OBJECTIVE:To observe the efficacy and safety of Xingpi yang'er granule in the treatment of primary nocturnal en-uresis 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 5-6 years 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,cAMP,cGMP,cAMP/cGMP be-fore and after treatment,recurrence rate and the incidence of adverse reactions in 2 groups were observed. RESULTS:The total ef-fective 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 cGMP in 2 groups were significantly lower than before,and observation group was significantly lower than control group;bladder capacity,serum AVP,cAMP and cAMP/cGMP in 2 groups were signifi-cantly 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 recur-rence 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.