bluuebunny/crossref_metadata_2025_split huggingface dataset:
Therapeutic efficacy and immunoregulatory effect of Qiangji Jianli Capsule for patients with myasthenia gravis
Authors: Weng Senhui , Fan Zhixin , Qiu Guoyu , Liu Fengbin , Huang Linwen , Li Jinghao , Jiang Xiaotao , Song Zhixuan , Gao Yuxia , Zhong Zhuotai , He Long , Kang Liping , Wu Yunlong , Chen Benshu , Jiang Qilong 
Published: December 2020

Abstract

Introduction:
Myasthenia gravis (MG) is an autoimmune disease in which antibodies directly target components of the neuromuscular junction, causing neuromuscular conduction damage that leads to muscle weakness. The current pharmaceutical treatment for MG is still not ideal to address the problems of disease progression, high recurrence rate, and drug side effects. Clinical observations suggest that traditional Chinese medicine (TCM) can strengthen immunity and improve symptoms of MG patients, delay the progression of the disease, reduce or even prevent the need for immunosuppressive therapy when used in combination with acetylcholinesterase inhibitors or low-dose prednisone, as well as improve the quality of life of patients. The Qiangji Jianli Capsule (QJC) is a combination of medicinal herbs which is used in traditional Chinese medicine. Since MG is a rare disorder, randomized controlled trials comparing large cohorts are difficult to conduct. Therefore, we proposed to aggregate data from a small series of N-of-1 trials to assess the effect of the Chinese medical prescription QJC, which strengthens the spleen and nourishes Qi, as an add-on treatment for MG with spleen and stomach Qi deficiency syndrome.

Methods and analysis:
Single-center, randomized, double-blind, multiple crossover N-of-1 studies will compare QJC versus placebo in 5 adult MG patients with spleen and stomach Qi deficiency syndrome. Patients will undergo 3 cycles of two 4-week intervention periods. According to the treatment schedule, patients will continue to be treated with pyridine bromide tablets, prednisone acetate, tablets and/or tacrolimus capsules throughout the entire trial. Each period consisting of 4-week oral add-on treatment with QJC will be compared with 4-week add-on treatment with a placebo. The primary endpoints are quantitative myasthenia gravis (QMG) test; measurement of the amount of Treg cells and cytokines such as interferon-γ (IFN-γ), interleukin-4 (IL-4), interleukin-17A (IL-17A), and transforming growth factor-β (TGF-β); and corticosteroid or immunosuppressive agent dosage. Secondary outcome measures: Clinical: Evaluation of the effect of TCM syndromes; MG-activities of daily living (MG-ADL) scales; adverse events.

Ethics and dissemination:
This study was approved by The First Affiliated Hospital of Guangzhou University of Chinese Medicine (GZUCM), No. ZYYECK[2019]038. The results will be published in a peer-reviewed publication. Regulatory stakeholders will comment on the suitability of the trial for market authorization and reimbursement purposes. Trial registration: Chinese Clinical Trial Register, ID: ChiCTR2000033516. Registered on 3 June 2020, http://www.chictr.org.cn/showprojen.aspx?proj=54618.
C-reactive protein for simple prediction of mortality in patients with acute non-variceal upper gastrointestinal bleeding
Authors: Park Se Hwan , Mun Yoon Gwon , Lim Chul-Hyun , Cho Yu Kyung , Park Jae Myung 
Published: December 2020

