中国中药杂志

2020, v.45(21) 5083-5092

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针刺对比氟桂利嗪治疗偏头痛有效性及安全性评价:随机对照试验的系统评价及Meta分析
Systematic review and Meta-analysis on randomized controlled trial of efficacy and safety for acupuncture versus Flunarizine in treatment of migraine

贾敏;张允岭;鲁喦;廖星;梁晓;魏竞竞;陈倩;付国静;雷林;
JIA Min;ZHANG Yun-ling;LU Yan;LIAO Xing;LIANG Xiao;WEI Jing-jing;CHEN Qian;FU Guo-jing;LEI Lin;Xiyuan Hospital, China Academy of Chinese Medical Sciences;Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;Graduate School, Beijing University of Chinese Medicine;

摘要(Abstract):

为系统评价针刺对比氟桂利嗪治疗偏头痛的疗效和安全性,该研究检索四大中文数据库(CNKI,VIP,WanFang,CBM),三大英文数据库(Cochrane Library,EMbase,Medline)和ClinicalTrials.gov,检索时间为各数据库建库至2020年1月8日。按照设定的纳入标准和排除标准筛选出针刺对比氟桂利嗪治疗偏头痛的随机对照试验(randomized controlled trial,RCT)。采用"Cochrane偏倚风险评估"工具对所纳入的研究进行评价,应用RevMan 5.3对纳入研究进行Meta分析,并采用GRADE系统对结局指标证据进行质量的评价和推荐强度的分级。最终纳入23个研究,除4个多臂试验外,总样本量1 548例,针刺组785例,氟桂利嗪组763例。纳入研究总体质量不高。Meta分析结果显示,减少头痛频率方面,针刺组优于氟桂利嗪组(SMD=-1.00,95%CI[-1.45,-0.54],P<0.000 1);减轻头痛强度方面,针刺组优于氟桂利嗪组(SMD=-1.05,95%CI[-1.41,-0.68],P<0.000 01);减少头痛持续时间方面,针刺组优于氟桂利嗪组(SMD=-1.42,95%CI[-1.83,-1.02],P<0.000 1);减少服用止痛药频率方面,针刺组优于氟桂利嗪组(MD=-0.17,95%CI [-0.21,-0.13],P<0.000 01);减轻发作伴随症状方面,针刺组优于氟桂利嗪组(SMD=-0.94,95%CI[-1.35,-0.52],P<0.000 1);GRADE系统显示以上结局指标证据级别均为极低,推荐意见为弱推荐。不良反应发生方面,纳入研究针刺组报告的不良反应均为轻度不良反应。故现有证据表明针刺较氟桂利嗪治疗偏头痛成年患者有较好的疗效。但鉴于纳入研究偏倚风险较高,需谨慎使用该研究的结论,今后需开展更多高质量研究予以验证。
To systematically evaluate the efficacy and safety of acupuncture versus Flunarizine hydrochloride in the treatment of migraine. Four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Cochrane Library, EMbase, Medline) and ClinicalTrail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to January 8, 2020. Randomized controlled trial(RCT) for acupuncture versus Flunarizine in the treatment of migraine were screened out according to inclusion criteria and exclusion criteria. The included studies were evaluated with the Cochrane bias risk assessment tool. The included studies was conducted by RevMan 5.3, and the outcome indicators were evaluated for evidence quality and strength of recommendation by the GRADE system. A total of 1 033 literatures were retrieved, and 23 studies were finally included. Except for 4 multiarm tests, the total sample size was 1 548, including 785 in acupuncture group and 763 in Flunarizine group. The overall quality of the included studies was not high. Meta-analysis results showed that the acupuncture group was superior to the Flunarizine group in reduction of headache frequency(SMD=-1.00, 95%CI[-1.45,-0.54], P<0.000 1). In reduction of headache intensity, acupuncture group was superior to Flunarizine group(SMD=-1.05, 95%CI[-1.41,-0.68], P<0.000 01). In reduction of headache duration, acupuncture group was superior to Flunarizine group(SMD=-1.42, 95%CI[-1.83,-1.02], P<0.000 1). The acupuncture group was superior to Flunarizine group(MD=-0.17, 95%CI[-0.21,-0.13], P<0.000 01) in reduction of the painkillers taking frequency. The acupuncture group was superior to Flunarizine group(SMD=-0.94, 95%CI[-1.35,-0.52], P<0.000 1) in allevia-tion of paroxysmal symptoms, such as nausea and vomiting. The GRADE system showed that the evidence level of the above indicators was extremely low, and the strength of recommendation was low. As for the occurrence of adverse reactions, the adverse reactions reported in the acupuncture group included in the study were all mild adverse reactions, like drowsiness, subcutaneous bleeding, local pain, subcutaneous hematoma and dizziness needle. The available evidence showed that acupuncture has a better efficacy than Flunarizine hydrochloride in the treatment of migraine in adult patients. However, due to the high bias risk in the included studies, the conclusions of this study shall be adopted with caution, and more high-quality studies shall be carried out for verification in the future.

关键词(KeyWords): 针刺;氟桂利嗪;偏头痛;系统评价;Meta分析;GRADE系统
acupuncture;Flunarizine;migraine;systematic review;Meta-analysis;GRADE system

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金项目(81774159);; 中医药诊疗标准化关键技术研究项目(Z0479);; 国家中医药管理局中医药传承与创新“百千万”人才工程(岐黄学者-国家中医药领军人才支持计划)(国中医药人教发[2018]12号);; 中央级公益性科研院所基本科研业务费专项(ZZ13-024-3)

作者(Author): 贾敏;张允岭;鲁喦;廖星;梁晓;魏竞竞;陈倩;付国静;雷林;
JIA Min;ZHANG Yun-ling;LU Yan;LIAO Xing;LIANG Xiao;WEI Jing-jing;CHEN Qian;FU Guo-jing;LEI Lin;Xiyuan Hospital, China Academy of Chinese Medical Sciences;Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;Graduate School, Beijing University of Chinese Medicine;

Email:

DOI: 10.19540/j.cnki.cjcmm.20200521.502

参考文献(References):

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