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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 evaluate the efficacy and safety of lauromacrogol 400 in the treatment of varicose veins of the lower extremities. Methods: A prospective, randomized, double-blind, controlled study was used. From March 2008 to March 2009, outpatients from Xuanwu Hospital, Capital Medical University, a total of 96 patients were enrolled in Phase Ⅱ clinical trial of monodisaccharide 400 for the treatment of varicose veins of lower extremities, including 5 males and 91 females, with an average age of 46 ± 10 )year old. The varicose veins of 96 patients were divided into spider veins, reticular veins and large / medium veins by type, each of 32 cases, which were divided into the treatment group (24 cases each) and the control group according to the ratio of 3: 1 8 cases). Patients in the splenic vein, reticular vein, and middle / large vein of the treatment group were given varicose vein injection of 0.5% (0.1-0.2 mL), 1% (0.1-0.3 mL), and 3% (0.5-2.0 mL) Alcohol 400 injection, control group patients injected the same volume of water for injection. 2 to 4 weeks for a course of treatment, treatment of 1 to 3 courses. The main efficacy indicators (improvement of varicose veins), secondary efficacy indicators (patient satisfaction) and adverse reactions were observed and the efficacy and safety were evaluated. Results: 88 patients completed the test, 8 patients shedding. The therapeutic efficacies of spider vein, reticular vein and large / medium vein were 87.0%, 95.2% and 82.6% respectively in the treatment group and 0, 14.3% and 0 in the control group. The corresponding data of the treatment group and the control group were (P <0.01). The scores of satisfaction in the treatment group were 4.43 ± 1.16, 4.75 ± 0.44 and 3.58 ± 1.44 respectively, and in the control group were 2.33 ± 0.82, 2.43 ± 1.13 and 2.25 ± 0.71, the treatment group and the control group (P <0.01). The safety scores of the treatment group were 4.87 ± 0.34, 4.70 ± 0.47 and 4.28 ± 0.90 respectively, while those of the control group were 4.67 ± 0.52, 4.90 ± 0.10 and 4.88 ± 0.36, there was no significant difference between the two groups (P> 0.05); The incidence of adverse events in the treatment group and the control group were 37.5% and 25.0% respectively, with no significant difference (P> 0.05) . Conclusion: La Guinaol 400 injection is an effective and safe treatment for varicose veins of the lower extremities.