bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and safety of Mudan granules for painful diabetic peripheral neuropathy
Authors: Zhang Aixia , Wang Qian , Liu Min , Tan Mengxia , Zhang Xiaodan , Wu Raoping 
Published: April 2022

Abstract

Background:
As one of the most challenging complications in the management of diabetes mellitus, painful diabetic peripheral neuropathy (PDPN) is accompanied by various clinical manifestations, including numbness, burning, coldness, and other sensory abnormalities in the extremities. Meanwhile, PDPN seriously affects the life quality of patients and causes great pain. Western medicine mostly provides symptomatic treatments, such as antioxidants, aldose reductase inhibitors, nerve nutrition, microcirculation improvement, and analgesic drugs on the basis of blood sugar control. Although certain efficacy has been achieved, the problem has not been solved at root. Mudan granules have some advantages in the treatment of PDPN, but there is insufficient high-quality clinical studies to verify this. Therefore, the purpose of this study was to evaluate the efficacy and safety of Mudan granules in treating PDPN.

Methods:
A randomized, double-blind, placebo, and parallel-controlled trial design was used to study the efficacy and safety of Mudan granules in the treatment of PDPN. In this study, 93 patients with painful diabetic neuropathy were recruited and randomly divided into a treatment group and a placebo group based on 1:1. The treatment group was given Mudan granules and the control group accepted placebo treatment, and the basic treatment was performed according to the recommended guidelines. During the treatment period, the patients’ visual analog scores, clinical efficacy, Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) scores, nerve conduction velocity, and drug-induced adverse reactions were observed at baseline after 8 and 10 weeks.

Discussion:
This study will evaluate the efficacy and safety of Mudan granules in treating PDPN. The experimental results will provide evidence support to treat PDPN with Mudan granules.

Trial registration:
DOI 10.17605/OSF.IO/5CE32.
A comparison of high-flow nasal cannula and standard facemask as pre-oxygenation technique for general anesthesia
Authors: Kuo Hsien-Cheng , Liu Wan-Chi , Li Chun-Cheng , Cherng Yih-Giun , Chen Jui-Tai , Wu Hsiang-Ling , Tai Ying-Hsuan 
Published: April 2022

Abstract

Background:
Current practice guidelines recommend the use of nasal cannula as an alternative pre-oxygenation method for tracheal intubation. However, the efficacy of high-flow nasal oxygenation versus standard facemask oxygenation has not been fully evaluated.

Methods:
We searched PubMed, Cochrane Library, and ClinicalTrials.gov for English-language studies published from January 1, 2000 to November 30, 2021. We included randomized controlled trials which compared high-flow nasal oxygenation and facemask oxygenation as the pre-oxygenation maneuver. Primary outcome was arterial partial pressure of oxygen (PaO2) after pre-oxygenation. Secondary outcomes were safe apnea time, arterial desaturation during intubation, lowest peripheral capillary oxygen saturation during intubation, and patient comfort score. Random-effects models and Mantel–Haenszel method were used for data synthesis.

Results:
A total of 16 randomized controlled trials and 1148 patients were included. High-flow nasal oxygenation achieved a higher PaO2 compared with facemask, mean difference: 64.86 mm Hg (95% confidence interval [CI]: 32.33–97.40, P < .0001). Safe apnea time was longer in high-flow nasal oxygenation, mean difference: 131.03 seconds (95% CI: 59.39–202.66, P < .0001). There was no difference in the risk of peri-intubation desaturation or lowest peripheral capillary oxygen saturation between groups. Patient comfort score was higher in high-flow nasal oxygenation, mean difference: 1.00 (95% CI: 0.46–1.54, P = .0003).

Conclusion:
High-flow nasal oxygenation better enhanced PaO2 and extended safe apnea time and is not inferior to facemask oxygenation in preventing desaturation during tracheal intubation. High-flow nasal oxygenation may be considered as an alternative method, especially for patients with a potential difficult airway.
Analysis of cognitive dysfunction and its risk factors in patients with hypertension
Authors: Zhuo Xiuping , Huang Meinv , Wu Meifang 
Published: April 2022

