运脾益肾方联合重组人生长激素治疗脾肾两虚型青春期大骨龄特发性矮身材女童临床研究
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R272

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国家卫生健康委能力建设和继续教育中心专项研究(GWJJZX20251001071)


Clinical Study on Yunpi Yishen Prescription Combined with Recombinant Human Growth Hormone in the Treatment of Idiopathic Short Stature Girls with Advanced Bone Age in Adolescents of Spleen and Kidney Deficiency Type
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    摘要:

    目的:观察运脾益肾方联合重组人生长激素(rhGH) 治疗脾肾两虚型青春期大骨龄特发性矮身材 的临床疗效。方法:选择2022年1月—2024年1月在安阳市中医院儿科门诊治疗的100例脾肾两虚型青春期大 骨龄特发性矮身材女童作为研究对象,按照随机数字表法分为对照组和观察组各50例。对照组因失访脱落 5例,最终纳入45例;观察组因失访脱落6例,最终纳入44例。对照组给予rhGH治疗,观察组给予运脾益肾 方联合rhGH治疗。2组均治疗52周。治疗52周后评价临床疗效,比较2组治疗前及治疗各时间点的身高、 Chronological Age 身高标准差积分(HtSDS_CA)、Bone Age 身高标准差积分(HtSDS_BA) 以及空腹血 糖(FBG)、空腹胰岛素(FINS)、促甲状腺激素(TSH)、游离三碘甲状腺原氨酸(FT3)、游离四碘甲状腺原 氨酸(FT4) 及胰岛素样生长因子-1 (IGF-1) 水平,记录不良反应的发生情况。结果:①临床疗效:治疗 52周后,观察组总有效率90.91%(40/44),高于对照组(73.33%,33/45)(P<0.05)。②生长指标:2组身高、 生长速率、HtSDS_CA 值及HtSDS_BA 值分别整体比较, 差异均有统计学意义(P<0.05)。2 组身高、 HtSDS_CA值及HtSDS_BA值均随治疗时间的延长呈增长趋势,生长速率则均先升高,后逐渐下降,于治疗 13周达到峰值。观察组治疗26周、39周、52周后的身高均高于对照组(P<0.05),治疗13周、26周、39周、 52 周后的生长速率、HtSDS_CA 值及HtSDS_BA 值均高于对照组(P<0.05)。2 组治疗13 周、26 周、39 周、 52 周后的身高、HtSDS_CA 值均较治疗前、治疗1 周后、治疗4 周后升高(P<0.05),并均较前一时点升 高(P<0.05)。观察组治疗4周后的生长速率较治疗前、治疗1周后升高(P<0.05)。2组的生长速率均在治疗 13 周后达到峰值,治疗26 周、39 周、52 周后的生长速率随治疗时间的延长呈下降趋势。2 组治疗13 周、 26周、39周、52周后的生长速率均较治疗前、治疗1周、治疗4周后增加,治疗26周、39周、52周后的生长 速率均较前一时点下降,差异均有统计学意义(P<0.05)。观察组治疗13 周、26 周、39 周、52 周后的 HtSDS_BA值均较治疗前、治疗1周后、治疗4周后升高(P<0.05),并均较前一时点升高(P<0.05)。对照组 治疗13周后的HtSDS_BA值均较治疗前升高(P<0.05),治疗26周、39周、52周后的HtSDS_BA均较治疗前、治 疗1周、治疗4周后升高(P<0.05),治疗39周、52周后的HtSDS_BA值均较治疗13周后升高(P<0.05),治 疗52周后的HtSDS_BA值较治疗26周后升高(P<0.05)。③糖代谢指标:2组FBG、FINS水平分别整体比较, 差异均有统计学意义(P<0.05)。2组的FBG水平均随治疗时间的延长呈上升趋势,对照组的FINS水平随治疗 时间的延长呈上升趋势,观察组的FINS水平则呈下降趋势。观察组治疗13周、26周、39周、52周后的FBG水 平均较治疗前升高(P<0.05),治疗39周、52周后的FBG水平均较治疗13周后升高(P<0.05),治疗52周 后的FBG水平较治疗26周后升高(P<0.05)。对照组治疗13周、26周、39周、52周后的FBG水平均较治疗 前升高(P<0.05),治疗39周后的FBG水平均较治疗13周、26周后升高(P<0.05),治疗52周后的FBG水平 均较治疗13周、26周、39周后升高(P<0.05)。观察组治疗52周后的FINS水平较治疗前下降(P<0.05)。对 照组治疗39 周后的FINS 水平较治疗前升高(P<0.05),治疗52 周后的FINS 水平均较治疗前及治疗13 周、 26 周、39 周后升高(P<0.05)。2 组治疗13 周、26 周后的FBG、FINS 水平分别比较,差异均无统计学意 义(P>0.05)。观察组治疗39周、52周后的FBG、FINS水平均低于对照组(P<0.05)。④甲状腺功能指标: 2组的FT4、TSH水平均随治疗时间的延长呈下降趋势,2组的FT3水平随治疗时间的延长呈升高趋势。对照组 FT3、FT4、TSH水平分别整体比较,差异均有统计学意义(P<0.05)。对照组治疗52周后的FT3水平均较治 疗前、治疗13周后、治疗26周后升高,差异均有统计学意义(P<0.05)。对照组治疗52周后的FINS水平 较治疗13周后下降,差异有统计学意义(P<0.05)。观察组的TSH、FT3、FT4水平分别整体比较,差异均无 统计学意义(P>0.05)。观察组治疗39周、52周后的TSH水平均高于对照组(P<0.05)。2组IGF-1水平分 别整体比较,差异均有统计学意义(P<0.05)。2组IGF-1水平均随治疗时间的延长呈上升趋势。2组治疗 13 周、26 周、39周、52周后的IGF-1水平均较治疗前升高(P<0.05),治疗39周后的IGF-1水平均较治疗 13周后升高(P<0.05),治疗52周后的IGF-1水平均较治疗13周、26周后升高(P<0.05),治疗26周、39周、 52 周后的IGF-1 水平均较前一时点上升(P<0.05)。观察组治疗39 周、52 周后的IGF-1 水平均高于对照 组(P<0.05)。⑤治疗的安全性:2组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:运脾益肾 方联合rhGH治疗可有效促进脾肾两虚型青春期大骨龄特发性矮身材女童临床效果显著,可提高生长速率,且 安全性良好,对糖代谢和甲状腺功能的影响小。

