摘要
目的评估保妇康栓治疗轻度宫颈上皮内瘤变(cervical intraepithelial neoplasia grade1,CIN1)的临床效果。方法对2012年1至6月山西省阳城县和河南省新密市子宫颈癌筛查中病理确诊的67例CIN1患者,进行随机、双盲、安慰剂对照的临床试验。按1∶1比例随机分组,试验组给予保妇康栓,对照组给予保妇康栓模拟栓。两组均阴道用药3个月经周期(16天/月,1次/晚,2粒/次),在停药3个月和9个月后采集宫颈脱落细胞进行HPV DNA检测,并进行阴道镜检查和活检,以评价HPV转阴率和CIN1逆转率。结果有63例患者获得疗效评价数据,试验组31例,对照组32例。停药3个月后,试验组CIN1治疗有效率和HPV转阴率(61.3%和31.0%)均高于对照组(58.1%和27.6%)。停药9个月后,试验组CIN1治疗有效率和HPV转阴率分别为71.0%和55.6%,均高于对照组(54.8%和29.6%),但差异均无统计学意义(P>0.05)。结论保妇康栓对CIN1逆转可能具有促进作用,但尚需延长观察时间及扩大样本量加以证明。
Objective To evaluate the efficacy of Baofukang suppository for the treatment of cervical intraepithelial neoplasia grade 1 (CIN1). Methods From January to June, 2012, 67 women with biopsy-confirmed CIN1 were recruited from a cervical cancer screening study in Yangcheng County, Shanxi province and Xinmi County, Henan province. A randomized, double-blind, placebo-controlled clinical trial was carried out. Women were randomized allocated to the experimental group and control group as per the proportion of 1: 1. The experimental group was treated with Baofukang suppository, and the control group was given the simulation of Baofukang suppository. Women in both groups used drugs or simulation vaginally for 3 menstrual cycles (16d/month, 1 time/night, 2 suppositories/time). After 3 months and 9 months of withdrawal following 3 months medication, all of women were called back for HPV DNA testing and biopsies under colposcopy to evaluate HPV removal rates and CIN1 effective rates. Results Finally, 63 women got the efficacy data, in which 31 from the experimental group and 32 from the control group. After 3 months of withdrawal following 3 months mediation, CIN1 effective rate and HPV removal rate in the experimental group were higher than the ones in control group [61.3% ( 19/31 ) vs. 58.1% ( 18/31 ), 31.0% (9/29) vs. 27. 6% (8/29)]. After 9 months of withdrawal, CIN1 effective rate and HPV removal rate in the experimental group were increased to 71.0% (22/31) and 55.6% ( 15/27), and higher than the ones in the control group[54. 8% (17/31) and 29. 6% (8/27) ]. The differences between two groups were not statistically significant ( P 〉 0.05 ). Conclusion The study indicated Baofukang suppository might promote CIN1 regression, which should be confirmed by the clinical trials with large sample sizes and prolonged observation in the future.
出处
《中国肿瘤临床与康复》
2014年第6期647-650,共4页
Chinese Journal of Clinical Oncology and Rehabilitation
关键词
宫颈上皮内瘤样病变
人乳头状瘤病毒
保妇康栓
随机对照试验
Cervical intraepithelial neoplasia
Human papillomavirus
Baofukang suppository
Randomized controlled trial