Efficacy and safety of Xileisan combined with mesalazine for ulcerative colitis:A meta-analysis and trial sequential analysis

BACKGROUND The benefits and risks of Xileisan(XLS)in the treatment of ulcerative colitis(UC)remain unclear.AIM The present study aimed to evaluate the efficacy and safety of the combination of XLS and mesalazine when treating UC.METHODS We searched eight databases for clinical trials evaluating the combination of XLS and mesalazine in the treatment of UC,up to January 2024.Meta-analysis and trial sequential analysis(TSA)were performed using Revman 5.3 and TSA 0.9.5.10 beta,respectively.RESULTS The present study included 13 clinical studies involving 990 patients,of which 501 patients received XLS combined with mesalazine while 489 patients received mesalazine alone.The meta-analysis showed that,in terms of efficacy,the combination of XLS and mesalazine significantly improved the clinical efficacy rate by 22%[risk ratio(RR)=1.22;95%CI:1.15–1.28;P<0.00001]and mucosal improvement rate by 25%(RR=1.25;95%CI:1.12–1.39;P=0.0001),while significantly reducing the duration of abdominal pain by 2.25 days[mean difference(MD)=-2.25;95%CI:-3.35 to-1.14;P<0.0001],diarrhea by 2.06 days(MD=-2.06;95%CI:-3.92 to-0.20;P=0.03),hematochezia by 2.32 days(MD=-2.32;95%CI:-4.02 to-0.62;P=0.008),tumor necrosis factor alpha by 16.25 ng/mL(MD=-16.25;95%CI:-20.48 to-12.01;P<0.00001),and interleukin-6 by 14.14 ng/mL(MD=-14.14;95%CI:-24.89 to-3.39;P=0.01).The TSA indicated conclusiveness in the meta-analysis of the efficacy endpoints.In terms of safety,the meta-analysis revealed that the combination of XLS and mesalazine did not increase the occurrence of total and gastrointestinal adverse events,abdominal distension,and erythema(P>0.05).The TSA showed non conclusive findings in the meta-analysis of the safety endpoints.Harbord’s test showed no publication bias(P=0.734).CONCLUSION Treatment with XLS alleviated the clinical symptoms,intestinal mucosal injury,and inflammatory response in patients with UC,while demonstrating good safety.

Efficacy and Safety of Traditional Chinese Patent Medicine Qizhi Weitong Granules(气滞胃痛颗粒)in Irritable Bowel Syndrome with Predominant Constipation:A Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials

Objective:To systematically review the efficacy and clinical safety of Qizhi Weitong Granules(气滞胃痛颗粒)(QZWT)in the treatment of irritable bowel syndrome with predominant constipation(IBS-C).Methods:Randomized controlled trials(RCTs)of QZWT in patients with IBS-C were retrieved from Pub Med,EMBASE,Cochrane Library,China National Knowledge Infrastructure(CNKI),Wanfang,Chinese Scientific Journals Database(VIP),and Chinese Biological Medical Database(CBM)from inception to December 3,2022.Conventional meta-analysis with random-effects model or fixed-effects model and trial sequential analysis(TSA)were performed by Review Manager 5.4,Stata and TSA software.Results:A total of 4 RCTs and 368 patients with IBS-C were included in this study.The findings of the meta-analysis indicated that the cure and efficacy rate of the experimental group was significantly higher than that of the control group[RR=2.19;(95%CI,1.35–3.55),P<0.01;RR=1.14;(95%CI,1.03–1.27),P<0.05],while the result of Bristol Score was negative.The funnel plot was probably symmetry,and the P value was>0.05 in the Egger test,which confirmed the nonexistence of significant publication bias in this outcome.TSA showed the cumulative z-value crossed the traditional threshold and TSA threshold,while it didn't get to the required information size.Finally,2 studies reported adverse events after QZWT treatment,including 3 cases of diarrhea.No serious adverse events were reported.Conclusion:QZWT was an effective and safe complementary therapy in the treatment of IBS-C with no obvious adverse reactions.TSA analysis confirmed our meta-analysis results.Therefore,QZWT may be a potential candidate for the treatment of IBS-C.However,due to the limited quality of current studies,more long-term,randomized,double-blinded clinical trials are needed in future studies.