Abstract
To observe whether obstructive sleep apnea syndrome (OSAS) can aggravate the cognitive dysfunction of patients with hypertension (HTN), and to explore other risk factors.
One hundred one hypertensive patients were selected for information collection. After the polysomnography test, they were divided into HTN-obstructive sleep apnea (OSA) and HTN groups. The Montreal cognitive assessment and the mini-mental state examination scales were used to appraise the patients’ cognitive function. Logistic regressive analysis was used to determine the risk factors of cognitive dysfunction in patients with HTN.
Compared with the HTN patients, HTN-OSA patients performed worse in mini-mental state examination (25.5 ± 2.9 vs 23.5 ± 3.2; P = .01) and Montreal cognitive assessment (28 ± 1.58 vs 21.2 ± 3.96; P = .003), and patients in the HTN-OSA group seemed more likely to suffer from dementia (31% vs 66%; P < .01). The apnea-hypopnea index (AHI) in the HTN group was lower than HTN-OSA group. Through multivariate logistic regression analysis, we can found that alcohol drinking, body mass index, long-term medication, diabetes, hypercholesterolemia, coronary heart disease, and OSAS were the independent risk factors of cognitive dysfunction in patients with HTN.
OSAS can aggravate the cognitive dysfunction of hypertensive patients, besides, drinking, high-body mass index, long-term medication, diabetes, hypercholesterolemia, and coronary heart disease were also the risk factors of cognitive dysfunction in patients with hypertension. The cognitive dysfunction of patients with HTN can benefit from sleep apnea treatment.
Effectiveness of intervention for aromatase inhibitor-associated musculoskeletal symptoms
Authors: Meng Hui , Chen Yuhan , Yu Mingwei , Wang Xiaomin 
Published: April 2022

AbstractBackground:Aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) are among the most common prominent side effects in patients using aromatase inhibitors (AIs) for breast cancer. Muscle and joint pain, morning stiffness, arthritis, and bone loss are common clinical symptoms in individuals. Traditional Chinese medicine (TCM) has been demonstrated to be useful in the treatment of AIMSS in previous investigations, although the sample sizes were limited, and systematic reviews were inadequate. The effectiveness and safety of TCM in the treatment of AIMSS will be investigated in this study.Methods:Randomized controlled trials from January 2010 to October 2021 were limited to English or Chinese. We searched PubMed, EMBASE, Cochrane Library, Web of Science, Medline, China Biomedical Database (CBM), China National Knowledge Infrastructure (CNKI), Wanfang database, and the VIP database. Two researchers reviewed the literature and retrieved the data independently. Review Manager V5.3.was used to conduct the statistical analysis.Results:This systematic review and meta-analysis presents the most recent data on the use of TCM to treat AIMSS and offers a scientifically sound foundation for therapeutic practice. Upon completion, the findings will be submitted to a peer-reviewed journal.Ethics and dissemination:As the systematic review protocol did not involve human subjects, ethical approval was not required.PROSPERO registration number:CRD42020192553.
McLeod syndrome with a novel XK frameshift mutation
Authors: Xia Shilin , Yu Xinrui , Song Fan , Sun Bo , Wang Ying 
Published: April 2022

Abstract

Rationale:
McLeod syndrome (MLS) is a rare X-linked neurohematologic disorder caused by loss-of-function mutations in the XK gene. However, variations in the XK gene remain to be elucidated. Here, we report the clinical phenotype and genetic features of a patient with MLS caused by a novel frameshift mutation in the XK gene.

Patient concerns:
A 44-year-old man presented with chorea, cognitive impairment, mental disorders, and seizures accompanied by peripheral neuropathy, hyperCKemia, and acanthocytosis. The proband's mother had a mild chorea. One older brother who died 10 years ago without a confirmed diagnosis showed symptoms of both chorea and mental disorders, while the other brother also developed mild chorea.

Diagnosis:
The patient was diagnosed with MLS based on the family history, clinical manifestations, and accessory examinations. Whole-exome sequencing studies revealed a novel frameshift mutation resulting from a nucleotide variation in exon 2 (452delA) that leads to an amino acid residue conversion from Gln to Arg and early termination of the XK protein (Gln151ArgfsTer2). The patient and one of his older brothers were hemizygotes, and his mother was heterozygous.

Interventions:
The patient was treated with haloperidol to control chorea and levetiracetam to control seizures.

Outcomes:
Six months after treatment, the proband was seizure-free, but showed little improvement in chorea and cognitive dysfunction.

