针刺治疗围绝经期综合征的系统评价及GRADE证据质量评价＊

目的 评价针刺治疗围绝经期综合征（Perimenopausal syndrome,PMS）的疗效、安全性及相关随机对照试验证据水平。方法 检索主要中英文数据库,收集针刺治疗PMS的随机对照研究,检索时间为2008.01.01-2018.12.31,主要结局指标为治疗总有效率,次要结局指标为Kupperman指数、更年期评定量表、潮热评分,对纳入文献进行质量评价,用RevMan5.3软件进行Meta分析,并按照GRADE标准进行证据质量评价。结果 共纳入30篇文章,共计2767例病例。1.Meta分析结果提示：针刺治疗PMS总有效率优于西药组［OR =3.72,95%CI （2.57,5.46）,P<0.0001］及中药组［OR=8.54,95%CI （3.72,19.58）,P<0.0001］,差异有统计学意义;针刺对比西药［MD=-3.53,95% CI（-4.12,-2.93）,P<0.0001］、中药［MD=-0.43,95% CI（-0.82, 1.67）,P<0.0001］能明显降低Kupperman指数评分,针刺对照西药差异有统计学意义;针刺较假针刺能降低潮热发作评分［MD=-0.30,95% CI（-0.79,0.19）,P=0.23］,差异无统计学意义;针刺较假针刺能降低更年期评分量表得分 ［MD=-0.72,95%CI（-2.47,1.03）,P=0.53］,差异无统计学意义。2.不良反应：18篇研究提及不良反应,且都未见严重不良反应,12篇未提及。3.根据GRADE方法评价,总有效率及潮热发作评分证据质量为低级,其余为极低级。结论 针刺较药物（中、西药）治疗围绝经期综合征具有更好的疗效,但受纳入研究证据质量的限制,上述结论尚需开展更多高质量的研究予以验证,临床进行弱推荐。

Systematic Evaluation of Acupuncture Therapy for Perimenopausal Syndrome and GRADE Evidence Quality Evaluation

objective Evaluation of acupuncture treatment of Perimenopausal syndrome (Perimenopausal syndrome, PMS) of the efficacy, safety and related randomized controlled trial evidence level.Methods To retrieve database in both English and Chinese, mainly collected acupuncture therapy randomized controlled study of PMS, the retrieval time for 2008.01.01-2018.12.31, main outcome indicators for the total effective rate treatment, secondary outcome indicators for Kupperman index, the scale for assessment of menopause, hot flashes. The quality of the included literature was evaluated, meta-analysis was conducted with RevMan5.3 software, and the quality of evidence was evaluated according to GRADE standard.Results A total of 30 articles were included, with a total of 2767 cases. 1. Meta analysis showed that the total effective rate of acupuncture treatment on PMS was better than that of western medicine group OR = 3.72, 95%ci (2.57,5.46), P < 0.0001] and Chinese medicine group OR = 8.54, 95%ci (3.72,19.58), P < 0.0001], with statistically significant differences. Compared with western medicine MD = -3.53, 95%ci (-4.12,-2.93), P < 0.0001] and Chinese medicine MD = -0.43, 95%ci (-0.82,1.67), P < 0.0001], acupuncture significantly reduced the score of Kupperman index. Compared with sham acupuncture, acupuncture could reduce the score of hot flashes MD = -0.30, 95%ci (-0.79,0.19), P = 0.23], and the difference was not statistically significant. Compared with sham acupuncture, acupuncture can reduce the score of menopause scale MD = -0.72, 95%CI (-2.47,1.03), P = 0.53], and the difference is not statistically significant. 2. Adverse reactions: adverse reactions were mentioned in 18 studies, and no serious adverse reactions were found, while 12 studies were not mentioned. 3. According to GRADE method evaluation, the evidence quality of total effective rate and hot flashes attack score was low, and the rest was extremely low.Conclusion Acupuncture has better efficacy than drugs (Chinese and western) in treating perimenopausal syndrome. However, due to the limitation of the quality of evidence included in the study, the above conclusions need to be verified by more high-quality studies and weakly recommended clinically.