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徐海霞,张菲菲,孙海英,耿利娜,时毓民.滋阴泻火颗粒治疗特发性中枢性性早熟（阴虚火旺证）女童的临床研究[J].湖南中医药大学学报英文版,2022,42(3):457-464.[Click to copy
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| 滋阴泻火颗粒治疗特发性中枢性性早熟（阴虚火旺证）女童的临床研究 |
| 徐海霞,张菲菲,孙海英,耿利娜,时毓民 |
| (上海中医药大学附属市中医医院, 上海 200071;复旦大学附属儿科医院, 上海 201102) |
| 摘要: |
| 目的 观察时毓民教授经验方滋阴泻火颗粒治疗特发性中枢性性早熟（阴虚火旺证）女童的临床疗效和安全性。方法 收集上海中医药大学附属市中医医院、复旦大学附属儿科医院2020年7月至2021年6月符合纳入标准的性早熟女童患儿82例，采用随机、单盲、阳性对照的方法，运用随机数字法分为治疗组（41例）和对照组（41例），治疗组予滋阴泻火颗粒，对照组予知柏地黄汤治疗，治疗疗程均为6个月。分别观察两组患儿治疗前后主症（乳房Tanner分期、阴毛Tanner分期、阴道分泌物、月经初潮、主症总积分）、次症（五心烦热、潮热盗汗、颧红耳赤、咽干口燥、烦躁易怒、小便短黄、大便秘结、次症总积分）、性激素水平[雌二醇（estradiol, E2）、卵泡刺激素（follicle stimulating hormone, FSH）、促黄体生成素（luteinizing hormone, LH）、泌乳素（prolactin, PRL）]、子宫容积、卵巢容积、骨龄指数、卵泡大小等以评价临床疗效，并记录临床不良反应事件。结果 治疗组临床总有效率优于对照组（P<0.05）。治疗组主症（乳房Tanner分期、阴道分泌物、主症总积分）、次症（潮热盗汗、咽干口燥、颧红耳赤、次症总积分）、子宫容积、卵巢容积、卵泡大小、骨龄指数、血清性激素（LH、FSH、PRL）较治疗前均有改善且优于对照组（P<0.05）；对照组乳房Tanner分期、主症总积分、子宫容积、卵巢容积、卵泡大小、血清性激素（LH、FSH、PRL）较治疗前无明显变化（P>0.05）,而阴道分泌物、次症（潮热盗汗、咽干口燥、颧红耳赤、次症总积分）、骨龄指数均有改善（P<0.05）；治疗组与对照组次症（烦躁易怒、五心烦热、小便短黄、大便干结）积分均有改善（P<0.05），但组间比较差异无统计学意义（P>0.05）；治疗组与对照组阴毛Tanner分期、月经初潮、E2水平治疗前后组内、组间比较差异无统计学意义（P>0.05）。两组治疗后安全性指标均正常，无不良事件发生。结论 滋阴泻火颗粒可有效改善特发性中枢性性早熟（阴虚火旺证）女童的临床症候，降低血清性激素水平，缩小子宫容积、卵巢容积及卵泡大小，抑制骨龄的快速增长，临床疗效显著，安全性可靠，值得进一步推广。 |
| 关键词: 特发性中枢性性早熟 女童 阴虚火旺证 滋阴泻火颗粒 知柏地黄汤 临床研究 |
| DOI：10.3969/j.issn.1674-070X.2022.03.021 |
| Received:September 27, 2021 |
| 基金项目:国家中医药管理局第六批全国老中医药专家学术经验继承工作项目（国中医药人教发﹝2017﹞29号）；上海市卫生健康委员会项目（2020LP049）；中国民族医药学会儿科分会项目（2021Z2192-400618）；上海市中医药管理局项目（ZY-SYJS-5）。 |
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| Clinical study on Ziyin Xiehuo Granule in the treatment of girls with idiopathic central precocious puberty (Yin deficiency and fire vigorous syndrome) |
| XU Haixia,ZHANG Feifei,SUN Haiying,GENG Lina,SHI Yumin |
| (Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China;Children's Hospital of Fudan University, Shanghai 201102, China) |
| Abstract: |
| Objective To observe the clinical efficacy and safety of professor Shi Yumin’s experienced formula Ziyin Xiehuo Granule in the treatment of idiopathic central precocious puberty (Yin deficiency and fire vigorous syndrome) girls. Methods 82 precocious puberty girls that were seeing a doctor in Shanghai Municipal Hospital of Traditional Chinese Medicine, Children’s Hospital of Fudan University from July 2020 to June 2021 were collected who met the inclusion criteria; a randomized, single-blind, and positive control method was used; random number method was used to divide them into a treatment group (41 cases) and a control group (41 cases). The treatment group was treated with Ziyin Xiehuo Granule and the control group was treated with Zhibai Dihuang Decoction, their treatment course were 6 months. The major symptoms (breast Tanner stage, pubic hair Tanner stage, vaginal secretion, menarche, total integral of major symptoms), the secondary symptoms (five heart upset heat, hot flashes and night sweat, red cheekbones and red ears, dry throat and mouth, irritability, short yellow urine, constipation, secondary symptoms score), sex hormone level [estradiol (E2), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL)], uterine and ovarian volume, bone age index and follicle size of the two groups before and after treatment were observed to evaluate the clinical efficacy, and the clinical adverse reaction events were recorded. Results The total clinical effective rate in the treatment group was better than that in the control group (P<0.05). After treatment, main symptoms (breast Tanner stage, vaginal secretion, total score of main symptoms), secondary symptoms (hot flashes and night sweats, dry throat, red cheekbones and red ears, total score of secondary symptoms), uterine volume, ovarian volume, follicle size, bone age index, serum sex hormone (LH, FSH, PRL) of treatment group were improved compared with those before treatment and better than the control group (P<0.05). In the control group, there was no significant change in breast Tanner stage, total score of main symptoms, uterine volume, ovarian volume, follicle size, serum sex hormone (LH, FSH, PRL) compared with that before treatment (P>0.05), vaginal secretion, secondary symptoms (hot flashes and night sweats, dry throat, red cheekbones and red ears, total score of secondary symptoms) and bone age index were improved compared with those before treatment (P<0.05). After treatment, secondary symptoms (irritability, five heart upset heat, short yellow urine, dry stool) of the treatment group and the control group were improved compared with those before treatment (P<0.05), and the comparison between the groups was not statistically significant (P>0.05); there was no significant difference in pubic hair Tanner stage, menarche and E2 level between the treatment group and the control group before and after treatment (P>0.05). The safety indicators of the two groups were normal after treatment, no adverse events occurred. Conclusion Ziyin Xiehuo Granule can effectively improve the clinical symptoms of girls with idiopathic central precocious puberty (Yin deficiency and fire vigorous syndrome), reduce serum sex hormones levels, reduce uterine, ovarian volume and follicle size, and inhibit bone age rapid growth, has remarkable clinical efficacy, safe and reliable, worthy of further promotion. |
| Key words: idiopathic central precocious puberty girl Yin deficiency and fire vigorous syndrome Ziyin Xiehuo Granule Zhibai Dihuang Decoction clinical research |
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