Abstract
In upper gastrointestinal bleeding (UGIB), scoring systems using multiple variables were developed to predict patient outcomes. We evaluated serum C-reactive protein (CRP) for simple prediction of patient mortality after acute non-variceal UGIB.
The associated factors for 30-day mortality was investigated by regression analysis in patients with acute non-variceal UGIB (N = 1232). The area under the receiver operating characteristics (AUROC) curve was analyzed with serum CRP in these patients and a prospective cohort (N = 435). The discriminant validity of serum CRP was compared to other prognostic scoring systems by means of AUROC curve analysis.
Serum CRP was significantly higher in the expired than survived patients (median, 4.53 vs 0.49; P < .001). The odds ratio of serum CRP was 4.18 (2.10–9.27) in multivariate analysis. The odds ratio of high serum CRP was higher than Rockall score (4.15 vs 1.29), AIMS65 (3.55 vs 1.71) and Glasgow-Blatchford score (4.32 vs 1.08) in multivariate analyses. The AUROC of serum CRP at bleeding was 0.78 for 30-day mortality (P < .001). In the validation set, serum CRP was also significantly higher in the expired than survived patients, of which AUROC was 0.73 (P < .001). In predicting 30-day mortality, the AUROC with serum CRP was not inferior to that of other scoring systems.
Serum CRP at bleeding can be simply used to identify the patients with high mortality after acute non-variceal UGIB.
Efficacy and safety of modified Yupingfeng formula in treating allergic rhinitis
Authors: Liao Chao , Liu Ting , Zeng Zhen , Wang Dandan , Tang Guangjun , Wang Huan , Tian Li 
Published: December 2020

Abstract

Background:
Allergic rhinitis (AR) is a non-infectious chronic nasal mucosal disease mediated mainly by IgE, which affects 40% of the global population and has a recurrence rate of more than 50%. The modified Yupingfeng formula (MYPFF) is widely used in the treatment of allergic rhinitis in China. However, there is no evidence-based medical evidence for the efficacy and safety of MYPFF in the treatment of allergic rhinitis.

Methods:
Database as China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific Journal Database (VIP database), Wan-Fang Database, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, and Web of Science will be searched for relevant literature from inception to September 2020. Data extraction will be performed on the obtained literature. Then RevMan V.5.3 will be used for the assessment of the risk of bias and data synthesis.

Results:
The results will be published in a peer-reviewed journal.

Conclusion:
The conclusion of the study will provide an evidence to efficacy and safety of MYPFF in treating allergic rhinitis, which will be of significant meaning for further research and clinical practice.

OSF registration number:
10.17605/OSF.IO/RV9P4.
Evaluation of an effectiveness and safety of the electroacupuncture in the management of intractable neuropathic pain
Authors: Moon Jee Youn , Lee Chang-Soon , Yoo Yongjae , Lee Suji , Lee Sang Hoon , Lee Seunghoon 
Published: December 2020

Abstract

Background:
There is no sufficient evidence on the effectiveness of acupuncture for neuropathic pain. This protocol describes a study that aims to evaluate the effectiveness and safety of electroacupuncture combined with conventional medicine for patients with intractable neuropathic pain, when compared with conventional medicine alone.

Methods/design:
This study is a prospective, open-labeled, randomized, cross-over clinical trial. A total of 40 patients with neuropathic pain who had a numeric rating scale (NRS) score of over 4 despite receiving conventional treatment for more than 3 months will be enrolled. Participants will receive conventional treatment for neuropathic pain (treatment C) or treatment C combined with 12 additional sessions of electroacupuncture treatment (treatment A) for 6 weeks. Participants will be randomly assigned to 1 of the 2 sequence groups (AC and CA group) with a 1:1 allocation. The differences of responder in the composite efficacy outcomes, which consist of the NRS, Brief Pain Inventory-Short Form (BPI-SF) pain subscale, and global assessment at 6 weeks after randomization will be examined as the primary outcome. Secondary outcomes include differences in the NRS, the Short-Form McGill Pain Questionnaire, BPI-SF, Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Medical Outcomes Study Sleep Scale, global assessment, EQ-5D, and incremental cost-effective ratio at 6 and 15 weeks after randomization. Adverse events, vital signs, and physical examinations will be recorded to evaluate safety.

Discussion:
The study protocol for this trial will provide up-to-date evidence on the effectiveness and safety of electroacupuncture for patients with intractable neuropathic pain. The results will be disseminated through a peer-reviewed journal and conference presentations.