Effects of mindfulness meditation on anxiety, depression, stress, and mindfulness in nursing students: a meta-analysis and trial sequential analysis of randomized controlled trials

Objective:The aim of this study was to assess the effectiveness of mindfulness meditation(MM)on anxiety,depression,stress and mindfulness in nursing students.Methods:A comprehensive search and screening procedures were conducted to locate all MM interventions implemented with nursing students.For randomized controlled trials(RCTs)in accordance with the inclusion criteria,a search was conducted in PubMed,Embase,Web of Science,Medline,PsycINFO,Cumulative Index to Nursing and Allied Health(CINAHL),Cochrane Central Register of Controlled Trials(CENTRAL),China Biology Medicine(CBM),Chinese National Knowledge Infrastructure(CNKI)and Wanfang.Databases were retrieved from inception through August 2018.Additional studies were identified through hand searches and Internet searches.Two reviewers collected relevant data of eligible articles according to the data extraction tables.Based on Cochrane Handbook,critical appraisal of the methodological quality was assessed by two other reviewers.An Excel form was used to extract main characteristics of included RCTs.Meta-analysis and trial sequential analysis(TSA)were carried out using software RevMan 5.3 and TSA 0.9.Results:Five RCTs with 257 nursing students were included.Only two studies were assessed as high quality and three studies were evaluated as moderate quality.Meta-analysis showed that,comparing with the control group,MM could significantly improve anxiety(SMD=?0.45,95%CI?0.73 to?0.17,P=0.001)and stress(SMD=?0.69,95%CI?0.97 to?0.40,P<0.001).TSA results confirmed that the outcome of the merger is credible.It could also significantly improve depression level of nursing students after 8 weeks intervention duration(SMD=?0.70,95%CI?1.14 to?0.26,P=0.002).However,there was no beneficial effect on depression level of nursing students with 1 week intervention duration(SMD=0.09,95%CI?0.42 to 0.59,P=0.74)and its effects on mindfulness level of nursing students also did not show statistical significance(SMD=0.37,95%CI?0.04 to 0.77,P=0.07).No definitive conclusions were drawn from the TSA.Conclusions:The results of this meta-analysis indicated that MM could effectively reduce the level of anxiety and stress of nursing students.TSA confirmed that the results of meta-analysis are credible.For depression,it could also significantly improve depression of nursing students with 8 weeks intervention,but there was no significant effect on nursing students with 1 week intervention duration.There was also no beneficial effect on mindfulness level of nursing students.However,TSA indicated that the accumulated evidence is still inconclusive.We suggest that more well-designed clinical trials with large sample and higher quality would be required in future to draw a definitive conclusion.

Systematic evaluation and trial sequential analysis of warming acupuncture combined with joint mobilization in the treatment of scapulohumeral periarthritis

Objective:To evaluate the clinical efficacy of warming acupuncture combined with joint mobilization for the treatment of scapulohumeral periarthritis.Methods:A search for published randomized controlled trials(RCT)investigating warming acupuncture combined with joint mobilization for the treatment of scapulohumeral periarthritis was performed using the Cochrane Library,PubMed,Embase,and Web of Science databases.According to requirements of the Cochrane systematic review,all evaluations of RCT investigating warming acupuncture with joint mobilization in the treatment of scapulohumeral periarthritis were performed via method quality assessment,data extraction,and data analysis.Revman 5.3 and Stata 12.0 statistical software were used for the meta-analysis,and the trial sequential analysis(TSA)software estimated the required information size for each outcome.Results:A total of 14 articles were retrieved for meta-analysis,which included 551 cases in the treatment group and 539 cases in the control group.Meta-analysis showed that:(1)warming acupuncture combined with joint mobilization improved total efficiency[OR=6.16,95%CI(3.79,10.00),Z=7.34;P<0.001),TSA results confirmed the results of the meta-analysis;(2)warming acupuncture combined with joint mobilization improved the cure rate[OR=2.84,95%CI(2.19,3.70),P<0.001],TSA results revealed that no further tests were needed to verify;(3)warming acupuncture combined with joint mobilization reduced the number of treatments required for healing[MD=-7.49,95%CI(-9.75,-5.23),P<0.001],TSA results confirmed the results of the meta-analysis;(4)in comparing visual analog scale scores before and after treatment,meta-analysis result showed that:SMD=-2.01,95%CI(-2.37,-1.65),P<0.001,the difference was statistically significant,TSA results confirmed the results of the meta-analysis.Conclusion:Warming acupuncture combined with joint mobilization had a significant effect on the treatment of scapulohumeral periarthritis.

