[1]禹远远,侯卫东,丁红霞,等.丹栀逍遥胶囊联合醋酸曲普瑞林治疗特发性中枢性性早熟女性患儿疗效观察[J].新乡医学院学报,2021,38(11):1048-1052.[doi:10.7683/xxyxyxb.2021.11.009]
 YU Yuanyuan,HOU Weidong,DING Hongxia,et al.Effect of Danzhi Xiaoyao Capsule combined with triptorelin acetate in the treatment of female children with idiopathic central precocious puberty[J].Journal of Xinxiang Medical University,2021,38(11):1048-1052.[doi:10.7683/xxyxyxb.2021.11.009]
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丹栀逍遥胶囊联合醋酸曲普瑞林治疗特发性中枢性性早熟女性患儿疗效观察
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《新乡医学院学报》[ISSN:1004-7239/CN:41-1186/R]

卷:
38
期数:
2021年11
页码:
1048-1052
栏目:
临床研究
出版日期:
2021-11-05

文章信息/Info

Title:
Effect of Danzhi Xiaoyao Capsule combined with triptorelin acetate in the treatment of female children with idiopathic central precocious puberty
作者:
禹远远1侯卫东1丁红霞1李会敏1梁亚飞1琚 玮2
(1.平顶山市第一人民医院内分泌代谢科,河南 平顶山 467000;2.河南中医药大学第一附属医院儿科,河南 郑州 450000)
Author(s):
YU Yuanyuan1HOU Weidong1DING Hongxia1LI Huimin1LIANG Yafei1JU Wei2
(1.Department of Endocrinology and Metabolism,the First People′s Hospital of Pingdingshan,Pingdingshan 467000,Henan Province,China2.Department of Pediatrics,the First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou 450000,Henan Province,China)
关键词:
丹栀逍遥胶囊醋酸曲普瑞林特发性中枢性性早熟性激素骨代谢
Keywords:
Danzhi Xiaoyao Capsulestriptorelin acetateidiopathic central precocious pubertysex hormonesbone metabolism
分类号:
R725.8
DOI:
10.7683/xxyxyxb.2021.11.009
文献标志码:
A
摘要:
目的 探讨丹栀逍遥胶囊联合醋酸曲普瑞林治疗特发性中枢性性早熟(ICPP)女性患儿的临床疗效。方法 选"择2016年2月至2019年1月平顶山市第一人民医院内分泌代谢科收治的110例ICPP女性患儿为研究对象,根据治疗方法将患儿分为对照组和观察组,每组各55例。对照组患儿给予醋酸曲普瑞林深部肌内注射治疗,初始剂量100 μg·kg-1,然后根据患儿发育程度调整剂量为80~100 μg·kg-1,每次最大剂量≤3.75 mg,首月15 d注射1次,次月开始28~30 d使用1次,治疗3个月后调整剂量为60~80 μg·kg-1,共治疗6个月;观察组患儿在对照组治疗基础上给予丹栀逍遥胶囊(规格0.45 g)口服,每次4粒,每日2次,共治疗6个月。治疗前及治疗6个月后采用化学发光免疫分析仪检测2组患儿血清性激素卵泡刺激素(FSH)、黄体生成素(LH)、雌二醇素(E2)水平。治疗6个月后评估2组患儿临床疗效,并计算总有效率。治疗前及治疗6个月后对2组患儿的中医症候程度进行评分。治疗前及治疗6个月采用电化学发光免疫分析法检测2组患儿血清Ⅰ型前胶原氨基端延长肽(PⅠNP)、Ⅰ型胶原羧基端β特殊序列(β-CTx)、N端骨钙素(N-MID)水平。记录治疗期间2组患儿胃肠道反应、头晕等不良反应发生情况,并计算不良反应发生率。结果 治疗前2组患儿血清FSH、LH、E2水平比较差异无统计学意义(P>0.05);治疗6个月后,2组患儿血清FSH、LH、E2水平均显著低于治疗前(P<0.05),观察组患儿血清FSH、LH、E2水平均显著低于对照组(P<0.05)。观察组和对照组患儿治愈、显效、有效、无效例数等级分布比较差异有统计学意义(Z=6.135,P<0.05);观察组患儿总有效率显著高于对照组(χ2=4.453,P<0.05);治疗前2组患儿中医症候主症、次症、总分比较差异无统计学意义(P>0.05);治疗6个月后,2组患儿中医症候主症、次症、总分均显著低于治疗前(P<0.05),观察组患儿中医症候次症、总分显著低于对照组(P<0.05),2组患儿中医症候主症积分比较差异无统计学意义(P>0.05)。治疗前2组患儿血清PⅠNP、β-CTx、N-MID水平比较差异无统计学意义(P>0.05);治疗6个月后,2组患儿血清PⅠNP、N-MID水平均显著低于治疗前,β-CTx水平显著高于治疗前(P<0.05);治疗6个月后,观察组患儿血清PⅠNP、N-MID水平显著低于对照组,β-CTx水平显著高于对照组(P<0.05)。治疗期间,对照组患儿出现头晕1例、胃肠道反应2例,不良反应发生率为5.45%;观察组患儿出现头晕2例、胃肠道反应3例,不良反应发生率为10.91%;2组患儿不良反应发生率比较差异无统计学意义(χ2=0.484,P>0.05)。结论 丹栀逍遥胶囊联合醋酸曲普瑞林治疗ICPP患儿疗效显著,在调节机体性激素、骨骼发育方面发挥积极有效的作用,且安全可靠。
Abstract:
Objective To investigate the clinical efficacy of Danzhi Xiaoyao Capsule combined with triptorelin acetate in the treatment of female children with idiopathic central precocious puberty (ICPP).Methods A total of 110 female children with ICPP who were admitted to the Department of Endocrinology and Metabolism,the First People′s Hospital of Pingdingshan from February 2016 to January 2019 were selected as the research subjects.The patients were divided into the control group and the observation group according to the treatment method,with 55 cases in each group.The children in the control group were given deep intramuscular injection of triptorelin acetate,the initial dose was 100 μg·kg-1,then the dose was adjusted to 80-100 μg·kg-1 according to the children′s development,with the maximum dose ≤3.75 mg each time,once every 15 d in the first month,and once every 28-30 days in the next month,the dose was adjusted to 60-80 μg·kg-1 after 3 months of treatment,treatment for 6 months.On the basis of treatment the control group,children in the observation group were given Danzhi Xiaoyao Capsules (specification 0.45 g) orally,4 