| In pediatric clinical practice,precocious puberty is a common endocrine disorder that has been receiving increasing attention as its incidence continues to rise.The occurrence of this disease may be closely related to factors such as environmental pollution and dietary structure.If left undetected and untreated,the epiphyseal plates of affected children may close earlier than those of their peers,leading to a failure to reach normal height It is common for adult males to have a height below 160cm and adult females to have a height below 150cm.In addition,if the onset of secondary sexual characteristics occurs earlier than in same-aged children,affected children may develop psychological problems such as low self-esteem and fear,which can negatively affect their physical and mental health.Therefore,improving the prevention and treatment of precocious puberty in children has become an important research topic in the field of pediatrics..Teacher Liu Yuqing is good at treating gynecological diseases in children and has rich experience in treating precocious puberty.According to many years of clinical experience,Teacher Liu believes that Zhibai Dihuang Wan,which is commonly used in modern times to treat yin deficiency and fire excess syndrome,has certain limitations,as Professor Guo Zhiqiang,a gynecologist,believes that "female yin is often insufficient and yang is also often virtual" "and" phellodendron amurense and Anemarrhena asphodeloides are often used to clear deficiency heat,and the disadvantages of injuring yang are ignored ".Teacher Liu admired Qian Yi,a physician in the Song Dynasty,and Qian Yi’s famous prescription"Liuwei Dihuang Wan" has a good effect in various pediatric diseases,and its nourishing yin effect has received the attention of the majority of physicians.The treatment of precocious puberty in children has a long course of treatment,and childhood has a prominent feature compared with adults,that is,growth and development,so the prescription of medication should not only nourish yin to control the rapid development of children but also replenish qi to help their normal growth.Thus,the main pathogenesis of Teacher Liu’s general precocious puberty is deficiency of both qi and yin,imbalance of yin and yang.From the root of the disease,Sijun Dihuang Yin as an empirical prescription for the treatment of precocious puberty,the effect is significant,good clinical efficacy has been recognized by the majority of children with precocious puberty and their parents.Objective:To provide a preliminary evaluation of the effectiveness and safety of the Sijun Dihuang Decoction in treating true precocious puberty in girls,and to provide a new treatment option for the traditional Chinese medicine treatment of precocious puberty in girls.Research method:This study adopts a single-center,prospective,open-label clinical trial method.Sixty cases of true precocious puberty in female children who visited the TCM pediatrics outpatient department of Dongzhimen Hospital from December 2021 to October 2022 are planned to be included.All subjects will be given the prescription of Si Jun Di Huang drink,which is the granules without decoction from Dongzhimen Hospital.The medication will be taken at a dose of one bag,twice a day,in the morning and evening,for a total of two consecutive courses,each lasting three months.The traditional Chinese medicine syndrome score,sex hormone levels(including LH,FSH,and E2),breast Tanner stage changes before treatment,at 3 months of treatment,and at 6 months of treatment will be recorded,as well as bone age index before treatment and 6 months after treatment.SPSS 25.0 statistical software will be used to perform data analysis to evaluate the clinical efficacy of Si Jun Di Huang drink in treating true precocious puberty in female children.The physical condition of the patients will be closely monitored,and any possible adverse reaction symptoms will be recorded in a timely manner to evaluate the safety of the treatment.Results:1.Traditional Chinese Medicine(TCM)symptom efficacy:We analyzed the therapeutic effects of 60 cases of true precocious puberty patients.The treatment period was 6 months,with 13 cases cured,16 cases significantly improved,17 cases effective,and 14 cases ineffective,with a total effective rate of 76.67%.2.Comparison of total scores of TCM syndromes:After 3 and 6 months of treatment,the total score of traditional Chinese medicine(TCM)symptoms,the total score of TCM primary symptoms,and the score of TCM secondary symptoms were significantly reduced compared to before treatment,with statistically significant differences(P<0.01).Compared with the score at 3 months of treatment,the total score of TCM symptoms slightly decreased at 6 months,but the difference was not statistically significant(P>0.05).Compared with the score at 3 months of treatment,the total score of TCM primary symptoms and the score of TCM secondary symptoms at 6 months were significantly reduced,with statistically significant differences(P<0.01).3.Comparison of main symptom scores in traditional Chinese medicine:The breast development score and vaginal discharge score of the patients significantly decreased after 3 and 6 months of treatment compared to before treatment,and the differences were statistically significant(P<0.01).Compared with 3 months of treatment,the breast development score and vaginal discharge score were still significantly reduced after 6 months of treatment,and the differences were statistically significant(P<0.01).There was no significant difference in pubic hair development between before treatment and 3 and 6 months after treatment P>0.05).None of the patients had menarche during the 3 and 6 months before and after treatment.4.Comparison of sub-symptom scores in traditional Chinese medicine:After 3 months of treatment,the irritability symptom score of the patient slightly decreased,but the difference was not statistically significant(P>0.05).Compared to before treatment,after 3 months of treatment,the urinary and fecal symptoms,as well as tongue and pulse symptoms,decreased significantly and the differences were statistically significant(P<0.05).After 6 months of treatment,compared to before treatment,the patient’s irritability,urinary and fecal symptoms,as well as tongue and pulse symptoms,all decreased significantly,and the differences were statistically significant(P<0.01).Compared to 3 months of treatment,after 6 months of treatment,the patient’s irritability symptom score,urinary and fecal symptoms,as well as tongue and pulse symptoms,all decreased significantly,and the differences were statistically significant(P<0.01).During the 3 and 6 months of treatment,the patient did not experience symptoms of hot flashes,facial flushing,night sweats,or dry throat and mouth.5.Comparison of bone age index:After 6 months of treatment,the bone age index of the patient significantly decreased,and the difference compared to before treatment was statistically significant(P<0.01).6.Comparison of sex hormones FSH,LH,E2:The FSH,LH,and E2 levels of the patient significantly decreased after 3 and 6 months of treatment compared to before treatment,and the differences were statistically significant(P<0.01).Compared to 3 months of treatment,the FSH,LH,and E2 levels of the patient significantly decreased after 6 months of treatment,and the differences were statistically significant(P<0.01).7.Tanner stage comparison of breast:Before treatment,there were no cases in stage B1,17 cases in stage B2,37 cases in stage B3,and 6 cases in stage B4.After 3 months of treatment,the number of cases in stage B1 increased to 3,the number of cases in stage B2 increased to 20,the number of cases in stage B3 decreased to 31,and the number of cases in stage B4 remained unchanged at 6.After 6 months of treatment,the number of cases in stage B1 increased to 15,the number of cases in stage B2 increased to 30,the number of cases in stage B3 decreased to 9,and the number of cases in stage B4 remained unchanged.8.Safety:In this study,60 children with true precocious puberty did not experience any adverse reactions during the treatment period.Conclusion:Si Jun Di Huang Yin is clinically effective in the treatment of girls with true precocious puberty.It can improve clinical symptoms such as early breast development and increased vaginal secretions,relieve related symptoms such as irritability,frequent urination,and constipation,reduce the child’s bone age index,decrease FSH,LH,and E2 levels,and decrease the Tanner staging of the child’s breast.It is safe and effective without any adverse reactions,and it is necessary to further explore and apply it in clinical practice. |
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