Moxibustion treatment for knee osteoarthritis： cumulative meta-analysis and trial sequential analysis

Objective： To evaluate the effect of moxibustion on knee osteoarthritis patients with cumulative meta-analysis, and trial sequential analysis was applied to test the authenticity of results. Methods： We searched PubMed, EMbase, The Cochrane Library, CNKI and CBM to collect RCTs about moxibustion on knee osteoarthritis patients. The selection of literature, data extraction and evaluation of eligible literature were carried out independently by two reviewers. Then Stata11.0 software was used for data analysis. Result： Totally 11 RCTs involved 1005 patients were recruited. The results of meta-analysis showed that no significant differences were found between the two groups in VAS, moxibustion is better than drug therapy in effective rate [OR = 0.40, 95%CI （0.27, 0.60）] and knee score [SMD = -0.70, 95%CI （-1.22, -0.19）]. The result of trial sequential analysis indicated that the sample size didn＇t reach the TSA Boundary on VAS, the sample size of effectiveness achieved Require Information Size. In the indicator of knee score has obtained certain re- sult before reaching the Require Information Size. Conclusion： moxibustion is superior to drug therapy on treatment knee osteoarthritis. However, large sample size and high-quality studies are still needed.

Jinhuang powder for the treatment of diabetic foot ulcers:an updated metaanalysis with power analysis and trial sequential analysis

Background:Traditional Chinese Medicines(TCM)had been indicated to benefit for the chronic non-infectious diseases,such as cancers,hypertension,primary dysmenorrheal,etc.Although randomized controlled trials(RCTs)had been conducted,there was still the controversy on the efficacy of Jinhuang powder for diabetic foot ulcers(DFUs).Objective:This systematic review aimed to objectively evaluate the potential of Jinhuang powder for DFUs.Methods:Seven databases(CNKI,Chongqing VIP,Wanfang database,CBM,the Cochrane Library,PubMed and Web of Science)were searched to retrieve RCTs up to December,2016;and the relevant references of the eligible studies were screened.According to the eligible criteria,the literature was screened;data were extracted;and then the methodological quality was assessed.The meta-analysis,power analysis and trial sequential analysis(TSA)were performed by using Meta analyst software(version beta 3.13),Stata 12.0,Power and Precision statistical software package(Biostat)and TSA software(version0.9),respectively.Results:Finally,three RCTs with 198 participants were included.The results of meta-analysis showed that there were statistically significant differences between groups in(1)the cure rate(RR,1.25;95%CI.1.10to1.41;P=0.00)and(2)the wound healing time(SMD,-3.404;95%CI,-5.821 to -0.987;P=0.00).Three trials presented more than 80% power with 0.05α-errors in both outcomes and the power of two meta-analyses to pool different outcomes presented more than 95%.The TSA showed that the summary results were certain.Conclusion:The external application with Jinhuang powder was an effective and cost-effective therapy for DFUs.The power analysis and TSA showed that the efficacy of Jinhuang powder dressing for the treatment of DFUs is conclusive.

Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland:A meta-analysis and trial sequential analysis

Objective:To evaluate the efficacy and safety of Rupi Sanjie(RPSJ)capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland.Methods:A meta-analysis was conducted on randomized controlled trials(RCT)related to RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary gland.The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions.RevMan5.3 and Stata14.0 were used for data analyses.Trial sequential analysis was performed to estimate the sample size of systematic review base on TSA software v0.9.Results:Twenty-two RCTs were totally included in this study,involving 2135 patients.The result showed the clinical recurrence rate of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment alone group(RR:0.25,95%CI[0.17,0.37],P<0.01).The clinical cure rate and total effective rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical treatment group(RR:1.63,95%CI[1.46,1.82],P<0.01);(RR:1.29,95%CI[1.22,1.37],P<0.01).Application of RPSJ capsule decreased the occurrence of adverse events including nausea,vomiting,irregular menstruation,constipation,dizziness,and headache etc.(RR:0.90,95%CI[0.54,1.49],P=0.68).The results of trial sequential analysis demonstrated that the current available data did not reach the expected value.Conclusion:RPSJ capsule plus the conventional surgical treatment was more effective in reducing the clinical recurrence rate,and improving the total clinical effective rate and clinical cure rate,with a decrease in the occurrence of adverse events.

