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
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.