    Abstract:

    Abstract:Objective:To observe the clinical efficacy of Yunpi Yishen Prescription combined with recombinant human growth hormone (rhGH) in the treatment of idiopathic short stature with advanced bone age in adolescents of spleen and kidney deficiency type. Methods:A total of 100 girls with idiopathic short stature with advanced bone age in adolescents of spleen and kidney deficiency type,who were treated at the Pediatric Outpatient Clinic of Anyang Hospital of Traditional Chinese Medicine from January 2022 to January 2024,were enrolled. They were randomly divided into the control group and the observation group according to a random number table method,with 50 cases in each group. In the control group,five patients were lost to follow-up and thus 45 were included in the final analysis;in the observation group,six patients were lost to follow-up and thus 44 were included in the final analysis. The control group was treated with rhGH,while the observation group was treated with Yunpi Yishen Prescription combined with rhGH. Both groups were treated for 52 weeks. After 52 weeks of treatment, clinical efficacy was evaluated. Height, chronological age height standard deviation score (HtSDS_CA),bone age height standard deviation score (HtSDS_BA),fasting blood glucose (FBG), fasting insulin (FINS), thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), and insulin-like growth factor-1 (IGF-1) levels were compared between the two groups before treatment and at each time point during treatment. Adverse reactions were also recorded. Results:①Clinical efficacy: After 52 weeks of treatment,the total effective rate in the observation group was 90.91% (40/44),higher than that of 73.33% (33/45) in the control group (P<0.05).②Growth indicators:Overall comparisons of height,growth velocity, HtSDS_CA, and HtSDS_BA between the two groups showed statistically significant differences (P<0.05). Height, HtSDS_CA, and HtSDS_BA in both groups demonstrated an increasing trend over the course of treatment, whereas growth velocity in both groups initially increased and then gradually decreased, reaching a peak at 13 weeks after treatment. The height in the observation group was significantly higher than that in the control group at 26, 39, and 52 weeks after treatment (P<0.05),and the growth velocity,HtSDS_CA,and HtSDS_BA in the observation group were significantly higher than those in the control group at 13, 26, 39, and 52 weeks after treatment (P<0.05). After 13, 26, 39, and 52 weeks of treatment, the height and HtSDS_CA values in both groups were significantly higher than those before treatment, 1 week after treatment, and 4 weeks after treatment (P<0.05), and were also significantly higher than those at the immediately preceding time point (P<0.05). In the observation group, growth velocity at 4 weeks after treatment was significantly higher than those before treamtnet and 1 week after treatment (P< 0.05). The growth velocity in both groups reached a peak at 13 weeks after treatment,and showed a decreasing trend at 26,39,and 52 weeks after treatment as the treatment duration extended. Growth velocity at 13,26,39,and 52 weeks after treatment in both groups was significantly higher than that before treatment,1 week after treatment,and 4 weeks after treatment (P<0.05),whereas growth velocity at 26,39,and 52 weeks after treatment were significantly lower than those at the immediately preceding time point (P<0.05). In the observation group,HtSDS_BA values at 13,26, 39,and 52 weeks after treatment were significantly higher than those before treatment,1 week after treatment,and 4 weeks after treatment (P<0.05), and were also significantly higher than those at the immediately preceding time point( P<0.05). In the control group,the HtSDS_BA value at 13 weeks after treatment was significantly higher than that before treatment (P<0.05). HtSDS_BA values at 26, 39, and 52 weeks were significantly higher than those before treatment,1 week after treatment,and 4 weeks after treatment (P<0.05). Furthermore,HtSDS_BA values at 39 and 52 weeks after treatment were significantly higher than that at 13 weeks after treatment (P<0.05),and the value at 52 weeks after treatment was significantly higher than that at 26 weeks after treatment( P<0.05). ③Glucose metabolism indicators: Overall comparisons of FBG and FINS levels between the