护理干预与提高临床药物试验质量的相关性研究

Influence of nursing intervention on improvement of quality of clinical trial of drugs

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。

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 analyzed at the end of the research. Results There was a patient withdrawing from the research in the experimental group and two patients in the control group. There were 37 patients in the experimental group showing complete medical compliance （88.10%） and 27 cases （64.29%） in the control group. The difference of medical compliance between those two groups was statistically significant （P〈0.05）. Conclusion Nursing intervention can significantly improve the medical compliance of subjects with chronic hepatitis B and ensure the quality of clinical drug trials.