| Objective Through clinical research to observe the clinical efficacy of Self-Xiao Ru Decoction in the treatment of Isolated Premature Thelarche of children with liver stagnation and fire,and to confirm the treatment of Isolated Premature Thelarche by traditional Chinese medicine "Self-Xiao Ru Decoction" role in order to better guide the clinical practice of traditional Chinese medicine.Methods A total of 66 children with Isolated Premature Thelarche(liver stagnation and fire syndrome)were selected and randomly divided into an observation group of 33 cases and a control group of 33 cases.The two groups of children were given basic intervention such as diet,nutrition,exercise,sleep,etc.The observation group was given the traditional Chinese medicine "Self-Xiao Ru Decoction" orally and basic intervention,and the control group received no special treatment except for the basic intervention,and 3 months was a course of treatment,a total of 1 course of treatment.The breast development stages,breast ultrasound,uterine and ovarian ultrasound,sex hormones,TCM syndrome changes and adverse drug reactions were observed before and after treatment in the two groups,and statistical analysis was performed.1.Comparison of changes in basic sex hormone levels between two groups:The difference of the morning basal Luteinizing Hormone(m LH)and the Follicle-Stimulating Hormone(FSH)in the observation group after treatment was statistically significant compared with that before treatment(P<0.01),while the differences in the Estradiol(E2),Prolactin(PRL)and Progesterone(P)were not statistically significant compared with those before treatment(P>0.05).The differences of m LH,FSH,E2,PRL and P in the control group after treatment were not statistically significant compared with those before treatment(P>0.05).After treatment,the differences in m LH and FSH between the two groups was statistically significant(P<0.05),but the differences in E2,PRL and P were not statistically significant between the two groups after treatment(P>0.05).2.Comparison of ultrasound changes of breast,uterus and ovary between two groups: The maximum diameter of mammary gland in the two groups decreased after treatment(P<0.01),and the reduction in the observation group was greater,and the difference between the two groups was statistically significant(P<0.05).The differences of uterine length,ovarian volume and maximum diameter of follicles in the observation group after treatment were statistically significant compared with those before treatment(P<0.05),while the differences in the control group after treatment in terms of uterine length,ovarian volume and maximum follicle diameter were not statistically significant compared with those before treatment(P > 0.05),and the difference between the two groups was statistically significant(P<0.05).3.Comparison of TCM syndrome scores between the two groups after treatment: The TCM syndrome scores of both groups were effectively reduced after treatment(P<0.01),and the score of the observation group decreased more significantly,showing difference between the two groups was statistically significant(P<0.05).The total effective rate of TCM syndromes in the observation group was 93.55%,which was higher than 75.76% in theResults control group,and the difference between the two groups was statistically significant(P<0.05).4.Comparison of total effective rate of Isolated Premature Thelarche between two groups: 12 cases in the observation group were cured,5 cases were markedly effective,and 8 cases were effective.In the control group,6 cases were cured,4 cases were markedly effective,and 11 cases were effective.The total clinical efficacy rate of the observation group was 80.65%,which was higher than 63.64% of the control group,and the difference between the two groups was statistically significant(P<0.05).5.Safety observation: There were no obvious adverse reactions in the two groups of children,and there was no obvious abnormality in the safety indicators.Conclusion1.Self-Xiao Ru Decoction combined with basic intervention can improve the maximum breast diameter,uterine length,ovarian volume,maximum follicle diameter,m LH,FSH in children with Isolated Premature Thelarche,and the effect is better than that of simple basic intervention.2.Self-Xiao Ru Decoction combined with basic intervention can improve the TCM syndrome of Isolated Premature Thelarche,the effect is better than simple basic intervention.3.Self-Xiao Ru Decoction combined with basic intervention and simple basic intervention can improve the symptoms of Isolated Premature Thelarche,and the effect of the former is better than that of the simple basic intervention group.4.The self-prepared Xiaoru prescription is safe and has no obvious adverse reactions. |
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