目的 系统评价派特灵治疗高危型人乳头瘤病毒（high-risk human papillomavirus，HR-HPV）感染的疗效和安全性。方法 计算机检索中国知网（CNKI）、万方（Wangfang）、维普网（VIP）、中国生物医学文献数据库（CBM）、PubMed、EMbase、Cochrane Library数据库建库至2021年3月的随机对照试验（randomized controlled trial，RCT），由2名研究评价员根据纳入和排除标准独立对文献进行筛选、数据提取和质量评价后，采用RevMan 5.3软件进行Meta分析。结果 共纳入22篇文献，总样本量为2248例。用药结束3、6、9、12个月后派特灵组的HR-HPV转阴率分别是随访对照组的2.54、2.61、2.02、1.47倍。用药结束3个月后派特灵组HPV病毒载量明显低于随访对照组，2组临床疗效对比具有统计学意义[MD=-486.72，95% CI（-505.90，-467.54），P<0.000 01]；用药结束6个月后派特灵组HPV病毒载量明显低于随访对照组，2组临床疗效对比具有统计学意义[MD=-617.34，95% CI（-855.12，-39.55），P<0.000 01]。用药结束6、9、12个月后非手术派特灵组HPV E6/E7 mRNA拷贝水平下降幅度高于随访对照组，差异具有统计学意义（Z值分别为-4.216、-4.151、-4.359，P均<0.001）。用药结束6、9、12个月后术后派特灵组HPV E6/E7 mRNA拷贝水平下降幅度高于随访对照组，差异具有统计学意义（Z值分别为-2.880、-3.226、-2.914，P值均<0.05）。用药结束3、6、9个月派特灵组病灶消退率明显高于随访对照组，差异均具有统计学意义（P值分别为0.017、0.009、0.023）。派特灵与保妇康栓相比，2组临床疗效不具有统计学意义[RR=1.24，95% CI（0.75，2.03），P=0.40]；派特灵与干扰素相比，2组临床疗效对比具有统计学意义[RR=1.95，95% CI（1.57，2.41），P<0.000 01]，表明派特灵对HR-HPV的疗效优于干扰素。结论 派特灵治疗HR-HPV疗效显著，安全性较高值得临床进一步推广。相较于干扰素，派特灵疗效更为显著。但由于受纳入研究样本量所限，研究结果有可能存在偏倚，尚需更多高质量大样本的临床研究予以验证。

Objective To systematically evaluate the efficacy and safety of Paiteling (派特灵) in the treatment of high-risk human papillomavirus (HR-HPV) infection. Methods Randomized controlled trials (RCT) in CNKI, Wanfang database, VIP database (VIP), CBM database, PubMed, EMbase and the Cochrane Library were all searched from their inception to March, 2021. Two researchers independently screened the articles, extracted the data and evaluated the quality of the articles according to the inclusion and exclusion criteria, the RevMan 5.3 software was used for Meta-analysis. Results A total of 2248 cases were included in 22 RCTs. Three, six, nine, 12 months after the end of the medication, the efficacy of the Paiteling group on HR-HPV infection was better than that of the follow-up control group, and the negative conversion rate was 2.54, 2.61, 2.02 and 1.47 times that of the follow-up control group, respectively. Three months after the end of the medication, the HPV viral load of the Paiteling group was significantly lower than that of the follow-up control group, and the clinical efficacy comparison between the two groups was statistically significant[MD=-486.72, 95% CI (-505.90, -467.54), P<0.000 01]; Six months after the end of the medication, the HPV viral load of the Paiteling group was significantly lower than that of the follow-up control group, and the clinical efficacy comparison between the two groups was statistically significant[MD=-617.34, 95% CI (-855.12, -39.55), P<0.000 01]. The decrease of HPV E6/E7 mRNA copy levels in the non-surgical Paiteling group was higher than that in the follow-up control group at six, nine, and 12 months after the end of the medication, and the difference was significant (the Z values were -4.216, -4.151, and -4.359, respectively, all P<0.001). The decrease of HPV E6/E7 mRNA copy levels in the Paiteling group was higher than that of the follow-up control group at six, nine, and 12 months after after the end of the medication, and the difference was significant (the Z values were -2.880, -3.226, -2.914, all P<0.05). At three, six, and nine months after the medication, the regression rate of the lesions in the Paiteling group was significantly higher than that of the follow-up control group, and the differences were statistically significant (the P values were 0.017, 0.009, 0.023). The comparison of clinical efficacy between the two groups of Paiteling and Baofukang Suppository (保妇康栓) was not statistically significant[RR=1.24, 95% CI (0.75, 2.03), P=0.40]. Compared with interferon, the comparison of clinical efficacy between the two groups is statistically significant[RR=1.95, 95% CI (1.57, 2.41), P<0.000 01]. The efficacy of Paiteling on HR-HPV was better than the interferon. Conclusion Paiteling has significant efficacy in treating HR-HPV infection, and its high safety is worthy of further clinical promotion. Compared with interferon, Paiteling has a more obvious effect. However, due to the limited sample size of the included studies, the results of the study may be biased, and more high-quality and large-sample clinical studies are needed for verification.

R285.64

江苏省中药药效与安全性评价重点实验室—江苏正阳药业联合开放课题（JKLPSE201902）