摘要
目的:分析某院甲磺酸阿帕替尼片超说明书用药情况及其不良反应发生情况,为临床合理用药提供参考。方法:回顾性分析某院2015年9月~2017年7月33例使用甲磺酸阿帕替尼片患者的性别、年龄、原发肿瘤、药品用法用量及其药品不良反应/事件(ADR/ADE)等特点。结果:甲磺酸阿帕替尼片适应证超说明书用药19例,占57.58%。常用剂量为250 mg或500 mg,低于说明书850 mg推荐剂量。ADR/ADE发生率为48.48%,大多数是1级、2级或3级ADR/ADE,常见血液和淋巴系统损害、高血压和消化道出血等。结论:某院甲磺酸阿帕替尼片大部分超说明书用药,ADR/ADE发生率为48.48%,多数ADR/ADE可通过暂停给药、调整剂量或对症治疗得以控制。
Objective： To analyze post-marketing off-label uses and adverse reactions of apatinib mesylate tablets in the clinical use,and to provide references for rational drug use in the clinic. Methods： We conducted a retrospective medical record review of 33 inpatients with application of apatinib mesylate tablets from September 2015 to July 2017 in a hospital,and analyzed the characters of the patient sex,age,primary tumor,dosage and administration and adverse drug reaction/event（ ADR/ADE） etc. Results： The off-label ratios of the indications for apatinib mesylate tablets were 57. 58%（ 19 patients）. The clinical common dose of apatinib mesylate tablets was 250 mg or 500 mg,less than the dose of 850 mg recommended in drug instruction. The rate of adverse events were 48. 48%,mostly grade 1,2 or 3. And they were mainly blood and lymphatic system disorders,hypertension and alimentary tract hemorrhage. Conclusion： Most of the medical order of apatinib mesylate tablets was involved in the off-label drug use. The rate of adverse events were 48. 48%. And most of these ADRs could be controlled by suspending administration,adjusting dosage or symptomatic treatment.
出处
《药物流行病学杂志》
CAS
2018年第3期180-184,共5页
Chinese Journal of Pharmacoepidemiology
