口服褪黑素对血液透析患者生活质量、睡眠及血压的影响：一项随机临床试验
The effect of oral melatonin on the quality of life, sleep and blood pressure of hemodialysis patients: a randomized clinical trial.
作者信息
Larki Rozina Abbasi, Iranmanesh Arash, Gholami Danial, Manzouri Leila
机构信息
Department of Nephrology, Yasuj University of Medical Sciences, Yasuj, Iran.
Student Research Committee, Yasuj University of Medical Sciences, Yasuj, Iran.
出版信息
BMC Nephrol. 2025 Aug 11;26(1):451. doi: 10.1186/s12882-025-04387-7.
BACKGROUND
Considering the effect of melatonin on the quality of life and sleep in various diseases such as cancer, in the present study, the effect of melatonin was investigated on the quality of life, sleep, and blood pressure of hemodialysis patient.
METHODS
This study was conducted as a double-blind clinical trial. The patients were randomly divided into two groups of 41 people receiving 3 mg of oral melatonin or placebo at night for six weeks. After taking written informed consent, all patients completed demographic, Pittsburgh Sleep Quality Index (PSQI), and Kidney Disease Quality of Life Questionnaire-Short Form (KDQOL-SF) questionnaires. The nurse of dialysis ward measured and recorded systolic and diastolic blood pressure in all patients during dialysis. At the end of the study, the questionnaires were completed again by the patients, and their blood pressure was measured and re-recorded. The data was statistically analyzed using SPSS software .
RESULTS
Mean age of patients in melatonin and placebo group was 48.97 ± 9.77 and 50.07 ± 12.65, respectively ( = 0.661). There was no statistically difference between two groups regarding gender distribution ( = 0.64) and Body mass index ( = 0.15), duration of hemodialysis ( = 0.54), systolic blood pressure ( = 0.7), diastolic blood pressure ( = 0.13), PSQI score ( = 0.73) and KDQOL-SF score in all domains ( > 0.05) before intervention. After intervention, there was no significant difference between two groups regarding systolic blood pressure ( = 0.83) and diastolic blood pressure ( = 0.21, but PSQI score ( = 0.0001) was significantly different between two groups. KDQOL-SF score in kidney disease domains was significantly different between two groups only in sleep domain ( = 0.003).
CONCLUSIONS
The present study showed that melatonin improves sleep quality but only sleep domain, physical function and energy domains of quality of life improved. There was no significant change in the blood pressure of the patients. It is recommended to conduct more studies with longer duration melatonin use for assessing its effect on quality of life and check 24- hour ambulatory blood pressure for precise assessment of melatonin effect on blood pressure.
TRIAL REGISTRATION
IRCT20230205057333N1, Date of registration: 2023/03/15, Available at http://www.irct.behdasht.gov.ir.
背景
考虑到褪黑素对癌症等多种疾病患者生活质量和睡眠的影响，本研究探讨了褪黑素对血液透析患者生活质量、睡眠和血压的影响。
方法
本研究为双盲临床试验。患者被随机分为两组，每组41人，一组在夜间口服3毫克褪黑素，另一组口服安慰剂，为期六周。在获得书面知情同意后，所有患者完成了人口统计学、匹兹堡睡眠质量指数（PSQI）和肾脏病生活质量简表（KDQOL-SF）问卷。透析病房的护士在透析期间测量并记录了所有患者的收缩压和舒张压。研究结束时，患者再次完成问卷，并再次测量和记录血压。使用SPSS软件对数据进行统计学分析。
结果
褪黑素组和安慰剂组患者的平均年龄分别为48.97±9.77岁和50.07±12.65岁（P = 0.661）。两组在性别分布（P = 0.64）、体重指数（P = 0.15）、血液透析时长（P = 0.54）、收缩压（P = 0.7）、舒张压（P = 0.13）、PSQI评分（P = 0.73）以及干预前所有领域的KDQOL-SF评分方面均无统计学差异（P＞0.05）。干预后，两组在收缩压（P = 0.83）和舒张压（P = 0.21）方面无显著差异，但两组的PSQI评分有显著差异（P = 0.0001）。两组在肾脏病领域的KDQOL-SF评分仅在睡眠领域有显著差异（P = 0.003）。
结论
本研究表明，褪黑素可改善睡眠质量，但仅改善生活质量的睡眠领域、身体功能和精力领域。患者血压无显著变化。建议开展更多使用褪黑素时间更长的研究，以评估其对生活质量的影响，并检查24小时动态血压，以精确评估褪黑素对血压的影响。
试验注册
IRCT20230205057333N1，注册日期：2023年3月15日，可在http://www.irct.behdasht.gov.ir查询。
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