沙库巴曲-缬沙坦在非透析依赖性慢性肾脏病3~5期合并高血压患者中降压的有效性和安全性

Efficacy and safety of sacubitril-valsartan in lowering blood pressure in non-dialysis-dependent patients with stage 3-5 chronic kidney disease

目的评价沙库巴曲-缬沙坦(sacubitril-valsartan,SV)在非透析依赖性慢性肾脏病(non-dialysis dependent chronic kidney disease,NDD-CKD)3~5期合并高血压患者中降压的有效性和安全性,为SV在NDD-CKD 3~5期患者中的应用提供临床数据。方法该研究为回顾性研究,纳入2022年3月1日至2023年6月30日在东南大学附属中大医院单用SV或联合应用2~4种降压药后降压效果不理想基础上加用SV的NDD-CKD 3~5期合并高血压的成年患者。SV的剂量范围为25 mg 1次/d至200 mg 2次/d,主要观察结局为血压控制情况,比较患者基线值与用药后1~2个月内的血压及实验室检查指标的变化,同时记录不良反应情况。结果共37例NDD-CKD 3~5期合并高血压患者入选该研究,年龄29~85岁,男性15例(40.5%),SV服药时间为1(1,1)个月。至研究终点,患者收缩压、舒张压、脉压平均值均低于基线值,降幅分别为20.4(9.6,28.8)mmHg(1 mmHg=0.133 kPa,Z=-5.243,P<0.001)、(6.9±7.6)mmHg(t=5.532,P<0.001)及13.0(8.0,18.8)mmHg(Z=-4.941,P<0.001)。研究期间8例(21.6%)患者出现肾功能恶化,用药前后患者血肌酐和估算肾小球滤过率的差异均无统计学意义(分别Z=-0.487,P=0.626;Z=-0.110,P=0.912)。研究期间未观察到高钾血症、症状性低血压、血管神经性水肿、肝功能损害及血红蛋白水平降低等不良反应。结论SV可有效降低NDD-CKD 3~5期合并高血压患者血压,且安全性良好。

Objective To evaluate the efficacy and safety of sacubitril-valsartan(SV)in reducing blood pressure in patients with non-dialysis-dependent chronic kidney disease(NDD-CKD)stage 3-5 and concomitant hypertension.Methods It was a retrospective study.Adult NDD-CKD stage 3-5 patients with hypertension treated with SV alone or in combination with SV on the basis of 2 to 4 antihypertensive drugs having unsatisfactory effects from March 1,2022 to June 30,2023 in Zhongda Hospital Affiliated to Southeast University were included.SV doses ranged from 25 mg once daily to 200 mg twice daily.The primary outcome was blood pressure control.The changes of blood pressure and laboratory examination indexes between baseline and 1 to 2 months after SV treatment were compared,and adverse events were also recorded.Results A total of 37 NDD-CKD stages 3-5 patients with hypertension were included in the study,with age ranging from 29 to 85 years old,and 15 males(40.5%).The SV duration of medication was 1(1,1)month.At the study endpoint,there was a significant decrease in mean systolic blood pressure,diastolic blood pressure,and pulse pressure from baseline,with reduction of 20.4(9.6,28.8)mmHg(1 mmHg=0.133 kPa,Z=-5.243,P<0.001),(6.9±7.6)mmHg(t=5.532,P<0.001),and 13.0(8.0,18.8)mmHg(Z=-4.941,P<0.001),respectively.During the study period,8 patients(21.6%)experienced worsening of renal function,and there were no statistically significant differences in the changes of serum creatinine and estimated glomerular filtration rate before and after treatment(Z=-0.487,P=0.626;Z=-0.110,P=0.912,respectively).No adverse drug reactions such as hyperkalemia,symptomatic hypotension,angioedema,hepatic impairment,and decreased hemoglobin level were observed during the study period.Conclusion SV effectively lowers blood pressure in NDD-CKD stage 3-5 patients with hypertension and exhibits good safety.