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[摘要]
目的 系统评价苦参凝胶治疗宫颈高危型人乳头瘤病毒(HR-HPV)感染的有效性。方法 计算机检索The Cochrane Library、PubMed、Embase、Medline、Wanfang、VIP、CNKI及CBM数据库,搜索苦参凝胶治疗宫颈HR-HPV感染的随机对照试验(RCT),检索时限截止至2019年12月。由2名研究者独立筛选文献、提取资料、评价文献偏倚风险后,以RevMan 5.3软件进行Meta分析。结果 共纳入5个RCT,包括583个病例。Meta分析结果显示,单用苦参凝胶或联合微波/LEEP治疗宫颈HR-HPV感染或合并宫颈上皮内瘤变(CIN)在HR-HPV转阴率[RR=1.38,95% CI(1.20,1.58),P<0.000 01]、降低HPV-DNA病毒载量[MD=-0.70,95% CI(-0.85,-0.56),P<0.000 01]、减少微波/LEEP术后并发症发生率[RR=0.45,95% CI(0.32,0.65),P<0.000 1]方面疗效均优于随访对照组;苦参凝胶治疗宫颈HR-HPV感染转阴率高于干扰素组(P<0.05);LEEP术后联合苦参凝胶治疗宫颈HR-HPV感染合并CIN2/CIN3术后1年复发率与随访对照组比较无显著差异(P>0.05)。结论 苦参凝胶治疗宫颈HR-HPV感染可提高转阴率,降低HPV-DNA病毒载量,减少合并宫颈CIN微波/LEEP术后并发症,疗效优于随访对照组或干扰素对照组,但尚无确切证据表明LEEP术后使用苦参凝胶可降低宫颈CIN2/CIN3复发率。由于受纳入研究文献数量及质量的限制,研究结果有待更多高质量的RCT进一步验证和更新。
[Key word]
[Abstract]
Objective To systematically evaluate the effectiveness of Kushen Gel in the treatment of cervical high-risk human papillomavirus (HR-HPV) infection. Methods The Cochrane Library, PubMed, Embase, Medline, Wanfang, VIP, CNKI, and CBM databases were electronically searched to collect randomized controlled trials (RCTs) on Kushen Gel in the treatment of the cervical high-risk HPV infection from their inception to December 2019. Two researchers screened the articles, extracted the data, assessed the risk of bias of the eligble studies independently, and performed Meta-analysis with RevMan 5.3. Results A total of 583 cases were included in five RCTs. The Meta-analysis showed that HR-HPV negative rate[RR=1.38, 95% CI(1.20, 1.58), P<0.000 01], reduction of HPV-DNA virus load[MD=-0.70, 95% CI (-0.85, -0.56), P<0.000 01], and the reduction of postoperative complication rate[RR=0.45, 95% CI (0.32, 0.65), P<0.000 1] of applying Kushen Gel alone or applying Kushen Gel combined with microwave/LEEP therapy in the treatment of cervical HR-HPV infection or combined with cervical intraepithelial neoplasia (CIN) were significantly higher than those in the follow-up group; The HR-HPV negative rate of Kushen Gel was higher than interferon group (P<0.05); There was no significant difference in the one year recurrence rate after LEEP combined with Kushen Gel in the treatment of cervical HR-HPV infection combined with CIN2/CIN3 compared with the follow-up control group (P > 0.05). Conclusion The therapeutic effect of applying Kushen Gel can increase the rate of clearance of HPV, reduce HPV-DNA load, and reduce postoperative complication. There is no evidence that the use of Kushen Gel after LEEP can reduce the recurrence rate of CIN2/CIN3. Due to the limitation of the quantity and quality of the included studies, the results need to be further verified and updated by more high-quality RCTs.
[中图分类号]
R28;R287.4
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