Safety of Quinolones in Children: A Systematic Review and Meta-Analysis,Pediatric Drugs

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Safety of Quinolones in Children: A Systematic Review and Meta-Analysis
Pediatric Drugs ( IF 3.4 ) Pub Date : 2022-06-30 , DOI: 10.1007/s40272-022-00513-2
Siyu Li _{1,

2,

3,

4} , Zhe Chen _{1,

2,

3} , Liang Huang _{1,

2,

3} , Zheng Liu _{1,

2,

3,

4} , Yuqing Shi _{1,

2,

3,

5} , Miao Zhang _{1,

2,

3,

5} , Hailong Li _{1,

2,

3} , Linan Zeng _{1,

2,

3} , Jiaqi Ni _{1,

2,

5} , Yu Zhu ₆ , Zhi-Jun Jia _{1,

2,

3,

5} , Guo Cheng _{3,

6,

7} , Lingli Zhang _{1,

2,

3}

Affiliation

Background

The results of animal experiments show that quinolone antibacterial drugs may permanently damage the soft tissues of the weight-bearing joints of young animals. Out of safety concerns, using quinolones in children has always been controversial.

Objective

The aim of this study was to assess the risk of using quinolones in children and provide evidence for clinicians to support decision making.

Data Sources

The MEDLINE (Ovid), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), International Pharmaceutical Abstracts (Ovid), CINAHL, CNKI, VIP, and WanFang Data databases were searched from inception to 8 September 2021.

Study Selection

All types of studies that reported the safety data of quinolones in children, including clinical trials and observational studies.

Data Extraction

Data extraction and cross-checking were completed by two independent reviewers using a pilot-tested standardized data extraction form.

Results

The overall incidence rate of adverse drug events (ADEs) in children using systemic quinolones was 5.39% and the most common ADEs were gastrointestinal reactions (incidence rate, 2.02%). Quinolone-induced musculoskeletal ADEs in children were uncommon (0.76%). Meta-analysis results showed that the risk of musculoskeletal ADEs in children using quinolones was higher than children in the control group (51 studies; rate ratio [RR] 2.03, 95% confidence interval [CI] 1.82–2.26; p < 0.001; I² = 18.6%; moderate-quality evidence). However, the subgroup analysis results showed that differences might only be observed in children who were followed up for 2 months to 1 year (2–6 months: RR 2.56, 95% CI 2.26–2.89; 7 months to 1 year: RR 1.35, 95% CI 0.98–1.86). Moreover, children (adolescents) aged between 13 and 18 years might be sensitive to the musculoskeletal toxicity of quinolones (RR 2.69, 95% CI 2.37–3.05; moderate-quality evidence) and the risk of levofloxacin-induced musculoskeletal ADEs might be higher (RR 1.33, 95% CI 1.00–1.77; low-quality evidence).

Conclusions

Although the existing evidence shows that quinolone-induced musculoskeletal ADEs seem to be only short-term and reversible, and no serious skeletal and muscular system damage cases have been reported in children, quinolones should be avoided unless necessary in children because the incidence rate of quinolone-related ADEs is not low and they are broad-spectrum antibiotics that will induce the emergence of resistant strains if used frequently.

中文翻译：

儿童喹诺酮类药物的安全性：系统评价和荟萃分析

背景

动物实验结果表明，喹诺酮类抗菌药物可能对幼小动物负重关节的软组织造成永久性损伤。出于安全考虑，在儿童中使用喹诺酮类药物一直存在争议。

客观的

本研究的目的是评估在儿童中使用喹诺酮类药物的风险，并为临床医生提供支持决策的证据。

数据源

检索了 MEDLINE (Ovid)、EMBASE、Cochrane Central Register of Controlled Trials (CENTRAL)、International Pharmaceutical Abstracts (Ovid)、CINAHL、CNKI、VIP 和 WanFang Data 数据库，检索时间为 2021 年 9 月 8 日。

研究选择

报告儿童喹诺酮类药物安全性数据的所有类型的研究，包括临床试验和观察性研究。

数据提取

数据提取和交叉检查由两名独立审查员使用经过试点测试的标准化数据提取表完成。

结果

儿童全身使用喹诺酮类药物不良事件（ADEs）的总发生率为5.39%，最常见的ADEs为胃肠道反应（发生率为2.02%）。喹诺酮类药物引起的儿童肌肉骨骼 ADE 并不常见（0.76%）。Meta 分析结果显示，使用喹诺酮类药物的儿童发生肌肉骨骼 ADEs 的风险高于对照组儿童（51 项研究；比率 [RR] 2.03，95% 置信区间 [CI] 1.82–2.26；p < 0.001；I ² = 18.6%；中等质量的证据）。然而，亚组分析结果显示，可能仅在随访 2 个月至 1 年的儿童中观察到差异（2-6 个月：RR 2.56，95% CI 2.26-2.89；7 个月至 1 年：RR 1.35， 95% CI 0.98–1.86)。此外，13 至 18 岁的儿童（青少年）可能对喹诺酮类药物的肌肉骨骼毒性敏感（RR 2.69, 95% CI 2.37–3.05；中等质量证据），左氧氟沙星诱导的肌肉骨骼 ADE 的风险可能更高。 RR 1.33，95% CI 1.00–1.77；低质量证据）。