bluuebunny/crossref_metadata_2025 huggingface dataset:
Neurocardiovascular coupling in congenital diaphragmatic hernia patients undergoing different types of surgical treatment
Authors: Hendrikx Dries , Costerus Sophie A. , Zahn Katrin , Perez-Ortiz Alba , Dorado Alexander Caicedo , Van Huffel Sabine , de Graaff Jurgen , Wijnen René , Wessel Lucas , Tibboel Dick , Naulaers Gunnar
Published: December 2021

BACKGROUND

The effect of peri-operative management on the neonatal brain is largely unknown. Triggers for perioperative brain injury might be revealed by studying changes in neonatal physiology peri-operatively.

OBJECTIVE

To study neonatal pathophysiology and cerebral blood flow regulation peri-operatively using the neuro-cardiovascular graph.

DESIGN

Observational, prospective cohort study on perioperative neuromonitoring. Neonates were included between July 2018 and April 2020.

SETTING

Multicentre study in two high-volume tertiary university hospitals.

PATIENTS

Neonates with congenital diaphragmatic hernia were eligible if they received surgical treatment within the first 28 days of life. Exclusion criteria were major cardiac or chromosomal anomalies, or syndromes associated with altered cerebral perfusion or major neurodevelopmental impairment. The neonates were stratified into different groups by type of peri-operative management.

INTERVENTION

Each patient was monitored using near-infrared spectroscopy and EEG in addition to the routine peri-operative monitoring. Neurocardiovascular graphs were computed off-line.

MAIN OUTCOME MEASURES

The primary endpoint was the difference in neurocardiovascular graph connectivity in the groups over time.

RESULTS

Thirty-six patients were included. The intraoperative graph connectivity decreased in all patients operated upon in the operation room (OR) with sevoflurane-based anaesthesia (P < 0.001) but remained stable in all patients operated upon in the neonatal intensive care unit (NICU) with midazolam-based anaesthesia. Thoracoscopic surgery in the OR was associated with the largest median connectivity reduction (0.33 to 0.12, P < 0.001) and a loss of baroreflex and neurovascular coupling. During open surgery in the OR, all regulation mechanisms remained intact. Open surgery in the NICU was associated with the highest neurovascular coupling values.

CONCLUSION

Neurocardiovascular graphs provided more insight into the effect of the peri-operative management on the pathophysiology of neonates undergoing surgery. The neonate's clinical condition as well as the surgical and the anaesthesiological approach affected the neonatal physiology and CBF regulation mechanisms at different levels.

TRIAL REGISTRATION

NL6972, URL: https://www.trialre-gister.nl/trial/6972.
Drug–Drug Interactions Between Mycophenolic Acid and Proton Pump Inhibitors: A Systematic Review and Meta-Analysis
Authors: Sakuludomkan Wannachai , Na Takuathung Mingkwan , Dukaew Nahathai , Koonrungsesomboon Nut
Published: December 2021

Purpose:

The objective of the present study was to determine the impact of proton pump inhibitors (PPIs) on the pharmacokinetics and pharmacodynamics of mycophenolic acid (MPA).

Methods:

PubMed, Embase, Web of Sciences, and Scopus were systematically searched to identify relevant studies reporting pharmacokinetic parameters [including trough concentration (C0), maximum concentration (Cmax), time to maximum concentration (Tmax), the dose-adjusted area under the concentration–time curve from time 0–12 hours (AUC0–12 h/D), and half-life (t1/2)], and pharmacodynamic outcomes of MPA (eg, acute graft rejection and adverse drug reactions), with and without PPI administration. Pooled effect estimates were calculated using a random-effects model.

Results:

Twelve studies involving 473 participants were eligible for inclusion, 11 of which were included in the meta-analysis. PPI exposure was significantly associated with lower C0 [mean difference (MD) = −0.62 mg/L; P = 0.003] lower C
max (MD = −4.71 mg/L; P = 0.01), and longer Tmax (MD = 0.30 hours; P = 0.0001) of MPA. However, no significant association was observed between PPI exposure and AUC0–12 h/D, t1/2, or any pharmacodynamic outcomes. Based on subgroup analysis, it can be suggested that a significant association between PPI exposure and altered MPA pharmacokinetics was mainly associated with mycophenolate mofetil but not enteric-coated mycophenolate sodium.

Conclusions:

Coadministration of PPIs and mycophenolate mofetil significantly altered the pharmacokinetics of MPA, particularly by decreasing MPA absorption. However, PPI-MPA interactions did not impact pharmacodynamic outcomes of MPA.
Has the Time Come for Systematic Therapeutic Drug Monitoring of First-Line and WHO Group A Antituberculosis Drugs?
Authors: Lemaitre Florian
Published: December 2021

Tuberculosis (TB) is a major global health issue, with approximately 10 million people being infected each year, and is the leading cause of mortality from infectious disease, with 1.5 million deaths a year. Optimal TB treatment requires a combination of drugs for an adequate treatment duration owing to persistent organisms, hardly accessible infection sites, and a high risk of resistance selection. Long-term therapy increases the risk of patients' loss of adherence, adverse drug reactions, and drug–drug interactions, potentially leading to treatment failure. The high interpatient variability of TB drug exposure is another point eliciting interest in therapeutic drug monitoring (TDM) to optimize treatment. Studies reporting clinically relevant exposure thresholds, which might be proposed as targets toward treatment personalization, are discussed. Practical TDM strategies have also been reported to circumvent issues related to delayed drug absorption and the need for multiple samples when evaluating the area under the curve of drug concentrations. The need for treatment individualization is further emphasized because of the development of multidrug-resistant TB or extensively drug-resistant TB. Finally, the willingness to shorten the treatment duration while maintaining success is also a driver for ensuring adequate exposure to TB drugs with TDM. The aim of the present review was to underline the role of TDM in drug-susceptible TB and World Health Organization group A TB drugs.
Early versus Delayed Implant Exchange after Periprosthetic Breast Infection: A Single Center Study
Authors: Falola Reuben A. , Shin Hope D. , Monsivais Sharon E. , Czerwinski Wendy L.
Published: December 2021

Background:

Breast implant infections are challenging problems for both plastic surgeons and patients. They may require readmissions, re-operations, and have the potential to compromise the final result. Our goal was to determine whether early operative intervention (return to the operating room <72 h after diagnosis of infection) or intravenous antibiotics with later operative intervention increased long-term retention of a prosthesis.

