摘要
目的 对九味虑平颗粒治疗广泛性焦虑障碍 (generalizedanxietydisorder,GAD)的疗效和安全性进行评价。方法 选择符合CCMD Ⅲ诊断标准之广泛性焦虑障碍患者 2 2 7例 ,采用随机双盲、双模拟、阳性药物 (盐酸丁螺环酮 )对照试验的方法分为九味虑平颗粒组 (试验组 ) 114例和丁螺环酮组 (对照组 )113例 ,利用HAMA评分、CGI GI评分和TESS评分、不良反应记录等指标对治疗前和治疗后 1、2、3、4周的5个时点进行疗效和安全性的评估。结果 意向性治疗分析发现 :在各个观察时点 ,两组HAMA评分的下降无统计学意义 (t检验 ,P >0 0 5 ) ;观察结束时 ,九味虑平颗粒组有效率为 87 72 % ,丁螺环酮组为87 6 1% ,两组间差异亦无统计学意义 (CMH检验 ,P >0 0 5 )。根据CGI GI评分进行的有效率分析显示 ,九味虑平颗粒与丁螺环酮的疗效两组间无显著性差异 (秩和检验 ,P >0 0 5 )。九味虑平颗粒组副作用发生率为 16 6 7% ,各副作用发生率分别为 :口干 8 77% ,头昏 7 0 2 % ,恶心呕吐 2 6 3% ,便秘 2 6 3%以及腹泻1 75 % ;盐酸丁螺环酮副反应发生率为 30 97% ,各副作用发生率分别为 :口干 15 0 4 %、便秘 6 19%、恶心呕吐 4 4 2 %、腹泻 4 4 2 %、头昏 3 4 5 %和心动过速 1 77% ;
Objective To evaluate the clinical effectiveness and safety of Jiu Wei Lv Ping particle in the treatment of generalized anxiety disorder (GAD). Methods The multi-center, randomized double-blind method was used to observe 227 GAD patients who were divided into the treatment group ( n=114, treated with Jiu Wei Lv Ping particle 6 g, three times a day) and the control group ( n=113, treated with buspirone 10 mg, three times a day). HAMD score, and CGI-GI score were used to evaluate the clinical efficacy. TESS score and the list of symptom-recording were used to observe the safety. All the outcomes for evaluation before and after treatment at week 1, week 2, week 3 and week 4. Results According to intention-to-treat analysis (ITT) , the level of decrease of HAMA score from baseline at each observational point of the treatment group was similar to that of the control group ( t test, P>0.05). At the end point, the effective rate of treatment group was 87.72%, and the effective rate of the control group was 87.61%. There was no significant difference between the two groups (CMH test, P>0.05). According to the score of CGI-GI at each observational point, there was no difference of the effective rate between the treatment group and the control group (student test, P>0.05). The side effect rate of the treatment group was 16.67%, The frequent symptoms were thirst (8.77%), dizziness (7.02%), nausea (2.63%), constipation (2.63%) and diarrhea (1.75%). The side effect rate of the control group was 30.97%, The frequent symptoms were thirst (15.04%), constipation (6.19%), nausea (4.42%), diarrhea (4.42%), dizziness (3.45%) and tachycardia (1.77%). The side effect of the treatment group was lower than that of the control group. But there was no significant difference between the two groups according to the score of TESS ( F test, P>0.05)). Conclusions The therapeutic action of Jiu Wei Lv Ping particle in the treatment of GAD is affirmed with less side effects. It is valuable to use clinically.
出处
《中国循证医学杂志》
CSCD
2004年第8期523-527,536,共6页
Chinese Journal of Evidence-based Medicine
关键词
九味虑平颗粒
广泛性焦虑
随机对照试验
Jiu Wei Lv Ping
General Anxiety Disorder
Randomized controlled trial
