目的 评价临床上苯磺酸氨氯地平超药品说明书剂量用药的有效性和安全性，促进临床合理用药。方法 从郑州大学第一附属医院2021年1月1日—12月31日苯磺酸氨氯地平所有超说明书用药的2 438名患者中，筛选出日剂量＞10 mg的难治性高血压（RH）患者，统计患者基本信息、超剂量用药情况等，统计患者超剂量用药前及超剂量用药后第7天的血压值，统计苯磺酸氨氯地平超剂量用药前后心率及肾功能参数变化，进而对超剂量用药有效性及安全性进行评价分析。结果 统计得到郑州大学第一附属医院2021年苯磺酸氨氯地平超剂量用药的RH患者共193例，其中118例来自肾脏内科，且72%为慢性肾病（CKD）5期患者。超剂量用药后患者血压明显降低，且以日剂量为20～30 mg时血压降幅最大，血压达标率最高。不同年龄组患者超剂量用药后降压有效率及血压达标率无明显差异，但40岁以上的患者不良反应发生率增加，整体不良反应发生率为24%。结论 郑州大学第一附属医院苯磺酸氨氯地平超剂量用药人群多为CKD患者，大部分患者超剂量用药后血压控制有明显改善，且以苯磺酸氨氯地平日剂量在20～30 mg者降压效果最优，安全性较好。

Objective To evaluate the efficacy and safety of amlodipine besylate at doses exceeding the drug instructions in clinical practice, and to promote rational drug use in clinical practice. Method From January 1, 2021 to December 31, 2021, a total of 2 438 patients who exceeded the prescribed dosage of amlodipine besylate were selected from the First Affiliated Hospital of Zhengzhou University. Patients with refractory hypertension (RH) with a daily dose greater than 10 mg were screened, and their basic information and overdose usage were collected. The blood pressure values of the patients before and on the 7th day after the overdose were recorded, as well as the changes in heart rate and renal function parameters before and after the overdose of amlodipine besylate. Further evaluate and analyze the effectiveness and safety of high-dose medication. Results The results showed that in 2021, a total of 193 patients with refractory hypertension were treated with high-dose amlodipine besylate in the hospital, of which 118 were from the nephrology department, and 72% were patients with chronic kidney disease (CKD) stage five. After highdose medication, the patient's blood pressure significantly decreased, and the maximum blood pressure drop and blood pressure compliance rate were observed at a daily dose of 20—30 mg. There was no significant difference in the effective rate and blood pressure compliance rate of patients in different age groups after high-dose medication, but the incidence of adverse reactions increased in patients over 40 years old, with an overall adverse reaction rate of 24%. Conclusion The majority of patients receiving high-dose amlodipine besylate in this hospital are CKD patients, and the majority of patients show significant improvement in blood pressure control after high-dose use. Among them, amlodipine besylate with a daily dose of 20—30 mg has the best antihypertensive effect and good safety.

R971

国家自然科学基金青年基金项目（81803823）；河南省科技厅科技攻关项目（182102310540）