去氨加压素治疗中老年男性夜尿症的疗效与安全性

Effects and safeties of desmopressin on nocturia in medium-elderly men

目的探讨去氨加压素治疗中老年男性夜尿症的疗效与安全性。方法选取2014年12月至2016年3月收治的中老年男性夜尿症患者。纳入标准：年龄t〉40岁；主诉为夜尿症，夜尿次数≥1次。排除标准：夜间遗尿；同时服用其他药物治疗下尿路症状或睡眠障碍；同时服用利尿剂；尿崩症；其他影响肾髓质的疾病；急性尿路感染；急迫性尿失禁；肾功能不全；神经源性膀胱；糖尿病；抗利尿激素分泌异常综合征；原发性烦渴；血清钠〈135mmoL／L；有前列腺或盆腔手术史；肝功能异常；研究者认为不适合参与本试验者。采用随机数字表法将患者分为试验组和对照组。试验组每晚睡前口服用醋酸去氨加压素0．2mg，对照组每晚睡前口服盐酸坦索罗辛0．2mg，共4周。治疗前3d和每次复诊（每周1次）前3d均记录排尿日记，记录平均夜尿次数和无干扰睡眠时间（HUS）。治疗前后记录夜间生活质量评分（NQOL）、生活质量评分（QOL）以及不良事件。试验组治疗前和治疗后1、4周查血清钠。结果本研究共纳入34例患者，试验组和对照组各17例。试验组和对照组的年龄分别为（65．1±11．2）岁和（63．9±9．3）岁；病程分别为（3．0±5．0）年和（2．3±2．6）年；治疗前夜尿次数分别为（3．8±1．2）次和（3．2±1．4）次；HUS分别为（1．8±1．7）h和（1．8±0．6）h；NQOL分别为（51．8±13．8）分和（41．2±13．6）分；QOL分别为（4．0±1．0）分和（3．9±0．9）分，两组比较差异均无统计学意义（P〉0．05）。治疗4周后，试验组和对照组夜尿次数分别为（1．7±1．0）分和（2．0±0．9）次；HUS分别为（4．0±0．7）h和（2．6±0．7）h；NQOL分别为（20．9±12．0）分和（30．6±12．4）分；QOL分别为（1．4±1．1）分和（2．9±1．0）分，差异均有统计学意义（P〈0．05）。两组与治疗前比较差异均有统计学意义（P〈0．05）。治疗后2、3、4周试验组与对照组各项指标改善程度比较差异均有统计学意义（P〈0．05）。试验组治疗前和治疗后1、4周的血清钠分别为（140．3±3．9）、（139．2±4．3）、（140．6±3．1）mmol／L。试验组出现头晕2例，其中1例将剂量改为0．1mg后症状消失，1例症状可耐受，未处理；胃肠道不适2例，心悸、口干各1例，症状均可耐受。对照组出现口干2例，鼻塞、头晕、气短各1例，症状均可耐受。两组不良反应发生率比较差异无统计学意义（P：0．714）。结论醋酸去氨加压素能改善中老年男性夜尿症症状，提高患者生活质量，安全性良好。

Objective To explore the effects and safeties of desmopressin on nocturia in elderly men. Methods We used random number table to divide patients into 2 groups. The patient in treatment group took desmopressin acetate tablets 0. 2 nag orally and the patient in control group took tamsulosin hydrochloridc sustained release capsule 0.2 mg orally before sleep for 4 weeks. The patient recorded 24 hours voiding diaries for 3 days and worked out mean number of nocturnal voids, hours of undisturbed sleep （HUS） before treatment and before subsequent visit weekly. Before treatment and 1 to 4 weeks after treatment, mean number of nocturnal voids, HUS, night quality of life （NQOL） , quality of life （QOL） , adverse event were recorded. Before treatment, 1 week and 4 weeks after treatment,blood serum sodium was checked in treatment group. Results 42 men had been diagnosed with nocturia in outpatient department of investigator from December 2014 to March 2016,34 of them were recruited in our study and randomly enter the treatment group or control group. Each group consisted of 17 cases. There was no statistical difference in the baseline data between two groups （ all P 〉 0.05 ）. The average ages of treatment group and the control group were （ 65. 1 _± 11.2 ） and （63.9 ± 9.3 ） years old, the courses of disease were （ 3.0 -± 5.0） and （ 2.3 - 2.6） years, respectively. Before treatment mean numbers of nocturnal voids were （3.8±1.2） and （ 3.2 ± 1.4） times,HUSwere （1.8-±l.7）and （1.8±0.6）h, NQOLwere （51.8±13.8） and （41.2±13.6）, QOL were （4.0 ± 1.0） and （3.9 ± 0.9）, respectively. Four weeks after treatment, mean numbers of nocturnal voids decreased to （ 1.6 ± 1.0） and （2.0 ± 0.9） times, HUS increased to （4.0 ± 0.7 ） and （2.6 ± 0.7 ） h, NQOL decreased to （20.9 ± 12.0） and （30.6 ± 12.4） , QOL decreased to （ 1.4 ± 1.1 ） and （2.9±1.0 ） in treatment group and control group, respectively. Every index of the two groups were statistically significant differences compared with that before treatment （ P 〈 0.05 ）. There were statistically significant differences in the degree of improvement between treatment group and control group from 2 weeks to 4 weeks after treatment （ P 〈 0. 05 ）. Therefore, the degree of improvement of treatment group was superiored to the control group. Before treatment and both 1 week and 4 weeks after treatment, the blood serum sodium of patients in treatment group were （ 140.3 ± 3.9 ）, （ 139.2± 4.3 ） and （ 140.6± 3. 1 ） mmol/ L,respectively. Two patients of treatment group appeared dizzy during the follow-up period. In one of both, the symptom disappeared after the dose decreased from 0.2 mg to 0.1 mg per night. The symptom sustained and the dose was not changed in the other one. In treatment group, two other patients suffered from dyspepsia, one palpitation and one thirst. Those symptoms could be tolerated and the dose was not changed. In control group,2 patients suffered from thirst,one nasal congestion, one dizzy and one short of breath. All of those symptoms could be tolerated and the dose was not changed. There was not statistical difference between the occurrence rate of adverse events in the 2 groups （ P = 0. 714 ）. Conclusions Desmopressin improve the quality of life of patients, and has good