Effects of sertraline in the prevention of low blood pressure in patients undergoing hemodialysis

Abstract Introduction: Intradialytic hypotension (IDH) is a major complication of hemodialysis, with a prevalence of about 25% during hemodialysis sessions, causing increased morbidity and mortality. Objective: To study the effects of sertraline to prevent IDH in hemodialysis patients. Methods: This was a double-blind, crossover clinical trial comparing the use of sertraline versus placebo to reduce intradialytic hypotension. Results: Sixteen patients completed the two phases of the study during a 12-week period. The IDH prevalence was 32%. A comparison between intradialytic interventions, intradialytic symptoms, and IDH episodes revealed no statistical difference in the reduction of IDH episodes (p = 0.207) between the two intervention groups. However, the risk of IDH interventions was 60% higher in the placebo group compared to the sertraline group, and the risk of IDH symptoms was 40% higher in the placebo group compared to the sertraline group. Survival analysis using Kaplan-Meier estimator supported the results of this study. Sertraline presented a number needed to treat (NNT) of 16.3 patients to prevent an episode from IDH intervention and 14.2 patients to prevent an episode from intradialytic symptoms. Conclusion: This study suggests that the use of sertraline may be beneficial to reduce the number of symptoms and ID interventions, although there was no statistically significant difference in the blood pressure levels.

摘要：
引言：透析中低血压（Intradialytic hypotension, IDH）是血液透析的主要并发症，在血液透析疗程中患病率约为25%，可导致患者发病率与死亡率升高。
研究目的：探讨舍曲林（sertraline）预防血液透析患者发生透析中低血压的效果。
研究方法：本研究为双盲交叉临床试验，对比舍曲林与安慰剂（placebo）在降低透析中低血压发生率中的作用。
研究结果：共有16名患者在12周周期内完成了两个阶段的研究。透析中低血压患病率为32%。对透析中干预措施、透析中症状及透析中低血压发作情况进行比较后发现，两组在减少透析中低血压发作次数上无统计学差异（p=0.207）。然而，安慰剂组需接受透析中低血压干预的风险较舍曲林组高60%，出现透析中低血压相关症状的风险较舍曲林组高40%。采用Kaplan-Meier估计法进行的生存分析验证了本研究结果。舍曲林的需治数（number needed to treat, NNT）为16.3，可预防1次透析中低血压干预事件；预防1次透析中低血压相关症状所需的需治数为14.2。
研究结论：本研究表明，尽管两组患者的血压水平未出现统计学显著性差异，但使用舍曲林或可减少透析中症状及透析中低血压干预的发生次数，具有一定临床获益。