Methods:

A retrospective review was conducted of patients who were hospitalized or underwent reoperation for an infection from 2006 through 2016. The length of hospitalization, length of IV antibiotic use, and retention of the breast prosthesis at 3-months after reoperation were recorded for each patient.

Results:

A total of 43 patients were included in our study. Of these, 33 patients underwent early intervention, and 10 patients underwent delayed intervention. The average length of stay was significantly shorter in the early versus delayed return to OR group (4.1 versus 6.4 days; P = 0.008). The average duration of antibiotics was shorter in the early intervention group than the delayed group (5.1 versus 6.4 days; P = 0.28). At 3-months postoperatively, a greater proportion of patients in the early intervention group compared with the delayed group retained their breast prostheses (87.5% versus 60%; P = 0.25).

Conclusions:

The results of this study demonstrate that breast implants may be salvaged after early (<72 hours) or delayed (>72 hours) operative intervention; however, early intervention is associated with a significantly shorter length of stay, and trends toward a shorter antibiotic course and higher rate of implant retention at 3 months.
Analysis of Corneal Scheimpflug Densitometry and Ocular Wavefront Aberrations Post Descemet Stripping Automated Endothelial Keratoplasty
Authors: Arora Ritu , Gupta Palak , Sahu Jigyasa , Jain Parul , Vishwanath Shweta , Shroff Rushad
Published: December 2021

Purpose:

To assess the role of corneal densitometry and wavefront aberrations post Descemet stripping automated endothelial keratoplasty (DSAEK) and their correlation with visual acuity.

Methods:

Twenty-seven eyes of 25 patients with nonresolving corneal edema for more than 3 months as a result of Fuchs endothelial corneal dystrophy, pseudophakic bullous keratopathy, or secondary endothelial dysfunction were enrolled in a prospective interventional study and underwent DSAEK. Postoperative evaluation for corneal aberrations, including Higher order aberrations (HOAs) and corneal densitometry (CD), was performed using anterior-segment optical coherence tomography (Avanti RTvue XR; Optovue) and Scheimpflug imaging (Pentacam, Oculus Optikgeräte GmbH, Wetzlar, Germany) at 6 months. A correlation analysis of corneal aberrations, including HOAs and CD, with postoperative best-corrected visual acuity at 6 months was performed.

Results:

Mean best-corrected visual acuity (BCVA) improved from 1.67±0.53 log of minimum angle of resolution (logMAR) to 0.2±0.22 logMAR post DSAEK at 6 months (P≤0.0001). At 6 months, mean root-mean-square (RMS) total corneal aberrations (includes HOA and low-order aberration [LOA]), RMS total HOA, and RMS LOA of the central 6-mm zone were 4.99±2.64, 1.80±0.9, and 4.55±2.64, respectively. The mean corneal densitometry from anterior, central, and posterior zones were 39.12±12.77, 23.9±7.2, and 13.54±2.04 gray scale units, respectively. Total anterior aberrations (r=0.051; P=0.006), anterior LOA (r=0.049; P=0.009), total corneal aberrations (r=0.051; P=0.001), total HOAs (r=0.095; P=0.057) and LOAs (r=0.050; P=0.002), and total CD from 0 to 2 mm (r=0.010; P=0.038) and 2 to 6 mm (r=0.014; P=0.018) showed a significant inverse correlation with postoperative BCVA.

Conclusion:

There was an inverse relationship between post DSAEK BCVA and total corneal HOAs and full-thickness densitometry at 6 months. Scheimpflug imaging with added tools for corneal aberration and densitometry analysis gives further insight into the suboptimal vision achieved despite transparent corneas post DSAEK.
Association of Metabolic Syndrome With Glaucoma and Ocular Hypertension in a Midwest United States Population
Authors: Wu Kristi Y. , Hodge David O. , White Launia J. , McDonald Jacinta , Roddy Gavin W.
Published: December 2021

Précis:

For patients with glaucoma, metabolic syndrome was associated with higher intraocular pressure and greater central corneal thickness. Patients with metabolic syndrome were more likely to have ocular hypertension.

Purpose:

The purpose of this study was to determine whether glaucomatous optic neuropathy, also known as glaucoma, and ocular hypertension are more likely to occur in patients with metabolic syndrome.

Patients and Methods:

Patients in Olmsted County, MN, were identified as having metabolic syndrome based on diagnosis codes, laboratory values, and/or medication use to meet 3 or more of the 5 standard criteria for diagnosing metabolic syndrome: systemic hypertension, hyperglycemia, hypertriglyceridemia, reduced high-density lipoprotein cholesterol, and central adiposity defined by increased body mass index. Patients with glaucoma, including primary open angle, low tension, pigment dispersion, and pseudoexfoliation, were identified using diagnostic codes. The charts of patients with glaucoma were individually reviewed to collect visual acuity, intraocular pressure, cup to disc ratio, central corneal thickness, visual field mean deviation, retinal nerve fiber layer thickness, and treatment of intraocular pressure. Patients with ocular hypertension were separately identified and similarly evaluated.

