volume and serum brain-derived neurotrophic factor as potential diagnostic markers of conversion from amnestic mild cognitive impairment to Alzheimer disease
Authors: Fang Yan , Du Naiyi , Xing Longyan , Duo Yali , Zheng Lei
Published: July 2019

Amnestic mild cognitive impairment (aMCI) is a transitional stage between normal aging and Alzheimer disease (AD), and is associated with an increased risk of AD. Many studies have shown that apolipoprotein E epsilon 4 (APOE ε4) genotype is a major genetic predictor of AD progression, especially in patients with aMCI. However, the application of APOE genotyping in the diagnosis of MCI progressing to AD is limited by its low sensitivity and specificity, which often leads to high false-positive rate. The aim of this study was to evaluate serum brain-derived neurotrophic factor (BDNF) and hippocampal volume as predictors of aMCI to AD transition in APOE ε4 genotype patients.

A total of 178 subjects were diagnosed with aMCI. The patients with aMCI that progressed to AD within 2 years were included in the MCI-AD group (n = 86), those maintaining an aMCI diagnosis after 2 years were placed in the MCI-MCI group (n = 92), and neurologically healthy age-matched individuals were set as controls (n = 90). APOE genotypes were determined. Blood samples from all subjects were drawn at baseline, 12 months, and 24 months for serum BNDF assessments. Hippocampal delineations were monitored by magnetic resonance imaging.

Compared to control group, aMCI-AD patients (the patients with aMCI that progressed to AD within 2 years) exhibited worse performance on cognitive and neuropsychological batteries. Meanwhile, we found that aMCI-AD patients were associated with abnormally low serum BDNF level and greater hippocampal volume loss than MCI-MCI patients (patients maintaining an aMCI diagnosis after 2 years). Moreover, patients with aMCI who were carriers of APOE ε4 showed a notable decrease in serum BDNF and a significant reduction in hippocampal volume, especially in those who progressed to AD.

The present study demonstrates that aMCI that evolves into AD in patients with the APOE ε4 genotype may be predicted by hippocampal volume and serum BDNF.