我院肾病综合征超说明书用药分析

Analysis of Off-label Drug Use in Nephrotic Syndrome in Our Hospital

目的：分析我院治疗肾病综合征超说明书用药的合理性,为临床合理用药提供科学依据,并进一步规范我院超说明书用药行为。方法：选取本院2014年11月-2015年4月诊断为肾病综合征的门诊处方1 908张,列出所有超说明书药品;通过查阅相关指南、文献等对其用药合理性进行分析评价。结果：超说明书用药中他克莫司胶囊、吗替麦考酚酯胶囊、注射用环磷酰胺、环孢素软胶囊、双嘧达莫片、硫酸羟氯喹片、华法林钠片等均有国内外指南推荐,有较高循证医学证据级别;雷公藤多苷片、来氟米特片有大量临床文献支持;以上9种药符合用药合理性。蚓激酶肠溶胶囊、丹参川芎嗪注射液、匹多莫德分散片仅有少数期刊报道;细菌溶解产物胶囊、硼酸粉无相关资料支持,属医师经验用药;以上5种药属于不合理用药。结论：肾病综合征超说明书用药现象普遍存在,用药情况大部分合理,临床医师应当谨慎用药。我院需对有较高循证医学证据的超说明书用药行为进一步规范化管理,以提高临床合理用药水平以及处方的合理率。

Objective： To analyze the rationality of off-label drug use in nephritic syndrome prescriptions to provide scientific basis for clinical rational drug use and further regulate the off-label drug use in our hospital. Methods： Totally 1 908 outpatient prescriptions of nephritic syndrome selected from our hospital during November 2014 to April 2015 were analyzed, and all the off-label drugs were listed. The rationality of the off-label drug use was analyzed and evaluated by searching the related kidney disease guidelines and literatures. Results： The off-label drug use of tacrolimus capsules, mycophenolate mofetil capsules, cyclophosphamide for injection, ciclosporin soft capsules, dipyridamole tablets, hydroxychloroquine sulfate tablets and warfarin sodium tablets were recommended by domestic and overseas guidelines with better evidence of evidence-based medicines. Tripterygium glycosides tablets and leflunomide tablets were supported by the literatures on clinical studies at home and abroad. The above 9 kinds of off-label drugs were rational drug use. Lumbrokinase enteric-coated capsules, salvia miltiorrhiza and ligustrazine injection and pidotimod dispersible tablets were reported only by a handful of journals. Bacteria lysate capsules and boric acid powder had no related information support, which belonged to the empirical prescriptions of physicians. The above 5 kinds of off-label drugs were not rational drug use. Conclusion ： It is a widely existing phenomenon that the medication in nephrotic syndrome is beyond the instruction, the most of off-label drug use are reasonable, and clinicians should prescribe medicines carefully. Our hospital needs to further standardize the management of off-label drug use supported by higher evidence in order to improve the level of clinical rational drug use and the reasonable rate of prescriptions.