Trial registration:
Clinical Research Information Service, ID: KCT0003615. Registered on March 12, 2019. https://cris.nih.go.kr/cris/search/search_result_st01_kren.jsp?seq=13410& ltype=&rtype=
Jingui Shenqi pill for nocturia due to nocturnal polyuria
Authors: Fan Zhipeng , Wang Zhaodi , Deng Jiashuai , Jiang Yong 
Published: December 2020

Abstract

Background:
The incidence of nocturia is high and will seriously affect patients’ physical and mental health. Nocturnal polyuria is the most critical cause of nocturia, There are few drugs currently used to treat nocturia due to Nocturnal Polyuria (NP). The guide highly recommends only Desmopressin. There is an urgent need to find new drugs. Jingui Shenqi pill (JSP) is a Chinese patent medicine, it is widely used in China to treat NP. However, there is no evidence-based medical evidence to prove its safety and effectiveness. The purpose of this systematic review is to evaluate the efficacy and safety of JSP in the treatment of NP.

Methods:
We will search the randomized controlled trials (RCTs) including JSP for NP and published from the inception of the database to Oct 2020 by the following eight databases: Embase, Cochrane Library, PubMed, MEDLINE, the China National Knowledge Infrastructure, Cqvip Database, and Wanfang Data, the Chinese Biomedical Literature Database. There is no language and publication status restriction. The primary outcomes will include Nocturnal urine volume, the number of nocturnal voids, Nocturnal polyuria index (Nocturnal total urine volume /24 h total urine volume). We will perform the data synthesis, sensitivity analysis, subgroup analysis, and bias assessment risk using RevMan V.5.3. The reporting bias will be assessed using a funnel plot and Egger test.

Results:
This study may provide additional evidence of JSP for NP in the effectiveness and safety and alternative therapy for NP.

Conclusions:
In this systematic review, we will assess whether JSP is an effective and safe medicine for nocturia.
A protocol for an interventional study on the impact of transcutaneous parasacral nerve stimulation in children with functional constipation
Authors: Coelho Giovanna Maria , Machado Nilton Carlos , Carvalho Mary de Assis , Rego Rebeca Mayara Padilha , Vieira Stefani Rabelo , Ortolan Erika Veruska Paiva , Lourenção Pedro Luiz Toledo de Arruda 
Published: December 2020

Abstract

Introduction:
Transcutaneous parasacral nerve stimulation (TPNS) via electrodes placed over the sacrum can activate afferent neuronal networks noninvasively, leading to sacral reflexes that may improve colonic motility. Thus, TPNS can be considered a promising, noninvasive, and safe method for the treatment of constipation. However, there is no published study investigating its use in children with functional constipation. This is a single-center, prospective, longitudinal, and interventional study designed to assess the applicability and clinical outcomes of TPNS in functionally constipated children.

Patient concerns:
Parents or guardians of patients will be informed of the purpose of the study and will sign an informed consent form. The participants may leave the study at any time without any restrictions.

Diagnosis:
Twenty-eight children (7–18 years old) who were diagnosed with intestinal constipation (Rome IV criteria) will be included.

Interventions:
The patients will be submitted to daily sessions of TPNS for a period of 4 or 8 weeks and will be invited to participate in semistructured interviews at 3 or 4 moments: 1 week before the beginning of TPNS; immediately after the 4 and/or 8 weeks of TPNS; and 4 weeks after the end of the intervention period. In these appointments, the aspects related to bowel habits and quality of life will be assessed.

Outcomes:
This study will evaluate the increase in the number of bowel movements and stool consistency, the decrease in the number of episodes of retentive fecal incontinence, and the indirect improvement in the overall quality of life.

Conclusion:
we expect that this study protocol can show the efficacy of this promising method to assist the treatment of children with functional constipation.
Comparative efficacy and safety of traditional Chinese patent medicine in the treatment of Mycoplasma pneumoniae pneumonia in children
Authors: He Hongan , Wang Xiao , Xiao Yanyan , Zheng Jialin , Wang Jinjuan , Zhang Baoqing 
Published: December 2020

Abstract

Background:

Mycoplasma pneumoniae pneumonia (MPP) is a common respiratory disease in children. Its incidence rate is increasing year by year. The drug resistance rate of macrolide antibiotics and other conventional treatment methods is higher, and there are limitations in clinical application. Traditional Chinese patent medicine (TCPM) is a powerful weapon to treat this disease. At present, there is no comparison of the safety and effectiveness of multiple TCPMs in the treatment of MPP in children. Therefore, we take the method of network meta-analysis to systematically compare the efficacy of various TCPMs in the treatment of this disease.