Bushen Huoxue method combined with ACEI/ARB in treating diabetic kidney disease (stage Ⅲ):A meta-analysis and trial sequential analysis

Objective:To evaluate the efficiency of Bushen Huoxue method with ACEI/ARB in treating diabetic kidney disease(stageⅢ).Methods:A total of 8 major electronic databases(CNKI,WanFang,VIP,Sinomed,Pubmed,Embase,Cochrane Liberary,Web of Science)were retrieved since the establishment of the database to October 9,2019.Two reviewers extracted data,and assessed the methodological quality of the included studies.The analysis was made by Stata 15.0 and TSA 0.9 softwares.Results:A total of 10 RCT studies were obtained,including 711 patients with diabetic kidney disease of stageⅢ.Meta-analysis showed that the method of Bushen Huoxue with ACEI/ARB could reduce UAER[WMD=-31.24,95%CI(-42.98,-19.51)],β2-GM[WMD=-92.95,95%CI(-166.05,-19.85)],LDL-C[WMD=-0.19,95%CI(0.19,-0.30)].However,there were no significant effect for HbAlc[WMD=-0.08,95%CI(-0.17,-0.00)],Scr[WMD=-12.96,95%CI(-39.82,13.90)],BUN[WMD=-0.14,95%CI(-0.44,0.17)].The result of TSA indicated that the method of Bushen Huoxue with ACEI/ARB was effective in the treatment of diabetic kidney disease of stageⅢ.Conclusion:The study show that the method of Bushen Huoxue with ACEI/ARB can reduce urinary protein,renal tubular injury and LDL-C in patients with diabetic kidney disease of stageⅢ,and had no effect on HbAlc and renal function.But the conclusion of this study needs further research of high quality.

Meta-analysis and Trial Sequential Analysis of Compound Qingdai Capsule in the Treatment of Psoriasis

[Objectives]To analyze the efficacy of Compound Qingdai Capsule in the treatment of psoriasis and conduct a systematic evaluation.[Methods]The clinical total effective rate,PASI index score,IL-17 level,IL-23 level,TNF-level,and adverse reactions were analyzed.TSA 0.9 software was used to conduct sequential analysis of the total effective rate,and subgroup analysis was performed according to the average age of the experimental group.[Results]Single application of Compound Qingdai Capsule or in combination with other methods in the treatment of psoriasis was superior to non-Compound Qingdai Capsule group,and the side effects were less than non-Compound Qingdai Capsule group;the n≥40 year-old group had certain heterogeneity,suggesting that the difference was statistically significant,and the effective rate was higher than that of the control group.The funnel plot showed that the graph was asymmetrical,and there may be publication bias or the possibility of low-quality literature.The TSA results indicated that the actual sample size was far lower than the expected sample size,and the cumulative Z value did not reach the TSA cut-off value and more trials need to be included to confirm the efficacy.[Conclusions]Compound Qingdai Capsule has a clear curative effect on psoriasis,and its safety is high.This study can provide relevant evidence for the effectiveness of Chinese patent drugs(CPD)in treating psoriasis.

Maintenance Chemotherapy in Ovarian Cancer: A Trial-Sequential Analysis

In patients with epithelian ovarian cancer who have achieved remission after initial surgery and induction chemotherapy, the role of maintenance chemotherapy is controversial. We carried out a trial-sequential analysis that included 4 randomised controlled trials. The end-point was progression at 3 years while the boundary for non-inferiority was set at ±20% in risk ratio. The results of our trial-sequential analysis indicated the futility of maintenance chemotherapy, i.e. proof of no effectiveness. Consequently, no further trials of this type should be performed to assess the effectiveness of this intervention in this clinical condition.

Fire needling for herpes zoster: A systematic review and meta-analysis of randomized clinical trials

Objective:To evaluate the effectiveness and safety of fire needling for herpes zoster from randomized clinical trials (RCTs).Methods:We searched Cochrane Central Register of Controlled Trials,Pubmed,Sino-Med,CNKI,VIP,WanFang databases,and conference proceedings to November,2017.RCTs were eligible if they tested fire needling for treating herpes zoster more than 3 times.Two authors screened all references,assessed the risk of bias,extracted data,independently,and analyzed data using Trial Sequential Analysis (TSA).Treatment effects were presented as risk ratio (RR)for binary data and standardized mean difference (SMD) for continuous data with 95% confidence interval (CI).Results:We included 27 RCTs with a total of 1933 participants.Only one RCT had low risk of bias,and the others were of high or moderate risk of bias.For total effectiveness rate (proportion of total number of people who were cured or significant symptom improved),there was no significant difference between Western medicine (acyclovir,valacyclovir,adenosine cobalamin) and fire needling (risk ratio 1.05,95% CI 0.98 to 1.12;n =5).For pain relief (VAS scale):fire needling used alone showed lower scores than Western medicine (SMD-1.37,95% CI-1.77 to-0.97;n =2) or external medicine (diclofenac) (SMD-2.23,95% CI-2.81 to-1.64;n =1).Combination of fire needling and Western medicine was better than Western medicine alone in relieving pain (VAS scale) (SMD-2.19,95% CI-3.40 to-0.97,I2 =94%;n =4).Patients receiving fire needling had lower incidence of neuralgia than those receiving Western medicine (3.3% vs 26.7%,RR 0.09,95% Cl 0.01 to 0.82;n =1) at follow up for 30 days.No serious adverse events such as infection were reported.Conclusion:Fire needling appears to offer relief for alleviating pain in herpes zoster.As the sample size of included trials was small and the quality of studies was generally low,rigorous clinical trials with robust reporting and appropriate outcome measures are still needed.

