醒脾养儿颗粒治疗小儿原发性夜间遗尿症的临床观察

Clinical Observation of Xingpi Yang'er Granule in the Treatment of Primary Nocturnal Enuresis in Children

目的:观察醒脾养儿颗粒治疗小儿原发性夜间遗尿症的疗效和安全性。方法:97例原发性夜间遗尿症患儿随机分为对照组(46例)和观察组(51例)。对照组患儿给予消旋山莨菪碱片0.5 mg/(kg·d),口服,每日1次+维生素B1片10 mg,口服,每日3次+谷维素片10 mg,口服,每日3次+睡前30 min口服盐酸甲氯芬酯胶囊0.1 g,口服,每日1次。观察组患儿在对照组治疗的基础上加服醒脾养儿颗粒5~6岁0.4 g,7~14岁0.6 g,每日3次。两组均连续治疗4周。观察两组患儿的临床疗效,治疗前后肾阳虚症状积分、唤醒阈、膀胱容量、膀胱容量壁厚指数(BVWI)、遗尿频率、血清精氨酸加压素(AVP)、环磷酸腺苷(c AMP)、环磷酸鸟苷(c GMP)、c AMP/c GMP,复发率及不良反应发生情况。结果:观察组患儿总有效率显著高于对照组,差异有统计学意义(P<0.01)。治疗后,两组患儿肾阳虚症状积分、唤醒阈、BVWI、遗尿频率、血清c GMP均显著低于同组治疗前,且观察组显著低于对照组;两组患儿膀胱容量、血清AVP、c AMP、c AMP/c GMP均显著高于同组治疗前,且观察组显著高于对照组,差异均有统计学意义(P<0.01)。治疗3个月后,两组总有效患儿复发率比较,差异无统计学意义(P>0.05);治疗6个月后,观察组总有效患儿复发率显著低于对照组,差异有统计学意义(P<0.01)。两组患儿不良反应发生率比较,差异无统计学意义(P>0.05)。结论:在常规治疗的基础上,醒脾养儿颗粒治疗小儿原发性夜间遗尿症的疗效和安全性均较好,可改善患儿肾阳虚症状及唤醒阈,提高患儿的膀胱容量和血清AVP。

OBJECTIVE：To observe the efficacy and safety of Xingpi yang＇er granule in the treatment of primary nocturnal enuresis in children. METHODS：97 children with primary nocturnal enuresis were randomly divided into control group（46 cases）and observation group（51 cases）. Control group received Racemic anisodamine tablet 0.5 mg/（kg.d）,orally,once a day＋Vitamin B1 tablet 10 mg,orally,3 times a day＋Oryzanol tablet 10 mg,orally,3 times a day ＋ Meclofenac hydrochloride capsule 0.1 g 30 min before going to bed,orally,once a day. Observation group was additionally received Xingpi yang＇er granule 0.4 g for 5-6years old and 0.6 g for 7-14 years old,3 times a day. They were treated for 4 weeks. Clinical efficacy,kidney Yang deficiency score,wake-up threshold,bladder capacity,bladder volume,BVWI,enuresis frequency,AVP,c AMP,c GMP,c AMP/c GMP before and after treatment,recurrence rate and the incidence of adverse reactions in 2 groups were observed. RESULTS：The total effective rate in observation group was significantly higher than control group（P〈0.01）. After treatment,the kidney Yang deficiency score,wake-up threshold,BVWI,enuresis frequency and c GMP in 2 groups were significantly lower than before,and observation group was significantly lower than control group;bladder capacity,serum AVP,c AMP and c AMP/c GMP in 2 groups were significantly higher than before,and observation group was significantly higher than control group（P〉0.01）. After 3 months,there was no significant difference in the recurrence rate in total effective children（P〈0.05）;after 6 months,the total effective rate recurrence rate in observation group was significantly lower than control group（P〈0.01）. And there was no significant difference in the incidence of adverse reactions（P〉0.05）. CONCLUSIONS：Based on conventional treatment,Xingpi yang＇er granule shows good efficacy and safety in the treatment of primary nocturnal enuresis in children,which can improve children＇s kidney Yang deficiency score,wake-up threshold and bladder capacity and serum AVP.