Methods:
We will conduct comprehensive searches of Cochrane Library, PubMed, Web of Science, Clinical Trials, China National Knowledge Infrastructure, Chinese Scientific Journals Database, Chinese BioMedical Literature, Wanfang Database, and other electronic databases. The time frame is set from the establishment of the database to October 2020. All randomized controlled trials that meet the inclusion criteria will be included in this study. The 2 researchers will independently screen the literature according to the inclusion criteria, extract the data, and assess the bias risk of the included study. We will evaluate all the obtained data and evidence through Bayesian network meta-analysis, and use Stata 15.0 to process and analyze the data.

Results:
Through this study, we will evaluate the efficacy and safety of a variety of TCPMs for the treatment of MPP in children.

Conclusion:
The purpose of this study is to provide a strong reference for clinical application of TCPMs in the treatment of MPP in children, and to provide an important basis for clinicians to make correct judgments and put forward accurate treatment plans.

Ethics and dissemination:
This review does not involve any human or animal experiments and therefore does not require ethical approval.

INPLASY registration number:
INPLASY 2020100108
Proprioceptive training on the recovery of total knee arthroplasty patients
Authors: Wu Jia-qi , Bao Hong-wei , Mao Lin-bo , Liu Ling-feng , Li Yong-mei , Hou Jing-zhao , Wu Can-hua , Zhou Yue-jiang , Wang Zhao , Cheng Yan-xiao , Wu Jian 
Published: December 2020

Abstract

Background:
Total knee arthroplasty is a common surgery for end-stage of knee osteoarthritis. Proprioceptive training has become an important part in athletes training programmes in different sports. However, the effects of proprioceptive training on the recovery of total knee arthroplasty were unknown. This meta-analysis, with its comprehensive and rigorous methodology, will provide better insight into this problem.

Methods and analysis:
Electronic databases including PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI) database, Wanfang Database and Chinese Biomedical Literature Database (CBM) were searched from its inception to October 21, 2020. We only included proprioceptive training vs placebo in patients after total knee arthroplasty and pooled results were summarized by STATA 12.0 software. Two researchers independently selected the study and assessed the quality of the included studies. The heterogeneity was measured by I
2 tests (I
2 < 50 indicates little heterogeneity, I
2 ≥ 50 indicates high heterogeneity). Publication bias was ruled out by funnel plot and statistically assessed by Beggs test (P > .05 as no publication bias).

Results:
Results will be published in relevant peer-reviewed journals.

Conclusion:
Our study aims to systematically present the clinical effects of proprioceptive training after total knee arthroplasty patients, which will be provide clinical guidance for total knee arthroplasty patients.
Appearance and morphologic features of laryngeal tuberculosis using laryngoscopy
Authors: Zang Jian , Tian Ying , Jiang Xuejun , Lin Xu-Yong 
Published: December 2020

Abstract
Laryngeal tuberculosis (LTB) is highly contagious and can cause permanent laryngeal damage. Therefore, correctly identifying laryngoscopic LTB lesion locations, sizes, and morphologic features are essential for LTB diagnoses. This study aimed to explore the appearance and morphologic features of LTB and correlated these features with clinical symptoms.
We retrospectively analysed 39 LTB patients in our hospital between January 2013 and December 2019. Medical records, including clinical presentation, lesion appearance (locations, sizes, and morphology), complementary examination results, and histopathologic features were summarized and analysed.
In this patient cohort, dysphonia and sore throat were the two most common clinical symptoms. In LTB patients with extensive lesions, ulcerative lesions were most common, and the proportion of cases with concurrent pulmonary tuberculosis (86.4%, P = .033) infection was higher, as were the positive rates of sputum smears (72.7%, P = .011) and cultures (86.4%, P = .002) than patients without concurrent pulmonary TB and with more localized and exophytic lesions. The histopathologic features of LTB-related ulcerative lesions included fewer granulomas and more areas with caseous necrosis. These lesions were more likely to have acid-fast bacilli detected with a Ziehl–Neelsen stain than exophytic lesions that rarely showed detectable bacilli.
A complete knowledge regarding the visual and morphologic features of LTB on laryngoscopy is needed for the early detection and diagnosis of LTB. Our study revealed the lesion sites, sizes, and morphologic features of LTB. These parameters were also correlated with patient clinical symptoms. Future studies are needed to support and expand the results of this retrospective study.
Long-term risk of pneumothorax in asthmatic children
Authors: Lin Chien-Heng , Lin Cheng-Li , Lin Wei-Ching , Wei Chang-Ching 
Published: December 2020

