皮肤科外用药物临床试验的护理规范探讨

目的 探讨皮肤科外用药物临床试验(GCP)的护理规范.方法 分析近五年来我科主持或参与的五项皮肤科外用药物GCP研究的护理资料.结果 皮肤科外用药物GCP的护理规范主要包括两部分,即完善的试验前准备:(1)培训参与研究的护理人员;(2)协助研究者人组受试者;(3)协助研究者与受试者签署知情同意书;(4)严格按GCP规范准备试验药物与医疗设备.严谨周密的试验过程中护理规范:(1)严格按试验方案给药;(2)注意监测和提高受试者的依从性;(3)认真观察用药后的反应,准确及时地做好记录;(4)正确采集标本,为试验结果 的分析、评价提供客观、准确的依据;(5)尽可能提高剩余药物及空盒的回收率.结论 外用药物GCP研究的规范化护理可以提高GCP研究的质量.

Study on nursing standardizations for the GCP of topical used drugs in dermatology

Objective To investigate the nursing standardizations for the Good clinical practice (GCP) of topical used drugs in dermatology. Methods Analyzed the nursing materials of GCP studies on topical used drugs, which were presided or participated in by our dermatology department in the past five years. Results The nursing standardizations for the GCP of topical used drugs are mainly consisted of two parts: good-preparations before study and careful-nursing during study. The former includes:1st, training for nursing staff. 2nd, as-sistance in the admission of trial persons. 3rd, assistance in signing the informed consents. 4th, careful-preparations for the drugs and medical equipments according to the GCP procedures. And the following five items be-long to the latter: medication according to the experimental schemes; observations on the compliance of the trial persons; careful observations and accurate records of the administration effects; correct collections of samples; improved recovery of remaining drugs and packages. Conclusion The nursing standardizations for the GCP of topical used drugs can improve its quality.