Lesson:
We describe a family with MLS caused by a novel frameshift mutation in the XK gene. The causes of the mild clinical presentation in the proband's mother require further investigation.
Single-stage intraoperative ERCP combined with laparoscopic cholecystectomy versus preoperative ERCP Followed by laparoscopic cholecystectomy in the management of cholecystocholedocholithiasis
Authors: Liao Yang , Cai Qichen , Zhang Xiaozhou , Li Fugui 
Published: April 2022

Abstract

Objectives
The optimal treatment strategy for cholecystocholedocholithiasis is still controversial. We conducted an up-to-date meta-analysis to compare the efficacy and safety of the intra- endoscopic retrograde cholangiopancreatography (ERCP) + LC procedure with the traditional pre-ERCP +  laparoscopic cholecystectomy (LC) procedure in the management of cholecystocholedocholithiasis.

Methods
We searched the PubMed, Embase, Cochrane Library, and Web of Science databases up to September 2020. Published randomized controlled trials comparing intra-ERCP + LC and pre-ERCP + LC were considered. This meta-analysis was performed by Review Manager Version 5.3, and outcomes were documented by pooled risk ratio (RR) and mean difference (MD) with 95% confidence intervals.

Results
Eight studies with a total of 977 patients were included in this meta-analysis. There was no significant difference between the two groups regarding CBD stone clearance (RR = 1.03, P = .27), postoperative papilla bleeding (RR = 0.41, P = .13), postoperative cholangitis (RR = 0.87, P = .79), and operation conversion rate (RR = 0.71, P = .26). The length of hospital stay was shorter in the intra-ERCP + LC group (MD = −2.75, P < .05), and intra-ERCP + LC was associated with lower overall morbidity (RR = 0.54, P < .05), postoperative pancreatitis (RR = 0.29, P < .05) and cannulation failure rate (RR = 0.22, P < .05).

Conclusions
Intra-ERCP + LC was a safer approach for patients with cholecystocholedocholithiasis. It could facilitate intubation, shorten hospital stay, and lower postoperative complications, especially postoperative pancreatitis, and reduce stone residue and reduce the possibility of reoperation for stone removal.
Unilateral branch retinal artery occlusion in a patient with systemic lupus erythematosus
Authors: Zhang Linglin , Guan Chaoqiang , Ye Zuke , Lu Yan 
Published: April 2022

Abstract

Rationale:
Ocular involvements in systemic lupus erythematosus (SLE) are not rare but extremely varied. Here we present a very meaningful case with unilateral branch retinal artery occlusion (BRAO) secondary to undetected SLE, for which immunotherapy showed significant effect, which led to complete resolution of macular edema.

Patient concerns:
A 31-year-old female patient, so far without any previous illnesses, presented with a sudden onset of painless diminution of vision in left eye for 5 days. Diagnosis: Signs of branch retinal artery occlusion and macular ischemic edema were observed on the left fundus, which was further confirmed by Fundus fluorescein angiography and OCT. BRAO was initially proposed. However, after ophthalmological treatment for BRAO, visual acuity and macular edema improvement was limited. Physical examination revealed erythema on the hands and feet, together with her experience of hair loss and joint pain. The patient was diagnosed with SLE.

Interventions and outcomes:
The patient received systemic immunotherapy, which resulted in visual improvement to 20/20.

Lessons:
This is a rare monocular vaso-occlusive retinopathy in SLE with mainly diffuse nonperfusion and small arterial and arteriolar occlusion in the retina, as distinct from more common vasculitis. Even without intravitreal injection of anti-VEGF, systemic immunotherapy can be effective for the treatment of macular edema.
The telemedicine experience: using principles of clinical excellence to identify disparities and optimize care
Authors: Khan Sheena , Llinas Edward J. , Danoff Sonye K. , Llinas Rafael H. , Marsh Elisabeth B. 
Published: April 2022

Abstract
The use of telemedicine has increased significantly during the Corona virus disease 2019 pandemic. This manuscript serves to identify the underlying principles of clinical excellence in telemedicine and to determine whether effective care practices can be generalized as a one-size-fits-all model or must instead be tailored to individual patient populations.
A survey assessing care quality and patient satisfaction for patients using telemedicine was created and administered via email to 2 urban cohorts of varying demographics and socioeconomic backgrounds: a population of patients with prior stroke and cerebrovascular disease, and a cohort of patients followed for interstitial lung disease. Results were compared across groups to determine the generalizability of effective practices across populations.
Individuals taking part in telemedicine were more likely to be White, more affluent, and woman, regardless of clinical diagnosis compared with a similar cohort of patients seen in-person the year prior. A lower-than-expected number of patients who were Black and of lower socioeconomic status followed up virtually, indicating potential barriers to access. Overall, patients who participated in televisits were satisfied with the experience and felt that the care met their medical needs; however, those who were older were more likely to experience technical difficulties and prefer in-person visits, while those with less education were less likely to feel that their questions were addressed in an understandable way.
When thoughtfully designed, telemedicine practices can be an effective model for patient care, though implementation must consider population characteristics including age, education, and socioeconomic status, and strategies such as ease of access versus optimization of communication strategies should be tailored to meet individual patient needs.
Income and social support related with mental health during COVID-19 outbreak in China
Authors: Huang Chenwei , Feng Qiyun , Zhang Borui , Ren Huiguang , Liu Zihao , Kang Yuwei , Zhang Fan 
Published: April 2022

