戒毒中药正通宁颗粒冲剂正常志愿者耐受性试验研究  

A DOUBLE-BLIND STUDY ON TOLERABILITY OF HERBAL COMPOUND ZHENGTONGNING IN HEALTHY VOLUNTEERS

作　　者：郭崧[1] 姜佐宁[1] 盛利霞[1] 

机构地区：[1]首都医科大学附属北京安定医院中国药物依赖治疗中心,北京100009

出　　处：《中国药物依赖性杂志》2000年第4期278-282,共5页Chinese Journal of Drug Dependence

摘　　要：目的··:研究健康志愿者对戒毒中药正通宁颗粒冲剂的耐受性。方法··:30名20 -40a的健康受试者随机进入试验组和安慰剂组。试验组药物剂量从15 -180g.d -1按不同剂量分组 ,采用双盲双模拟的给药方法进行观察。结果··:各服药组生命体征变化均在正常范围。主要不良反应有 :口干、嗜睡、头晕、头疼、轻飘感、视物模糊。1例谷丙转氨酶增高 ,2例心电图呈一过性T波改变。结论·· :健康受试者对于正通宁颗粒冲剂的耐受性较好 ,不良反应较轻 ,安全性较高。建议Ⅱ期临床试验药物使用剂量为120 -180g.Objective: To study the tolerability of Chinese herbal compound Zhengtongning among healthy volunteers. Method: 30 subjects (20-40 years old) were randomly assigned to two groups, subjects receive placebo or Zhengtongning from 15 g to 180 g.d-1 in the double-blind study. The adverse drug reactions were recorded every two hours. Result: Changes of physiological signs including body temperature, blood pressure, respiration rate and heart rate varied in normal range. The adverse drug reactions were found including dry mouth, drowsiness, dizziness, headache, weakness, and blurred version. Transient slight abnormal results of ALT and ECG were reported in few cases as well. Conclusion: Zhengtongning has a wide range of safety and highly tolerable. Daily dosage of 120 g to 180 g was recommended for continuative clinical trial phaseⅡ.

关 键 词：耐受试验 中药 正通宁 戒断症状 海洛因依赖 

分 类 号：R259.955[医药卫生—中西医结合] R285.5[医药卫生—中医内科学]