two groups revealed statistically significant differences (P<0.05). In both groups, FBG levels showed an increasing trend over the course of treatment; in the control group,FINS levels also showed an increasing trend over time,whereas in the observation group,FINS levels exhibited a decreasing trend. In the observation group,FBG levels at 13,26,39,and 52 weeks after treatment were significantly higher than those before treatment (P<0.05). Furthermore,FBG levels at 39 and 52 weeks after treatment were significantly higher than those at 13 weeks after treatment (P<0.05), and the FBG level at 52 weeks after treatment was significantly higher than that at 26 weeks after treatment (P<0.05). In the control group,FBG levels at 13, 26, 39, and 52 weeks after treatment were significantly higher than those before treatment (P<0.05). Specifically, the FBG level at 39 weeks after treatment was significantly higher than those at 13 and 26 weeks after treatment( P<0.05),and the FBG level at 52 weeks after treatment was significantly higher than those at 13,26,and 39 weeks after treatment (P<0.05). In the observation group, the FINS level at 52 weeks after treatment was significantly lower than that before treatment (P<0.05). In the control group,FINS levels at 39 weeks after treatment were significantly higher than those before treatment (P<0.05), and the FINS level at 52 weeks after treatment was significantly higher than those before afterment,13 weeks after treatment,26 weeks after treatment,and 39 weeks after treatment (P<0.05). There were no statistically significant differences in FBG or FINS levels between the two groups at 13 and 26 weeks after treatment (P>0.05).At 39 and 52 weeks after treatment, both FBG and FINS levels in the observation group were significantly lower than those in the control group (P<0.05). ④Thyroid function indicators:In both groups,FT4 and TSH levels displayed a decreasing trend over the treatment period,whereas FT3 levels showed an increasing trend. In the control group, overall comparisons of FT3, FT4, and TSH levels showed statistically significant differences (P<0.05). The FT3 level after 52 weeks of treatment in the control group was significantly higher than those before treatment, at 13 weeks, and at 26 weeks after treatment (P<0.05). Additionally, the FINS level after 52 weeks of treatment in the control group was significantly lower than that at 13 weeks after treatment (P<0.05). In contrast, overall comparisons of TSH, FT3, and FT4 levels in the observation group showed no statistically significant differences (P>0.05). However,the TSH level in the observation group was significantly higher than those in the control group after 39 and 52 weeks of treatment (P<0.05). Overall comparisons of IGF-1 levels between the two groups showed statistically significant differences (P<0.05). IGF-1 levels in both groups demonstrated an increasing trend over time. After 13,26,39,and 52 weeks of treatment,IGF-1 levels in both groups were significantly higher than those before treatment( P<0.05). IGF-1 levels in both groups at 39 weeks after treatment were higher than those at 13 weeks after treatment (P<0.05). IGF-1 levels in both groups at 52 weeks after treatment were higher than those at 13 and 26 weeks after treatment (P<0.05). IGF-1 levels at 26,39,and 52 weeks after treatment in both groups were significantly higher than those at the immediately preceding time point (P<0.05). IGF-1 levels in the observation group were significantly higher than those in the control group at 39 and 52 weeks after treatment (P<0.05). ⑤Treatment safety: No statistically significant difference was observed in the incidence of adverse reactions between the two groups (P>0.05). Conclusion: The combination of Yunpi Yishen Prescription and rhGH demonstrates significant clinical efficacy in promoting growth among girls with idiopathic short stature with advanced bone age in adolescents of spleen and kidney deficiency type. It effectively enhances growth velocity,exhibits a favorable safety profile,and has minimal impact on glucose metabolism and thyroid function.

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王志敬,卢书芳,许志平.运脾益肾方联合重组人生长激素治疗脾肾两虚型青春期大骨龄特发性矮身材女童临床研究[J].新中医,2026,58(6):98-107

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  • 在线发布日期: 2026-03-31
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