基于GRADE证据质量评级的针灸治疗产后痹的Meta分析与试验序贯分析

A Meta-analysis and experimental sequential analysis of acupuncture and moxibustion treatment for postpartum arthralgia based on GRADE evidence quality rating

目的:对针灸治疗产后痹的临床随机对照试验进行Meta分析与试验序贯分析,借此评价其临床疗效与安全性。方法:计算机检索七大中英文数据库,涵盖中国知网、万方数据知识服务平台、维普中文科技期刊数据库、CBM、Embase、PubMed、Cochrane Library,检索建库至2022年4月7日的针灸治疗产后痹的临床随机对照试验文献。文献采用EndNote软件管理,文献质量运用Cochrane风险偏倚工具评价;Meta分析结果采用RevMan5.3软件合并,Meta分析结果的稳定性使用Stata 16.0软件进行敏感性分析;结局指标临床有效率采用TSA v0.9软件进行试验序贯分析,采用GRADE系统对结局指标的证据质量进行评级。结果:共纳入18项临床随机对照试验,合计1438例产后痹患者。Meta分析结果表明,针灸治疗产后痹可显著提高本病的临床有效率,且优于对照组[RR=1.20,95%CI(1.14,1.25)],亦能改善视觉模拟评分法(Visual Analogue Scale,VAS)疼痛评分[WMD=-1.44,95%CI(-1.76,-1.12)]、腰痛Oswestry功能障碍指数(Oswestry Disability Index,ODI)评分[WMD=-7.16,95%CI(-8.55,-5.76)]、肢体酸痛中医症状积分[WMD=-0.70,95%CI(-0.93,-0.46)]、肢体麻木中医症状积分[WMD=-0.54,95%CI(-0.64,-0.44)]、治疗后复发率[RR=0.27,95%CI(0.11,0.65)],组间差异具有统计学意义。文献质量评价结果显示,多数纳入研究的方法学质量较低。试验序贯分析表明,目前累计样本量已经达到研究期望值。GRADE证据评级结果提示,针灸治疗产后痹的相关结局指标的证据质量评级为中级、低级以及极低级。结论:针灸治疗产后痹具有较好的安全性且疗效确切。但鉴于部分纳入研究的方法学设计有所欠缺,尚需更多高质量的临床随机对照试验来证明这一结论。

Objective:To evaluate the clinical efficacy and safety of acupuncture in the treatment of postpartum arthralgia in clinical randomized controlled trials by Meta-analysis and trial sequential analysis.Methods:Senen Chinese and English databases including CNKI,WANFANG,VIP,CBM,Embase,PubMed,and Cochrane Library were searched by computer,and the clinical randomized controlled trials(RCTs)of acupuncture and moxibustion for the treatment of postpartum arthralgia from April 7,2022 were searched.EndNote software was used for literature management.Literature quality was assessed using the Cochrane risk bias tool.The results of Meta-analysis were combined by RevMan 5.3 software.The stability of Meta-analysis results was analyzed by sensitivity analysis using Stata 16.0 software.Outcome index,clinical effective rate,was analyzed in sequence using TSA v0.9 software.The quality of evidence for outcome measures was rated using the GRADE system.Results:A total of 18 clinical RCTs were included in the study,covering 1438 patients with postpartum arthralgia.The results of the Meta-analysis showed that acupuncture treatment of postpartum arthralgia could significantly improve the clinical effective rate of the disease,which was superior to that in the control group[RR=1.20,95%CI(1.14,1.25)],and it could also ameliorate the VAS pain score[WMD=-1.44,95%CI(-1.76,-1.12)],ODI score of low back pain[WMD=-7.16,95%CI(-8.55,-5.76)],TCM symptom score of limb soreness[WMD=-0.70,95%CI(-0.93,-0.46)],TCM symptom score of limb numbness[WMD=-0.54,95%CI(-0.64,-0.44)],and recurrence rate after treatment[RR=0.27,95%CI(0.11,0.65)].Literature quality evaluation results showed that the methodological quality of most included studies was low.The experimental sequential analysis showed that the cumulative sample size had reached the expected value of the study.The GRADE evidence rating results suggested that the quality of evidence for outcome measures related to acupuncture treatment for postpartum arthralgia was rated as intermediate,low,and extremely low.Conclusion:Acupuncture treatment of postpartum arthralgia has a good safety and curative effect.However,due to the deficiencies in the methodological design of some included studies,more high-quality clinical randomized controlled trials are needed to prove this conclusion.