Abstract
To investigate psychological response of Chinese public during the regular prevention and control of Corona Virus Disease 2019 (COVID-19), and explore the relationship among income loss, social support and mental health.
Five hundred twenty-six participants were randomly selected by snowball sampling method. Chinese version of Perceived Psychological Stress Scale, Perceived Social Support Scale, self-rating anxiety scale, and the PTSD Checklist for DSM-5 were used to measure the levels of psychological stress, social support, anxiety, and post-traumatic stress disorder (PTSD) symptoms. Demographic variables, income loss and income satisfaction during the outbreak period were also collected.
The prevalence rate of anxiety, PTSD symptoms and stress problems were 19.8%, 23.8%, and 24.7% respectively. Multiple Regression Analysis illustrated that social support associated with stress, anxiety and PTSD after controlling demographic variables; for non-student samples, stress, anxiety, and PTSD were corelated with change in income and social support.
During the regular prevention and control of COVID-19, social support might help reducing stress, anxiety, and PTSD symptoms. In addition to social support, change of income level was also an important factor for mental health. This study suggested the importance of maintaining a steady income after acute outbreak of COVID-19.
Long-term efficacy and safety of levonorgestrel-releasing intrauterine system as a maintenance treatment for endometriosis
Authors: Kim Hye Yun , Song Soo Youn , Jung Soo Hwa , Song Hyun Jeong , Lee Mina , Lee Ki Hwan , Jung Ye Won , Yoo Heon Jong 
Published: April 2022

Abstract
This study evaluated the efficacy and feasibility of long-term use of levonorgestrel releasing intrauterine system (LNG-IUS) in endometriosis patients after using LNG-IUS for >5 years as their postoperative maintenance therapy.
Data were obtained retrospectively from patients who maintained medical therapy for >5 years after surgical treatment of endometriosis from January 2008 to April 2015. Patients were divided into study group and control group according to the type of medication; the study group consisted of patients who received LNG-IUS as maintenance therapy, and patients in the control group received combined oral contraceptives (ethinyl estradiol 20 μg and drospirenone 3 mg) or dienogest 2 mg.
A total of 263 patients (94 patients in the study group, 169 in the control group) were included in the study. 91.5% (86/94) of the patients in the study group maintained the treatment for >5 years, whereas only 21.9% (37/169) of patients in the control group maintained the treatment for >5 years.
LNG-IUS significantly decreased the pain score for non-cyclic pelvic/back pain (from 4.0 ± 1.6 to 0.6 ± 1.3, P < .001), dysmenorrhea (from 6.5 ± 1.7 to 6.5 ± 1.7, P < .001), and dyspareunia/dyschezia (from 6.5 ± 1.7 to 1.3 ± 1.4, P = .006) after 1 year, and the effect was persistent for 10 years (P < .01). When compared with control group, the effect on pain reduction was comparable to the oral contraceptives or dienogest, with less systemic side effects such as mood change or nausea.
LNG-IUS for >5 years as a postoperative maintenance therapy for endometriosis patients is an effective and feasible treatment that shows significant effect on pain reduction with less systemic side effect compared with other types of treatment. Therefore, LNG-IUS can be recommended as a long-term postoperative therapy for endometriosis patients who do not plan to become pregnant for several years.
Impact of pegfilgrastim approval on relative dose intensity and outcomes of R-CHOP for diffuse large B-cell lymphoma
Authors: Morita Yuka , Kanemasa Yusuke , Sasaki Yuki , Ohigashi An , Tamura Taichi , Nakamura Shohei , Yagi Yu , Kageyama Akihiko , Omuro Yasushi , Shimoyama Tatsu 
Published: April 2022

