期刊论文

Analysis on safety of pamidronate disodium as adjuvant therapy in children with congenital pseudarthrosis of tibia

Xie, J.

中文

药物不良反应杂志

1008-5734

2021

23

5

260-265

10.3760/cma.j.cn114015-20210101-00001

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 inci‑ dences 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 Pami‑ dronate 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. 【Key words】 Pseudarthrosis; Congenital abnormalities; Child; Pamidronate; Drug‑related side effects and adverse reactions Fund programs: Natural Science Foundation of China Hunan Province (2019JJ80041); Scientific Research Project of China Hunan Provincial Health Commission (20200647) DOI: 10.3760/cma.j.cn114015‑20210101‑00001

本校为第一机构

目的:了解帕米膦酸二钠用于儿童先天性胫骨假关节（CPT）辅助治疗的安全性。方法:收集2019年7月1日至2020年6月30日在湖南省儿童医院骨科住院期间初次应用帕米膦酸二钠并完成3剂治疗CPT患儿的病历资料进行回顾性分析。帕米膦酸二钠的用药方案均为第1天0.5 mg/kg，第2和3天1.0 mg/kg，溶于0.9%氯化钠注射液250 ml中缓慢静脉滴注（>3 h）。监测静脉给药过程中和用药后不良反应发生情况，采集第3剂治疗结束后2~3 h患儿外周静脉血复查血钙和血磷。将患儿按年龄分为≤1岁组、>1~3岁组和>3岁组，比较不同年龄组患儿用药后不良反应发生情况的差异。结果:纳入分析的患儿共81例，男性54例，女性27例；年龄...

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...