大补阴丸联合醋酸亮丙瑞林微球治疗女童特发性中枢性性早熟阴虚火旺证临床研究
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R725.8

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Clinical Study on Dabuyin Pills Combined with Leuprolide Acetate Microspheres for Girls with Idiopathic Precocious Puberty with Yin Deficiency Resulting in Vigorous Fire Syndrome
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    摘要:

    目的:观察大补阴丸联合醋酸亮丙瑞林微球治疗女童特发性中枢性性早熟(ICPP) 阴虚火旺证的 临床疗效及其安全性。方法:按随机数字表法将102 例ICPP 阴虚火旺证女童分入2 组(各51 例)。对照组给 予醋酸亮丙瑞林微球治疗,治疗组给予大补阴丸联合醋酸亮丙瑞林微球治疗。观察2 组临床疗效及不良反应发 生情况,比较2 组治疗前后中医证候评分、第二性征发育指标及性激素水平[血清卵泡刺激素(FSH)、黄体生 成素(LH)、雌二醇(E2) ]的变化。结果:对照组临床疗效总有效率为82.35%,治疗组为96.08%,2 组比 较,差异有统计学意义(P<0.05)。治疗后,2 组乳房发育、潮热盗汗、烦躁易怒、大便秘结中医证候评分均 较治疗前下降(P<0.05),治疗组上述4 项评分均低于对照组(P<0.05)。治疗后,2 组子宫容积、卵泡直 径、卵巢容积、乳腺大小指标值均较治疗前下降(P<0.05),治疗组上述4 项指标值均低于对照组(P< 0.05)。治疗后,2 组FSH、LH、E2 水平均较治疗前下降(P<0.05),治疗组FSH、LH、E2 水平均低于对照 组(P<0.05)。对照组不良反应发生率为11.76%,治疗组不良反应发生率为3.92%,2 组比较,差异无统计学 意义(P>0.05)。结论:大补阴丸联合醋酸亮丙瑞林微球治疗ICPP 阴虚火旺证女童能改善临床症状,调整第 二性征发育,降低性激素,安全性高。

    Abstract:

    Abstract: Objective: To observe the clinical effect and safety of Dabuyin Pills combined with Leuprolide Acetate Microspheres on girls with idiopathic central precocious puberty (ICPP) with yin deficiency resulting in vigorous fire syndrome. Methods: A total of 102 cases of ICPP girls with yin deficiency resulting in vigorous fire syndrome were selected and divided into the control group and the treatment group according to the random number table method,with 51 cases in each group. The control group was treated with Leuprolide Acetate Microspheres, and the treatment group was treated with Dabuyin Pills combined with Leuprolide Acetate Microspheres. The clinical effects and the rate of side reactions in the two groups were observed;the changes in traditional Chinese medicine (TCM) syndrome scores,development indexes of secondary sex characteristics,and sex hormone levels [follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) in serum] were compared before and after treatment in two groups. Results:The effective rate was 82.35% in control group and 96.08% in treatment group with significant difference(P<0.05). After treatment,the scores of TCM syndromes including breast development, tidal fever and night sweating, agitation and irascibility, and constipation in two groups were decreased(P<0.05), the above four scores in treatment group were lower compared with control group (P<0.05). After treatment, the indexes of uterine volume, follicle diameter, ovarian volume and breast size in two groups were decreased(P<0.05),and the indexes of uterine volume,follicle diameter, ovarian volume and breast size in the treatment group were lower compared with control group (P<0.05). After treatment,the levels of FSH,LH and E2 in the two groups were decreased(P<0.05),and the levels of FSH,LH and E2 in the treatment group were lower compared with control group (P<0.05). The incidence of adverse reactions was 11.76% in control group and 3.92% in treatment group with no significant difference(P>0.05). Conclusion: Dabuyin Pills combined with Leuprolide Acetate Microspheres for ICPP girls with yin deficiency resulting in vigorous fire syndrome can improve clinical symptoms, adjust the development process of secondary sexual characteristics and reduce the levels of sex hormones,with high safety.

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童露云,杨雪芳.大补阴丸联合醋酸亮丙瑞林微球治疗女童特发性中枢性性早熟阴虚火旺证临床研究[J].新中医,2024,56(5):31-35

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  • 在线发布日期: 2024-03-14
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