Results:

For patients with glaucoma, those with metabolic syndrome had higher intraocular pressure and greater central corneal thickness compared with those without metabolic syndrome. After adjustment for central corneal thickness, there was no longer a significant difference in intraocular pressure between groups. Metabolic syndrome was also associated with the diagnosis of ocular hypertension, and although central corneal thickness trended higher in patients with metabolic syndrome, it did not attain statistical significance.

Conclusion:

In Olmsted County, though metabolic syndrome was associated with ocular hypertension and higher intraocular pressure in patients with glaucoma, the results were likely related to a thicker central corneal in this patient population.
The Role of Manual Compression in Doppler Ultrasound Mapping of Arteriovenous Vascular Malformations in the Upper and Lower Extremities
Authors: Laaengh Massoni Claudine , Laurian Claude , Paraskevas Nikos , Cerceau Pierre , Lemarchand-Venencie Francoise , Boccara Olivia , Salvan Didier , Faucon Benoit , Le Clerc Nicolas , Borsik Michel , Aymard Armand , Civelli Vittorio , Houdart Emmanuel , Bisdorff-Bresson Annouk
Published: December 2021

Doppler ultrasonography (US) is an important noninvasive technique for diagnosing and assessing arteriovenous malformation (AVM). US, magnetic resonance, computed tomography, and angiograms make it possible to locate and describe these malformations, in particular the nidus. The AVM nidus shows as a high-density tangle of tortuous and dilated vessels (arteries and veins) caused by abnormal communications (AV shunts) between these vessels. Locating these AV shunts precisely within the nidus is difficult. A new manual compression technique used during US exploration allows us to accurately differentiate afferent/efferent vessels from the AV shunts located in the nidus.
Management of stable coronary artery disease and atrial fibrillation with anti-thrombotic therapy
Authors: Malladi Srikanth , Hamid Kewan , Pendyala Nitin Chandra , Veerapaneni Vijaysai , Deliwala Smit , Dubre Donald , Elian Samir A. , Singh Adiraj
Published: December 2021

Introduction:

Long term management of patients with stable coronary artery disease of >1 year after myocardial infarction (MI) or percutaneous coronary intervention and atrial fibrillation is unclear. Current guidelines recommend using oral anti-coagulation (OAC) alone although the recommendation is weak and there is low quality evidence. Two new randomized control trials (RCTs) were published recently. We conducted an updated meta-analysis to evaluate the effect of these studies on patient outcomes

Objective:

To conduct a systematic review and meta-analysis of published RCTs and observational studies to compare OAC alone versus OAC plus single anti-platelet therapy.

Methods:

Electronic searches were conducted using appropriate terms from 3 databases. Relevant studies included. Data extracted and analysis were performed using STATA.

Measurements:

Summary statistics were pooled and measured for primary and secondary outcomes of both treatment arms.

Main results:

Eight studies involving 10,120 patients were included for the analysis. Five thousand two hundred thirty-seven patients were on combination therapy while 4883 were on OAC alone. There was no statistically significant difference in the primary outcome of major adverse cardiac events (hazard ratio [HR] 1.067; 95% confidence interval [CI] 0.912–1.249; P value .417). There was no statistically significant difference even in the measured secondary outcomes namely all cause mortality (HR 1.048; 95% CI 0.830–1.323; P value .695), cardiovascular mortality (HR 0.863; 95% CI 0.593–1.254; P value .439). However, we found statistically significant difference between the 2 groups in the incidence of MI with higher incidence in mono therapy group (HR 1.229; 95% CI 1.011–1.495; P value .039) and higher incidence of major bleeding in the combination therapy group in the subgroup analysis (HR 0.649; 95% CI 0.464–0.907; P value .011).

Conclusion:

We found no reduction of major adverse cardiac event between combination therapy and mono therapy. Although mono therapy showed increased risk of major bleeding overall, subgroup analysis of the RCTs showed increased risk of major bleeding in the combination therapy group. MI was higher in the mono therapy group compared to the combination therapy group, however this outcome was not reproducible in the subgroup analysis of the RCTs.
Efficacy and safety of Shenkang injection in the treatment of chronic renal failure
Authors: Mei JuXiang , Yang LingLing , Wang Deqin , Wang HaiXia
Published: December 2021

Background:

Chronic renal failure (CRF) is the final outcome of the development of multiple kidney diseases, and there is no effective method at home and abroad. Traditional Chinese medicine is found to play a major role in the treatment of the non-replacement stage of CRF. Shenkang injection can not only nourish the kidney, but also promote blood circulation and remove blood stasis, which is suitable for the treatment of CRF. This study aims to explore the efficacy and safety of Shenkang injection for CRF and provide evidence for clinical practice.

Methods:

This was a prospective randomized controlled trial. One hundred four patients with CRF were randomly divided into treatment groups and control groups according to 1:1, with 52 patients in each group. The control group received basic treatment of western medicine and the treatment group was given Shenkang injection intravenously on the basis of control group. Both groups were given standard treatment for 4 weeks with concurrent follow-up for 1 month. The outcome indicators included: total efficiency, symptom scores, creatinine clearance rate, serum creatinine, blood urea nitrogen, CystatinC, liver function, blood routine, urine routine, incidence of adverse reactions, etc. Data analysis was performed using SPSS 25.0 software.

Discussion:

This study will evaluate the efficacy and safety of Shenkang injection for CRF, and the results of this trial will provide clinical evidence for the treatment of CRF.

