陈琦 尹仁芳 张君冬 杨硕

摘要：目的  基于Meta分析系统评价当归四逆汤治疗原发性痛经的疗效与安全性，为临床治疗原发性痛经提供依据。方法  计算机检索中国知识资源总库（CNKI）、中国学术期刊数据库（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、Cochrane Library和Web of Science数据库，收集当归四逆汤治疗原发性痛经的随机对照试验（RCT），检索时间范围自建库至2020年10月。由2名研究者独立筛选文献，提取资料，采用Cochrane Handbook 5.3的风险评估工具评价纳入文献的偏倚风险，采用RevMan 5.3软件对临床疗效进行统计分析。结果  共纳入文献13篇，涉及患者1311例。Meta分析结果显示：当归四逆汤单独加减使用或配合艾灸、电磁波治疗仪治疗总有效率优于常规西药（RR=1.26，95%CI[1.18，1.34]，Z=7.31，P<0.000 01）、中成药（RR=1.40，95%CI[1.24，1.58]，Z=5.35，P<0.000 01），差异有统计学意义;且试验组较对照组复发率低（RR=0.21，95%CI[0.09，0.50]，Z=3.55，P=0.000 4）、疼痛程度减轻（MD=-3.35，95%CI[-3.77，-2.93]，Z=15.58，P<0.000 01）、不良反应少。结论  当归四逆汤治疗原发性痛经疗效优于常规疗法，且不良反应少，但纳入的研究多数存在随机方法不明、分配隐藏不明、盲法不明、结局数据不完整等问题，总体质量不高，仍需要更多高质量RCT进一步验证。

关键词：原发性痛经;当归四逆汤;系统评价;Meta分析

中圖分类号：R2-05    文献标识码：A    文章编号：2095-5707（2021）03-0025-06

DOI： 10.3969/j.issn.2095-5707.2021.03.005        开放科学（资源服务）标识码（OSID）：

Efficacy of Danggui Sini Decoction for Primary Dysmenorrhea： A Meta-Analysis

CHEN Qi， YIN Ren-fang， ZHANG Jun-dong， YANG Shuo*

（Institute of Information on Traditional Chinese Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China）

Abstract： Objective To systematically evaluate the efficacy and safety of Danggui Sini Decoction in the treatment of primary dysmenorrhea based on Meta-analysis; To provide basis for clinical treatment of primary dysmenorrhea. Methods The databases of CNKI， Wang Fang， VIP， CBM， PubMed， Cochrane Library and Web of Science were retrieved by computer to collect RCTs of Danggui Sini Decoction in the treatment of primary dysmenorrhea. The retrieval time was from the establishment of the databases to October， 2020. Two researchers independently screened the literature and extracted data. The risk assessment tool of Cochrane Handbook 5.3 was used to evaluate the risk of bias in the included literature， and RevMan 5.3 software was used to conduct statistical analysis of clinical efficacy. Results Totally 13 RCTs were included， involving 1293 patients. Meta-analysis results showed that the total effective rate of Danggui Sini Decoction （used alone or combined with other therapies， such as moxibustion and electromagnetic wave therapy instrument） for primary dysmenorrhea was better than Western routine medicine （RR=1.26， 95%CI [1.18， 1.34]， Z=7.31， P<0.000 01）， and Chinese patent medicine （RR=1.40， 95%CI [1.24， 1.58]， Z=5.35， P<0.000 01）， with statistical significance; moreover， the recurrence rate of the experimental group was lower than that of the control group （RR=0.21， 95%CI [0.09， 0.50]， Z=3.55， P=0.000 4）， and the degree of pain was reduced （MD=-3.35， 95%CI [-3.77， -2.93]， Z=15.58， P<0.000 01）， with few adverse reactions. Conclusion The efficacy of Danggui Sini Decoction in treating primary dysmenorrhea is better than that of conventional therapy and the therapy has fewer adverse reactions. However， most of the studies included in this article have problems such as unclear randomization methods， unclear allocation concealment， unclear blind method， and incomplete outcome data， so the quality of included literature is not high. Therefore， more high-quality RCTs are needed for further verification.

Key words： primary dysmenorrhea; Danggui Sini Decoction; systematic review; Meta-analysis

痛经是常见的妇科疾病，一般分为原发性痛经和继发性痛经。原发性痛经又称为功能性痛经，是指女性在生殖器并无病变的情况下，在经期发生腹部疼痛、坠胀，伴有恶心、呕吐、腹泻等症状的疾病，为内分泌失调所致[1]。症状严重者不仅影响生活和学习，还给患者带来了心理压力。现代医学认为，经期前子宫内膜前列腺素（PG）和白细胞介素（IL）分泌过多，促进子宫不断收缩，导致子宫血流量减少，这个过程产生的酸性代谢物在子宫肌层堆积，刺激神经末梢，产生疼痛感[2]，子宫的进一步收缩也会刺激PG释放，如此循环。目前，西医对原发性痛……