唤醒疗法与去氨加压素治疗儿童原发性遗尿症的非随机对照试验

摘要 目的 比较人工唤醒、闹钟、报警器3种唤醒治疗方式与去氨加压素治疗原发性遗尿症（PNE）患儿的疗效和依从性。方法 纳入首都医科大学附属北京儿童医院2012年4月至2013年8月就诊的6~14岁PNE患儿，根据就诊先后顺序分为人工唤醒、闹钟、报警器和去氨加压素组。4组均在基础治疗上给予相应干预，记录遗尿日记。于治疗1、3、6个月随访时，评估疗效、依从性和安全性，并行意向性分析。疗效以遗尿症状好转为评价指标。采用logistic回归分析依从性、遗尿家族史、膀胱容量等因素与疗效的相关性。结果 120例患儿符合纳入和排除标准进入研究，每组各30例。①去氨加压素、报警器、闹钟和人工唤醒组的治疗6个月的总有效率为76.7%、93.3%、56.7%和76.7%，报警器组显著高于闹钟组（P<0.0125）；去氨加压素组和报警器组、人工唤醒组总有效率差异无统计学意义(P≥0.0125)。②报警器组27/30例（90.0%）依从性较好，其次为去氨加压素（24/30,80.0%）、人工唤醒（18/30,60.0%）和闹钟组（16/30,53.3%）; 报警器组优于人工唤醒组（P=0.007）和闹钟组（P=0.002），报警器组和去氨加压素组差异无统计学意义。③Logistic回归分析结果显示，存在PNE家族史是影响治愈的危险因素（P=0.007，OR=0.204，95%CI: 0.064~0.652）。④报警器组1例出现湿疹，去氨加压素组观察到鼻出血1例，低钠血症2例。结论 报警器、去氨加压素治疗PNE的疗效相近，且依从性和安全性均较好，可作为PNE患儿的首选治疗。

Non-randomized controlled trial of 3 alarm treatments and desmopressin for children with primary nocturnal enuresis

Abstract Objective To compare the efficacy and compliance of body-worn, bell, alarm device and desmopressin treatment for primary nocturnal enuresis (PNE) in children. Methods A 6-month cilinical trial was performed with patients aged from 6 to 14 years with PNE in Beijing Children′s Hospital from April 2012 to August 2013. Patients were divided into body-worn, bell, alarm device and desmopressin treatment groups according to the visiting sequence. History was taken for all included children. Corresponding treatments were given on the basis of basic intervention and enuresis diary. Efficacy, compliance and safety were analyzed after follow-up at 1,3,6 months of the treatments by intent-to-analysis. Efficacy was evaluated by the decrease of wetting nights. Group differences in efficacy and compliance and adjustment of family history, functional bladder capacity and other characteristics were analyzed by logistic regression. Results A total of 120 patients were recruited in the clinical controlled trial according to the inclusive and exclusive criteria , thirty for each group. ①The efficacy of desmopressin, alarm device, body-worn and bell was 76.7%, 93.3%, 56.7% and 76.7% at 6 months follow-up. The efficacy with alarm device was better than bell at the 6 months of follow-up (P<0.0125). There was no difference between body-worn, alarm device and desmopressin (P≥0.0125). ②27/30（90%）of alarm device group, 24/30（80%）of desmopressin , 18/30（60%）of body-worn, 16/30（53.3%）of bell group could insist on the treatment. The compliance of alarm device was better than body-worn（P=0.007）and bell groups（P=0.002）. There was no difference between alarm device and desmopressin groups in compliance.③Logistic regression analysis which analyzed factors affecting curative effect showed that family history was a risk factor（P=0.007，OR=0.204，95%CI: 0.064-0.652）.④ No adverse affairs were observed in body-worn and bell groups. One child in alarm device group had eczema in inner side of the right thigh and groin because he could not wake up in time. One case of epistaxis and two cases of hyponatremia were observed in desmopressin group. Conclusion Both of the alarm device and desmopressin have a high cure rate and good compliance and safety. Therefore, the alarm device and desmopressin can be chosen as the first-line treatment.