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目的:评估国产克林霉素磷酸酯注射液说明书与国外原研药说明书差异所致用药风险,探索仿制药风险管理研究模式,促进合理用药。方法:引入基于矩阵法和层次分析法的安全风险评估模型,通过Borda序值法计算风险总值,定性评估克林霉素磷酸酯注射液国内外说明书差异可能导致的用药风险。结果:国产克林霉素磷酸酯注射液说明书与国外原研药说明书差异较大,可能导致不合理用药、药物致伪膜性结肠炎(CDAD)误诊、患者用药依从度不高、患者不能自我发现CDAD等5方面的风险,综合风险总值为3.7,风险较高。结论:我国克林霉素磷酸酯注射液说明书与国外原研药说明书存在较大差异,差异造成用药安全高风险。
OBJECTIVE: To evaluate the risk of drug use due to the difference between the instructions of domestic clindamycin phosphate injection and the original foreign drug specification, and explore the research mode of generic drug risk management to promote rational drug use. Methods: The safety risk assessment model based on matrix method and analytic hierarchy process was introduced. The total risk value was calculated by Borda ordinal value method, and the risk of medication was qualitatively evaluated by the difference of the instructions of clindamycin phosphate injection at home and abroad. Results: The difference between the instructions of domestic clindamycin phosphate injection and that of the original foreign research drug may lead to irrational use of drugs, misdiagnosis of drug-induced pseudomembranous colitis (CDAD), poor compliance of patients and self-discovery of patients CDAD and other 5 aspects of the risk, the overall risk of 3.7, the higher the risk. Conclusion: There is a big difference between the instructions of clindamycin phosphate injection in China and that of original research drug in foreign countries. The difference causes high risk of drug safety.