Effectiveness and safety of a newly designed self-assembling gel in the treatment of endoscopic submucosal dissection-induced gastric ulcer: A multicenter randomized controlled trial.

Objectives: To evaluate the effectiveness and safety of a newly designed self-assembling gel in treating ESD-induced gastric ulcers in patients. Methods: This open-label, multicenter, randomized controlled trial enrolled patients who underwent ESD between September 2020 and May 2021. Patients were randomized (1:1) to receive the gel (applied to cover the entire ulcer bed under endoscopic guidance immediately after ESD; gel group) or not (control group). The primary outcome was the ulcer healing rate at 28 days. And the secondary outcomes were the delayed bleeding, changes in the ulcer stage, and adverse events. Results: Finally, 125 patients (mean age, 63.7 years; 70 [56.0%] males) were enrolled. The ulcer healing rate was higher in the gel group than in the control group at 28 days (96.9 ± 4.1% vs. 94.7 ± 5.0%; p = 0.001). The ulcer reduction rate at 28 days differed significantly (p < 0.001) between ulcers with majority gel coverage (99.8%), ulcers with minority gel coverage (96.2%), and ulcers with no gel coverage (98.0%). Delayed bleeding was found in 1/63 gel-treated patients (1.6%) versus 5/62 controls (8.1%). A1-stage ulcers were found in 16/63 patients in the gel group versus 44/62 patients in the control group (25.4% vs. 71.0%, p < 0.001) at 3-5 days. Conclusion: The newly developed self-assembling gel was safe and effective in accelerating gastric ulcer healing in patients after ESD. Clinical Trial Registration: UMIN Clinical Trials Registry System (registration number, ChiCTR2100052935).

Efficacy and Safety of Chinese Medicine for COVID-19: A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aimed to evaluate the efficacy and safety of traditional Chinese medicine for COVID-19 treatment with a focus on the benefits of symptomatic relief and time-related indexes. Seven electronic databases (PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, Chongqing VIP, Wanfang Data, and Chinese Clinical Trial Registry) were systematically searched from their beginning to April 2021. Only randomized controlled trials (RCTs) comparing patients using Western therapy (WT) alone and those using additional Chinese medicine (WT [Formula: see text] CM) were included. Primary outcomes included overall efficacy, lung recovery, and time to viral assay conversion. Secondary outcomes included time and rate of individual symptom recovery, laboratory indicators, and adverse events. Overall, 15 RCTs, including 1469 participants, were included in this review. WT [Formula: see text] CM significantly improved overall efficacy (risk ratio, RR [Formula: see text] 1.21; 95% CI: 1.12 to 1.30; [Formula: see text] [Formula: see text] 0.01) and lung recovery (RR [Formula: see text] 1.30; 95% CI:1.19 to 1.42; [Formula: see text] [Formula: see text] 0.01) and shortened the time to viral assay conversion (weighted mean differences, WMD [Formula: see text]1.38; 95% CI: -1.98 to -0.78; [Formula: see text] [Formula: see text] 0.01) and duration of chest distress (WMD [Formula: see text] 2.41; 95% CI: -2.99 to -1.83; [Formula: see text] [Formula: see text] 0.01) compared to WT alone. There was no difference in safety between the WT [Formula: see text] CM and WT groups (RR [Formula: see text] 0.94; 95% CI: 0.64 to 1.39; [Formula: see text] 0.76). In conclusion, the synthesized evidence from 15 RCTs showed that additional Chinese medication may improve treatment efficacy, relieve symptoms, promote lung recovery, and reduce the inflammatory response against COVID-19, while not increasing the risk of adverse events compared with conventional Western medication alone.

Characteristics analysis for clinical study design relating to COVID-19 based on the database of ClinicalTrials.gov.

