抗菌药物说明书对肾功能不全患者用药标注的调查与分析

The use labeling of antibiotics for the patients with renal insufficiency:An investigation and analysis

目的:调查我院常用抗菌药物说明书中对肾功能不全人群用药信息标注的完整性和准确性。方法:对我院常用110种抗菌药物说明书进行调查分析,从药代动力学数据标注、是否有对肾功能不全患者可否使用的标注及剂量调整标注等方面评价说明书对肾功能不全患者药物使用信息的完整性和准确性。结果:在我院使用的110种抗菌药物说明书中,107种(97.3%)对抗菌药物药代动力学参数有标注,103种(93.6%)抗菌药物有对肾功能不全患者可否使用的标注,63种(57.3%)对肾功能不全患者剂量调整有明确的标注,33种(30%)对透析患者的剂量调整有标注。结论:部分抗菌药物说明书对肾功能不全患者用药缺少相关提示或调整标注。建议药品生产厂家、尤其是国内生产厂家对说明书信息的完整性和精确性进行改进。

Objective：To investigate the integrity and accuracy of use labeling description for the patients with renal insufficiency in the package inserts of antibiotics in our hospital.Methods：110 package inserts of antibiotics commonly used in our hospital were investigated and analyzed.The integrity and accuracy of use direction for the patients with renal insufficiency was evaluated on the following aspects：the description of the pharmacodynamic（PD） data,the permission notice for renal insufficiency patients,and the dosage adjustment suggestion for the renal insufficiency patients,etc.Results：In the 110 drug leaflets of antibiotics used in our hospital,the PD parameters were labeled in 107（97.3%） package inserts,the permission notice for renal insufficiency patients was labeled in 103（93.6%） package inserts,the dosage adjustment suggestion for renal insufficiency patients was labeled in 63（57.3%） package inserts and the dosage adjustment suggestion for dialysis patients was labeled in 33（30%） package inserts.Conclusions：Some leaflets of antibiotics used in our hospital had less or no related suggestion or adjustment labeling for the patients with renal insufficiency.It is suggested that the manufacturers,especially the domestic manufacturers,should improve the integrity and accuracy of the information in drug leaflets.