Abstract
Pneumothorax is a life-threatening complication during acute asthma attack. However, long-term risk of pneumothorax in asthmatic children remains unknown.
In this retrospective cohort study, 333,657 children were defined as asthma cohort and a 1:1 matched non-asthma cohort were generated from 2000 to 2011. At the end of 2012, the incidence of pneumothorax in asthma and non-asthma cohorts and asthma to non-asthma hazard ratios (HRs) with confidence intervals (CIs) of pneumothorax were analyzed.
The incidence of pneumothorax was 1.35-fold higher in the asthma cohort than that in the non-asthma cohort. The asthma to non-asthma HRs of pneumothorax were higher in children younger than 6 years (1.76, 95% CI: 1.21–2.57) and in girls (2.27; 95% CI: 1.23–4.16). The HRs of pneumothorax were higher in asthmatic children with more asthma-related out-patient clinic visits/per year (>5 visits; HR: 2.81; 95% CI: 1.79–4.42), more emergency department visits/per year (>4 visits; HR: 1.68; 95% CI: 1.02–2.78), and longer hospitalization days due to asthma (>4 days; HR: 3.42; 95% CI: 1.52–6.94) (P < .0001, the trend test).
Asthmatic children had greater risk for pneumothorax, particularly in young children and in those with severe and uncontrolled asthma.
Effects of neuro-adaptive electrostimulation therapy on pain and disability in fibromyalgia
Authors: Udina-Cortés Carlos , Fernández-Carnero Josué , Romano Alberto Arribas , Cuenca-Zaldívar Juan Nicolás , Villafañe Jorge Hugo , Castro-Marrero Jesús , Alguacil-Diego Isabel Maria 
Published: December 2020

Abstract

Background:
To evaluate the effectiveness of non-invasive neuro-adaptive electrostimulation (NAE) therapy for treating chronic pain and disability in patients with fibromyalgia.

Method/design:
A prospective, randomized, sham-controlled study was conducted in 37 women with fibromyalgia. Participants were randomly assigned to receive either active NAE (n = 20) or stimulation with a sham device (n = 17). Participants in the experimental arm received eight 30-minute sessions over 4 weeks (2 sessions per week). The sham group received eight 30-minute sessions of sham stimulation. Therapeutic effects on pain relief, disability, and quality of life were evaluated using outcome measures at baseline, at 4 weeks, and after 3 months’ follow-up.

Results:
The findings indicated a significant reduction of pain in the active NAE group compared with the sham group immediately post-intervention, with a difference on the Visual Analog Scale (VAS) of 3 points (P = .001), and at 3 months’ follow-up (P = .02). There were significant intragroup differences between the groups (P < .05) at post-intervention. After the intervention, both groups presented significant reductions on the Fibromyalgia Impact Questionnaire (FIQ) with respect to baseline (P = .004), but not at the 3-month follow-up. In the conditioned pain modulation (CPM) in thumb variable we found significant differences between the groups at the 3-month follow-up (P = .02). No additional benefits for conditioned pain modulation and disability were observed between groups at the 3-month follow-up. Furthermore, anxiety/depression and catastrophizing improved in both groups, but no differences between groups were found.

Conclusions:
In this fibromyalgia cohort, NAE therapy significantly improved pain and quality of life at 4 weeks, but not at 3-month follow-up, compared with the sham stimulation group. Future investigations are needed in larger populations to confirm these findings.