BACKGROUND AND OBJECTIVE: The novel coronavirus disease (COVID-19) outbreak is currently ravaging populations worldwide. Many studies were registered and conducted in rapid response to the epidemic, but how to choose the proper design for clinical trials remains the main concern. This study aimed to determine the fundamental characteristics of study design during the COVID-19 pandemic and provide references for other emerging infectious diseases. METHODS: We searched the database of ClinicalTrials.gov with the keyword "COVID-19" and compared the results with the design features of other conventional studies except for COVID-19. RESULTS: From January 1, 2020 to September 30, 2021, 55,334 trials were registered at ClinicalTrials.gov. Of all the registered trials, 6,408 were related to COVID-19 (11.58%). There were significant differences in the proportion of observational studies between COVID-19 (43.48%) and others (23.27%). The completion rate of observational trials and interventional trials in COVID-19 was 29.04% and 25.84%, respectively. COVID-19 trials showed a higher rate of completion than others (P<0.01). The time distribution and trend of observational studies and interventional studies varied considerably. CONCLUSION: Appropriately designed trials can help to improve research efficiency and reduce the possibility of research failure. In addition to randomized controlled trials, observational and single-armed studies are also worth considering.

Sacral electroacupuncture as a treatment for urge urinary incontinence: a prospective case series.

OBJECTIVE: To examine the impact of electroacupuncture (EA) at the 'four sacral points' on urge urinary incontinence (UUI). METHODS: Twenty-five patients diagnosed with UUI or urgency-predominant mixed urinary incontinence (MUI) were treated by EA at the 'four sacral points'. EA was performed in the sacrococcygeal region using disposable sterile 0.40-mm-diameter acupuncture needles that were either 100 or 125 mm in length. Treatments were delivered once every other day. Before and after treatment, a questionnaire measuring symptom severity and quality of life associated with UUI was administered. RESULTS: The median total score (interquartile range) from the severity of symptoms and the quality of life questionnaire (Q-score) of the participants was significantly reduced from 12 (7.5, 15) before treatment to 3 (0, 6) after 6 (6, 12) EA treatments. The Q-score of urgency-predominant MUI and UUI was 8 (5, 14.5) and 12.5 (11, 15), respectively, before treatment; after treatment these were reduced to 2 (0, 7.5) and 4.5 (2, 6), respectively. There was no statistically significant difference in the Q-score between urgency-predominant MUI and UUI before and after treatment. Upon treatment completion, seven patients (28%) were 'cured' (improvement rate 100%). Treatments were considered 'markedly effective' (improvement rate 75% to <100%) in four patients (16%), 'effective' (improvement rate 50% to <75%) in eight patients (32%), 'minimally effective' (improvement rate 25% to <50%) in three patients (12%), and 'ineffective' (improvement rate <25%) in three patients (12%). The overall success rate (comprising 'cured', 'markedly effective' and 'effective' categories) was 76%, and no adverse effects associated with acupuncture treatment were reported. CONCLUSION: EA at the 'four sacral points' was associated with statistically significant improvements in UUI.

A Comparative Study on the Health Status and Behavioral Lifestyle of Centenarians and Non-centenarians in Zhejiang Province, China-A Cross-Sectional Study.

Background: The growth rate of centenarians was unusually rapid in recent decades, ushering in an era of longevity. This study aims to explore the difference between centenarians and non-centenarians using quantitative research, and to scientifically guide residents to develop the correct lifestyle and health care ways. Methods: From October 2013 to August 2017. A cross-sectional survey was conducted on 271 centenarians and 570 non-centenarians by using a questionnaire to assess longevity and health issues which was developed for the needs of the study, who came from 29 counties and districts in 11 cities of Zhejiang province, China. Two hundred and fifty-five valid questionnaires were returned, with an effective response rate of 94.1%. Meanwhile, data of 526 non-centenarians from Zhejiang province was collected as a control group, with an effective response rate of 92.3%. Results: The prevalence rates of tumor, stomach and duodenal ulcer, diabetes, bronchial asthma, and chronic obstructive pulmonary disease, tuberculosis among centenarians were all lower than those among non-centenarians. The oral health of centenarians is better than that of non-centenarians. The consumption of coarse cereals, pasta, other staple foods and fruits among centenarians was higher than that of non-centenarians. The percentage of centenarians who smoke or engage in recreational activities every day was lower than that of non-centenarians. Conclusions: We should give full play to the role of preventive medicine and health management to safeguard the health of residents. Pay attention to oral health, and develop the good habit of loving teeth. The diet should be rich and varied, and increase the intake of grains and fruits. Give up smoking, limit alcohol, spirit-preserving with calming, follow the law of scientific regimen.

