Influence Of Nourishing Yin And Soothing Liver Method On Hormone,Insulin-Like Growth Factor And Leptin In Simple Premature Thelarche

Background:Simple Premature Thelarche (SPT) belongs to partial precocious puberty, which means isolated thelarche in young girls less than 8 years old without maturation of other secondary sexual characters. Previously, it was thought to be self-limitied, until 2007 years "central(true) precocious puberty treatment guideline" definitely presented that in the event of having no clinical portent signs, simple premature thelarche turns into central precocious puberty. With the standard of living rising, its incidence presents escalating trend. Clinical study shows that SPT girls significantly different from healthy girls in behaviour issues, such as gloom, breaking the rules, withdrawal from society, introversion. Preventing and treating SPT earlyer are particularly important. Its pathogenesis is believed to be neuro-endocrine system in disorder. It refers to two axises:gonad axis and growth acceleration hormone axis; that is Hypothalamic Pituitary Gonadal Axis and The Growth Hormone-Insulin-Like Growth Factor-Ⅰaxis. The axises have indivisible interaction with premature and keeping productive function in adults. Western medicine has no clearly and effective treatment, Rujieping (Asparagus Bromelain) capsule is compound preparation, it has the function of softening hardness to dissipate stagnation and anti-inflammatory analgesic.It is used in curing hyperplasiaofmammaryglands and as the SPT experience of drug use. Chinese medcine adjust Qi-Blood, Yin-Yang, to make the body "yin and yang in harmonious, spirit will be peaceful",displays unique advantages in treating SPT. The principle of treatment includes nourishing yin to reduce pathogenic fire, adjusting liver and kidney, strengthening the spleen to reducing phlegm and eliminating dampness, regulating vital energy and activate blood and dissolve phlegm, and so on. Tutors's earlier stage on clinical study about add-subtract zhi-bai-di-huang decoction curing SPT found the total effective rate reached 90.9%, and put forward the assume of blood serum Growth Hormone, Insulin-Like Growth Factor, Leptin, having connections with SPT. This study bases on the theory "Yang is often enough, yin is often in deficient;Liver is often enough, Kidney is often in deficient", puts forward the therapy of nourishing yin and soothing liver. For the past few years, Studies found that IGF-Ⅰ, Leptin are regulatory factors in HPGA starting, but its'relationship with SPT is still not clear. The study complied with randomized, controlled, blinded principles aims at rigorous scientific validating the clinical efficacy with Nourishing Yin and soothing liver method in treating SPT, and do study with the Rujieping capsule group as control. Children breast diameter, hormone levels, IGF-Ⅰ, Leptin levels, uterine and ovarian volumes, breast noctovisor scan as the efficiency indexes,to further explore GH, IGF-Ⅰ.Leptin with the SPT mechanism of action. Provide a scientific basis for clinical application to prevent SPT turns into precocious puberty.Objective:observing before and after treatment of serum FSH, LH, E2content changes, to understand the functional status of children HPGA and investigate the mechanism of add-subtract of zhi-bai-di-huang decoction in treating SPT; by observing serum GH, IGF-Ⅰ, Leptin content changes before and after treatment, discuss with GH-IGF-ⅠAxis and Leptin In the role of SPT pathogenesis. In order to find new means of prevention and treatment, new ways to prevent SPT turning into complete central precocious puberty, stop or fade away secondary sexual characteristics, prevent premature menstrual cramps, delay bone age grown up and improve final height.Methods:Study of 60 cases of girls, are from March 2008 to March 2010 in Guangzhou Traditional Chinese Medicine Hospital pediatric clinic and diagnosed as SPT of the girls, according to a simple random check of randomly divided into treatment group and control group 30 cases as a result of balance. Rujieping is capsule, add-subtract zhi-bai-di-huang decoction is decoction, are easy distinquished, therefore single-blind clinical trial is adopted. Treatment group:oral add-subtract zhi-bai-di-huang decoction, each 125ml, 2 times a day,3 months is a course of treatment. Control group:oral Rujieping(asparagus, bromelain) capsule,2 tablets each time,3 times a day, 3 months is a course of treatment. During treating were not combined with other therapies. Before