补肾活血法联合血液透析治疗慢性肾衰竭的Meta分析

[目的]对补肾活血法联合血液透析治疗慢性肾衰竭的文献进行Meta分析。[方法]计算机检索中国期刊全文数据库(CNKI)、万方数据库知识服务平台(WangFang)、Pubmed、EmBase等数据库,筛选补肾活血法联合血液透析治疗慢性肾功能不全的随机对照试验,检索时间为自建库起至2022年9月7日。运用Cochrane风险偏倚评估工具进行文献质量评价,应用Review Manager 5.3软件进行Meta分析,使用Stata14.0软件进行Egger检验,以评估发表偏倚,若存在发表偏倚则进一步运用非参数剪补法评估偏倚对结果的影响。运用GRADEprofiler3.6软件对本研究涉及结局指标进行证据质量评价。[结果]纳入14篇相关研究文献,共1316例患者,试验组660例,对照组656例。Meta分析结果显示,补肾活血法联合血液透析在降低血肌酐(Scr)、尿素氮(BUN)水平、中医证候积分方面优于单纯血液透析组,提高肌酐清除率(Ccr)、有效率方面联合组优于单纯血液透析组,差异具有统计学意义,但证据质量有待提高。两组的不良反应发生率未见统计学差异。发表偏倚检验及非参数剪布法结果提示血Scr、BUN指标存在偏倚,但偏倚结果对结果未造成影响。[结论]研究证明补肾活血法联合血液透析治疗慢性肾衰竭疗效显著,可以降低Scr、BUN、中医证候积分,提高Ccr水平,且未见不良反应增加。但需要更多高质量、大规模的研究来进一步验证。

超声清创联合负压封闭引流治疗糖尿病足溃疡的Meta分析与试验序贯分析

目的系统评价超声清创联合负压封闭引流(VSD)治疗糖尿病足溃疡(DFU)的有效性和安全性。方法计算机检索中国知网、万方数据知识服务平台、维普资讯中文期刊服务平台、PubMed、Web of Science、Embase、The Cochrane Library等数据库,纳入关于超声清创联合VSD治疗DFU的随机对照研究和队列研究。筛选文献并进行质量评价后,采用Stata/MP 17.0软件行Meta分析,采用TSA 0.9软件行试验序贯分析。结果共纳入16篇文献,包含1413例DFU患者,其中试验组(超声清创联合VSD)719例、对照组(常规清创联合VSD)694例。Meta分析结果显示:超声清创联合VSD的总有效率、视觉模拟量表(VAS)评分、住院时间、换药次数、细菌清除率、经皮氧分压和一般不良事件发生率、严重不良事件发生率优于常规清创联合VSD(P<0.05)。试验序贯分析结果提示研究结果具有稳健性。结论与常规清创联合VSD相比,超声清创联合VSD治疗DFU可获得更高的总有效率,更好地改善创面感染情况和组织氧供,缩短住院时间和减少换药次数,总体安全性更好。