Trial registration:

OSF Registration number: DOI 10.17605/OSF.IO/K9C5T.
Trends and projections in cutaneous melanoma death in the Netherlands from 1950 to 2045
Authors: van Niekerk Catharina C. , Groenewoud Hans M.M. , Verbeek André L.M.
Published: December 2021

Child sun protection has recently been linked to the future disappearance of fatal melanoma in adults in successive generations. In the Netherlands, however, mortality rates from melanoma have increased gradually from the 1950s, with some indication of stabilisation since 2010, which may be compatible with a birth cohort effect by sun-protective measures and screening. To study the trajectories ahead a trend analysis was applied. Numbers of people with cutaneous melanoma as underlying cause of death from 1950 to 2018 and population data were derived from Statistics Netherlands. A graphical approach was used to explore trends in mortality by age, calendar period, and cohorts born in the successive periods of 1889 to 1979. Age–period–cohort modelling outcomes and population forecasts provided projections of mortality until 2045. Based on 24,151 cases of melanoma death (13,256 men, 10,895 women), age-standardised mortality rates were similar from 1950 to 1989 for both genders, and increased thereafter more in men. The age-curve patterns changed gradually towards higher death rates at older age, implying the existence of a birth cohort effect. The age–period–cohort models showed an increase in melanoma mortality rates in successive generations. For women, the birth cohort effect plateaued for generations born since the mid-1980s. The projected total mortality number was predicted to rise in the next 3 decades.

It is concluded that a small future decline of mortality in younger generations can be expected in the Netherlands, but mortality is still rising for the total population.
Platelet rich plasma versus glucocorticoid for plantar fasciitis
Authors: Ge Rongrong , Chen Shuying , Jiang Jiawang , Wang Bangmin , Zeng You , Cao Qianan , Wu Jun , Liu Yunfeng
Published: December 2021

Background:

Plantar fasciitis (PF) is the most common cause of heel pain in adult. There are a variety of ways to treat PF, but these treatments have varied result in their effectiveness, and exist different degrees of limitations. At present, clinical studies focus on the effect of glucocorticoid (GC) and platelet rich plasma (PRP) in the treatment of PF, but there is a lack of systematic evaluation PRP and GC's clinical effect towards PF. This study aims to evaluate the long-term efficacy of GCs and PRP in the treatment of PF by means of meta-analysis.

Methods:

The literature of a randomized controlled clinical trial of PRP in the treatment of plantantifasciitis was searched on the Internet. Retrieve 7 databases. EndNote X9 software was used for document management. The Jadad scale was used to score the literature. Risk assessment of the literature was conducted according to Cochrane's systematic evaluation manual 5.0. RevMan5.3 software was used for literature risk bias analysis. Stata12.0 software is used for sensitivity analysis.

Results:

This study will provide effective evidence-based evidence for the long-term efficacy of PRP and GC in treating PF.

Conclusion:

A systematic review and meta-analysis were conducted for the comparison of the long-term effect of PRP and GC on plantar fascia in the treatment of PF.
Transmission dynamics and successful control measures of SARS-CoV-2 in the mega-size city of Guangzhou, China
Authors: Zhao Hongjun , Zhang Zhoubin , Lun Wenhui , Chen Zongqiu , Lu Xiaoxiao , Li Jingrong , Qiu Fuman , Li Shunming , Mao Chun , Lu Ying , Chen Jinbin , He Qing , Lu Jiachun , Yang Zhicong
Published: December 2021

The severe acute respiratory syndrome coronavirus 2 has caused a worldwide pandemic. Control measures differ among countries and have a varying degree of effectiveness, which requires assessment. To evaluate the effectiveness of public health interventions of the coronavirus disease 2019 (COVID-19) in Guangzhou by 3 periods according to interventions: January 7 to 22 (no intervention), January 23 to February 23 (implemented intensive interventions), and February 24 to May 17 (the normalization mode of COVID-19 prevention and control).

We collected the information of 745 COVID-19 patients and their close contacts as well as control measures in Guangzhou from January 7 to May 17, 2020. We estimated the epidemiological characteristics, disease spectrum of COVID-19 cases, key time-to-event intervals, and effective reproduction number over the 3 periods. The basic reproduction number of severe acute respiratory syndrome coronavirus 2 was also calculated over period 1.

Approximately 45.8%, 49.8%, and 4.4% of cases from close contacts were asymptomatic, symptomatic, and severe, respectively. The median incubation period was 5.3 days (the percentiles of 2.5–97.5, 1.5–18.4 days) and the median serial interval fitted with gamma distribution was 5.1 days (the percentiles of 2.5–97.5, 0.8–15.9 days). The estimated median of onset-to-quarantined time in Period 1 to 3 were 7.5, 3.4, and 2.9 days (the percentiles of 2.5–97.5, 2.1–14.2, 3.9–14.7, and 6.0–20.0 days) respectively and the median of onset-to-confirmation time in period 1 to 3 were 8.9, 4.9 and 2.4 days (the percentiles of 2.5–97.5, 2.6–16.6, 0.9–14.6, and 0.5–11.8 days). In period 1, the reproduction number was 0.9 (95% confidence interval, 0.5–1.4) and fluctuated below 1.0 before January 22 except for January 14. The effective reproduction number gradually decreased in the period 2 with the lowest point of 0.1 on February 20, then increased again since March 27 and reach a spike of 1.8 on April 12. The number decreased to below 1.0 after April 17 and decreased further to <0.2 after May 7 in the period 3.