Comparison of efficacy and safety between electroacupuncture at 'four sacral points' and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial.

INTRODUCTION: Electroacupuncture at 'four sacral points', also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at 'four sacral points' for the management of urinary incontinence after stroke. METHODS AND ANALYSIS: This is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at 'four sacral points' along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline. ETHICS AND DISSEMINATION: This protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059-01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR-IOR-17012847; Pre-result.

Standardization of medical service indicators: A useful technique for hospital administration.

BACKGROUND: Many comparability problems appear in the process of the performance assessment of medical service. When comparing medical evaluation indicators across hospitals, or even within the same hospital, over time, the differences in the population composition such as types of diseases, comorbidities, demographic characteristics should be taken into account. This study aims to introduce a standardization technique for medical service indicators and provide a new insight on the comparability of medical data. METHODS: The medical records of 142592 inpatient from three hospitals in 2017 were included in this study. Chi-square and Kruskal-Wallis tests were used to explore the compositions of confounding factors among populations. The procedure of stratified standardization technique was applied to compare the differences of the average length of stay and the average hospitalization expense among three hospitals. RESULTS: Age, gender, comorbidity, and principal diagnoses category were considered as confounding factors. After correcting all factors, the average length of stay of hospital A and C were increased by 0.21 and 1.20 days, respectively, while that of hospital B was reduced by 1.54 days. The average hospitalization expenses of hospital A and C were increased by 1494 and 660 Yuan, whilst that of hospital B was decreased by 810 Yuan. CONCLUSIONS: Standardization method will be helpful to improve the comparability of medical service indicators in hospital administration. It could be a practical technique and worthy of promotion.

Association of Human Leukocyte Antigen DRB1*15 and DRB1*15:01 Polymorphisms with Response to Immunosuppressive Therapy in Patients with Aplastic Anemia: A Meta-Analysis.

This study aimed to review and quantitatively analyze (1) the association of aplastic anemia (AA) with human leukocyte antigen (HLA)-DRB1*15 and HLA-DRB1*15:01 polymorphisms and (2) the association of HLA-DRB1*15 and HLA-DRB1*15:01 polymorphisms with response to immunosuppressive therapy (IST) in AA. Published studies have reported conflicting and heterogeneous results regarding the association of HLA-DRB1*15 and HLA-DRB1*15:01 polymorphisms with response to IST in AA. The PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Chinese BioMedical Literature, Wangfang and Chinese Social Sciences Citation Index databases were searched. All relevant publications were searched through December 2015. Odds ratio (OR), risk ratio (RR), and 95% confidence intervals (CI) for the comparison between case-control or cohort studies were evaluated. Finally, 24 articles were identified. For HLA-DRB1*15 and HLA-DRB1*15:01, the OR (95% CI) was 2.24(1.33-3.77), P < 0.01 and 2.50(1.73-3.62), P < 0.01, respectively; and the overall pooled RR was 1.72 (1.30-2.29), P < 0.01 and 1.59 (1.29-1.96), P < 0.01, respectively. Statistical evidence showed no publication bias (P > 0.05). Sensitivity analyses revealed that the results were statistically robust. The meta-analysis suggested that HLA-DRB1*15 and HLA-DRB1*15:01 polymorphisms might be associated with increased AA risk in Asians. IST might be more effective in HLA-DRB1*15+ and HLA-DRB1*15:01+ Asian patients with AA than in HLA-DRB1*15- and HLA-DRB1*15:01- Asian patients with AA. Future studies with adequate methodological quality on gene-gene and gene-environment interactions and gene treatment may yield valid results.