基于GRADE证据质量评级的小青龙汤治疗过敏性鼻炎系统评价与试验序贯分析

目的:系统评价小青龙汤治疗过敏性鼻炎的临床疗效和安全性,分析证据质量,验证研究结果的可信度。方法:检索中国知网、万方数据库、维普中文期刊服务平台、中国生物医学文献数据库、PubMed、Web of Science、The Cochrane Library等数据库中从建库至2023年7月31日小青龙汤治疗过敏性鼻炎的文献。对所得文献进行筛选、资料提取和评估,使用RevMan5.3软件进行Meta分析,使用Stata 16.0软件进行敏感性分析,使用TSA V0.9软件进行试验序贯分析,使用GRADEpro软件对结局指标进行证据质量评级。结果:纳入20篇随机对照试验(Randomized Controlled Trial,RCT),患者1 723例。Meta分析结果显示,试验组比对照组有更好的临床疗效[相对危险度(RR)=1.19,95%置信区间(CI)(1.14,1.25),P <0.000 01]。试验组在降低半年复发率[RR=0.50, 95%CI (0.32,0.78),P=0.002],降低鼻塞[加权均数差(WMD)=-0.20,95%CI(-0.26,-0.13),P <0.000 01]、流涕[WMD=-0.09,95%CI(-0.15,-0.03),P=0.004]、喷嚏[WMD=-0.21,95%CI(-0.28,-0.13),P <0.000 01]等症状积分及体征积分[WMD=-0.25,95%CI(-0.37,-0.14),P <0.000 1]和血清白细胞介素-4水平[WMD=-4.23,95%CI(-7.22,-1.23),P=0.006]方面均优于对照组。试验序贯分析进一步肯定了小青龙汤治疗过敏性鼻炎的疗效。GRADE证据质量分级显示,临床有效率、不良反应发生率、鼻痒积分为低质量证据,其余均为极低质量证据。结论:小青龙汤治疗过敏性鼻炎安全有效,但需要纳入更高质量的临床研究进一步验证。

重复经颅磁刺激联合阿戈美拉汀治疗抑郁症有效性与安全性的Meta分析与试验序贯分析

目的系统评价重复经颅磁刺激(rTMS)联合阿戈美拉汀治疗抑郁症的有效性与安全性。方法计算机检索PubMed、Embase、Cochrane Library、Web of Science、CNKI、VIP、WanFang Data、SinoMed和Yiigle数据库,搜集rTMS联合阿戈美拉汀(联合组)对比阿戈美拉汀单用或联合伪刺激(对照组)治疗抑郁症的随机对照试验(RCT)。检索时限均为建库至2024年5月10日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.4软件进行Meta分析,采用GRADE分级系统评价结局指标的证据级别,采用TSA 0.9.5.1 Beta软件进行试验序贯分析。结果共纳入15个RCT,包括1196例患者。Meta分析结果显示,与对照组相比,联合组患者的有效率较高[RR=1.24,95%CI(1.15,1.34),P<0.001],抑郁量表评分[SMD=-2.95,95%CI(-3.71,-2.19),P<0.001]、焦虑量表评分[SMD=-2.21,95%CI(-3.29,-1.14),P<0.001]、匹兹堡睡眠量表(PSQI)评分[MD=-1.69,95%CI(-2.79,-0.59),P=0.003]较低;而两组患者的去甲肾上腺素(NE)水平、5-羟色胺(5-HT)水平、不良反应发生率差异均无统计学意义(P>0.05)。GRADE证据分级结果显示,有效率、不良反应发生率的证据等级为中等质量;抑郁量表评分、NE水平的证据等级为低质量;焦虑量表评分、PSQI评分、5-HT水平的证据等级为极低质量。试验序贯分析结果显示,联合组患者的有效率优于对照组的分析结果较为可靠,结论排除假阳性的可能。结论rTMS联合阿戈美拉汀治疗抑郁症在有效率、抑郁量表评分、焦虑量表评分和PSQI评分方面优于阿戈美拉汀单用或联合伪刺激,不良反应发生率与阿戈美拉汀单用或联合伪刺激等同。

