托特罗定叠加槐杞黄颗粒和心理行为干预治疗晨尿渗透浓度正常的原发性遗尿症患儿的随机平行对照研究

摘要

目的：对去氨加压素（ DDAVP）治疗无效的、晨尿渗透浓度正常的原发性遗尿（ PNE）患儿，以托特罗定为基础叠加槐杞黄颗粒和心理行为干预，寻求最佳治疗方案。方法对DDAVP治疗无效的PNE门诊患儿经过1个月的药物洗脱期，以区组随机方法分为3组：西药组（托特罗定）、中西药组（托特罗定+槐杞黄颗粒）和联合组（托特罗定+槐杞黄颗粒+心理行为干预）行平行随机对照试验，入组时依据患儿及其家长回忆的月遗尿次数视为基线遗尿次数，在治疗结束时（近期）和治疗结束后3个月（远期）评估疗效并行意向性分析。结果符合纳入排除标准的234例PNE患儿进入本文分析，3组各78例，3组间年龄、性别和基线遗尿次数差异均无统计学意义（ P均＞0.05）；近期和远期总有效率，联合组和中西药组均好于西药组，差异有统计学意义（ P分别为0.017和＜0.001）；近期总有效率，联合组与中西药组差异无统计学意义（P＞0.05），远期总有效率，联合组与中西药组差异有统计学意义（P=0.005），联合组近期和远期得到1例有益结果需要治疗PNE人数（NNT）分别为6.5（95％CI：3.7~25.3）和2.4（95％CI：1.8~3.6），中西药组远期NNT为和4.6（95％CI：2.7~15.2）。结论托特罗定+槐杞黄颗粒+心理行为干预2.4例DDAVP治疗无效的晨尿渗透浓度正常的PNE患儿在远期疗效上有1例有效，而且置信区间很窄，对这一结果信心很大。%Objective Primary nocturnal enuresis( PNE)children with normal osmotic concentration who were ineffective to desmopressin( DDAVP)were treated with tolterodine combined with Huai Qi Huang and mental behavioral therapy,to seek the best treatment. Methods PNE children in the outpatient clinic who were ineffective to DDVAP for one month were randomized and allocated into western medicine group( tolterodine oral ),Chinese and western medicine group( tolterodine and Huai Qi Huang oral)and combined treatment group( tolterodine,Huai Qi Huang oral and mental behavioral therapy). PNE children and their parents recalled the number of enuresis in one month as the baseline number. Efficacy was evaluated at the end of the treatment and 3 months after the treatment,and intention-to-treat analysis was performed. Results A total of 234 children with enuresis were recruited for analysis,with 78 cases in each group. There was no significant difference in age,gender and baseline number of enuresis(P=0. 778;χ2 =0. 933,P=0. 627;F=0. 141,P=0. 868). The total effective rate in Chinese and western medicine group and combined treatment group was better than western medicine group at the end of the treatment and 3 months after treatment (P=0. 017 and <0. 001). There was no significant difference in total effective rate between combined treatment group and Chinese and western medicine group at the end of the treatment(P>0. 05),but differences were observed 3 months after the treatment(P=0. 005). NNT of combined treatment were 6. 5(95%CI:3. 7-25. 3)at the end of the treatment,and 2. 4(95%CI:1. 8-3. 6)3 months after the treatment;NNT of Chinese and western medicine group was 4. 6(95%CI:2. 7-15. 2)3 months after the treatment,respectively. Conclusion If 2. 4 patients were treated by tolterodine,Huai Qi Huang oral and mental behavioral therapy,one of them was effective for long-term efficacy,the confidence intervals was very narrow. The results were reliable.