Analysis on safety of pamidronate disodium as adjuvant therapy in children with congenital pseudarthrosis of tibia
School of Nursing, University of South China, Hunan Province, Hengyang 421001, China; Nursing Department, Hunan Children′s Hospital, Changsha 410007, China; Department of Orthopedics, Hunan Children′s Hospital, Changsha 410007, China; Department of Pharmacy, Hunan Children′s Hospital, Changsha 410007, China
Abstract：Objective To explore the safety of pamidronate disodium as adjuvant therapy in children with congenital pseudarthrosis of tibia (CPT). Methods Medical record data of children with CPT who received pamidronate disodium for the first time and completed 3 doses of treatment during hospitalization in Department of Orthopedics, Hunan Children′s Hospital from July 1, 2019 to June 30, 2020 were collected and analyzed retrospectively. The regimen of medication was slow IV infusion of pamidronate disodium 0.5-mg/kg on day 1 and 1.0-mg/kg on days 2 and 3, dissolved in 0.9% sodium chloride injection 250-ml (the infusion time was >3 hours). Adverse reactions were monitored during and after the IV infusion. Peripheral venous blood was collected 2-3 hours after finishing the 3rd dose of treatment and blood calcium and phosphorus levels were detected. The children were divided into ≤1 year old group, >1-3 years old group, and >3 years old group, and the occurrence of adverse reactions in different age groups were compared. Results A total of 81 children were enrolled in the analysis, including 54 males and 27 females, aged 0.4 to 15.4 years, with 10 cases in the ≤1 year old group, 46 in the >1 to 3 years old group, and 25 in the >3 years old group. After medication in the 81 children, fever with temperature ≥38.0-℃ occurred 53 times in 34 children (42.0%), of which 39 times were grade 1 (38.0-39.0-℃) and 14 times were grade 2 (>39.0-40.0-℃). The incidence of fever on the day after the 2nd dose was significantly higher than that after the 1st and 3rd doses (all P<0.05). The differences in the incidence of fever and the degree of fever among the 3 groups were not statistically significant (all P>0.05). The temperature of children with fever decreased to below 38.0-℃ within 1-16-hours after drug-therapy or physical cooling. After the 3rd dose of treatment, the levels of serum calcium and phosphorus were significantly lower than those before administration ［(2.06±0.17) mmol/L vs. (2.42±0.12) mmol/L, (1.01±0.23)mmol/L vs. (1.71±0.18)mmol/L, all P<0.001］. The incidences of hypocalcemia and hypophosphatemia were 56.8% (46/81) and 19.8% (16/81) respectively, but none of patients with hypocalcemia and hypophosphatemia had obvious related symptoms. Conclusions Pamidronate disodium is safe as adjunctive therapy in children with CPT. The main adverse reactions are fever, asymptomatic hypocalcemia, and hypophosphatemia. Fever can be recovered quickly after intervention, and the levels of serum calcium and phosphorus can return to within the normal range after drug withdrawal.
黄源，谢鑑辉，梅海波，谭谦，赵昕，欧阳雅琦，易银芝，莫莎莎. 帕米膦酸二钠用于儿童先天性胫骨假关节辅助治疗的安全性分析[J]. 药物不良反应杂志, 2021, 23(5): 260-265.
Huang Yuan, Xie Jianhui, Mei Haibo, Tan Qian, Zhao Xin, Ouyang Yaqi, Yi Yinzhi, Mo Shasha. Analysis on safety of pamidronate disodium as adjuvant therapy in children with congenital pseudarthrosis of tibia. Adverse Drug Reactions Journal, 2021, 23(5): 260-265.