电针治疗卒中后失眠Meta分析与试验序贯分析

目的:系统评价电针治疗卒中后失眠的临床疗效。方法:检索中国知网(CNKI)、万方数据知识服务平台(万方数据)、中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM)、PubMed、Web of Science、Embase、Cochrane Library等数据库中以电针为主要治疗措施治疗卒中后失眠的随机对照试验(RCTs)文献,检索时限为建库至2023年10月31日。对纳入文献进行数据提取,采用Cochrane RoB 2.0风险偏倚评价工具对纳入研究进行评价,Review Manager 5.4.1软件进行Meta分析,TSA 0.9.5.10 Beta软件进行试验序贯分析。结果:共纳入8项研究,涉及516例患者。Meta分析结果显示,在总有效率方面,电针联合传统针刺优于传统针刺[RR=1.14, 95%CI (1.03, 1.27), Z=2.41, P=0.02],电针与药物比较差异无统计学意义[RR=1.11,95%CI (0.92,1.33),Z=1.10,P=0.27],电针联合药物优于药物[RR=1.21,95%CI (1.02,1.43),Z=2.21,P=0.03]。在降低匹兹堡睡眠质量指数(PSQI)总分方面,电针联合传统针刺优于传统针刺[MD=-1.61,95%CI (-2.21,-1.01),Z=5.22,P<0.001],电针与药物比较差异无统计学意义[MD=-3.01,95%CI (-6.61,0.59),Z=1.64,P=0.10],电针联合药物优于药物[MD=-1.65,95%CI (-2.02,-1.28),Z=8.85,P<0.001]。在改善神经功能缺损方面,电针联合传统针刺优于传统针刺[MD=-1.65,95%CI (-2.18,-1.12),Z=6.10,P<0.001]。在改善抑郁程度方面,电针联合传统针刺优于传统针刺[MD=-1.42,95%CI (-2.23,-0.61),Z=3.44,P<0.001]。经敏感性分析验证,本研究关于总有效率的Meta分析结果稳定。试验序贯分析结果显示,在总有效率方面,电针联合传统针刺优于传统针刺的分析结果较为稳健,结论可排除假阳性;电针与药物比较无明显差异的分析结果需要纳入更多试验来验证;电针联合药物优于药物的分析结果需要纳入更多试验以排除假阳性结论。结论:在治疗卒中后失眠疗效方面,电针联合传统针刺优于传统针刺,电针联合药物优于药物。结论有待更多高质量的RCTs支持。

Efficacy and safety of the heated gel mattress for prevention of hypothermia in preterm infants during intra-hospital transport： a meta-analysis

Objective： To evaluate the efficacy and safety of the heated gel mattress for prevention of heat loss on preterm infants with hypothermia during the transport systematically and objectively. Methods： Systematic searches on PubMed, EM- BASE, Cochrane Library, Web of Science, CBM, CNKI, Wanfang and VIP were performed for randomized controlled trials （RCTs） or quasi-RCTs which explored the effects of heated gel mattress on prevention of hypothermia in premature infants relative to conventional alternatives. Studies were screened according to inclusion and exclusion criteria, extracted data and assessed quality. Then, meta-analysis and trial sequential analysis were performed by RevMan 5.3 and TSA vO.9 software developed at the Copenhagen Clinical Trials Center in Denmark, independently. Results： This systematic review included 10 studies which comprised 7 RCTs and 3 quasi-RCTs, encompassing 773 patients. The results of meta-analysis showed that in heated gel mattress group admission temperature on neonatal intensive care unit （SMD, 0.63; 95% CI, 0.40 to 0.87; P = 0.00）, incidence of hypothermia （RR, 0.73; 95% CI, 0.57 to 0.93; P = 0.01） and hyperthermia （RR, 1.82; 95% CI, 1.31 to 2.541 P = 0.00） compared with the control group had significantly statistical difference; however, there was no significant difference in admission temperature on exothermic mattresses or TransWarmer mattress group, mortality, sepsis, retinopathy of prematurity, intraventricular hemorrhage Ⅲ/Ⅳ between two groups, trial sequential analysis confirmed that the pooled results of admission temperature on neonatal intensive care unit and hyperthermia were stable and reliable; but the combination of low-temperature incidence and mortality indicators suggested that the sample size was insufficient. Conclusion： Heated gel mattress is a safe and effective re- warming intervention that can improve body temperature of hypothermic preterm infants during transport, reduce the incidence of hypothermia and does not increase the incidence of morbidity and complications. However, it is recommended that clinical monitoring of body temperature should be performed dynamically to decrease the potential risk of high fever. In addition, due to the limitation of quantity and quality of included studies, its cost-effectiveness and far-reaching influence on long-term follow-up outcomes need further evaluation through clinical multicenter, large sample, and high-quality research.