Under prospective dynamic observation, close contacts turned into infected cases could provide a spectrum of COVID-19 cases from real-world settings. The lockdown of Wuhan and closed-loop management of people arriving Guangzhou were effective in halting the spread of the COVID-19 cases to Guangzhou. The spread of COVID-19 was successfully controlled in Guangzhou by social distancing, wearing a face mask, handwashing, disinfection in key places, mass testing, extensive contact tracing, and strict quarantine of close contacts.
Factors associated with prolonged hospitalization among patients transported by emergency medical services
Authors: Katayama Yusuke , Kitamura Tetsuhisa , Tanaka Jun , Nakao Shota , Nitta Masahiko , Fujimi Satoshi , Kuwagata Yasuyuki , Shimazu Takeshi , Matsuoka Tetsuya
Published: December 2021

The emergency medical system, one of the essential elements of public health, has been around for more than 50 years. Although many studies have assessed the factors associated with overcrowding and prolonged length of stay in emergency departments, whether the clinical characteristics and background of a patient are associated with prolonged hospitalization among patients transported by ambulance is unknown. The purpose of this study was to reveal factors associated with the continuation of hospitalization at 21 days after hospital admission among patients transported by ambulance using a population-based patient registry in Osaka, Japan.

This was a retrospective observational study whose study period was the three years from January 2016 to December 2018. In this study, we included patients who were hospitalized after transportation by ambulance in Osaka, Japan. The main outcome was continuation of hospitalization at 21 days after hospital admission. We calculated the adjusted odds ratios (AOR) and 95% confidence interval (CI) with a multivariable logistic regression model to assess factors associated with the outcome.

We included 481,886 patients in this study, of whom 158,551 remained hospitalized at 21 days after hospital admission and 323,335 had been discharged home by 21 days after hospital admission. Factors associated with prolonged hospitalization were elderly (AOR: 1.767 [95% CI: 1.730–1.805]), traffic accident (AOR: 1.231 [95% CI: 1.183–1.282]), no fixed address (AOR: 4.494 [95% CI: 3.632–5.314]), need for nursing care (AOR: 1.420 [95% CI: 1.397–1.443]) and solitary person (AOR: 1.085 [95% CI: 1.050–1.120]).

In this study, the elderly, traffic accidents, no fixed address, need for nursing care, and solitary person were associated with prolonged hospitalization of patients transported by ambulance in Japan.
Efficacy and safety of gemcitabine-capecitabine combination therapy for pancreatic cancer
Authors: Ouyang Guoqing , Wu Yongrong , Liu Zhen , Lu Wuchang , Li Shuai , Hao Shuqing , Pan Guangdong
Published: December 2021

Background:

Recent randomized controlled trials revealed the combination of gemcitabine and capecitabine (GemCap) regime shows promising efficacy in pancreatic cancer patients. Here, we conducted a meta-analysis to compare the efficacy and safety of gemcitabine (Gem) with GemCap for pancreatic cancer.

Methods:

The database of MEDLINE (PubMed), EMBASE, Cochrane Central Controster of Controlled Trials, Web of Science was searched for relevant randomized controlled trials before 8 April, 2020. The outcomes were overall survival (OS), 12-month survival rate, progress free survival (PFS), partial response rate (PRR), objective response rate (ORR), and Grade 3/4 toxicities.

Results:

Five randomized controlled trials involving 1879 patients were included in this study. The results showed that GemCap significantly improves the OS (hazard ratio = 1.15, 95% CI: 1.037-1.276, P = .008), PFS (hazard ratio = 1.211, 95% CI 1.09-1.344, P = 0), PRR (relative risk (RR) = 0.649, 95% CI 0.488-0.862, P = .003), ORR (RR = 0.605, 95% CI 0.458-0.799, P = 0), and the overall toxicity (RR = 0.708, 95% CI 0.620-0.808, P = .000) compared to Gem alone. However, no significant difference was found in 12-month survival.

Conclusions:

Despite a higher incidence of Grade 3/4 toxicity, GemCap was associated with better outcomes of OS, PFS, PRR, ORR, as compared with Gem, which is likely to become a promising therapy for pancreatic cancer.
Application of transcranial direct current stimulation in cricopharyngeal dysfunction with swallowing apraxia caused by stroke
Authors: Yang Juan , Yuan Huozhong
Published: December 2021

Rationale:

Dysphagia is a common complication after stroke. The 2 types of dysphagia with cricopharyngeal dysfunction and swallowing apraxia after stroke are relatively rare and difficult to treat; however, there are few clinical case reports of cricopharyngeal dysfunction and swallowing apraxia after stroke.

Patient concerns:

A case of cricopharyngeal dysfunction and swallowing apraxia due to cerebral infarction caused by atrial fibrillation in a 63-year-old woman who was followed up for 1 year.

Diagnoses:

The patient was diagnosed with cricopharyngeal dysfunction and swallowing apraxia caused by stroke based on the clinical course and imaging findings.

Interventions:

Pharmacotherapy and rehabilitation therapy.

Outcome:

The patient's swallowing function returned to normal, and her nasal feeding tubes were removed, and oral feeding was resumed.

Lessons:

The 2 types of dysphagia with cricopharyngeal dysfunction and swallowing apraxia after stroke are relatively rare and difficult to treat after stroke. Only by improving swallowing apraxia can patients perform mandatory swallowing and balloon dilatation treatment. However, transcranial direct current stimulation has a good therapeutic effect on the primary motor and sensory cortex of the tongue in patients with cricopharyngeal dysfunction and swallowing apraxia.
Effects of moxibustion for obesity
Authors: Kim Hyungsuk , Kim Koh-Woon , Chung Won-Seok
Published: December 2021

Background:

Obesity is a chronic disease associated with lethal health conditions. Moxibustion, a frequently used treatment in traditional Chinese medicine, is effective and safe for the treatment of obesity. However, the evidence has not been systematically collected and combined to date. This systematic review and meta-analysis will analyze the effects of moxibustion on obesity.

