Safety and Efficacy of Spironolactone in Dialysis-Dependent Patients: Meta-Analysis of Randomized Controlled Trials.

Safety and Efficacy of Spironolactone in Dialysis-Dependent Patients: Meta-Analysis of Randomized Controlled Trials.
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螺内酯在透析依赖患者中的安全性和有效性:随机对照试验的荟萃分析

DOI:
10.3389/fmed.2022.828189
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发表时间:
2022
影响因子:
3.9
通讯作者:
Yu C
Yu C
中科院分区:
医学3区
文献类型:
--
作者:
Liu J;Jia W;Yu C

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终末期肾病(ESRD)患者具有较高的心力衰竭风险。尽管盐皮质激素受体拮抗剂在缓解心脏纤维化方面具有有益作用,从而降低心血管疾病的发病率和心源性死亡风险,但其治疗益处和不良反应仍存在争议。我们进行了一项荟萃分析,以评估螺内酯在接受透析患者中的安全性和有效性。 我们在PubMed、Embase和Cochrane数据库中系统检索了随机对照试验(RCT)。主要结局指标包括全因死亡率(ACM)的变化、血清钾浓度、高钾血症和男性乳腺增生(GYN)的发生率。次要结局指标包括血压(BP)、左心室质量指数(LVMI)和左心室射血分数(LVEF)的变化。进一步进行了亚组分析和敏感性分析。本研究已在PROSPERO(国际系统评价前瞻性注册库;编号CRD42021287493)注册。 本汇总分析纳入了15项RCT,共1258例患者。螺内酯治疗显著降低了全因死亡率(RR = 0.42,P < 0.0001)、心血管复合终点事件(RR = 0.54,P = 0.008)和左心室质量指数(MD = -6.28,P = 0.002),同时也增加了男性乳腺增生的发生率(RR = 4.36,P = 0.0005)。然而,治疗后两组间左心室射血分数(MD = 2.63,P = 0.05)、收缩压(MD = -4.61,P = 0.14)和舒张压(MD = -0.12,P = 0.94)无变化。尽管补充螺内酯后血清钾浓度升高(MD = 0.22,P < 0.0001),但高钾血症风险保持不变(RR = 1.21,P = 0.31)。进一步的亚组分析发现,与欧美受试者相比,亚洲受试者的有利和不利影响更为明显。此外,治疗时长超过9个月的患者比治疗时长较短的患者获得更有利的影响。 这些结果突出了螺内酯对心血管指标(包括全因死亡率、心血管复合终点事件和左心室质量指数)的治疗效果。然而,男性乳腺增生发生率和血清钾水平的升高不容忽视,这表明对依赖透析的患者,尤其是亚洲患者进行密切监测至关重要。
Background Patients with end-stage renal disease (ESRD) are characterized with high risk of heart failure. Although mineralocorticoid receptor antagonists have beneficial effect on relieving cardiac fibrosis and, thus, reduce the incidence of cardiovascular disease and cardiac death, the therapeutic benefits and adverse effects are still controversial. We conducted a meta-analysis to measure the safety and efficacy of spironolactone in patients undergoing dialysis. Methods A systematic search for randomized controlled trials (RCTs) was performed in PubMed, Embase, and Cochrane databases. Primary outcomes included changes in all-cause mortality (ACM), serum potassium concentration, incidence of hyperkalemia and gynecomastia (GYN). Secondary outcomes included changes in blood pressure (BP), left ventricular mass index (LVMI) and left ventricular ejection fraction (LVEF). Subgroup analysis and sensitivity analysis were further conducted. This research was registered with PROSPERO (International Prospective Register of Systematic Reviews; No. CRD42021287493). Results Fifteen RCTs with 1,258 patients were enrolled in this pooled-analysis. Spironolactone treatment significantly decreased ACM (RR = 0.42, P < 0.0001), CCV (RR = 0.54, P = 0.008) and LVMI (MD = −6.28, P = 0.002), also increased occurrence of GYN (RR = 4.36, P = 0.0005). However, LVEF (MD = 2.63, P = 0.05), systolic BP (MD = −4.61, P = 0.14) and diastolic BP (MD = −0.12, P = 0.94) did not change between two groups after treatment. Although serum potassium concentration was increased (MD = 0.22, P < 0.0001) after spironolactone supplement, the risk of hyperkalemia remained unchanged (RR = 1.21, P = 0.31). Further subgroup analysis found more obvious advantageous as well as disadvantageous effects in Asian subjects than European or American ones. Also, with more than 9 months of treatment duration, patients achieved more favorable influence than shorter duration. Conclusions These results highlight the therapeutic effects of spironolactone on cardiovascular indexes, including ACM, CCV, and LVMI. However, the unignorable increase of GYN incidence and serum potassium level indicate that close monitor in dialysis-dependent patients, especially Asian patients, is essential.
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