capsules each time,2 times once day for 6 months.Before treatment and 6 months after treatment,the levels of serum sex hormone follicle-stimulating hormone (FSH),luteinizing hormone(LH),estradiol(E2)of children in the two groups were detected by chemiluminescence immunoassay.After 6 months of treatment,the clinical efficacy of children in the two groups was evaluated,and the total effective rate was calculated.Before treatment and 6 months after treatment,the degree of traditional Chinese medicine symptoms of children in the two groups was scored.Before treatment and 6 months after treatment,the levels of serum type I procollagen amino terminal elongation peptide (PⅠNP),Beta C-terminal cross-linked telopeptides of type Ⅰ collagen carboxy (β-CTx) and N-terminal osteocalcin (N-MID) of children in the two groups were detected by electrochemiluminescence immunoassay.During the treatment,the occurrence of gastrointestinal reactions,dizziness and other adverse reactions of children in the two groups was recorded,and the incidence of adverse reactions was calculated.Results Before treatment,there was no significant difference in serum FSH,LH,E2 levels of children between the two groups (P>0.05)after 6 months of treatment,the serum FSH,LH and E2 levels of children in the two groups were significantly lower than those before treatment (P<0.05),the serum FSH,LH and E2 levels of children in the observation group were significantly lower than those in the control group (P<0.05).There was a statistically significant difference in the grade distribution of the number of cured,markedly effective,effective and ineffective children between the observation group and the control group (Z=6.135,P<0.05)the total effective rate of children in the observation group was significantly higher than that in the control group (χ2=4.453,P<0.05).There was no significant difference in the main symptoms,secondary symptoms and total scores of children between the two groups before treatment (P>0.05)after 6 months of treatment,the main symptoms,secondary symptoms and total scores of children in the two groups were significantly lower than those before treatment (P<0.05),the traditional Chinese medicine syndromes and total scores of children in the observation group were significantly lower than those in the control group (P<0.05),there was no significant difference in the scores of main symptoms of traditional Chinese medicine of children between the two groups (P>0.05).There was no significant difference in the levels of serum PⅠNP,β-CTx and N-MID of children between the two groups before treatment (P>0.05)after 6 months of treatment,the levels of serum PⅠNP and N-MID of children in the two groups were significantly lower than those before treatment,and the level of β-CTx was significantly higher than that before treatment (P<0.05)after 6 months of treatment,the serum levels of PⅠNP and N-MID of children in the observation group were significantly lower than those in the control group,and the level of β-CTx was significantly higher than that in the control group (P<0.05).During the treatment period,the control group had 1 case of dizziness and 2 cases of gastrointestinal reactions,and the adverse reaction rate was 5.45%the observation group had 2 cases of dizziness and 3 cases of gastrointestinal reactions,and the adverse reaction rate was 10.91%there was no significant difference in the incidence of adverse reactions of children between the two groups (χ2=0.484,P>0.05).Conclusion Danzhi Xiaoyao Capsule combined with triptorelin acetate has a significant effect in the treatment of children with ICPP,and plays an active and effective role in regulating the body′s sex hormones and bone health,and is safe and reliable.

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更新日期/Last Update: 2021-11-05