Methods:

The following databases will be searched: Cochrane Central Register of Controlled Trials, MEDLINE/PubMed, EMBASE, 1 Chinese database (Chinese National Knowledge Infrastructure), 1 Japanese database (Citation Information by the National Institute of Informatics), and 3 Korean databases (Oriental Medicine Advanced Searching Integrated System, ScienceON, and KoreaMed). The quality of the included studies will be assessed according to the Cochrane Assessment Tool for Risk of Bias. Data from the included studies will be synthesized for meta-analysis. The primary outcome will be body weight, and the secondary outcomes will be body mass index, waist-hip ratio, waist circumference, hip circumference, and effective rate.

Results and Conclusion:

Ethical approval is not necessary for this study because it will not include any patient information. The results of this systematic review and meta-analysis will be publicly available and published in a peer-reviewed journal.

Registration number:

DOI 10.17605/OSF.IO/NTKDF (https://osf.io/ntkdf).
Efficacy and safety of Yangxue Qingnao granules for the treatment of essential hypertension
Authors: Liu Yongcheng , Guo Dong , Tian Ying , Fan Maoxia , Zhao Jisen
Published: December 2021

Background:

Essential hypertension is a major risk factor for many fatal cardiovascular and cerebrovascular diseases and has become a heavy burden on families and society. At present, the prevention and treatment of essential hypertension is still unsatisfactory. Yangxue Qingnao granules is a kind of Chinese patent medicine that has been used to treat essential hypertension. The objective of this protocol is to systematically evaluate the efficacy and safety of Yangxue Qingnao granules in the treatment of essential hypertension.

Methods:

Randomized controlled trials on Yangxue Qingnao granules for essential hypertension will be searched from the following databases: PubMed, EMbase, Web of Science, Cochrane Library, China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database, and China Biology Medicine disc from inception to August 27, 2021, regardless of language. Study screening and data extraction will be carried out by two independent reviewers. The quality of the included studies will be assessed using Cochrane risk-of-bias tool for randomized trials. Statistic analysis will be performed using RevMan 5.3 software. The quality of evidence will be assessed using GRADE approach.

Results:

This study will systematically evaluate the efficacy and safety of Yangxue Qingnao granules in the treatment of essential hypertension and provide high-quality evidence for clinical practice.

Conclusion:

The findings of this systematic review will provide high-quality evidence to verify the efficacy and safety of Yangxue Qingnao granules in the treatment of essential hypertension.

INPLASY registration number:

INPLASY202190015.
Prevalence and risk factors associated with repeat positive SARS-CoV-2 nucleic acid test results among discharged COVID-19 patients
Authors: Cui Yanru , Wang Jilin , Wang Gaofeng , Xie Xiuguo , Tian Lizhen
Published: December 2021

Background:

The COVID-19 (coronavirus disease 2019) pandemic continues to have an immense impact on the world at large. COVID-19 patients who meet the discharge criteria, may subsequently exhibit positive viral RNA test results upon subsequent evaluation. This phenomenon has been a major source of research and public health interest, and poses a major challenge to COVID-19 prevention, treatment, and standardized patient management.

Methods:

We will search the PubMed, MEDLINE, Embase, Cochrane Clinical Trials Database, China National Knowledge Infrastructure, Wanfang Database, Chinese Science Journal Database, and China Biology Medicine databases for all studies published as of November 2021. Data will be extracted independently by two researchers according to the eligibility criteria. Finally, RevMan 5.3.0 will be implemented for statistical analyses.

Results:

The results of this study will show the prevalence and risk factors associated with repeat positive SARS-CoV-2 nucleic acid test results among discharged COVID-19 patients.

Conclusions:

This study will provide a reliable evidence-based for the prevalence and risk factors associated with repeat positive SARS-CoV-2 nucleic acid test results among discharged COVID-19 patients.

Trial registration number:

CRD42021272447.
Fertility-preserving treatment in patients with early-stage endometrial cancer
Authors: Zhao Xiao-Li , Du Ze-Qing , Zhang Xuan , Yao Zhi , Liang Ying-Qiu , Zhao Su-Fen
Published: December 2021

Background:

Endometrial cancer (EC) is the second most common malignancy of the female reproductive system worldwide, and the standard treatment for early-stage EC potentially leads to permanent infertility. The objective of this study was to investigate the efficacies of different methods on fertility preservation in patients with early-stage EC.

Methods:

We searched the major online databases (PubMed, Embase, The Cochrane Library, and Web of Science) to collect the research literature on fertility preservation therapy in patients with early-stage well-differentiated EC aged ≤ 40 years from January 1999 to October 2019. The inclusion was performed using the R software (version R3.5.3) meta-analysis of a single rate. The efficacy of the following three fertility preservation treatments was evaluated from four aspects, the complete remission rate (CRR), recurrence rate (ReR), pregnancy rate (PregR), and live birth rate (LBR): a) taking oral progestin only therapy, b) hysteroscopic resection combined with progestin/levonorgestrel-releasing intrauterine system (LNG-IUS)/GnRH-a, c) LNG-IUS or combined with progestin/GnRH-a.