[Construction of early warning model of influenza-like illness in Zhejiang Province based on support vector machine].

OBJECTIVE: To construct a forecasting model of influenza-like illness in Zhejiang Province. METHODS: The number of influenza-like cases and related pathogens among outpatients and emergency patients were obtained from 11 sentinel hospitals in Zhejiang Province during 2012 to 2013 (total 104 weeks), and corresponding meteorological factors were also collected. The epidemiological characteristics of influenza during the period were then analyzed. Linear correlation and rank correlation analyses were conducted to explore the association between influenza-like illness and related factors. Optimal parameters were selected by cross validation. Support vector machine was used to construct the forecasting model of influenza-like illness in Zhejiang Province and verified by the historical data. RESULTS: Correlation analysis indicated that 8 factors were associated with influenza-like illness occurred in one week. The results of cross validation showed that the optimal parameters were C=3, ε=0.009 and γ=0.4. The results of influenza-like illness forecasting model after verification revealed that support vector machine had the accuracy of 50.0% for prediction with the same level, while it reached 96.7% for prediction within the range of one level higher or lower. CONCLUSION: Support vector machine is suitable for early warning of influenza-like illness.

Betulinic acid ameliorates endothelium-dependent relaxation in L-NAME-induced hypertensive rats by reducing oxidative stress.

Zizyphi Spinosi semen (ZSS) is one of the most widely used traditional Chinese herbs with protective effects on the cardiovascular system. It is not clear whether betulinic acid (BA), the key active constituent of ZSS, has beneficial cardiovascular effects on N(ω)-nitro-L-arginine methyl ester hydrochloride (L-NAME)-induced hypertensive rats. The objective of this study was to investigate the effect of BA on endothelium-dependent vasorelaxation in isolated aortic rings from L-NAME-induced hypertensive rats and its underlying mechanisms. Male Sprague-Dawley rats were injected with L-NAME (15 mg/kg/d, i.p.) for 4 weeks to induce hypertension. After treatment with L-NAME for 2 weeks, rats with mean blood pressure >120 mm Hg measured by tail-cuff method were considered hypertensive and then injected with BA (0.8, 4, 20 mg/kg/d, i.p.) for the last 2 weeks. The effect of BA on the tension of rat thoracic aortic rings was measured in an organ bath system. The levels of nitric oxide (NO), reactive oxygen species (ROS), and the activity of superoxide dismutase (SOD) and nitric oxide synthase (NOS) in aortas were assayed. We found that BA (0.1-100 µM) evoked a concentration-dependent vasorelaxation in endothelium-intact normal rat aortic rings, which was significantly attenuated by pretreatment with L-NAME (100 µM) or methylene blue (MB, 10 µM), but not by indomethacin (10 µM). Pretreatment with EC(50) (1.67 µM) concentration of BA enhanced the acetylcholine (ACh)-induced vasorelaxation, which was also markedly reversed by both L-NAME and MB. The blood pressure in hypertensive rats increased to 135.22±5.38 mm Hg (P<0.01 vs. control group), which was markedly attenuated by high dose of BA. The ACh-induced vasorelaxation in hypertensive rat aortic rings was impaired, which was markedly improved by chronic treatment with BA (20 mg/kg/d) for 2 weeks. The increase of ROS level and the decrease of NO level, SOD and eNOS activities in hypertensive rat aortas were all markedly inhibited by BA. These results indicate that BA decreased blood pressure and improved ACh-induced endothelium-dependent vasorelaxation in L-NAME-induced hypertension rats, which may be mediated by reducing oxidative stress and retaining the bioavailability of NO in the cardiovascular system.