| Objective:To preliminarily observe the efficacy and safety of leuprolide acetate in the treatment of Idiopathic central precocious puberty(ICPP).Methods:This is a retrospective clinical study.Children admitted to the Second Affiliated Hospital of Nanchang University Hospital from November 2020 to November 2022 and diagnosed as central precocious puberty were selected as research objects.According to the diagnosis,inclusion and exclusion criteria,75 cases were retained.According to the treatment plan,they were divided into long-term group and shortacting group.In the long-term group,32 females were included,while in the shortacting group,35 females were included.The long-term group was subcutaneously injected with 11.25 mg leuprolide acetate once every 3 months,while the short-acting group was subcutaneously injected with 3.75 mg leuprolide acetate once every 28 days.All the children were comprehensively examined before treatment,and returned to the clinic every 3 months after treatment for developmental assessment.The height,weight,LH,FSH,testosterone,estradiol,liver function,glucose metabolism index,lipid metabolism index,thyroid function,uterus,ovary,bone age(BA)was reviewed every 6 months,assessed growth rate,and height standard deviation score(Ht SDS)and weight standard deviation score(Wt SDS)were calculated.were recorded at each visit,and adverse reactions of all the children were analyzed.Follow-up was conducted for 6 months to evaluate the efficacy and safety of leuprolide acetate 3-month depot.Results:1.Height and weight: there were no significant differences in Ht SDS,△Ht SDS,Wt SDS,△Wt SDS between the long-acting group and the short-acting group(P > 0.05).There was no statistical difference in the growth rate of the two groups in6 months(P > 0.05).2.LH,FSH and estradiol: The levels of LH,FSH and estradiol in the longacting group at 3 and 6 months of treatment were significantly lower than the baseline level,with statistical significance(P < 0.05).After 3 months of treatment,there were statistical differences in FSH between the two groups(P < 0.05),the FSH level in the long-acting group was higher than that in the short-acting group,and there were no statistical differences in LH and estradiol levels(P > 0.05).There was no significant difference in LH,FSH and estradiol at 6 months of treatment(P > 0.05).There was no significant difference in effective inhibition rate between the two groups(P >0.05).3.Uterus and ovary: The size of uterus and ovary in the long-acting group decreased from the baseline level at 3 and 6 months of treatment,and the difference was statistically significant(P < 0.05).After 3 months of treatment,there was no significant difference in uterus and ovary size between the two groups(P > 0.05).The data at 6 months of treatment were compared,the uterus of the long-acting group was> that of the short-acting group,and there was no statistical difference in ovarian size(P > 0.05).4.Bone age: After 6 months of treatment,△ bone age was 0.31±0.28 years old and 0.68±0.59 years old in the long-acting group and the short-acting group,respectively.There was no statistical difference between the two groups(P > 0.05).5.Adverse events: There were no significant differences in AST,ALT,TC,TG,FPG,FT3,h TSH and other indexes compared with the baseline level at 3 months and6 months after treatment in the long-acting group(P > 0.05),while FT4 level was higher than the baseline level at 3 months,but still within the normal range.In this study,there were 9 cases of adverse reactions,the incidence of adverse reactions was15.6% in the long-acting group and 11.4% in the short-acting group.In the longacting group,there were 5 cases--"ignition effect" in 2 cases and pain at the injection site in 3 cases,while in the short-acting group,there were 4 cases--"ignition effect" in 2 cases and pain at the injection site in 2 cases.There was no significant difference in the incidence of adverse events between the two groups(P > 0.05).All the adverse reactions occurred in the study were recovered by themselves,and there were no serious adverse reactions.Conclusions:1.Preliminary observation showed that long-acting depot had a good inhibitory effect on ICPP without significant slowing down of growth rate,and no effect on body weight.The effect of long-acting depot on bone age,height and weight was similar to that of leuprolide acetate in one-month dosage form.2.The inhibition of FSH and uterus by long-acting depot might not be as good as that of leuprolide acetate one-month dosage form.3.The incidence of adverse events of long-acting depot was similar to the onemonth dosage form of leuprolide acetate,and no serious adverse reactions occurred. |
