聚桂醇400治疗下肢静脉曲张疗效和安全性的临床研究

Clinical studies on efficacy and safety of lauromacrogol 400 for the treatment of varicose veins of the lower extremities

目的:评价聚桂醇400治疗下肢静脉曲张的疗效和安全性。方法:采用前瞻性随机双盲对照研究方法。2008年3月至2009年3月,首都医科大学宣武医院门诊患者共有96例入选聚桂醇400治疗下肢静脉曲张的Ⅱ期临床试验,其中男性5例,女性91例,平均年龄(46±10)岁。96例患者的曲张静脉按类型分为蜘蛛静脉、网状静脉和大/中静脉,各为32例,将其按照3:1的比例分别分配进入治疗组(各24例)和对照组(各8例)。治疗组中蜘蛛静脉、网状静脉和大/中静脉的患者分别行曲张静脉内注射0.5%(0.1～0.2mL)、1%(0.1～0.3mL)和3%(0.5～2.0mL)聚桂醇400注射液,对照组患者注射相同体积的注射用水。2～4周为1个疗程,治疗1～3个疗程。观察主要疗效指标(曲张静脉改善程度)、次要疗效指标(患者满意度)及不良反应,并对疗效和安全性进行评估。结果:88例完成试验,8例脱落。治疗组中蜘蛛静脉、网状静脉和大/中静脉患者的治疗有效率分别为87.0%、95.2%和82.6%,对照组为0、14.3%和0;治疗组和对照组对应数据比较差异均有统计学意义(均P<0.01);治疗组患者满意度评分分别为4.43±1.16、4.75±0.44和3.58±1.44,对照组为2.33±0.82、2.43±1.13和2.25±0.71,治疗组和对照组对应数据比较差异均有统计学意义(均P<0.01);治疗组患者安全性评分分别为4.87±0.34、4.70±0.47和4.28±0.90,对照组为4.67±0.52、4.90±0.10和4.88±0.36,治疗组和对照组对应数据比较差异均无统计学意义(均P>0.05);治疗组和对照组不良事件发生率分别为37.5%和25.0%,差异无统计学意义(P>0.05)。结论:聚桂醇400注射液是一种治疗下肢静脉曲张有效且安全的药物。

Objective：To assess the efficacy and safety of lauromacrogol 400 for the treatment of varicose veins of the lower extremities. Methods：A prospective,randomized,double-blind trial was conducted. Ninety six outpatients from March 2008 to March 2009 in Xuanwu Hospital of Capital Medical University were selected into the phase Ⅱ clinical trials investigating the treatment of varicose veins of the lower extremities with lauromacrogol 400. Of them,5 patients were males and 91 were females with an average age of （46±10） years. The varicose veins were classified into spider veins,reticular veins,and medium to large-sized veins according to the types. Each type of varicose veins comprised 32 patients,which were allocated in a ratio of 31 into the treatment group （24 cases） and control group （8 cases）,respectively. The patients with spider veins,reticular veins,and medium to large-sized veins in the treatment group were injected with 0.5%（0.1-0.2 mL）,1% （0.1-0.3 mL）,3% （0.5-2.0 mL） lauromacrogol 400 into their varicose veins,respectively; and the patients in the control group received the same volume of water for injection,respectively. The patients received 1 to 3 treatment courses,and each course was 2 to 4 weeks. The main criterion for efficacy （improvement of varicose veins） and the secondary criterion for efficacy （patients＇satisfaction）,adverse reactions were observed; efficacy and safety of the drug were assessed. Results：Eighty-eight patients completed the trial,and 8 was lost during the trial. The response rates in the patients with spider veins,reticular veins,and medium to large-sized veins in the treatment group were 87.0%,95.2%,and 82.6%,respectively; and 0,14.3%,and 0 in the control group,respectively. The differences were statistically significant in comparison of the corresponding values between the treatment and control groups （all P〈0.05）. The scores of patients＇satisfaction in the treatment group were 4.43±1.16,4.75±0.44,and 3.58±1.44,respectively; and 2.33±0.82,2.43±1.13,and 2.25±0.71 in the control group,respectively. The differences were statistically significant in comparison of the corresponding values between the treatment and control groups （all P〈0.05）. The scores of safety assessment in the treatment group were 4.87±0.34,4.70±0.47,and 4.28±0.90,respectively; 4.67±0.52,4.90±0.01,and 4.88±0.36 in the control group,respectively. The differences were not statistically significant in comparison of the corresponding values between the treatment and control groups （all P〈0.05）. The incidence rate of adverse reactions in the treatment and control groups were 37.5% and 25.0%,respectively. The difference was not statistically significant between the treatment and control groups （P〈0.05）. Conclusion：Lauromacrogol 400 injection is an effective and safe drug for the treatment of varicose veins of the lower extremities.