中国中药杂志

2020, v.45(19) 4776-4783

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红金消结胶囊治疗乳腺增生症随机对照试验的系统评价与试验序贯分析
Systematic review and trial sequential analysis of randomized clinical trial of Hongjin Xiaojie Capsules for treatment of hyperplastic disease of breast

来保勇;贾丽燕;刘宇飞;楚爱景;张琼;裴晓华;
LAI Bao-yong;JIA Li-yan;LIU Yu-fei;CHU Ai-jing;ZHANG Qiong;PEI Xiao-hua;the Third Affiliated Hospital, Beijing University of Chinese Medicine;School of Traditional Chinese Medicine, Beijing University of Chinese Medicine;Fangshan Hospital, Beijing University of Chinese Medicine;

摘要(Abstract):

系统评价红金消结胶囊治疗乳腺增生症的临床有效性及安全性,为其临床应用提供参考依据。纳入单独采用红金消结胶囊治疗乳腺增生症的随机对照试验(randomized controlled trial, RCT)。检索中国知网(CNKI)、中国科技期刊数据库(VIP)、万方学位及会议论文数据库、中国生物医学文献数据库(SinoMed)、PubMed、Cochrane Library等数据库,检索截止到2019年10月1日,由2名研究者单独进行文献筛选和提取资料,参照Cochrane系统综述手册进行方法学质量评价。应用RevMan 5.3软件进行数据分析,二分类变量数据使用相对危险度(RR)分析,连续性变量数据采用均值差(MD)表示,均为95%置信区间。基于TSA v0.9软件进行试验序贯分析(trial sequential analysis, TSA)估算Meta分析的样本量。最终纳入14个RCT,患者3 057例。Meta分析结果表明,红金消结胶囊治疗乳腺增生症的痊愈率(RR=1.13,95%CI[1.03,1.25],P=0.01)和总有效率(RR=1.09,95%CI[1.05,1.13],P<0.000 1)均高于三苯氧胺组,差异有统计学意义;三苯氧胺组的不良反应发生率高于红金消结胶囊组,差异有统计学意义(RR=0.28,95%CI[0.16,0.49],P<0.001),不良反应涉及恶心、呕吐、腹痛、腹泻、月经不调、闭经、视物不清、头晕头痛等。TSA分析表明,目前累计研究样本量已经达到期望值,但研究结果可能受到高偏倚风险研究的影响,证据的效应强度不高,纳入研究的证据质量等级主要为低级或极低级,倒漏斗图提示纳入研究可能存在发表偏倚。红金消结胶囊治疗乳腺增生症在疗效及安全性等方面有潜在优势,尤其药物相关不良反应情况明显低于三苯氧胺等药物。然而,受纳入研究质量的影响,红金消结胶囊的疗效和安全性尚需要设计严谨的高质量临床试验进一步证实。
To systemically evaluate the clinical efficacy and safety of Hongjin Xiaojie Capsules for hyperplastic disease of breast(HDBA), so as to provide the evidence for its clinical application. The inclusion criteria are the RCT of single administration of Hongjin Xiaojie Capsules for treatment of HDBA. We retrieved following databases(CNKI, WanFang, VIP, SinoMed, Cochrane Library and PubMed) from their inception to October 1, 2019. Two researchers independently screened out literatures and extracted data, and assessed the methodological quality of eligible RCT according to the criteria in Cochrane Handbook for Systematic Reviews of Interventions. RevMan 5.3 was used for data analysis, binary data was summarized by risk ratio(RR) with confidence intervals(CI) of 95%, and continuous data were summarized by mean difference(MD) with CI of 95%. To estimate the sample size of systematic review, trial sequential analysis(TSA) was performed base on software TSA v0.9 version. Totally 14 RCTs were included, involving 3 057 patients. The results of Meta-analysis showed a significantly higher cure rate(RR=1.13, 95%CI[1.03, 1.25], P=0.01) and higher total effective rate(RR=1.09, 95%CI[1.05, 1.13], P<0.000 1) in Hongjin Xiaojie Capsules group than those in the Juyuansuan Tamoxifen group. The incidence of adverse events was significantly higher in Juyuansuan Tamoxifen group than that in Hongjin Xiaojie Capsules group(RR=0.28 95%CI[0.16, 0.49], P<0.001), and the adverse events included nausea, vomiting, abdominal pain, diarrhea, irregular menstruation, amenorrhea, unclear vision, dizziness and headache. The TSA for the cure rate demonstrated that the current available data reached the expected value. However, due to the low effect intensity of evidence, the pooled results might be affected by high risk bias of trials. The quality of evidence of included trials was generally low or very low. Inverted funnel diagram showed possible publication bias. This review suggested that Hongjin Xiaojie Capsules were potentially effective and safe in treatment of HDBA, especially, the incidences of drug-related adverse events from Hongjin Xiaojie Capsules were significantly lower than those from tamoxifen. However, because of lack of high-quality evidence for drawing a conclusion, more rigorously designed and high-quality trials are needed to confirm the efficacy and safety of Hongjin Xiaojie Capsules.

关键词(KeyWords): 红金消结胶囊;乳腺增生症;随机对照试验;系统评价;Meta分析
Hongjin Xiaojie Capsules;hyperplastic disease of breast;RCT;systematic review;Meta-analysis

Abstract:

Keywords:

基金项目(Foundation): 中成药治疗优势病种临床应用指南标准化项目(SATCM-2015-BZ402)

作者(Author): 来保勇;贾丽燕;刘宇飞;楚爱景;张琼;裴晓华;
LAI Bao-yong;JIA Li-yan;LIU Yu-fei;CHU Ai-jing;ZHANG Qiong;PEI Xiao-hua;the Third Affiliated Hospital, Beijing University of Chinese Medicine;School of Traditional Chinese Medicine, Beijing University of Chinese Medicine;Fangshan Hospital, Beijing University of Chinese Medicine;

Email:

DOI: 10.19540/j.cnki.cjcmm.20200221.504

参考文献(References):

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