聚甲酚磺醛凝胶治疗宫颈糜烂的随机、阳性药平行对照、多中心临床研究  

Policresulen gel in treatment of cervical erosion:a random,positive drug parallel controlled,multicenter clinical study

作　　者：王烨[1] 邹琴娣[1] 

机构地区：[1]复旦大学附属妇产科医院,上海200090

出　　处：《中国新药与临床杂志》2013年第8期628-631,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的评价聚甲酚磺醛凝胶治疗宫颈糜烂的有效性和安全性。方法将符合入组条件的宫颈糜烂患者随机分为试验组和对照组，试验组患者给予聚甲酚磺醛凝胶，对照组患者给予聚甲酚磺醛阴道栓，均于月经结束后第3～7日开始用药，隔日晚使用1支，共使用6次。评价用药前后宫颈糜烂的分型和分度变化、症状体征评分变化及安全性指标。结果共入组251例患者，试验组126例，对照组125例。按符合方案集（PPS），试验组有效率83．0％（n=106），对照组有效率82．1％（n=112），组间比较无显著差异（P〉0．05）。治疗宫颈糜烂有效性非劣效检验显示：预先设定的非劣标准为0．1，试验组非劣效于对照组。按安全数据集（SS），试验组不良事件发生率为12．7％（15／118），对照组为8．3％（10／120），组间无显著差异（JP〉0．05），且认为这些不良事件与药物无关。结论聚甲酚磺醛凝胶治疗宫颈糜烂安全、有效。AIM To evaluate the effectiveness and safety of policresulen gel in treatment of cervical erosion. METHODS All the chosen patients with cercial erosion were randomly divided into trial group （policresulen gel） and control group （policresulen vaginal suppository）. One piece/suppository was used every two nights for total 6 times, starting from 3 - 7 days after the end of menstruation. The patients were followed up and the change of erosion type, symptom and adverse events were recorded. RESULTS Totally 251 patients were included, 126 in the trial group and 125 in the control group. For Per-protocol Set （PPS）, the effectiveness was 83.0% in the trial group （n = 106） and 82.1% in the control group （n = 112）, showing no statistical difference （P 〉 0.05） ; there was non-inferiority in the trial group compared with the control group with non-inferior standard setting 0.1. For Safety Set （SS）, there were 15 adverse events in the trial group （12.7%, n = 118） and 10 in control group （8.3%, n = 120）, with no statistical difference （P 〉 0.05）. CONCLUSION Policresulen gel can be used effectively and safely in treatment of cercial erosion.

关 键 词：聚甲酚磺醛 宫颈糜烂 多中心研究 临床对照试验 

分 类 号：R711[医药卫生—妇产科学]