摘要
目的系统评价补肾活血散瘀汤治疗卵巢子宫内膜异位症(OEM)的有效性和安全性。方法网络检索Web of science、PubMed、知网、万方、维普等中英文数据库建库以来至2021年1月收录的补肾活血散瘀汤治疗OEM的随机对照试验(RCTs),采用RevMan 5.3软件进行Meta分析,同时对有效率进行试验序贯分析(TSA),应用GRADEprofiler 3.6.1进行证据质量评价。结果共纳入5项RCT,共计352例患者,Meta分析结果为补肾活血散瘀汤治疗OEM在有效率[RR=1.13,95%CI(1.04,1.22),P=0.003]、降低痛经积分[SMD=0.98,95%CI(0.67,1.28),P<0.00001]和降低中医证候积分[SMD=0.61,95%CI(0.38,0.84),P<0.00001]方面优于米非司酮,而在治愈率[RR=1.17,95%CI(0.72,1.89),P=0.52]、降低CA125水平[SMD=0.39,95%CI(-0.19,0.98),P=0.19]以及缩小囊肿最大横截面积[MD=0.02,95%CI(-1.49,1.53),P=0.98]与米非司酮没有统计学差异。TSA结果显示在有效率方面证据较为确切,GRADE证据评价结果为在有效率、降低中医证候积分和降低CA125水平方面证据为中等质量,在治愈率、减小囊肿最大横截面积方面证据为低质量,而在降低痛经积分证据为极低质量。结论补肾活血散瘀汤治疗OEM在有效率、降低中医证候积分、降低痛经积分以及不良反应方面较米非司酮表现更好,具有一定的临床应用价值。但限于证据质量,上述结论仍需大样本高质量的RCT进一步证实。
Objective To systematically evaluate the clinical efficacy and safety of Bushen Huoxue Sanyu Decoction(补肾活血散瘀汤)in the treatment of ovarian endometriosis(OEM).Methods To search for RCTs about Bushen Huoxue Sanyu Decoction treating OEM from Web of science,PubMed,CNKI,Wan Fang,and VIP from their establishment to January 2021.The RevMan5.3 software was used to conduct Meta-analysis of the outcome indicators,the trial sequential analysis(TSA)was performed on the effective rate,and the GRADEprofiler3.6.1 software was used to evaluate the quality of evidence.Results A total of 5 RCTs were included,involving 352 patients.The results of the Meta-analysis showed that Bushen Huoxue Sanyu Decoction more improved the effective rate[RR=1.13,95%CI(1.04,1.22),P=0.003],reduced traditional Chinese medicine syndrome score[SMD=0.61,95%CI(0.38,0.84),P<0.00001]and reduced dysmenorrhea score[SMD=0.98,95%CI(0.67,1.28),P<0.00001]than mifepristone(MIF),while in the cure rate[RR=1.17,95%CI(0.72,1.89),P=0.52],reducing CA125 level[SMD=0.39,95%CI(-0.19,0.98),P=0.19]and reducing ovarian cyst size[MD=0.02,95%CI(-1.49,1.53),P=0.98],Bushen Huoxue Sanyu Decoction was not statistically different with MIF.TSA result accepted that Bushen Huoxue Sanyu Decoction was more effective in the treatment of OEM.GRADE evidence evaluation result showed the certainty of evidence on the effective rate,traditional Chinese medicine syndrome score and CA125 level were of medium quality,that of the cure rate and ovarian cyst size were of low quality,and that of dysmenorrhea score was of very low quality.Conclusion The clinical efficacy and safety of Bushen Huoxue Sanyu Decoction in the treatment of ovarian endometriosis are relatively great.It can significantly reduce the traditional Chinese medicine syndrome scores and dysmenorrhea score,has fewer adverse reactions,and has certain clinical application value.However,due to the quality of evidence,the above conclusion still needs to be further confirmed by large sample and high quality RCTs.
作者
罗喜
范孝盈
李晓娟
张伶俐
LUO Xi;FAN Xiaoying;LI Xiaojuan;ZHANG Lingli(Hunan University of Chinese Medicine,Changsha 410208,Hunan,China;The First Affliated Hospital of Hunan Traditional Chinese Medicine College/Hunan province Directly Affliated TCM Hospital,Zhuzhou 41200,Hunan,China)
出处
《实用中医内科杂志》
2022年第7期88-91,I0006-I0007,共6页
Journal of Practical Traditional Chinese Internal Medicine
基金
湖南省医药卫生科研计划(B2015-77)。
