保妇康栓治疗宫颈高危型人乳头瘤病毒感染性疾病有效性和安全性系统评价

The efficacy and safety of Baofukang suppository for cervical high risk human papillomavirus (HR-HPV) infection:systematic review

关键词:  保妇康栓  宫颈高危型人乳头瘤病毒  系统评价  安全性  有效性

Key words:  Baofukang suppository  cervical high risk human papillomavirus  systematic review  efficacy  safety

摘要:

[目的] 系统评价保妇康栓治疗宫颈高危型人乳头瘤病毒（HR-HPV）感染性疾病的有效性与安全性。[方法] 计算机检索中国知网、万方、维普、SinoMed、PubMed及Cochrane数据库，检索期限均从建库至2017年3月。收集保妇康栓治疗宫颈HR-HPV感染性疾病的随机对照试验（RCT），两名评价者独立进行文献筛选与数据提取，采用Cochrane系统评价手册推荐的偏倚风险评估工具对纳入研究进行质量评价，争议通过讨论解决。[结果] 纳入13个RCT，共1 424例患者。Meta分析结果提示：在宫颈HR-HPV转阴率方面，保妇康栓具有明显疗效（RR=2.90，95% CI[1.92，4.36]，P<0.000 01），与西药联用亦可增强疗效（RR=1.39，95% CI[1.23，1.57]，P<0.000 01）；总有效率方面，保妇康栓与西药相比具有一定优势（RR=1.36，95% CI[1.11，1.66]，P=0.003），与西药联用亦可增强疗效（RR=1.35，95% CI[1.16，1.57]，P=0.000 1）；不良反应方面，保妇康栓组报告不良事件2例，经治疗后均缓解，西药组报告不良事件4例，差异无统计学意义。[结论] 保妇康栓治疗宫颈高危型人乳头瘤病毒感染性疾病疗效明显，且安全性较好。因所纳入研究样本较小，文献方法学质量较低，故结论需更多高质量研究来验证。

Abstract:

[Objective] To evaluate the efficacy and safety of Baofukang suppository in the treatment of high risk human cervical papillomavirus (HR-HPV).[Methods] The computer searches the Chinese knowledge database, the Wanfang database, the Weipu database, the SinoMed database, the PubMed database and the Cochrane database and the retrieval period is from the construction site to the March 2017. All randomized controlled trials (RCTs) of Baofukang treatment (HR-HPV) were collected. Two reviewers independently screened and extracted the data. The quality of the study methodology was evaluated using the Cochrane System Evaluation Manual Method, the dispute resolved through discussion.[Results] Thirteen RCTs were screened according to the inclusion criteria, and 1 424 patients were included in this study. Meta analysis showed that the Baofukang on the cervical HR-HPV negative rate, compared with the blank control (RR=2.90, 95%CI[1.92, 4.36]) (P<0.000 01), Baofukang and Western medicine Compare with Western medicine(RR=1.39, 95%CI[1.23, 1.57], P<0.000 01); on effective rate, Baofukang compare with Western medicine(RR=1.36,95%CI[1.11,1.66], P=0.003), Baofukang and Western medicine compare with Western medicine(RR=1.35,95%CI[1.16,1.57], P=0.000 1),the indicators are better than Western medicine; 2 cases of adverse events were reported in the group of Baofukang group (4 cases of adverse events reported in the control group).[Conclusion] The data analysis suggested that Baofukang was effective in the treatment of high risk human papillomavirus. Due to the relatively small number of research samples, the quality of the literature methodology is relatively low, the level of evidence has yet to be improved.