| Purpose:To observe the clinical efficacy and follow-up recurrence after the treatment of Funtional Constipation(Dryness-heat type)in children with Modified Zengye decoction,and to evaluate the efficacy and safety of Modified Zengye decoction,so as to provide revelence for the treatment of Funtional Constipation in children.Method:64 children diagnosed as dryness-heat type Funtional Constipation were selected andradomly divided into the treatment group and the control group,both of which obtain 32 cases.The cases of treatment group were treated with Modified Zengye decoction,while the cases of control group were given lactulose oral solution.The total treatment course of both groups was 12 weeks.The clinical efficacy of both groups was evaluated based on observing the changes in traditional Chinese medicine syndrome scores.The recurrence of the disease was evaluated with followed-up visit at 3 months after treatment.Then,the statistical analysis was conducted by SPSS19.0 software.Results:1.In this study,64 cases were included.2 cases were dropped out,therefore,62 cases completed the clinical observation,with 32 cases in the treatment group and 30 cases in the control group.There was no significant difference betweem two groups in gender,age,course of disease and traditional Chinese medicine syndrome scores before treatment,which showed they are comparable.2.Clinical efficacy of TCM syndrome:The total effective rate was 96.87% in the treatment group,among which 11 cases were cured,12 cases were markedly effective,and 8 cases were effective.While the total effective rate was 86.67% in the control group,among which 3 cases were cured,7 cases were markedly effective,and 16 cases were effective.The former was better than the latter with statistically significant difference(P<0.05).3.TCM syndrome score:(1)Intra group comparison:There was statistically significant difference in the total syndrome score in each group before and after treatment of 12 weeks(P< 0.05),indicating that both treatment are effective.(2)Comparison between groups:The difference in the total syndrome score was statistically significant between 2 groups(P <0.05).The improvement of symptoms and signs in the treatment group was better than the other.As for single symptom score,there were statistically significant differences between two groups in tool traits,defecation frequency,appetile,halitosis,feverish palms and soles and sleep disturbance syndrome scores after treatment(P < 0.05),but no statistically significant differences in defecation difficulty as well as abdominal pain and abdominal distension(P>0.05).4.Follow-up recurrence: It was found in 3-month follow-up visit that the recurrence rate was 6.45% in the treatment group with 2 cases of recrudescence,while 30.77% in the control group with 8 cases of recrudescence.The diffrence was statistically significant(P<0.05).5.Safety evalution:There was no obvious side-effect found in both groups.Conclusion:Modified Zengye decoction has definite therapeutic effect and high safety in treating dryness-heat type funtional constipation in children.Its clinical efficacy of improving the comprehensive syndrome of the disease is superior to that of lactulose oral solution,and is more sustained and stable than the latter as well.Thus,modified Zengye decoction deserves further clinical application. |