热敏灸辨证施护减少夜尿增多症患者夜间排尿次数和改善睡眠质量的多中心随机对照研究

Effect of Syndrome Differentiation and Dialectical Nursing with Thermal Sensitive Moxibustion on Reducing Nocturnal Micturition Frequency and Improving Sleep Quality in Nocturia Patients:A Multicenter Randomized Controlled Study

【目的】观察热敏灸在减少夜尿增多症患者夜间排尿次数及改善患者睡眠质量方面的疗效。【方法】采用多中心随机对照试验,将240例夜尿增多症患者随机分为热敏灸组126例和传统灸组114例,分别给予热敏灸和传统灸治疗,每周治疗1次,4次为1个疗程,共治疗3个疗程。观察2组患者治疗前后夜间排尿次数、夜间排尿量、夜间多尿指数、匹兹堡睡眠指数量表(PSQI)评分和每晚睡眠时间的变化情况,评价2组患者的中医证候疗效及安全性。【结果】(1)经治疗3个疗程(12周)后,热敏灸组的总有效率为84.13%(106/126),传统灸组为67.54%(77/114),组间比较,热敏灸组的中医证候疗效明显优于传统灸组(P<0.05)。(2)治疗后,2组患者夜间排尿量、夜间排尿次数、夜间多尿指数均较治疗前明显降低(P<0.05),且热敏灸组的降低作用均明显优于传统灸组(P<0.05或P<0.01)。(3)治疗后,2组患者PSQI评分均较治疗前明显降低(P<0.05),每晚睡眠时间均较治疗前明显延长(P<0.05),且热敏灸组在降低PSQI评分和延长每晚睡眠时间方面均明显优于传统灸组(P<0.01)。(4)研究过程中,2组患者均无明显不良反应,且患者的血、尿、大便常规及肝肾功能检查均未发现异常。【结论】热敏灸能有效减少夜尿增多症患者夜间排尿次数,改善患者的睡眠质量,其疗效优于传统灸法,且安全性较高。

Objective To observe the efficacy of thermal sensitive moxibustion in reducing nocturnal micturition frequency and improving sleep quality in patients with nocturia. Methods A multicenter randomized controlled trial was conducted. A total of 240 patients with nocturia were randomly divided into the thermal sensitive moxibustion group(126 cases)and the traditional moxibustion group(114 cases), and were treated with thermal sensitive moxibustion and traditional moxibustion respectively. The treatment was performed once a week, 4 times constituted a course and the treatment for the two groups lasted for 3 courses. The changes of nocturnal micturition frequency,nocturnal micturition volume,nighttime polyuria index,Pittsburgh Sleep Index(PSQI)scores and nightly sleep time in the two groups before and after treatment were observed,and the efficacy for TCM syndrome and clinical safety in the two groups were also evaluated. Results(1)After 3 treatment courses(12 weeks),the total effective rate of thermal sensitive moxibustion group was 84.13%(106/126), and that of the traditional moxibustion group was 67.54%(77/114). The intergroup comparison showed that the efficacy for TCM syndrome in the thermal sensitive moxibustion group was significantly superior to that in the traditional moxibustion group(P <0.05).(2)After treatment,nocturnal micturition volume,nocturnal micturition frequency and nighttime polyuria index of the two groups were significantly decreased compared with those before treatment(P < 0.05),and the effect on lowering the above indexes in the thermal sensitive moxibustion group was significantly superior to that in the traditional moxibustion group(P < 0.05 or P < 0.01).(3)After treatment,the PSQI scores of the two groups were significantly lower than those before treatment(P < 0.05),and the nightly sleep time was significantly longer than that before treatment(P < 0.05). The thermal sensitive moxibustion group had stronger effect on decreasing PSQI scores and prolonging nightly sleep time than the traditional moxibustion group(P < 0.01).(4)During the trial,there were no obvious adverse reactions occurring in the two groups,and no abnormalities were found in routine test of blood,urine,and stool as well as liver and kidney function of the patients. Conclusion Thermal sensitive moxibustion can effectively improve the nocturnal micturition frequency of patients with nocturia,and improve the quality of sleep in patients. Its efficacy and safety are superior to those of the traditional moxibustion.