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氨酚待因片Ⅲ期临床监测

MONITORING STUDIES DURING THE PHASE Ⅲ CLINIC OF ACETAMINOPEN CODEINE TABLET

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【作者】 李密荆欣刘彦红卢宜王者风金群英苏曼昭谈善华李美英谢玉芳郁天立李风珍蔡志基

【Author】 LI Mi;JING Xin;LIU Yan-Hong;LU Yi;WANG Zhe-Feng;JIN Qun-Ying;SU Man-Zhao;TAN Shan-Hua;LI Mei-Ying;XIE Yu-Fang;YU Tian-Li;LI Feng-Zhen;Cai Zhi-Ji National Institute on Drug Dependence Beijing Medical University, Beijmg

【机构】 北京医科大学中国药物依赖性研究所北京积水潭医院北京模具厂医务室中国医科大学第一医院中国医科大学口腔医院北京公安医院北京邮电医院北京第四医院北京广外医院北京隆福医院北京医科大学中国药物依赖性研究所 北京北京北京

【摘要】 采取药物使用处方分析,临床医生的评价,过量用药中毒急诊室调查和随访调查等多种方法对氨酚待因片上市后的不良反应,尤其是它在人群中产生依赖性或药物滥用的可能性进行了流行学考察与评价,并继续考察了本品的疗效。结果表明:(1)本品具有较好的镇痛作用,有效率达81.3%,其疗效涉及到多种疼痛;(2)无论对临床医生的调查还是随访调查,均未发现本品所致严重不良反应病例,氨酚待因片具有头晕、出汗、倦乏等轻度副作用,但发生率较低(0.8%);(3)药物依赖性和药物滥用流行学研究未发现氨酚待因片成瘾病例和在人群中滥用的倾向;(4)药物使用处方分析表明医院每天氨酚待因片的实际消耗量较低,只有24.24±14.81(X±SD)个DDD,绝大多数(94.6%) 的处方用药指数(DUT)都小于1.0,说明医生对开写本品相当慎重,用药基本合理。

【Abstract】 The objective of present studies was to monitor the adver-se effects of acetaminophen-codeine tablet witch contains 8. 4mg of codeinephosphate and 500mg of acetaminophen, investigate its possibility of drugabuse and drug dependence in community and continue evaluating its cura-tive effects by using drug utilization studies, doctors’ assessment piloted through a designed self-completion question naire, investigation in emergencydepartments and follow-up studies during the phase Ⅲ clinic. Results show:(1) this drug has a good effect and larger spectrum of analgesia with aeffective rate of 81. 3%; (2) side-effects (dizziness, sweating, sleepinessand tiredness) occurred in about 0. 8% of patients but were usually ofminor intensity, no serious adverse effects were observed; (3) no addictsand abuse phenomenon of the drug were monitored during the survey; (4)drug utilization studies in hospitals showed that the number of DDDs con-sumed per day on average was only 24. 24±14. 81 (X±SD) and the drugutilization index (DUI) was usually less than 1. 0, suggesting there was arational use of the drug.

  • 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,1989年04期
  • 【被引频次】4
  • 【下载频次】39
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