安神一号胶囊治疗焦虑症的疗效及安全性:双盲双模拟实验

Effect and reliability of anshen yihao capsule in treating anxiety: double-blind and double-dummy experiment

目的:观察安神一号胶囊治疗焦虑症的疗效和安全性。方法:采用随机双盲双模拟方法将甘肃中医学院附属医院住院或门诊就诊的符合《中国精神障碍分类与诊断标准》第3版或《美国精神障碍分类与诊断手册》第4版中各类焦虑性障碍的诊断标准的焦虑症患者200例分为治疗组和对照组,每组100例。实验组口服安神一号胶囊(甘肃中医学院附属医院药学研究中心生产,批号:20030516),4粒/次,3次/d;对照组口服多虑平(上海九福药业有限公司生产,批号:20030801),50～250mg/d。两组均治疗6周。两组病例均于治疗前、治疗第0,2,4和6周时分别计算汉密顿焦虑量表(HAMA)以及汉密顿抑郁量表(HAMD)总分和临床总体印象量表(CGI)评分,并以药物副反应量表(TESS)评定药物副反应。结果:两组患者HAMA和HAMD总分\CGI严重度在治疗第1周末开始下降,治疗组与对照组治疗后比较,差异均有显著性意义(t=2.610～160.400,P<0.01),治疗结束时两组HAMA减分率犤治疗组(0.74±0.24)%,对照组(0.74±0.24)%犦差异无显著性意义(t=0.088,P>0.05);HAMA有效率(治疗组为79.4%,对照组为85.4%),差异无显著性意义(P>0.05)。治疗组不良反应发生频率显著低于对照组,主要是消化系统、中枢神经系统等不良反应。结论:安神一号胶囊是一种安全有效的抗焦虑药。

AIM:To study the efficacy and safety of anshen yihao capsule in treating anxiety.METHODS:Totally 200 patients with anxiety hospitalized and treated in the Affiliated Hospital,Gansu College of Traditional Chinese Medicine,who were in accordance with the diagnostic standards of the third edition of Chinese Classification and Diagnostic Criteria of Mental Disorders and fourth edition of American Classification and Diagnostic Criteria of Mental Disorders,were enrolled and randomized into treatment group(n=100) and control group(n=100) for double-blind and double-dummy study.Patients in the treatment group were treated with anshen yihao,which is produced by the Research Center of Pharmacy of Affiliated Hospital,Gansu College of Traditional Chinese Medicine,No.20030516,taken orally 4 granules once and 3 times a day;while those in the control group received oral doxepin,which was produced by the Shanghai Jiufu Pharmaceutics Company,No.20030801,50 to 250 mg per day,and all the patients were treated for 6 weeks.The total scores of Hamilton anxiety scale(HAMA),Hamilton depression scale(HAMD),score of clinical global impression(CGI) scale were calculated,and the side effects of the drugs were evaluated with the treatment emergent symptom scale(TESS) in both groups before and 0,2,4 and 6 weeks after treatment respectively.RESULTS:The total scores of HAMA and HAMD severity of CGI began to reduce at the end of the 1st week of treatment in both groups, and the scores after treatment were all significantly different from those before treatment respectively in both groups(t=2.610 to 160.400,P< 0.01).At the end of treatment,the decreasing rate of HAMA score and effective rate of HAMA in the treatment group[(0.74±0.24)%,79.4%] were not remarkably different from those in the control group[(0.74±0.24)%,85.4%](t =0.088,P >0.005).The occurrence frequency of adverse effects,mainly in the digestive system and central nervous system,was significantly lower in the treatment group than in the control group.CONCLUSION:Anshen yihao capsule is a safe and effective antianxiety drug.