摘要
目的评价坦度螺酮治疗广泛性焦虑症的有效性和安全性。方法用随机化、双盲、双模拟、多中心、阳性药平行对照研究方法。共入组符合研究方案的病例236例,坦度螺酮组117例,丁螺环酮组119例。试验药的剂量为每日30-60mg,对照药的剂量为每日15-30 mg。结果两组病人的主要疗效指标HAMA评分在治疗结束时与基线比较均显著减低(P<O.01);临床总有效率坦度螺酮组为73.15％、丁螺环酮组为76.58％,坦度螺酮组的药物不良反应发生率与丁螺环酮组相当,分别为33.63％和30.77％。实验室检查结果发现,坦度螺酮对肝、肾功能的影响均不明显,且与丁螺环酮组之间无显著性差异。结论坦度螺酮是一个安全有效的新型抗焦虑药。
Objective To evaluate the efficacy and safety of tandospirone in the treatment of general anxiety disorders. Methods This is a randomized, double blind, double-dummy, multi-center, parallel positive controlled clinical study. Two hundred thirty six patients who met with the including criteria were enrolled, 117 cases in tandospirone group, 119 cases in buspirione group. The daily dose of tandospirone and buspirione are 30-60 mg and 15-30 mg, respectively. Results The significant statistical differences in hamilton anxiety scale score between baseline and endpoint were detected in both groups (P<0.01). Clinical effective rate were 73.15% for tandospirone, 76.58% for buspirone. The side effect of two groups are similar. The incidences of side effect were 33.63% and 30.77% , respectively. The major side effects were dry mouth, dizziness, constipation, stomach discomfort, poor appetite. The laboratory examination of two groups did not shown any biochemical abnormality. Conclusion Tandospirone is a novel anti-anxiety agent with well efficacy and safety.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2004年第1期21-24,共4页
The Chinese Journal of Clinical Pharmacology
