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目的探讨安体舒通联合血管紧张素转换酶抑制剂或血管紧张素受体阻断剂(ACEI/ARB)在IgA肾病中的疗效及安全性。方法采用前瞻性随机对照研究方法,将32例经3个月足量ACEI/ARB治疗蛋白尿仍﹥0.5g/d的原发性IgA肾病患者随机分为安体舒通治疗组和对照组,每组各16例。治疗组给予安体舒通(20mg/d)联合ACEI/ARB治疗,对照组仅给予ACEI/ARB治疗。入组后第1周、4周、8周、12周、6个月、9个月各随访1次。结果经过9个月的治疗,安体舒通治疗组尿蛋白变化率为-43.6%[95%可信区间(CI):-71.2%～-16.1%],对照组尿蛋白变化率为15.1%(95%CI:-18.7%～48.9%),两组比较差异有统计学意义(P=0.007)。蛋白尿绝对定量在治疗组明显降低(1.5g/dvs.0.7g/d,P=0.008),而对照组无明显变化(1.1g/dvs.1.1g/d,P=0.996)。安体舒通治疗组有9例(56.3%)发生蛋白尿缓解而对照组只有1例(6.3%,P=0.003)。2例男性患者在安体舒通治疗中出现乳房发育,所有患者未发生其他严重不良反应。结论 ACEI/ARB联合安体舒通可显著降低IgA肾病患者尿蛋白。
Objective To investigate the efficacy and safety of spironolactone combined with angiotensin converting enzyme inhibitor or angiotensin Ⅱ receptor blocker (ACEI / ARB) in IgA nephropathy. Methods A prospective randomized controlled study was conducted in 32 patients with primary IgA nephropathy who were treated with adequate ACEI / ARB for 3 months and their proteinuria was still> 0.5g / d. The patients were randomly divided into spironolactone treatment group and control group. Each group of 16 cases. The treatment group was given spironolactone (20mg / d) combined with ACEI / ARB treatment, the control group was given only ACEI / ARB treatment. The first week, 4 weeks, 8 weeks, 12 weeks, 6 months and 9 months after the operation were followed up for 1 time. Results After 9 months of treatment, the change rate of urinary protein in spironolactone treatment group was -43.6% [95% confidence interval (CI): -71.2% -16.1%], and the change rate of urinary protein in control group was 15.1% (95% CI: -18.7% -48.9%), the difference between the two groups was statistically significant (P = 0.007). The absolute quantification of albuminuria was significantly lower in the treatment group (1.5g / d vs.0.7g / d, P = 0.008), while there was no change in the control group (1.1g / d vs.1.1g / d, P = 0.996). In the spironolactone treatment group, proteinuria was relieved in 9 patients (56.3%) compared with only 1 patient in the control group (6.3%, P = 0.003). Two male patients developed diastole during spironolactone treatment and none of the other serious adverse reactions occurred. Conclusion ACEI / ARB combined with spironolactone can significantly reduce urine protein in IgA nephropathy patients.