保妇康栓联合抗生素治疗慢性盆腔炎有效性及安全性Meta分析

Meta-analysis of efficacy and safety of Baofukang Suppository combined with antibiotics in the treatment of chronic pelvic inflammatory disease

目的:保妇康栓是中成药外用栓剂,具有行气破瘀,生肌止痛的功效。保妇康栓临床常与抗生素联用治疗慢性盆腔炎,本研究应用Meta分析的方法评价保妇康栓联合抗生素治疗慢性盆腔炎的有效性和安全性,为保妇康栓治疗慢性盆腔炎的临床应用提供参考。方法:计算机检索中国知网、万方、维普、中国生物医学文献数据库、EMBASE、Pubmed及Cochrane Library数据库中保妇康栓治疗慢性盆腔炎的随机对照试验(RCT),数据库检索时间均为各数据库建库截止到2020年1月。以临床总有效率、炎症消退时间、药物治疗时间、复发率为主要结局指标;以临床症状疗效(下腹坠胀、附件增厚、子宫及附件压痛、子宫活动性差)和不良反应发生率为次要结局指标。分析软件采用Review Manager5.3和State 13.0。结果:共纳入11项RCT,共计1044名患者。Meta分析结果显示,保妇康栓联合抗生素组的临床总有效率(RR=1.21,[95%Cl(1.15,1.27)]P<0.00001)显著高于单用抗生素组;炎症消退时间和药物治疗时间显著优于单用抗生素组(MD=-4.96,[95%Cl(-5.54,-4.38)]P<0.00001;MD=-3.92,[95%Cl(-4.67,-3.17)]P<0.00001);复发率显著低于单用抗生素组(RR=0.17,[95%Cl(0.06,0.48)]P=0.0008);患者典型临床症状疗效(下腹坠胀、附件增厚、子宫及附件压痛、子宫活动性差)显著优于单用抗生素组(RR=0.20,[95%Cl(0.07,0.59)]P=0.004;RR=0.11,[95%Cl(0.03,0.38)]P=0.0006;RR=0.05,[95%Cl(0.01,0.28)]P=0.0005;RR=0.26,[95%Cl(0.12,0.54)]P=0.0003)。在安全性方面,试验组较对照组的不良反应发生率无明显性差异(RR=0.60,[95%Cl(0.33,1.10)]P=0.10),但有降低趋势。结论:保妇康栓联合抗生素能显著改善患者下腹坠胀、附件增厚、子宫及附件压痛、子宫活动性差等临床症状,临床总有效率显著提高,显著降低复发率,明显缩短患者炎症消退时间和药物治疗时间,安全性良好,是慢性盆腔炎临床治疗的有效手段。

Objective:Baofukang suppository is a Chinese medicine suppository for external use,with effective of promoting the circulation of qi and blood stasis and regenerating tissue to relieve pain,which is often combined with antibiotics to treat chronic pelvic inflammatory disease in clinic.This study used Meta-analysis to evaluate the efficacy and safety of Baofukang Suppository combined with antibiotics for the treatment of chronic pelvic inflammatory disease,to provide reference for the clinical application of Baofukang Suppository in the treatment of chronic pelvic inflammatory disease.Method:The randomized controlled trials(RCT)on the treatment of chronic pelvic inflammatory disease by Baofukang Suppository in CNKI,WanFang,VIP,SinoMed,EMBASE,Pubmed and Cochrane Library databases were searched by computer.The retrieval times of databases were set up to January 2020 for each database.The main outcome indicators were the total clinical efficiency,the time of inflammation resolution,the time of drug treatment and the recurrence rate.The secondary outcome indicators were adverse reactions and curative effect of clinical symptoms including hypogastrium bulge,accessory thickening,uterine and accessory tenderness,poor uterine activity.The analysis software used Review Manager 5.3 and State 13.0.Result:A total of 1044 patients were enrolled in 11 RCTS.The results of Meta-analysis showed that the clinical total effective rate of Baofukang Suppository combined with antibiotics group was significantly higher than that of single antibiotic group(RR=1.21,[95%Cl(1.15,1.27)]P<0.00001).The time of inflammation resolution and drug treatment were significantly shorter than that of single antibiotic group(MD=4.96,[95%Cl(-5.54,-4.38)]P<0.00001;MD=-3.92,[95%Cl(-4.67,-3.17)]P<0.00001).The recurrence rate was significantly lower than that of the single antibiotic group(RR=0.17,[95%Cl(0.06,0.48)]P=0.0008).The improvement curative effect of typical clinical symptoms including hypogastrium bulge,accessory thickening,uterine and accessory tenderness,poor uterine activity were significantly better than that of the single antibiotic group(RR=0.20,[95%Cl(0.07,0.59)]P=0.004;RR=0.11,[95%Cl(0.03,0.38)]P=0.0006;RR=0.05,[95%Cl(0.01,0.28)]P=0.0005;RR=0.26,[95%Cl(0.12,0.54)]P=0.0003).In terms of safety,there was no significant difference in the adverse reactions between the experimental group and the control group(RR=0.60,[95%CI(0.33,1.10)]P=0.10),but there was a decreasing tendency.Conclusion:Baofukang Suppository combined with antibiotics can significantly improve the patients’clinical symptoms,such as hypogastrium bulge,accessory thickening,uterine and accessory tenderness,poor uterine activity,significantly improve the clinical total effective rate,significantly reduce the recurrence rate,and significantly shorten the time of inflammation resolution and drug treatment,which is an effective means of clinical treatment of chronic pelvic inflammatory disease with good safety.