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护理干预与提高临床药物试验质量的相关性研究
引用本文:罗玲,张大志,袁春兰,蒋祖利,林年芬.护理干预与提高临床药物试验质量的相关性研究[J].重庆医学,2009,38(2).
作者姓名:罗玲  张大志  袁春兰  蒋祖利  林年芬
作者单位:重庆医科大学附属第二医院感染病科,400010
基金项目:重庆医科大学附属第二医院护理骨干科研资助项目 
摘    要:目的 通过护理干预,提高慢性乙型肝炎抗病毒治疗的临床药物试验受试者的依从性,从而提高肝病临床药物试验的质量.方法 将84例患有慢性乙型肝炎且符合参加阿德福韦抗病毒治疗的临床试验的志愿受试者随机分为实验组和对照组,每组各42例.对照组按照临床药物试验管理规范进行,实验组实施一系列护理干预,分别对两组受试者在试验结束后进行遵循医嘱行为调查.结果 (1)实验组有1例受试者退出试验,对照组有2例受试者退出试验.(2)实验组有37例能完全遵循医嘱,占88.10%,对照组有27例能完全遵循医嘱,占64.29%,两组遵循医嘱程度的差异有统计学意义(P<0.05).结论 护理干预可明显提高临床药物试验受试者治疗的依从性,从而保证临床药物试验的质量.

关 键 词:慢性乙型肝炎  护理干预  依从性  质量

Influence of nursing intervention on improvement of quality of clinical trial of drugs
LUO Ling,ZHANG Da-zhi,YUAN Chun-lan,et al..Influence of nursing intervention on improvement of quality of clinical trial of drugs[J].Chongqing Medical Journal,2009,38(2).
Authors:LUO Ling  ZHANG Da-zhi  YUAN Chun-lan  
Affiliation:LUO Ling,ZHANG Da-zhi,YUAN Chun-lan,et al.(Department of Infectious Diseases,Second Affiliated Hospital of Chongqing University of Medical Sciences,Chongqing 400010,China)
Abstract:Objective Through nursing intervention,to improve antiviral treatment compliance of subjects with chronic hepatitis B,and to enhance the quality of clinical drug trial.Methods Eighty-four cases of chronic hepatitis B using adefovir were randomly divided into experimental and control groups respectively,each 42 cases.Both groups were treated through the basic principle of GCP.In the experimental group a series of nursing interventions were used.The subjects' compliance behaviors during the trial were analyze...
Keywords:chronic hepatitis  nursing intervention  medical compliance  quality  
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