乳癖散结胶囊联合西药治疗乳腺增生症有效性和安全性的Meta分析

Meta analysis of the efficacy and safety of Rupi Sanjie Capsule combined with western medicine in the treatment of breast hyperplasia

目的 探索乳癖散结胶囊联合西药治疗乳腺增生症的有效性及安全性。方法 计算机检索中国知网(CNKI)、万方数据库(Wanfang)、维普数据库(VIP)、中国生物医学文献数据库(CBM)、中国临床试验注册中心(ChiCTR)、SinoMed、PubMed、Cochrane Library、Embase。检索时间截止到2020年9月22日,2名研究人员根据纳入标准和排除标准独立进行文献筛选和数据提取,同时方法学质量评价参考参照Cochrane系统综述手册。运用Review Manager 5.4软件进行数据分析,制定纳入标准和排除标准。结果 共纳入符合标准的文献12篇,包含患者1 819例,其中对照组877例,试验组942例。结果显示,试验组总有效率[OR=4.22,95%CI(2.93,6.08),P <0.000 01]和治愈率[OR=2.03,95%CI(1.67,2.47),P <0.000 01]高于对照组;胃肠道反应发生率[OR=0.44,95%CI(0.28,0.69),P=0.000 3]、月经紊乱发生率[OR=0.25,95%CI(0.14,0.43),P <0.000 01]和复发率[OR=0.26,95%CI(0.14,0.46),P <0.000 01]均低于对照组,差异有统计学意义(P <0.05)。两组头痛眩晕发生率[OR=0.23,95%CI(0.05,1.10),P=0.07]和继发性雌激素作用发生率[OR=0.23,95%CI(0.05,1.13),P=0.07]相近,但差异无统计学意义(P> 0.05)。结论 乳癖散结胶囊联合西药治疗乳腺增生症安全有效。

Objective To explore the efficacy and safety of Rupi Sanjie Capsule combined with western medicine in the treatment of breast hyperplasia. Methods CNKI, Wanfang, VIP, CBM, ChiCTR,Sino Med, PubMed,Cochrane Library and Embase were searched by computer. The retrieval time was up to September 22, 2020. According to the inclusion criteria and exclusion criteria, two researchers independently conducted literature screening and data extraction. Review Manager 5.4 software was used for data analysis, and inclusion criteria and exclusion criteria were formulated. Results A total of 12 articles were included, including 1,819 cases of breast hyperplasia, including 877 in control group and 366 in experimental group. The results showed that the total effective rate [OR = 4.22, 95% CI(2.93,6.08), P < 0.000 01] and cure rate [OR = 2.03, 95%CI(1.67, 2.47), P < 0.000 01] of the experimental group were higher than those of the control group. The incidence of gastrointestinal reaction [OR= 0.44, 95% CI(0.28, 0.69), P = 0.000 3], menstrual disorder [OR = 0.25, 95% CI(0.14, 0.43), P < 0.000 01) and relapse rate [OR = 0.26, 95%CI(0.14,0.46), P < 0.000 01] of the experimental group were lower than those of the control group, the differences were statistically significant(P< 0.05). The incidence of headache and dizziness [OR = 0.23, 95% CI(0.05,1.10), P = 0.07], and secondary estrogen effect [OR = 0.23, 95%CI(0.05,1.13), P = 0.07] were similar, there was no significant difference between the two groups(P > 0.05). Conclusion Rupi Sanjie Capsule combined with western medicine in the treatment of breast hyperplasia is safe and effective, which is worthy of promotion and application.