摘要
评价康妇消炎栓治疗盆腔炎性疾病的有效性和安全性。系统全面检索CNKI,VIP,Wan Fang,Sino Med中文数据库和Cochrane Library,Medline,Clinical Trail.gov英文数据库,检索时间为各数据库建库至2018年6月。按照预先设定的纳排标准筛选出康妇消炎栓治疗盆腔炎性疾病的随机对照试验,应用Cochrane风险评估工具进行研究质量评价,提取数据并运用RevMan 5.3软件进行Meta分析。共检索出675篇文献,最终纳入56个研究,总样本量6228例,试验组3267例,对照组2961例,所纳入研究总体质量普遍偏低。根据干预措施、结局指标将纳入研究分为不同的亚组进行分析。Meta分析主要结果:康妇消炎栓联合抗生素治疗盆腔炎性疾病复发率低于单用抗生素;康妇消炎栓联合抗生素在缓解腹痛症状、白带异常好转时间、腹部包块吸收时间、疼痛好转时间方面优于单用抗生素。安全性方面,康妇消炎栓联合抗生素不良反应发生率低于单用抗生素。该分析结果表明康妇消炎栓治疗盆腔炎性疾病具有一定疗效,尤其康妇消炎栓联合抗生素复发率低于单用抗生素,远期效果显著。未见严重不良反应发生。但受所纳入研究质量限制,上述结论还需进一步开展高质量、大样本、多中心的临床研究以进行验证。
To evaluate the efficacy and safety of Kangfu Xiaoyan Suppository in the treatment of pelvic inflammatory disease. Four Chinese databases,namely CNKI,VIP,WanFang and SinoMed,and three English databases Cochrane Library,namely Medline,and ClinicalTrail.gov were systematically and comprehensively retrieved from the establishment of each database to June 2018. The quality of the included studies was evaluated by using the risk assessment tools developed by the Cochrane Collaboration,and RevMan 5. 3 software was used for Meta-analysis. A total of 675 articles were retrieved,and finally 56 studies were included. The total sample size was 6 228,the test group included 3 267 cases,and the control group included 2 961 cases. The overall quality of the included studies was generally low. According to the intervention measures and outcome indicators,the included studies were divided into different subgroups for analysis. The main results of Meta-analysis showed that the recurrence rate of Kangfu Xiaoyan Suppository combined with antibiotics was lower than that of antibiotics alone. Kangfu Xiaoyan Suppository combined with antibiotics was superior to antibiotics alone in terms of abdominal pain,leucorrhea abnormality relief time,mass absorption time and pain relief time. In terms of safety,Kangfu Xiaoyan Suppository combined with antibiotics had a lower incidence of adverse reactions than antibiotics alone. Based on the results of this study,it is indicated that Kangfu Xiaoyan Suppository had a certain effect on the treatment of pelvic inflammatory disease,especially with a lower recurrence rate. The long-term effect is remarkable. No serious adverse reaction was observed. Restricted by the quality of the studies included,the above conclusion need to be further verified in high-quality,largesize,multi-center clinical researches.
作者
李盼盼
谢雁鸣
师伟
王连心
LI Pan-pan;XIE Yan-ming;SHI Wei;WANG Lian-xin(Institute of Basic Research in Clinical Medicine,China Academy of Chinies Medical Sciences,Beijing 100700,China;Shandong University of Traditional Chinese Medicine,Ji'nan 250000,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2019年第22期4962-4974,共13页
China Journal of Chinese Materia Medica
基金
中国中医科学院基本科研业务费自主选题项目(Z0546),中国中医科学院中医药“一带一路”合作专项(GH2017-04,GH2017-04-01)
国家自然科学基金面上项目(81873330)
国家药品监督管理局中国食品药品国际交流中心委托研究项目(Z0531)
关键词
康妇消炎栓
抗生素
盆腔炎性疾病
系统评价
META分析
Kangfu Xiaoyan Suppository
antibiotic
pelvic inflammatory disease
systematic review
Meta-analysis