桂枝茯苓胶囊(丸)联合曼月乐治疗子宫腺肌病疗效及安全性的Meta分析  

Meta-analysis of the Efficacy of Guizhi Fuling Capsules(Pills)Combined with Levonorgestrel Intrauterine System on Adenomyosis

作　　者：向利珠 侯璐瑶 周兰 黄芳婷 任一华 黄文玲[1] 黄海涛[1] XIANG Lizhu;HOU Luyao;ZHOU Lan;HUANG Fangting;REN Yihua;HUANG Wenling;HUANG Haitao(Dongfang Hospital of Beijing University of Chinese Medicine,Beijing 100078,China)

机构地区：[1]北京中医药大学第二临床医院东方医院,北京100078

出　　处：《世界中医药》2022年第13期1902-1910,共9页World Chinese Medicine

基　　金：国家自然科学基金青年科学基金项目(81704112)——基于线粒体能量代谢研究补肾调肝法防治卵巢衰老的机制;北京市科技计划项目-首都特色临床研究(Z141107002514147)——针药结合治疗卵巢储备功能下降的临床研究。

摘　　要：目的:系统评价桂枝茯苓胶囊(丸)联合曼月乐治疗子宫腺肌病的疗效和安全性。方法:运用计算机检索国家知识基础设施数据库、中国学术期刊数据库、中文科技期刊数据库、中国生物医学文献数据库、PubMed、The Cochrane Library、The Web of Science、Springer等中英文数据库从建库至2020年5月关于桂枝茯苓胶囊(丸)联合曼月乐治疗子宫腺肌病的随机对照试验和临床对照试验。应用Revman5.3软件进行Meta分析。结果:经筛选,纳入12篇文献,共1206例患者。Meta分析结果显示:桂枝茯苓胶囊(丸)联合曼月乐治疗子宫腺肌病临床总有效率更高(OR=3.31,95%Cl为2.12~5.18,P<0.00001),并能减轻痛经程度:慢性疼痛分级问卷法评分方法(MD=-0.46,95%CI为-0.62~-0.29,P<0.00001)和VAS评分方法(MD=-1.75,95%CI为-2.01~-1.49,P<0.00001),减少月经量(MD=-15.47,95%CI为-20.20~-10.73,P<0.00001),使子宫内膜厚度变薄(MD=-15.47,95%CI为-2.14~-2.38,P<0.00001),子宫体积缩小(MD=-16.23,95%CI为-19.45~-13.02,P<0.00001),降低血清促卵泡素(FSH)(MD=-1.30,95%CI为-1.86~-0.74,P<0.00001)、黄体生成素(LH)(MD=-1.18,95%CI为-1.37~-1.00,P<0.00001)和血清CA125水平(MD=-9.68,95%CI为-12.83~-6.54,P<0.00001),降低不良反应发生率(OR=0.53,95%CI为0.29~0.94,P=0.03)。结论:桂枝茯苓胶囊(丸)联合曼月乐治疗子宫腺肌病疗效优于单用曼月乐组,不良反应发生率低于单用曼月乐组。受纳入文献的数量和质量的限制,将来需要更大样本和高质量的研究文献,对二者联合治疗子宫腺肌病有更精确的评估。Objective:To evaluate the efficacy and safety of Guizhi Fuling Capsules(Pills)combined with levonorgestrel intrauterine system(LIS)in the treatment of patients with adenomyosis.Methods:Randomized controlled trials(RCTs)and clinical trials(CCTs)on the treatment of adenomyosis with Guizhi Fuling Capsules(Pills)and LIS were retrieved from China National Knowledge Infrastructure(CNKI),VIP,China Biology Medicine disc(CBMdisc),PubMed,The Cochrane Library,The Web of Science,Springer,and other databases(from inception to May of 2020).Revman5.3 was employed for Meta-analysis of the extracted data.Results:A total of 10 RCTs and 2 CCTs were screened out,involving 1206 patients.The Meta-analysis showed that Guizhi Fuling Capsules(Pills)combined with LIS demonstrated higher total effective rate in the treatment of adenomyosis(OR=3.31,95%CI=2.12 to 5.18,P<0.00001).Moreover,the combination alleviated the dysmenorrhea with decrease in chronic pain grade questionnaire score(MD=-0.46,95%CI=-0.62 to-0.29,P<0.00001)and Visual Analogue Scale(VAS)score(MD=-1.75,95%CI=-2.01 to-1.49,P<0.00001)and reduced menstrual blood volume(MD=-15.47,95%CI=-20.20 to-10.73,P<0.00001),endometrial thickness(MD=-15.47,95%CI=-2.14 to-2.38,P<0.00001),uterine volume(MD=-16.23,95%CI=-19.45 to-13.02,P<0.00001),serum follicle-stimulating hormone(FSH)(MD=-1.30,95%CI=-1.86 to-0.74,P<0.00001),serum luteinizing hormone(LH)(MD=-1.18,95%CI=-1.37 to-1.00,P<0.00001),serum CA125(MD=-9.68,95%CI=-12.83 to-6.54,P<0.00001),and the incidence of adverse reactions(OR=0.53,95%CI=0.29 to 0.94,P=0.03).Conclusion:The combination Guizhi Fuling Capsules(Pills)and LIS is superior to LIS alone in the treatment of adenomyosis,and the incidence of adverse reactions is lower than that of LIS alone.In the future,large-scale samples and high-quality articles should be included to further evaluate the combination.

关 键 词：桂枝茯苓胶囊(丸) 曼月乐 子宫腺肌病 阴道不规则出血 疗效评价 安全性 不良反应 META分析 

分 类 号：R271.1[医药卫生—中医妇科学]