目的 观察螺内酯联合沙库巴曲缬沙坦治疗高血压肾病患者的临床疗效及安全性.方法 将高血压肾病患者随机分为对照组和试验组.对照组予以沙库巴曲缬沙坦100～200 mg·d-1,晨服;试验组在对照组基础上联合小剂量螺内酯20 mg·d-1,晨服.2组均连续治疗12周.比较2组患者的临床疗效,观察治疗前后患者的血压、尿微量白蛋白(mAlb)、尿β2微球蛋白(β2-MG)及血清胱抑素C(Cys-C)、转化生长因子β1(TGF-β1)、结缔组织生长因子(CTGF)、血管紧张素Ⅱ(Ang Ⅱ)水平,以及药物不良反应发生情况.结果 试验组和对照组分别纳入87例、86例患者.治疗后,试验组和对照组总有效率分别为95.40％(83例/87例)和82.56％(71例/86例),在统计学上差异有统计学意义(P＜0.05).治疗后,试验组和对照组收缩压分别为(124.65±9.65)和(130.27±8.93)mmHg,舒张压分别为(75.08±7.14)和(80.45±7.35)mmHg,mAlb 分别为(42.58±5.65)和(51.28±6.64)mg·L-1,尿β2-MG 分别为(0.46±0.17)和(0.75±0.25)mg·L-1,24 h 尿蛋白定量分别为(138.49±46.64)和(216.48±65.27)mg,血清 Cys-C 分别为(0.63±0.26)和(0.85±0.24)mg·L-1,TGF-β1 分别为(98.67±21.43)和(112.46±26.72)pg·mL-1,CTGF 分别为(1 206.54±236.56)和(1 340.51±248.25)pg·mL-1,Ang Ⅱ 分别为(101.55±17.62)和(115.65±20.08)pg·mL-1,在统计学上差异均有统计学意义(均P＜0.05).试验组和对照组不良反应发生率分别为6.90％(6例/87例)和2.33％(2例/86例),在统计学上差异无统计学意义(P＞0.05).结论 螺内酯联合沙库巴曲缬沙坦治疗高血压肾病较单纯沙库巴曲缬沙坦治疗能更好地降低血压、改善肾功能、延缓肾纤维化进程,其疗效确切,且安全性较好.
Objective To observe the clinical efficacy and safety of spironolactone combined with sacubitril/valsartan in the treatment of patients with hypertensive nephropathy.Methods The patients with hypertensive nephropathy were randomly divided into control group and treatment group.The control group was treated with sacubitril/valsartan(100-200 mg·d-1 in the morning),and treatment group was combined with low-dose spironolactone treatment(20 mg·d-1 in the morning)on the basis of control group.Both groups were treated continuously for 12 weeks.The clinical efficacy was compared;the blood pressure,urinary microalbumin(mAlb),urinary β2 microglobulin(β2-MG)and serum cystatin C(Cys-C),transforming growth factor-β1(TGF-β1),connective tissue growth factor(CTGF)and angiotensin Ⅱ(Ang Ⅱ)and adverse drug reactions were observed before and after treatment.Results There were 87 cases in treatment group and 86 cases in control group were included respectively.After treatment,the total effective rates in treatment group and control group were 95.40％(83 cases/87 cases)and 82.56％(71 cases/86 cases),with significant difference(P＜0.05).After treatment,the systolic blood pressure values in treatment group and control group were(124.65±9.65)and(130.27±8.93)mmHg,the diastolic blood pressure values were(75.08±7.14)and(80.45±7.35)mmHg,urinary mAlb levels were(42.58±5.65)and(51.28±6.64)mg·L-1,urinary β2-MG levels were(0.46±0.17)and(0.75±0.25)mg·L-1,24 h urinary protein quantitation levels were(138.49±46.64)and(216.48±65.27)mg,serum Cys-C levels were(0.63±0.26)and(0.85±0.24)mg·L-1,TGF-β1 levels were(98.67±21.43)and(112.46±26.72)pg·mL-1,CTGF levels were(1 206.54±236.56)and(1 340.51±248.25)pg·mL-1,Ang Ⅱ levels were(101.55±17.62)and(115.65±20.08)pg·mL-1,all with significant difference(all P＜0.05).The incidence of adverse drug reactions in treatment group and control group were 6.90％(6 cases/87 cases)and 2.33％(2 cases/86 cases),with no significant difference(P＞0.05).Conclusion Compared with sacubitril/valsartan alone,spironolactone combined with sacubitril/valsartan can better reduce blood pressure,improve renal function and delay progression of renal fibrosis in the treatment of hypertensive nephropathy,and has definite efficacy,with good safety.
王琳琳;冯佳莉;刘圣君;乔振华;贾秀玲;韩小丽
河北北方学院附属第一医院肾脏内科,河北张家口 075000
药学
螺内酯;沙库巴曲缬沙坦;高血压肾病;肾功能
spironolactone;sacubitril/valsartan;hypertensive nephropathy;renal function
《中国临床药理学杂志》 2024 (008)
1091-1095 / 5
10.13699/j.cnki.1001-6821.2024.08.001
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