Abstract
Maintaining relative dose intensity (RDI) of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the prognosis of patients with diffuse large B-cell lymphoma (DLBCL). Pegfilgrastim was approved in Japan in November 2014 to prevent febrile neutropenia (FN) and maintain RDI.
In this retrospective study, we reviewed 334 patients with DLBCL who received 6 or more courses of R-CHOP and analyzed the differences in the RDI, overall survival (OS), and progression-free survival between patients whose treatment started after November 2014 (postapproval group) and those whose treatment started before October 2014 (pre-approval group).
The incidence of FN was lower (20% vs 38.3%, P < .001) and the RDI of R-CHOP was higher (86.8% vs 67.8%, P < .001) in the postapproval group. Pegfilgrastim was administered to many of these patients (76.8%) and was thought to have contributed to the high RDI maintenance in the postapproval group. Interrupted time-series analysis showed a significant rise of the RDI at the timing of pegfilgrastim approval in patients aged <70 years (estimated change: 18.1%, P < .001). The 5-year OS (85.7% vs 69.9%, P = .009) and progression-free survival (81.4% vs 64.4%, P = .011) were superior in the postapproval group. However, the differences were not significant in matched-pair analysis matching National Comprehensive Cancer Network-International Prognostic Index scores. Improved survival outcomes in this group were observed only among patients with Ann Arbor stage 3/4 (5-year OS: 83.7% vs 61.3%, P = .019) and high-risk on the National Comprehensive Cancer Network-International Prognostic Index (5-year OS: 80.7% vs 32.4%, P = .014). Multivariate analysis showed that a high RDI and low lactate dehydrogenase were associated with superior OS (RDI ≥ 85%, hazard ratio: 0.48, P = .016; lactate dehydrogenase > institutional upper limit of normal, hazard ratio: 2.38, P = .005).
The RDI of R-CHOP was able to be maintained at higher levels, the incidence of FN was lower, and significantly better clinical outcomes were achieved in clinically high-risk groups after pegfilgrastim approval. Maintaining a high RDI in R-CHOP by administering pegfilgrastim to those who are likely to have low RDI without it is important for achieving favorable outcomes in patients with DLBCL.
Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients
Authors: Zhang Xinyue , Hu Minhao , Li Siyu , Sha Shanyan , Mao Ruoyu , Liu Yu , Li Qiong , Lu Qing , Chen Weili , Zhang Ying , Wang Rong , Xu Huaijin , Wang Jieqiong , Qiao Yu , Chen Ziyi , Wu Huangan , Pan Yuncui , Wang Qian , Zhang Shuhui , Yang Fan , Li Jianwei , Liu Guangyu , Xue Xiaohong , Ji Yajie 
Published: April 2022

Abstract

Introduction:
Neoadjuvant chemotherapy (NAC) plays an important role in downgrading preoperative tumor size, providing information on regimen activity, and increases treatment efficacy in breast cancer patients. An increasing number of patients have sought Traditional Chinese Medicine (TCM) during NAC to relieve discomfort, regulate immune function, and improve survival. However, limited evidence is available on how concurrent TCM treatment combined with NAC affects tumor response. This study aims to assess the efficacy of Yanghe decoction, a classical warming Yang formula, on pathological complete response (pCR) and explore its mechanism via the phosphatidylinositol-3-kinase/ protein kinase B/nuclear factor kappa-B (PI3K/Akt/NF-κB) pathway-mediated immune-inflammation microenvironment.

Methods:
A single-center, randomized, placebo-controlled, double-blinded randomized control trial (RCT) was designed. This trial aims to recruit 128 participants with breast cancer scheduled to receive NAC in China. All participants will be randomly assigned (1:1) to the Neo-Yanghe group (Yanghe decoction plus NAC) or the control group (placebo plus NAC). The primary outcome will be evaluated by the proportion of participants achieving pCR. The secondary outcomes include the expression level of PI3K/Akt/NF-κB pathway-related proteins, the objective response rate, the time to response, serum level of immune-inflammatory indicators, quality of life, disease-free survival, and overall survival.

Discussion:
This study will be the first RCT to evaluate the efficacy of Yanghe decoction combined with NAC in treating breast cancer patients, and elucidate the antitumor mechanism via the PI3K/Akt/NF-κB pathway-mediated immune-inflammation microenvironment. If possible, Neo-Yanghe treatment pattern will be a better pharmacological intervention to manage breast cancer than chemotherapy alone. The results of the trial will provide research-based evidence for the development of integrated Chinese and Western medicine guidelines and expert consensus.

Trial registration: Chinese Clinical Trial Registry ChiCTR-INR-2000036943. Registered on September 28, 2020 (https://www.chictr.org.cn/hvshowproject.aspx?id=57141).