去氨加压素联合托伐普坦治疗高龄夜尿症患者的临床研究

Clinical study of desmopressin combined with tolvaptan in the treatment of elderly male patients with nocturia

目的研究去氨加压素联合托伐普坦治疗高龄夜尿症的疗效和安全性以及对睡眠质量的影响。方法选取2015年6月～2017年6月在解放军总医院门诊诊断为夜尿症的62例高龄男性患者进行前瞻性研究,按随机数表法分为研究组(去氨加压素联合托伐普坦治疗,32例)和对照组(安慰剂,30例)。研究组患者治疗期间于睡前口服0.1～0.2 mg去氨加压素片,晨起口服7.5 mg托伐普坦片;对照组患者于相同时间服用安慰剂,疗程为4周。比较两组治疗前后夜间尿量(NUV)、夜间排尿次数(NUTs)、夜间多尿指数(NPI)、第1段睡眠时间(IPUS)和血钠、渗透压变化以及不良事件发生情况。结果研究组NUV降低37.2%,对照组降低6.0%;研究组和对照组NUTs分别下降47.4%和12%,研究组NUTs减少50%及以上者占46.8%,对照组为10.0%;研究组和对照组NPI分别下降40.4%和4.3%;研究组第一段睡眠时间(IPUS)增加51.5%,对照组增加14.3%,两组间差异均有显著统计学意义(P <0.01)。治疗期间监测两组血钠和血浆渗透压均在正常范围,差异无统计学意义(P> 0.05)。两组中均有少数出现头晕、乏力、口干,但症状轻微,且均在短期内自行缓解。结论去氨加压素联合托伐普坦治疗高龄患者夜尿症安全有效,并能显著改善患者睡眠质量。

Objective The purpose of this study was to investigate efficacy,safety,and impact on quality of sleep of desmopressin combined with tolvaptan in the treatment of nocturia in the elderly. Methods Sixty two cases of elderly male patients diagnosed as nocturia in Outpatient Department of Chinese PLA General Hospital from June 2015 to June 2017 were selected and randomly divided into studygroup （desmopressin combined with tolvaptangroup,32 cases）,and control group （placebo group,30 cases）. The patients in study group were given 0.1-0.2 mg desmopressin orally at bedtime,and 7.5mg tolvaptan orally in the morning. At the same time,the control group received placebo orally,the course was 4 weeks. The nocturnal urine volume,times of nocturnal urine, nocturnal polyuria index,first awakening time,and the serum natrium and plasme osmotic pressure levels were compared before and after treatment betweenthe twogroups. Results Compared with the control group,the number of nocturnal urine,nocturnal micturition and nocturnal polyuria index decreased significantly after treatment,and the initial sleep time was significantly prolonged. The difference was statistically significant （P 〈 0.01）. The levels of serum natrium and plasme osmotic pressure were within the normal range. There were no obvious adverse events relatied with the medication. Conclusion Desmopressin combined with tolvaptan can be effective and safe in the treatment of elderly patients with nocturia,and can improve their sleep quality notably.