小儿助长方加减联合重组人生长激素治疗小儿特发性矮小症脾肾两虚证的效果及安全性

Clinical effect and safety of modified Xiao′er Zhuzhang prescription combined with recombinant human growth hormone in the treatment of idiopathic short stature with spleen-kidney deficiency syndrome in children

目的观察小儿助长方加减联合重组人生长激素(rhGH)治疗小儿特发性矮小症(ISS)脾肾两虚证的效果及安全性。方法选取2022年3月—2023年12月南京中医药大学附属医院儿科叶进教授门诊收治的ISS脾肾两虚证患儿60例,采用随机数字表法分为试验组和对照组,各30例。对照组患儿采用rhGH治疗,试验组患儿在对照组用药基础上联合小儿助长方加减治疗,2组均持续用药6个月。比较2组用药前、用药6个月后身高标准差积分(HtSDS)、骨龄(BA)、ΔHtSDS、ΔBA、胰岛素样生长因子-1(IGF-1)、25羟维生素D[25-(OH)D]、中医证候积分及安全性指标[空腹血糖(FPG)、胰岛素(INS)、甲状腺功能指标、肝功能指标、肾功能指标]。结果用药6个月后,2组HtSDS较用药前升高(P<0.01),试验组ΔHtSDS高于对照组(P<0.05);2组血清IGF-1、25-(OH)D均较用药前升高,且试验组高于对照组(P<0.05或P<0.01);对照组中医主症总积分低于用药前,试验组中医主、次症总积分均较用药前降低及低于对照组(P<0.01);用药6个月后,2组FPG、INS水平高于用药前,试验组FPG水平低于对照组(P<0.05或P<0.01)。结论小儿助长方加减联合rhGH治疗小儿ISS脾肾两虚证具有良好疗效,可在不加速BA进展的前提下有效增强促生长疗效,明显改善患儿临床症状,且可能会降低rhGH对糖代谢的影响,具有良好的安全性。

Objective To observe the clinical effect and safety of modified Xiao′er Zhuzhang prescription combined with rhGH in the treatment of ISS with spleen-kidney deficiency syndrome in children.Methods Sixty cases of children with ISS of spleen-kidney deficiency syndrome admitted to the Outpatient Clinic of Professor YE Jin,Department of Pediatrics,Affiliated Hospital of Nanjing University of Chinese Medicine from March 2022 to December 2023 were selected,and they were divided into the experimental group and the control group by randomized numerical table method,30 cases in each group.Children in the control group were treated with rhGH,and the children in the experimental group were treated with modified Xiao′er Zhuzhang prescription on the basis of the medication used in the control group,and both groups continued to be treated for 6 months.HtSDS,BA,ΔHtSDS,ΔBA,IGF-1,25-(OH)D,TCM syndromes score and safety indexes(FPG,INS,thyroid function indexes,liver and kidney function indexes)before and after 6 months of treatment were compared between the groups.Results After 6 months of drug administration,the HtSDS was higher compared with that before drug administration(P<0.01),ΔHtSDS in the experimental group was higher than in the control group(P<0.05);Serum IGF-1 and 25-(OH)D levels were elevated in the two groups,and the experimental group were higher than those in the control group(P<0.05 or P<0.01);Total TCM score of the primary syndromes of the control group was lower than before drug administration,and total TCM score of the primary and secondary syndromes of the experimental group were lower than those before drug administration and the control group(P<0.01);FPG,INS levels in the two groups were higher than those before drug administration,and FPG level in the experimental group was lower than that in the control group(P<0.05 or P<0.01).Conclusion Xiao′er Zhuzhang prescription combined with rhGH has good efficacy in the treatment of ISS with spleen-kidney deficiency syndrome in children,it can effectively enhance the growth-promoting efficacy without accelerating the progression of BA,significantly improve the clinical symptoms of children,and may reduce the effect of rhGH on glucose metabolism,which has a good safety profile.