临床药师干预对抗肿瘤药物临床试验方案偏离的影响  

Impact of clinical pharmacists on protocol deviation in anti-cancer drug clinical trial

作　　者：单娇娇[1] 汤依群[1] 史美祺[2] 夏国豪[2] 王丽[2] 方瑛[2] 赵杰[1] 

机构地区：[1]中国药科大学临床药学教研室 [2]江苏省肿瘤医院肿瘤内科

出　　处：《中国临床药理学与治疗学》2014年第1期33-37,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的:探讨临床药师加入抗肿瘤药物临床试验后对方案偏离发生率的影响。方法:选取江苏省肿瘤医院2011年9月至2013年2月参与抗肿瘤药物临床试验的受试者,分为未干预组和干预组。未干预组为2011年9月至2012年5月在研的受试者,干预组为2012年6月至2013年2月在研的受试者,分别统计两组受试者临床试验方案偏离发生的种类及发生率,观察临床药师干预对临床试验方案偏离的影响。结果:未干预组与干预组受试者方案偏离发生率之间的差异具有统计学意义(61.3%vs 43.9%,P<0.05),两组之间严重方案偏离发生率的差异也具有统计学意义(37.3%vs 19.7%,P<0.05)。结论:临床药师参与抗肿瘤药物临床试验,可降低受试者方案偏离的发生率,为临床药师在肿瘤内科开展工作提供了新的契机。AIM： To explore the impact of clinical pharmacists on the occurrence of protocol deviation in antineoplastic drug clinical trial. METHODS： Subjects between September 2011 and May 2012 were enrolled in non-intervention group, while intervention group included sub- jects between June 2012 and February 2013 with pharmaceutical intervention. The incidence of protocol deviation was analyzed and the effects of pharmaceutical intervention were observed. RESULTS： 61.3% cases in non-intervention group occurred protocol deviation including 37.3% major protocol deviation,in contrast, 43. 9% cases had protocol deviation including 19.7% major protocol deviation in intervention group. Protocol deviation （P〈0. 05） and major protocol deviation （P〈0.05） were significantly lower in intervention group. CONCLUSION： Clinical pharmacists could effectively reduce pro- tocol deviation in antineoplastic drug clinical tri- als. Being a part of clinical trials provides clini- cal pharmacist a new opportunity to work at the department of medical oncology.

关 键 词：临床试验方案 受试者 临床药师 方案偏离 

分 类 号：R95[医药卫生—药学]