目的评价应用硬化剂(聚桂醇400注射液)治疗下肢小静脉曲张的疗效和安全性。方法 3个不同浓度组共入选受试者72名,分别接受相应0.5%(A组),1%(B组),3%(C组)硬化剂的局部小曲张静脉内注射治疗。治疗包括3个疗程和1次最后检查(最后1次治疗后3个月进行),如果在第一或第二次注射后判断疗效为治疗完全成功,则不需要再继续治疗。观察疗效及不良反应。结果 3组有效率分别为86.96%,95.24%,82.61%,差异无统计学意义(P>0.05)。患者满意度评分分别为4.43±1.16,4.75±0.44,3.58±1.44,A组与B组之间比较,差异无统计学意义(P>0.05),A组或B组与C组之间比较,差异有统计学意义(P<0.05)。安全性评分3个剂量组分别为4.87±0.34,4.70±0.47,4.25±0.90,A组与C组之间,差异有统计学意义(P<0.05)。不良事件发生率为37.50%。结论应用硬化剂治疗下肢小静脉曲张,可以获得满意的疗效,且具有较好的安全性。 Objective To evaluate the efficacy and safety of sclerotherapy (La Gui Gui Jing 400 Injection) in the treatment of varicose veins of the lower extremities. Methods Totally 72 subjects were enrolled in three different concentration groups, and were treated with intracranial injection of 0.5% (A), 1% (B) and 3% (C) sclerotherapy respectively. Treatment includes 3 courses and 1 final examination (3 months after the last treatment). If the treatment is judged to be completely successful after the first or second injection, no further treatment is required. Observation of efficacy and adverse reactions. Results The effective rates of the three groups were 86.96%, 95.24% and 82.61% respectively, with no significant difference (P> 0.05). The scores of patient satisfaction were 4.43 ± 1.16, 4.75 ± 0.44 and 3.58 ± 1.44, respectively. There was no significant difference between group A and group B (P> 0.05), and between group A and group B and group C, The difference was statistically significant (P <0.05). The safety score of three dose groups were 4.87 ± 0.34, 4.70 ± 0.47 and 4.25 ± 0.90, respectively. There was significant difference between group A and group C (P <0.05). The incidence of adverse events was 37.50%. Conclusions The application of sclerosing agent in the treatment of varicose veins of lower extremities can achieve satisfactory curative effect with good safety.