两种中药栓剂治疗宫颈HR-HPV持续感染的多中心、随机、平行对照临床Ⅳ期试验

A multicenter,randomized,parallel-controlled phase Ⅳ trial of two chinese herbal suppositories in the treatment of persistent HR-HPV infection in the cervix

目的评估妇宁栓剂治疗宫颈高危型人乳头瘤病毒(HR-HPV)持续感染的有效性与安全性。方法选取240例经检测被确诊为HR-HPV持续感染患者,根据随机数字表法分为妇宁组与保妇康组,每组120例。妇宁组给予妇宁栓剂联合安慰剂治疗,保妇康组给予保妇康栓联合安慰剂治疗。比较两组HR-HPV转阴率、腰腹坠痛消失率及不同时间段病毒载量平均值。结果妇宁组HR-HPV转阴率、腰腹坠痛消失率分别为60.8%、87.5%,均高于保妇康组的47.5%、77.5%,差异有统计学意义(P<0.05)。两组治疗前、治疗1个月、2个月HR-HPV病毒平均载量比较,差异无统计学意义(P>0.05);两组治疗1个月、2个月、3个月的HR-HPV病毒平均载量均显著低于治疗前,妇宁组治疗3个月后明显低于保妇康组,差异具有统计学意义(P<0.05)。结论妇宁栓剂在宫颈HR-HPV持续感染患者治疗中,发挥着重要作用,具有安全、有效等优势,值得临床推广与应用。

Objective To evaluate the efficacy and safety of Funing suppository in the treatment of persistent cervical high-risk human papillomavirus(HR-HPV)infection.Methods 240 patients diagnosed with persistent HR-HPV infection were selected and divided into funing group and Baofukang group according to random number table method,with 120 cases in each group.The funing group was treated with funing suppository combined with placebo,and the Bafukang group was treated with Bafukang suppository combined with placebo.The negative conversion rate of HR-HPV,the disappearance rate of lumbar and abdominal drop pain and the average viral load in different time periods were compared between the two groups.Results The HR-HPV negative conversion rate and the disappearance rate of lumbar and abdominal drop pain in Funing group were 60.8%and 87.5%,respectively,higher than those in Bafukang group(47.5%and 77.5%,P<0.05).There was no significant difference in the average load of HR-HPV virus between the two groups before treatment,1 month and 2 months after treatment(P>0.05).The average load of HR-HPV virus at 1 month,2 months and 3 months in both groups was significantly lower than before treatment,and that in Funing group was significantly lower than that in Bafukang group after 3 months of treatment,with statistical significance(P<o.o5).Conclusion Funing suppository plays an important role in the treatment of patients with persistent cervical HR-HPV infection.It has the advantages of safety and effectiveness,and is worthy of clinical promotion and application.