Results:

A total of 23 articles were included in this study, including 446 patients with early-stage EC. In the group that took oral progestin only (n = 279), CRR, ReR, PregR, and LBR were 82% (95% confidence interval [CI], 74%–92%, P = .01), 38% (95% CI, 31%-45%, P = .35), 70% (95% CI, 62%–79%, P = .68), and 63% (95% CI, 55%–73%, P = .55), respectively. Hysteroscopic resection combined with progestin/LNG-IUS/GnRH-a therapy group (n = 96) achieved a CRR, ReR, PregR, and LBR of 95% (95% CI, 90%–100%, P = .42), 16% (95% CI, 6%–39%, P = .03), 84% (95% CI, 73%–96%, P = .39), and 72% (95% CI, 59%–87%, P = .28), respectively. LNG-IUS or combined with progestin/GnRH-a therapy group (n = 91) achieved a CRR, ReR, PregR, and LBR of 69% (95% CI, 54%–89%, P < .01), 30% (95% CI, 19%–49%, P = .36), 48% (95% CI, 18%–100%, P < .01), and 36% (95% CI, 10%–100%, P < .01), respectively.

Conclusion:

It is safe and effective for young patients with early-stage EC to receive oral progestin, hysteroscopic resection combined with progestin/LNG-IUS/GnRH-a, LNG-IUS, or progestin/GnRH-a.

INPLASY Registration number:

DOI 10.37766/inplasy2020.12.0137
Intravascular large B-cell lymphoma presenting as rapidly progressive dementia and stroke
Authors: Wu Ming , Lin Yinyao , Huang Xuehong , Zhang Bingjun
Published: December 2021

Rationale:

Intravascular large B-cell lymphoma (IVLBCL) is a rare form of large B-cell non-Hodgkin lymphoma. The diagnosis is challenging and frequently made at biopsy. Here we reported a case of IVLBCL limited to the central nervous system (CNS) presenting with progressive dementia and acute stroke, who was diagnosed by brain biopsy.

Patient concerns:

A 47-year-old woman was transferred to our hospital with a 6-month history of rapidly progressive dementia, and left limb weakness and numbness for 3 days. She was successively misdiagnosed with inflammatory demyelinating disease and stroke. Her condition deteriorated with elevated lactate dehydrogenase and multiple hyperintense lesions on the brain.

Diagnosis:

She was diagnosed with IVLBCL limited to the CNS by brain biopsy.

Interventions:

Bone marrow puncture and incisional random skin biopsy were not found neoplastic cells. Computed tomography scans were normal with no evidence of disease outside the CNS.

Outcomes:

The patient died due to rapid clinical aggravation.

Lessons:

IVLBCL limited to the CNS is an aggressive disease with high mortality. Making a timely and correct diagnosis is crucial for early appropriate treatment in IVLBCL patients.
Endovascular treatment for acute basilar artery occlusion via persistent primitive hypoglossal artery
Authors: Park Jung Soo , Shin Byoung-Soo , Kang Hyun Goo
Published: December 2021

Introduction:

Although their effectiveness and safety have not yet been established, endovascular treatments have recently been applied in the treatment of acute basilar artery occlusion. If not identified, persistent primitive hypoglossal artery, a rare variant of the posterior circulation, could be a barrier to the successful treatment of basilar artery occlusion.

Patient concerns:

An 83-year-old woman, who had been undergoing treatment for hypertension for 20 years, visited our hospital 3 hours after the onset of acute unresponsive mental deterioration. The patient was unresponsive to painful stimuli, and the pupils were equal and miotic.

Diagnosis:

Brain computed tomography angiography confirmed complete occlusion of the distal basilar artery and revealed a dilated branch arising from the right internal carotid artery at the C2 vertebral level.

Interventions:

Endovascular thrombectomy was performed directly via the right femoral artery. Complete recanalization was achieved via manual aspiration thrombectomy.

Outcomes:

Brain magnetic resonance imaging revealed multifocal cerebral infarctions in the bilateral thalamus, midbrain, and cerebellar vermis. The patient's neurological symptoms gradually improved.

Conclusions:

This is a rare case of basilar artery occlusion that was successfully treated with mechanical thrombectomy through persistent primitive hypoglossal artery. It is important to consider the potential clinical implications of this rare vascular variant.
A new spray-type adhesion barrier (AdSpray) improves condition for surgical treatment in the reversal of Hartmann procedure
Authors: Osumi Wataru , Yamamoto Masashi , Masubuchi Shinsuke , Hamamoto Hiroki , Ishii Masatsugu , Izuhara Keisuke , Taniguchi Kohei , Kuramoto Toru , Suzuki Yusuke , Tanaka Keitaro , Okuda Junji , Uchiyama Kazuhisa
Published: December 2021

Rationale:

Hartmann procedure (HP) often causes severe postoperative adhesions in the pelvic space; therefore, the reversal of Hartmann procedure (RHP) is a challenging surgery. A new spray-type antiadhesion agent, AdSpray, has been reported to be useful in three-dimensional fields such as the liver. However, there are no reports of its use in HP. We present a case of a male patient with rectal cancer who underwent laparoscopic HP with AdSpray to prevent postoperative adhesions.

Patient concerns:

A 52-year-old man presented with melena and constipation.

Diagnosis:

Colonoscopy revealed an almost obstructive type II tumor at the rectosigmoid colon, and histopathological examination revealed moderately differentiated adenocarcinoma. Enhanced abdominal computed tomography revealed slightly enlarged regional lymph nodes but no ascites around the tumor, and there was no metastasis to the liver or lungs. Therefore, we diagnosed clinical stage T4aN1bM0 rectosigmoid colon cancer. Intraoperatively, a metastatic tumor of the liver surface and a high degree of valve retention in the oral colon were identified.

Interventions:

After performing laparoscopic HP with AdSpray, we scheduled a laparoscopic RHP with staged hepatic surgery for synchronous liver metastasis from colorectal cancer 1 month later.

