欣生静片治疗广泛性焦虑症的随机、双盲、双模拟、多中心平行对照Ⅲ期临床试验研究.docVIP

欣生静片治疗广泛性焦虑症的随机、双盲、双模拟、多中心平行对照Ⅲ期临床试验研究 　　摘 要 目的：评价欣生静片治疗广泛性焦虑症（心肝火旺证）的有效性和安全性。方法：采用随机、双盲双模拟、多中心平行对照试验设计，试验组和对照组分别给予欣生静片和丁螺环酮治疗4周。结果：试验组的总有效率和疗效指数均优于对照组（P0.05）。两组均能显著改善HAMA评分，组间差异具有统计学意义（P0.01）。两组患者的中医症状均能改善，但试验组的总有效率及中医证候的愈显率和评分均优于对照组（P0.01）。两组的HAMD17项评分均有显著改善（P0.01），试验组优于对照组（P0.01）。试验组的不良反应发生率、严重程度显著低于对照组（P0.01）。结论：欣生静片治疗广泛性焦虑症安全、有效，显著优于丁螺环酮，临床应用价值高。 　　关键词 欣生静片 广泛性焦虑症 心肝火旺证 Ⅲ期临床试验 　　中图分类号：R286； R969.4 文献标识码：A 文章编号：1006-1533（2014）19-0024-06 　　Phase Ⅲ clinical trial of Xinshengjing tablet in the treatment of patients 　　with generalized anxiety disorder： a randomized， double-blind， 　　double-dummy， parallel and multicenter control clinical trails* 　　ZHANG Peizhi 　　（Shanghai Shuangji Pharmaceutical Co. Ltd.， Shanghai 201319， China） 　　ABSTRACT Objective： To evaluate the efficacy and safety of Xinshengjing tablet in the treatment of patients with generalized anxiety disorder （GAD） （the syndrome of hyperactivity of heart-liver fire）. Methods： A randomized， double-blind， double-dummy， parallel and multicenter control clinical trial was performed. Patients were divided into an experimental group and a control group and treated with Xinshengjing tablet or buspirone for four weeks， respectively. Results： The total effective rate and the therapy index were significantly higher in the experimental group than in the control group （P0.05）. HAMA scores in two groups were obviously improved and the differences were statistically significant （P0.01）. TCM syndromes in two groups were improved， however， the total effective rate and the cure rate and score of TCM syndromes were significantly higher in the experimental group than in the control group （P0.01）. HAMD-17 scores in two groups were significantly improved， which were much better in the experimental group than in the control group （P0.01）. The incidence and severity of adverse reaction event were lower in the experimental group than in the control group （P0.01） Conclusion： Xinshengjing tablet is safe and effective f