复方七叶皂苷钠凝胶治疗急性闭合性软组织损伤临床疗效及安全性评价

Evaluation of Curative Effect and Safety with Compound Sodium Aescinate Gel in Treatment of Acute Closed Soft Tissue Injury

目的 :观察复方七叶皂苷钠凝胶 (商品名 :欧莱 )对急性闭合性软组织损伤的临床疗效和安全性。方法 :采用多中心、随机、双盲、阳性药利百素凝胶平行对照研究 ,共完成 72对 (14 4例 )。所有病例均为临床确诊的急性闭合性软组织损伤患者 ,按损伤面积的大小 ,采用 1g凝胶 / 1%体表面积涂抹在患处 ,每日 4次 ,疗程 14d。 结果 :治疗前后试验组和对照组静态时疼痛强度、静态时疼痛强度等级、局部压痛强度、局部压痛等级和局部肿胀评估等指标缓解程度的比较有显著统计学意义 (P<0 .0 1) ,两组间各单项指标的缓解程度、疗效、有效率及总有效率的比较均无统计学意义 (P >0 .0 5 )。治疗后 3,7和 14d ,试验组总有效率分别达 17.14 % ,70 .0 0 %和 10 0 .0 0 %。对照组总有效率分别达 2 6 .39% ,70 .83%和 10 0 .0 0 %。两组各发生 1例不良反应 ,均表现为皮肤发红并见少量小丘疹 ,不良反应发生率均为 1.39%。结论 :复方七叶皂苷钠凝胶能安全有效地缓解和消除急性闭合性软组织损伤引起的静态时疼痛、局部压痛和局部胀肿 ,与利百素凝胶的疗效相当。

Objective: To observe the curative effect and safety with compound sodium aescinate gel in treatment of acute closed soft tissues injuries. Methods: A multi-center, randomized double-blined, parallel controlled trial was conducted in 72 pair of patients with acute closed soft tissues injuries, and compared with the positive Libaisu gel. 1% gel 1 g was used at surface of body, 4 times perday, the therapy duration was 14 days. Result: The remission degrees of eachsingle target in experimental group after treatment were more obvious compared with controlled group, the difference was significant between two groups ( P < 0.01 ). The total effective rate of 3, 7, and 14 days after treatment were 17.14% , 70.00% , and 100%, respectively. Conclusion: Compound sodium aecinate can remits and eliminates pain at static, local tenderness, and local swelling caused by acute closedsoft tissues injuries, its action is equal compared with Libaisu.