真武汤合血府逐瘀汤加减治疗慢性心力衰竭的Meta分析及试验序贯分析

目的 系统评价真武汤合血府逐瘀汤加减治疗慢性心力衰竭(CHF)的临床疗效。方法 计算机检索从建库至2022年3月1日万方数据库(Wanfang)、维普数据库(VIP)、中国知网(CNKI)、Cochrane Library、Web of Science、PubMed等数据库发表的所有关于真武汤合血府逐瘀汤加减治疗CHF的文献。纳入文献质量参照Cochrane评估标准评价,使用RevMan 5.4及TSA 0.9.5.10 Beta软件分别对数据进行Meta分析和试验序贯分析(TSA)。结果 纳入20项真武汤合血府逐瘀汤加减治疗CHF的随机对照研究,共计1 619例患者。与对照组比较,试验组(真武汤合血府逐瘀汤加减结合西医常规治疗)的临床疗效[RR=1.23,95%CI=(1.18,1.29),P<0.000 01]、左室射血分数[WMD=7.59,95%CI=(5.53,9.64),P<0.000 01]、心脏指数[WMD=0.32,95%CI=(0.25,0.39),P<0.000 01]显著提高,左室舒张末期内径缩小[WMD=-2.30,95%CI=(-2.41,-2.18),P<0.000 01],B型利钠肽[WMD=-25.47,95%CI=(-26.93,-24.02),P<0.000 01]及氨基末端脑钠肽前体[WMD=-281.44,95%CI=(-406.06,-156.83),P<0.000 01]降低,6 min步行距离明显增加[WMD=69.40,95%CI=(59.93,78.86),P<0.000 01],药物不良反应明显减少[RR=0.29,95%CI=(0.15,0.56),P=0.000 2]。试验序贯分析进一步证实了其临床疗效,排除了假阳性。结论 真武汤合血府逐瘀汤结合西医常规治疗CHF的临床疗效优于单纯西医常规治疗,且临床不良反应少。鉴于纳入文献的质量一般,上述结果尚需更多高质量、大样本的临床随机对照试予以证实。

浮针治疗带状疱疹后遗神经痛随机对照试验的Meta分析和试验序贯分析

【目的】运用Meta分析方法评价浮针治疗带状疱疹后遗神经痛的临床疗效。【方法】计算机检索中国知网期刊全文数据库(CNKI)、万方学术期刊全文数据库(Wanfang)、维普中文科技期刊数据库(VIP)、中国生物医学数据库(CBM)、美国生物医学信息检索系统(PubMed)、荷兰医学文摘(Embase)、国际循证医学图书馆(Cochrane Library)、科学网(web of science)等各大数据库中公开发表的有关浮针治疗带状疱疹后遗神经痛的随机对照试验(RCT)研究文献。对文献进行筛选、提取数据并进行质量评价,应用RevMan 5.3软件对文献进行Meta分析,运用TSA 0.9软件对有效率行试验序贯分析。【结果】最终共纳入13项研究进行Meta分析,纳入带状疱疹后遗神经痛研究对象共计955例。Meta分析结果显示,浮针组治疗带状疱疹后遗神经痛在总有效率[OR=4.11,95%CI(2.57,6.58),Z=5.90,P<0.00001]、愈显率[OR=3.49,95%CI(2.54,4.79),Z=7.71,P<0.00001]、视觉模拟量表(VAS)评分[MD=-1.41,95%CI(-1.66,-1.16),P<0.00001]、疼痛面积[MD=-37.12,95%CI(-42.47,-31.77),Z=13.59,P<0.00001]方面,均优于对照组。序贯分析提示,浮针治疗带状疱疹后遗神经痛总有效率纳入的研究同时穿过TSA界值与传统界值,进一步肯定浮针治疗带状疱疹后遗神经痛的临床疗效。【结论】浮针疗法可以有效缓解带状疱疹后遗神经痛的症状,但本研究所纳入文献的数量较少,缺乏更多高质量文献佐证,因此在今后临床试验中仍需进一步加以验证。

脂蛋白(a)水平与心房颤动发病风险相关性的Meta分析和试验序贯分析

目的:探讨脂蛋白(a)水平[Lp(a)]与心房颤动(房颤)发病风险的相关性。方法:检索PubMed、Embase、Cochrane图书馆、中国知网、万方数据库、维普网和中国生物医学文献数据库,收集评估Lp(a)水平与房颤发病风险相关性的队列研究。采用Stata 16.0软件进行Meta分析,采用Stata 16.0和R 4.1.1软件对房颤发病风险的时间-事件数据进行试验序贯分析(TSA)。结果:共纳入5项队列研究,包括489351例受试者。Meta分析显示,血清Lp(a)水平最高者与最低者相比,房颤发病风险并未显著增加(合并RR=0.92,95%CI:0.78~1.09,P=0.349)。但在受试者平均年龄≥62岁的研究中,Lp(a)水平高(≥29.9 mg/dl)与房颤发病风险降低有关(RR=0.85,95%CI:0.75~0.96,P=0.008)。TSA结果表明,当前Meta分析结果稳健,即可得出Lp(a)水平与房颤发病风险无关联的阴性结论。结论:本Meta分析表明,总体上,Lp(a)水平与房颤发病风险无关联,但在年龄≥62岁的人群中,Lp(a)水平与房颤发病风险呈负相关。