Efficacy And Safety Study Of Different Dose Of Recombinant Human Growth Hormone Therapy For Children With Different Causes And Short Stature

Objectives Different etiological factors including growth hormone deficiency(growythhorm)in the treatment of different doses of rhGHOne def iciency(GHD),idiopathic short stature(ISS),small gestational age(small For gestational age(SGA),congenital ovarian hypoplasia syndrome(Turner syndrome,TS)efficacy and safety.Methods A total of 197 cases of children with short stature were selected from January 2010 to January 2012 in the Pediatrics Department of Tangshan Maternal and Child Health Hospital.There were 93 males and 104 females with an average age of 8.26±2.7 years.There were 46 cases of GHD in children(30 males,16 females,age(7.95±3.3)years),88 children with ISS [42 males,46 females,age(8.9±2.7)[years old],26 children with Turner age [(9.9 ± 2.9)years old] and 37 children with SGA [21 males,16 females,age(6.3 ± 2.2)years].Inclusion criteria: 1)Diagnostic criteria for growth hormone deficiency,idiopathic dwarfness,small gestational age,congenital ovarian hypoplasia syndrome;2)resident population in Tangshan region,Han nationality;3)slow growth,growth rate<br><5<br> Cm/year(3 years old to prepubertal);4)No abnormalities in thyroid function,liver,kidney function,hepatitis B markers,fasting blood glucose,blood,and urine.Exclusion criteria: 1)suffering from a high incidence of tumor or tumor family;2)exclusion of the blood system,respiratory system,digestive system,urinary system,nervous system,congenital heart disease and other diseases that affect the growth and development of children and have been diagnosed;3)receiving him Classes of clinical research investigations or treatment;4)Children who have not been followed up.Recombinant human growth hormone was provided by Changchun Jinsai Pharmaceutical Co.,Ltd.,all of which were water-based,batch number(1111059,1202001-1202110)for 2 years.Four different causes were divided into low-dose treatment group and high-dose treatment group.The dose was 0.10,0.15 IU/(kg·d),subcutaneously injected into the umbilical or thigh subcutaneously 45 minutes before bedtime every night,each time the injection site was changed.Observed during the treatment of children with or without injection site swelling,itching,with or without headache,jet vomiting and other clinical manifestations of intracranial hypertension,with or without myalgia,joint pain and other symptoms,with or without femoral epiphysis spondylolisthesis(SCFE),spine side Outbreaks and other adverse reactions occur.The differences in height,annual growth rate,and height standard after treatment with rhGH for two groups of patients with different doses of four etiologies were calculated(additional bone age(BA),ageincreased value(ΔCA)).After 3 months,monitor thyroid function,fasting blood glucose,blood IGF-1,IGFBP-3 concentration;review bone age every 6 months,monitor height,body weight,and sexuality changes every year,while maintaining a balanced diet for children.Ample sleep and daily exercise for 60 minutes.Results The children with four causes had different doses of rhGH for the first year.Ht,Ht SDS,and GV in the two groups were significantly higher than before treatment.The high-dose group was superior to the low-dose group,and there was a statistically significant difference between groups(P<0.05).rhGH<br>The GV in the second year after treatment was lower than the first year,suggesting a catch-up growth in the first year of treatment,and a slower growth rate in the second year.However,the increase in Ht,Ht SDS,and GV in the high-dose group was still better than that in the low-dose group,and the difference was statistically significant(P < 0.05).In the four kinds of causes of low-dose group and high-dose group,the increase of bone age and the increase of biological age were basically consistent with the increase of treatment time.No skeletal age was observed.The study showed no significant difference in the ΔBA/ΔCA ratio(<br>P >0.05).Four kinds of etiology,IGF-1 and IGFBP-3 were elevated to varying degrees in both low-dose and high-dose groups after 2 years of treatment.There was no significant difference in the mean standard deviation of IGF-1 and IGFBP-3 among children with different etiologies(P > 0.05).Four of the four causes of short stature in children were followed up to lifelong,and there were four causes in the followup of children.GHD,ISS,SGA,and TS groups had a life-time height similar to the height of the target,and the difference between lifetime height and target height did not exist.Statistically significant(P > 0.05).In the low-dose GHD group,1 patient treated for 12 months to monitor thyroid function showed a decrease in T4 levels,and thyroxine tablets were given orally to monitor normal thyroid function recovery.In the ISS highdose group,local skin irritation occurred at the injection site in 1 case and subsided after about 1 day.There was no adverse reaction in the ISS low dose group.In the SGA highdose group,1 patient had knee joint pain for 6 months.No other clinical manifestations and monitoring-related indicators were normal.Considering the growth pain,the pain disappeared after calcium supplementation;rhGH treatment was continued.No adverse reactions occurred in the TS group.For children with short stature with different etiologies,adverse reactions were rare and the difference was not statistically significant(P>0.05).The above adverse reactions are mild and do not affect the overall treatment.Conclusions 1 The use of recombinant human growth hormone to treat different causes of dwarfism has a significant effect on promoting growth and height,which is beneficial to increase lifelong height;for a dwarf disease caused by different causes,the therapeutic effect of rhGH is positively correlated with the therapeutic dose.2 The rapid growth rate of annual growth in the first year of dwarfism with different etiologies is the most obvious,showing catch-up growth.In the second year of treatment,the annual growth rate was slower than that of the first year,but the high-dose group of the four etiological growth indicators was still better than the low-dose group.3 During the two-year treatment of recombinant human growth hormone,different therapeutic doses of four etiologies did not lead to bone age growth,and did not cause adverse effects on the potential growth ability of the children..