Outcomes:

No postoperative inflammatory adhesions were observed in the pelvis or around the rectal stump, allowing us to perform RHP by a single-incision laparoscopic surgery from the stoma site without any problem. The operation time for RHP was 80 minutes; the patient was in good general condition after the operation, and he was discharged on postoperative day 7.

Lessons:

In laparoscopic HP, Adspray was easy to use for three-dimensional fields such as the pelvis and effectively prevented postoperative inflammatory adhesions. Thus, RHP may become less risky and be performed more as a minimally invasive surgery.
Umbilical acupuncture for insomnia
Authors: Feng Zhi-tao , Ying Da-shi , Qiu Zhan-shuang , Li Tie , Xu Xiao-ru , Yang Ji-yu , Wang Zhi-hong
Published: December 2021

Background:

Insomnia is characterized by high incidence, easy recurrence, and difficulty in curing. Serious insomnia not only seriously affects the body organ function but also causes great damage psychological.

Umbilical acupuncture (UA) has fewer side effects and is increasingly used to treat insomnia. This study aimed to systematically review the effectiveness and safety of UA in the treatment of insomnia.

Methods:

Literature on UA for insomnia in PubMed, Excerpt Medica Database, the Cochrane Central Register of Controlled Trials, Web of Science, China National Knowledge Infrastructure Database, China Biomedical Literature Database, Chinese Scientific Journal Database, and Wan Fang Database were searched from the creation of these databases to October 3, 2021. In addition, the reference lists of studies meeting the inclusion criteria will also be searched to achieve a comprehensive retrieval of the maximum. All randomized controlled trials of UA for treating insomnia were included. Two reviewers will conduct literature screening, data extraction, and quality evaluation respectively. The main outcome was the Pittsburgh Sleep Quality Index, and the secondary outcomes included clinical efficacy, and safety. RevMan 5.4.1 software was used for mate analysis.

Results:

This study aimed to evaluate the current status of UA treatment for insomnia, with the aim of illustrating the effectiveness and safety of UA.

Conclusion:

This study will provides a high-quality evidence to evaluate the effectiveness and safety of UA in treating insomnia.

Registration:

PROSPERO CRD42021283036.
Acupuncture combine with Tuina for diabetic peripheral neuropathy
Authors: Li Xuefeng , Wang Heran , Zhou Xue , Ma Dongyang , Chai Jiapeng , Liu Jiayi , Qian Xin , Chen Chunhai , Chen Xinhua
Published: December 2021

Background:

Diabetic peripheral neuropathy (DPN) is one of the most common microvascular complications of diabetes mellitus, with an incidence ranging from 60% to 90%. With the change in modern dietary structure, the incidence of diabetes is increasing year by year, and DPN is also on the rise. Acupuncture and Tuina treatments are often combined to treat DPN; however, there has been no meta-analysis on their synergistic effect; therefore, we aimed to perform a systematic review and meta-analysis to estimate the effectiveness of acupuncture combined with Tuina in DPN treatment.

Methods:

Nine electronic databases were retrieved for this study. The English databases mainly retrieved PubMed, Web of Science, Embase, AMED, and the Cochrane Library, while the CNKI, VIP, CBM, and Wanfang databases were used to retrieve the Chinese literature; there was no definite time limit for the retrieval literature, and the languages were limited to Chinese and English. We will consider articles published between database initiation and November 2021. We used Review Manager 5.4 software provided by the Cochrane Collaborative Network for statistical analysis. We then assessed the quality and risk of the included studies and observed the outcome measures.

Results:

This study provides a high-quality synthesis to assess the effectiveness and safety of acupuncture combined with Tuina for treating DPN.

Conclusion:

This systematic review provided evidence to determine whether acupuncture combined with Tuina is an effective and safe intervention for patients with DPN.

Ethics and dissemination:

The protocol for this systematic review does not require ethical approval because it does not involve humans. This article will be published in peer-reviewed journals and presented at relevant conferences.

Systematic review registration:

INPLASY2021110017
The relationship between the drainage function of inguinal lymph nodes and unilateral pelvic cancer-related lymphedema
Authors: Hou Guozhu , Zhang Yuwei , Chen Libo , Li Fang , Jing Hongli
Published: December 2021

The aim of this study was to investigate the relationship between iliolumbar lymph nodes (LNs), inguinal LNs, and unilateral pelvic cancer-related lymphedema by retrospective analysis of lymphoscintigraphy data.

Ninety-six patients (3 men and 93 women; mean age, 53.3 ± 11.3 years) with pelvic cancer-related lymphedema were enrolled in this retrospective study. Lymphoscintigraphy was performed at 1 hour and 4 to 6 hours after injection. The visualization of inguinal LNs and iliolumbar LNs were recorded.

According to statistical analysis, the display of inguinal LNs in lymphoscintigraphy has a significant negative correlation with ipsilateral lower limb lymphedema (P < .01, r = –0.561). However, there is no correlation between the show of iliolumbar LNs and ipsilateral lower extremity lymphedema (P = .056, r = –0.138). When lymphoscintigraphy was performed at 1 hour after injection, there were 13 out of 96 patients without inguinal LNs revealed on imaging, but at 4 to 6 hours after injection, inguinal LNs were seen in lymphoscintigraphy.

The drainage function of inguinal LNs has a significant negative correlation with ipsilateral pelvic cancer-related lymphedema. Treatment dedicated to restoring the drainage function of LNs in the inguinal region may effectively relieve lymphedema. The image acquisition at 4 to 6 hours after injection is necessary for significant additional information.