目的 評(píng)價(jià)臨床上苯磺酸氨氯地平超藥品說(shuō)明書(shū)劑量用藥的有效性和安全性，促進(jìn)臨床合理用藥。方法 從鄭州大學(xué)第一附屬醫(yī)院2021年1月1日—12月31日苯磺酸氨氯地平所有超說(shuō)明書(shū)用藥的2 438名患者中，篩選出日劑量＞10 mg的難治性高血壓（RH）患者，統(tǒng)計(jì)患者基本信息、超劑量用藥情況等，統(tǒng)計(jì)患者超劑量用藥前及超劑量用藥后第7天的血壓值，統(tǒng)計(jì)苯磺酸氨氯地平超劑量用藥前后心率及腎功能參數(shù)變化，進(jìn)而對(duì)超劑量用藥有效性及安全性進(jìn)行評(píng)價(jià)分析。結(jié)果 統(tǒng)計(jì)得到鄭州大學(xué)第一附屬醫(yī)院2021年苯磺酸氨氯地平超劑量用藥的RH患者共193例，其中118例來(lái)自腎臟內(nèi)科，且72%為慢性腎病（CKD）5期患者。超劑量用藥后患者血壓明顯降低，且以日劑量為20～30 mg時(shí)血壓降幅最大，血壓達(dá)標(biāo)率最高。不同年齡組患者超劑量用藥后降壓有效率及血壓達(dá)標(biāo)率無(wú)明顯差異，但40歲以上的患者不良反應(yīng)發(fā)生率增加，整體不良反應(yīng)發(fā)生率為24%。結(jié)論 鄭州大學(xué)第一附屬醫(yī)院苯磺酸氨氯地平超劑量用藥人群多為CKD患者，大部分患者超劑量用藥后血壓控制有明顯改善，且以苯磺酸氨氯地平日劑量在20～30 mg者降壓效果最優(yōu)，安全性較好。

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

國(guó)家自然科學(xué)基金青年基金項(xiàng)目（81803823）；河南省科技廳科技攻關(guān)項(xiàng)目（182102310540）