| Objective: To observe the clinical effect of Sanjiao Zhiyi Recipe in the treatment of primary monosymptomatic enuresis(PMNE)in children of lung,spleen and kidney deficiency syndrome.Summarize and analyze the related pathogenesis and clinical characteristics of PMNE.To provide evidence-based medicine basis for treatment of PMNE based on theory of Sanjiao.Methods: Selected 140 children with PMNE of lung,spleen and kidney deficiency who met the inclusion and exclusion criteria in the pediatric outpatient department of Shandong Provincial Hospital of Traditional Chinese Medicine from November 2020 to July 2022.140 children were divided into treatment group and control group 1:1 according to the random number table method.The treatment group was given Sanjiao Zhiyi Recipe,and the control group was given Buzhong Yiqi Pill and Suoquan Pill.The course of treatment was 4 weeks.Recorded and analyzed the pathogenic factors and clinical characteristics of PMNE in children,and the changes of traditional Chinese medicine(TCM)syndrome score and enuresis frequency before and after 4 weeks of treatment.The curative effect of TCM syndrome was calculated by comparing the TCM syndrome score before and after 4 weeks of treatment to evaluate the improvement of the two groups on the main and secondary TCM symptoms of PMNE with deficiency of lung,spleen and kidney.The short-term curative effect of enuresis frequency was calculated by comparing the enuresis frequency before and after 4 weeks of treatment to evaluate the reduction of enuresis frequency in the two groups.At the same time,objectively measured the drug safety.Follow-up 6 months after the end of treatment,statistical analysis of the long-term curative effect of enuresis frequency and recurrence rate of enuresis.Result:1.Related pathogenesis and clinical characteristics of PMNE: 136 children were included in this study,68 in the treatment group and 68 in the control group.The age of visit was mainly 5-7 years old(50.74%).67(49.26%)children had family history of enuresis.21 children had a history of recurrent respiratory tract infection.4 children had a history of asthma.2 children had obstructive sleep apnea syndrome and 23 children had nocturnal snoring.136 children had no clearly diagnosed psych behavioral diseases.17 children had concomitant constipation.44.12% of children started urination training later than 12 months old.The time of removing diaper was mainly 19-36 months(62.50%).75.74% of children ate soup or porridge at dinner.The proportion of fluid intake within 1 hour and 3 hours before bedtime was 23.53% and 94.12% respectively.27.94% of the children had no regular habit of urinating at bedtime every day.2.Evaluation of bladder capacity and PMNE subtype :Guardians’ compliance of keeping 24-hour urination diary of children was good.78.68% of guardians could make standard record after the first instruction of record method.Of the 136 cases,18(13.24%)had a small functional bladder capacity(FBC)calculated by 24-hour urination diary,and 40(29.41%)were diagnosed with small bladder capacity by color Dopplar ultrasound of urinary system,with the difference of 22 cases.92 cases of FBC and nocturnal urine volume were normal.10 cases of nocturnal urine volume were normal but FBC was small.26 cases of FBC were normal but nocturnal polyuria,8 cases of FBC were small and nocturnal polyuria.3.Evaluation of curative effect of TCM syndrome: After 4 weeks of treatment,(1)Intra-group comparison: the main TCM symptoms,secondary TCM symptoms and total scores of the two groups were significantly reduced(P<0.05);(2)Comparison between groups: the frequency of enuresis,degree of sleep arousal,urine volume of enuresis,total score of main TCM symptoms,total score of secondary TCM symptoms and total score of TCM syndromes in the treatment group were significantly different from those in the control group(P<0.05).There were no significant differences between the two groups in the scores of hyperhidrosis,lusterless complexion,less breath and lazy speech,lack of energy,appetite and stool quality(P>0.05).(3)The effective rate of TCM syndrome: The effective rate of TCM syndrome in the treatment group(77.94%)was better than that in the control group(57.35%)(P<0.05).4.Evaluation of short-term curative effect of enuresis frequency: After4 weeks of treatment,the cure rate of short-term of enuresis frequency in the treatment group and the control group were 30.88% and 13.24% respectively,and the effective rate of short-term of enuresis frequency was 88.24% and73.53% respectively.Both of them had significant differences(P<0.05).It indicated that the treatment group had a better short-term curative effect of enuresis frequency.5.Evaluation of long-term curative effect of enuresis frequency: After follow-up,the cure rates of long-term of enuresis frequency in treatment group and the control group were 60.29% and 41.18% respectively.There was statistical difference(P<0.05).The recurrence rate of the treatment group(11.76%)was lower than that of the control group(25.00%)(P<0.05),which indicated that the long-term curative effect of enuresis frequency in the treatment group was better than that of the control group.6.Drug safety: No obvious adverse reactions occurred in all children during the treatment and follow-up.Conclusion: Sanjiao Zhiyi recipe and Buzhong Yiqi pill combined with Suquan pill were both effective and safe in improving the clinical symptoms of children with PMNE of lung,spleen and kidney deficiency syndrome.Compared with Buzhong Yiqi Pill combined with Suoquan Pill,Sanjiao Zhiyi Recipe has better curative effect on curative effect of TCM syndrome,short-term and long-term curative effect of enuresis frequency,and lower recurrence rate. |
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