抗肿瘤药物说明书的质量评价分析

目的：针对抗肿瘤药说明书常见争议问题统计分析并提出修改建议,为其修订提供依据。方法：收集整理抗肿瘤药物说明书147份,其中,西药说明书122份（国产79份、进口43份）,中药说明书25份。采用三种分类方法分析说明书中存在的常见问题,并对修改难度进行了评价。结果：国产和进口西药说明书存在的主要问题为"同一说明书对应多种规格的药品"（32.91%vs.25.58%,P>0.05）; "主要内容相互矛盾"（54.43%vs.32.56%,P>0.05）,修改难度中等。与西药说明书相比,中药说明书存在的主要问题为"说明书内容简单"（6.56%vs.36.00%,P<0.05）和"说明书内容不全"（4.00%vs.24.00%,P<0.05）,修改难度较大。结论：建议不断完善抗肿瘤药物说明书,保证患者安全用药。

Analysis of problems in antineoplastic drug instructions

OBJECTIVE To research on the current instructions of antineoplastic drugs and makes suggestions about common problems to provide a reference for the standardization of the instructions of antineoplastic drugs.METHODS Totally 147 drug instructions were collected, including instructions for 79 drugs in foreign countries, 43 instructions for drugs in China, 25 instructions for Chinese medicine and traditional Chinese medicine injections. Three classifying methods were adopted to analyze problems in instructions of antineoplastic drugs.RESULTS The problems of instructions for western drugs included "the same instructions for drugs of varied strengths" (32.91% vs. 25.58%, P>0.05), "contraindicated major contents" (54.43% vs. 32.56%, P>0.05), which were difficult to be modified. For instructions of traditional Chinese medicine, the present major problems included "too simple contents in the instructions" (6.56% vs. 36.00%, P<0.05), "incomplete contents of the instructions" (4.00% vs. 24.00%, P<0.05), which were very difficult to be modified.CONCLUSION The contents of instructions for antineoplastic drugs should be continuously improved to guarantee medication safety in patients.