and after treatment height, weight, clinical symptoms, breast diameter, serum FSH, LH, E2, IGF-Ⅰ, Leptin levels, blood, urine, heart, liver function tests, breast noctovisor scan, uterine volume, ovarian volume to comparison. All data are mean±standard deviation (x±s), measured data groups were analyzed by using two independent samples T-test; before and after treatment data using paired samples T-test; counted data usingχ2 test; paired rating information using symbols rank test. Statistical analysis completed by SPSS17.0 package.Results:1. Two groups Symptom Score:Total effective rate:the treatment group is 93.3%, the control group is 80%, The two results had significant differences.2. Breast diameter:The two groups before treatment breast diameter is non-significance difference, but the difference is significant after treatment, P equals 0.01, less than 0.05.3. Serum sex hormones examination results:Two groups of serum LH level before and after treatment, there are no significant differences, P equals 0.966, is greater than 0.05; FSH,E2 levels:Before treatment two groups have no significant difference, but after treatment with significant differences:P of FSH changes equals 0.005, less than 0.05; P of E2 changes equals 0.001, less than 0.05.4. GH,IGF-Ⅰ,Leptin results:Two groups of GH level before and after treatment have no significant differences; P equals 0.638, greater than 0.05. IGF-Ⅰ,Leptin levels:Before treatment two groups have no significant differences, but after treatment with significant differences:P of IGF-Ⅰchanges equals 0.007, less than 0.05; P of Leptin changes equals 0.018, less than 0.05.5. Two groups of blood routine, Urine Routine:before and after treatment, the results are nromal, have no significant differences.6. Electrocardiogram,alanine aminotransferase,aspartate aminotransferase,gamma glutamyl transferase,creatinine,Urea nitrogen of two groups before and after treatment, the results are normal, have no significant differences.7. Comparison of two breast scans:Disappearance rate of the breast glands: the treatment group is 43.3%, the control group is 20%, the results have significant differences. Z equals-2.45, P equals 0.014, less than 0.05.8. Comparison of two uterine volume:Treatment group before and after treatment P equals 0.142, more than 0.05, have no significant differences; The control group before and after treatment P equals 0.542, more than 0.05, have no significant differences; Compared with control group, Before treatment, P equals 0.232, more than 0.05, have no significant differences;After treatment, P equals 0.799, more than 0.05,have no significant differences.9. Comparison of two groups of ovarian volume:Treatment group before and after treatment P equals 0.000, less than 0.05, have significantly differences. The control group before and after treatment P equals 0.607, more than 0.05, have no significant differences. The two groups before treatment have no significant differences, P equals 0.258,more than 0.05;but after treatment, have significant differences,P equls 0.003, less than 0.05.10. Bone age:The two groups before treatment, bone age are consistent with the actual age, have no significant differences.11. Adverse drug reactions:were not found, the differences were not significant.Conclusions:1. Add-subtract zhi-bai-di-huang decoction of the breast swelling, irritability, disturbed sleep soundly at night, dry mouth suffering, poor appetite, abdominal distension, pulse rate and other lier constraint and deficiency of kidney Yin symptoms were more effective than Rujieping capsule group.2. Add-subtract zhi-bai-di-huang decoction mammary gland of the effect of reducing significantly.3. Add-subtract zhi-bai-di-huang decoction can reduce sex hormones FSH, E2 levels, lower IGF-Ⅰ, Leptin levels.4. SPT girls sex hormones FSH, E2 varying degrees higher than normal, after treatment, with the reduction of breast enlargement, FSH, E2levels also decreased, indicating the occurrence of this disease have relationship with serum FSH, E2 levels increased.5. SPT girls, serum IGF-Ⅰ, Leptin levels decreased significantly after treatment, so we conclude that IGF-Ⅰ, Leptin have relationship with the pathogenesis of SPT. 6. Add-subtract zhi-bai-di-huang decoction can clear retraction of ovarian volume, Rujieping capsule to the changes in ovarian volume had no effect.7. The two groups showed no significant side effects, low incidence of adverse reactions, so Add-subtract zhi-bai-di-huang decoction in treating SPT is safe and feasible.