348例心力衰竭患者沙库巴曲缬沙坦钠的临床应用的安全性评价和有效性分析

Safety evaluations and efficacy analysis of clinical applications of Sacubitril Valsartan sodium in 348 patients with heart failure

目的:对某院沙库巴曲缬沙坦钠的临床应用情况进行疗效分析和合理性评价,了解心力衰竭患者血管紧张素受体脑啡肽酶抑制剂沙库巴曲缬沙坦钠片的真实使用情况,为该药的规范化应用提供参考。方法:通过医院信息系统调取2018年1月-2020年1月该院使用沙库巴曲缬沙坦钠治疗心力衰竭门诊和住院患者的电子病历资料,对其性别、年龄、民族、合并症、心率、血压、用法用量、肌酐(CR)、血钾、血红蛋白、红细胞压积、左心室射血分数(LVEF)、左室舒末径(LVEDd)、N端-B型钠尿肽前体(NT-proBNP)、合并用药情况、适应证、禁忌证、与血管紧张素转换酶抑制剂(ACEI)或血管紧张素Ⅱ受体拮抗药(ARB)的转换情况、不良反应和靶剂量达标率等进行统计分析。结果:共有348例患者使用了沙库巴曲缬沙坦钠,71例用药时间小于3个月,277例随访时间大于3个月。无适应证(LVEF>40%)使用的有68例(24.55%),其中血钾>5.4 mmol·L-1的有6例(2.17%),CR>221μmol·L-1(2.5 mg·dL-1)的有10例(3.61%),对余下的196例进行疗效分析。34例(17.34%)初始剂量不合理,4例(2.04%)给药频次不合理,与ACEI转换不合理的有7例(3.57%),与ARB转换不合理的有2例(1.02%);9例(4.59%)患者出现了不良反应;5例(2.55%)患者达到目标剂量;95例(48.47%)患者血压达标。结论:该院沙库巴曲缬沙坦钠的使用与相关指南的要求存在一定差距,主要表现在禁忌证、用法用量、药物转换、初始给药剂量遍低等方面,尤其是无适应证用药。建议今后可通过药学授课、前置审方、医嘱点评等手段进一步规范该药的临床应用。

OBJECTIVE To explore the efficacy and rationality of clinical application of Sacubitril Valsartan sodium(SVS)and understand its use in patients with heart failure so as to provide references for its standardized application at a local hospital.METHODS Through accessing the hospital information system(HIS),electronic medical records of 348 SVS-treated outpatients and inpatients with heart failure were collected from January 2018 to January 2020.Gender, age, nationality, complications, heart rate, blood pressure, usage, dosage, creatinine(CR),potassium, hemoglobin, hemocrit, left ventricular ejection fraction(LVEF),left ventricular diameter(LVEDd)at the end of left ventricular radius, N-terminal-type B natriuretic peptide precursor(NT-proBNP),drug combination, indications, contraindications, conversion status of target dose for angiotensin converting enzyme inhibitors(ACEI)or angiotensin Ⅱ receptor antagonist medicine(ARB),adverse reactions and success rates were analyzed.RESULTS Among them, 71 cases were treated for under 3 months and 277 were followed up for over 3 months.Among non-indication users(LVEF>40%)(n=68,24.55%),there were serum potassium>5.4 mmol·L-1(n=6,2.17%)and CR>221 mol·L-1(2.5 mg·dL-1)(n=10,3.61%).The remaining 196 patients were analyzed for efficacy.There were unreasonable initial dose(n=34,17.34%),unreasonable frequency of dosing(n=4,2.04%),unreasonable conversion into ACEI(n=7,3.57%)and unreasonable conversion into ARB(n=2,1.02%).Nine cases(4.59%)developed adverse reactions.Target dose(n=5,2.55%)and blood pressure standard(n=95,48.47%)were reached.CONCLUSION A certain gap exists between institional usage of SVS and the requirements of the relevant guidelines.Major discreptances lie in contraindications, usage & dosage, drug conversion and low initial dose, especially off-label prescriptions.Clinical application of SVS should be further standardized by means of pharmaceutical instructions, pre-auditing of prescription and reviewing physician order in the future.