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(1)
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(P<0.05)。两组均能显著改善HAMA评分，组间差异具有统计学意义(P<0.01)。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(P<0.01)。两组的HAMD17项评分均有显著改善(P<0.01)，试验组优于对照组(P<0.01)。试验组的不良反应发生率、严重程度显著低于对照组(P<0.01)。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
, 百拇医药
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 (P<0.05). HAMA scores in two groups were obviously improved and the differences were statistically significant (P<0.01). 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 (P<0.01). HAMD-17 scores in two groups were significantly improved， which were much better in the experimental group than in the control group (P<0.01). The incidence and severity of adverse reaction event were lower in the experimental group than in the control group (P<0.01) Conclusion： Xinshengjing tablet is safe and effective for the treatment of patients with GAD and worthy of clinical application.
, 百拇医药
KEY WORDS Xinshengjing tablet； generalized anxiety disorder； the syndrome of hyperactivity of heart-liver fire； phase Ⅲ clinical trial
焦虑症又称焦虑性神经症，是以广泛和持续性的焦虑和反复发作的惊恐不安为主要特征的神经症性障碍，常伴有自主神经紊乱、肌肉紧张与运动性不安，临床上主要分为广泛性焦虑和惊恐障碍[1]。广泛性焦虑症(generalized anxiety dsorder，GAD)是焦虑症常见的表现形式，占到焦虑症的75%[2]，是以持续、过度、难以控制的担忧为特征的慢性焦虑障碍[3]。西医学认为焦虑症是环境和遗传因素共同作用的产物，焦虑症的发生与个体的生物学特征、社会心理因素有关。其发病机制目前尚未明了，在生化机制方面，主要有神经递质假说和神经内分泌功能紊乱假说[4-6]。本病属中医“郁证”、“不寐”等范畴，中医药立足于整体调节及辨证论治治疗焦虑症，临床应用具有理法方药的灵活性和药效的安全性等特点，取得了良好疗效[7]。欣生静片是上海双基药业有限公司自主创新研制的纯中药制剂，由栀子、丹皮、黄芩、葛根、菊花、磁石、牡蛎、赭石、酸枣仁、白芍、肉桂、丹参这12味药组成，具有泻肝清心、除烦安神之功效，用于治疗广泛性焦虑，中医辨证属心肝火旺证者。临床前研究采用小鼠四板实验、明暗箱实验，大鼠敞箱实验、足电击引起的僵住行为实验，证明欣可静片对焦虑动物模型具有明显的对抗和治疗作用。前期临床试验结果表明，欣生静片治疗广泛性焦虑(心肝火旺证)安全有效，于2006年4月-2007年12月期间开展Ⅲ期临床试验，进一步评价其疗效及安全性。, 百拇医药(张培智)
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
, 百拇医药
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 (P<0.05). HAMA scores in two groups were obviously improved and the differences were statistically significant (P<0.01). 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 (P<0.01). HAMD-17 scores in two groups were significantly improved， which were much better in the experimental group than in the control group (P<0.01). The incidence and severity of adverse reaction event were lower in the experimental group than in the control group (P<0.01) Conclusion： Xinshengjing tablet is safe and effective for the treatment of patients with GAD and worthy of clinical application.
, 百拇医药
KEY WORDS Xinshengjing tablet； generalized anxiety disorder； the syndrome of hyperactivity of heart-liver fire； phase Ⅲ clinical trial
焦虑症又称焦虑性神经症，是以广泛和持续性的焦虑和反复发作的惊恐不安为主要特征的神经症性障碍，常伴有自主神经紊乱、肌肉紧张与运动性不安，临床上主要分为广泛性焦虑和惊恐障碍[1]。广泛性焦虑症(generalized anxiety dsorder，GAD)是焦虑症常见的表现形式，占到焦虑症的75%[2]，是以持续、过度、难以控制的担忧为特征的慢性焦虑障碍[3]。西医学认为焦虑症是环境和遗传因素共同作用的产物，焦虑症的发生与个体的生物学特征、社会心理因素有关。其发病机制目前尚未明了，在生化机制方面，主要有神经递质假说和神经内分泌功能紊乱假说[4-6]。本病属中医“郁证”、“不寐”等范畴，中医药立足于整体调节及辨证论治治疗焦虑症，临床应用具有理法方药的灵活性和药效的安全性等特点，取得了良好疗效[7]。欣生静片是上海双基药业有限公司自主创新研制的纯中药制剂，由栀子、丹皮、黄芩、葛根、菊花、磁石、牡蛎、赭石、酸枣仁、白芍、肉桂、丹参这12味药组成，具有泻肝清心、除烦安神之功效，用于治疗广泛性焦虑，中医辨证属心肝火旺证者。临床前研究采用小鼠四板实验、明暗箱实验，大鼠敞箱实验、足电击引起的僵住行为实验，证明欣可静片对焦虑动物模型具有明显的对抗和治疗作用。前期临床试验结果表明，欣生静片治疗广泛性焦虑(心肝火旺证)安全有效，于2006年4月-2007年12月期间开展Ⅲ期临床试验，进一步评价其疗效及安全性。, 百拇医药(张培智)