Database_AKI_Study_Dec22_Anonymized.

Introduction
Between June and September 2022, an outbreak of acute kidney injury (AKI) occurred in The Gambia among children, with 82 cases and 66 deaths recorded. Medicines taken by children with AKI were found to contain unacceptable amounts of diethylene glycol (DEG) and ethylene glycol (EG). The objective of the study was to establish the likely cause of the AKI outbreak and associated risk factors.
Materials and methods
A case-cohort study was conducted in six of the seven regions of The Gambia. Cases were children eight years or younger, residing within the six regions in the study period and diagnosed with AKI within that period. Controls were children in the same age range as cases and residing within the same neighborhood as cases but without a diagnosis of AKI. Three hundred twenty-one children were recruited for the sub-cohort from which controls were selected. Data were analyzed using Marginal Structural Models for a point treatment with the inverse probability of treatment weights estimator. Multivariable logistic regression was used to identify risk factors for AKI using a 5% level of significance in the final model.
Results
Sixty-three cases and 258 controls were enrolled into the study. Of the 63 cases, 58 were confirmed and five were suspected cases. AKI among the children was causally associated with ingestion of adulterated medicine(s) (OR = 1.76 (1.60–1.92); p < 0.0001). Risk factors of AKI were the ingestion of adulterated medicine(s), concomitant medicines, and being of a younger age.
Conclusion
The acute kidney injury outbreak that occurred among children in The Gambia in the period June through September 2022 was causally associated with the ingestion of adulterated medicines. The risk was increased by consumption of concomitant medicines and being of a younger age. DEG adulteration of paediatric medicines has been an all-too -common event in multiple countries.

引言
2022年6月至9月，冈比亚暴发儿童急性肾损伤（acute kidney injury, AKI）疫情，累计报告82例病例、66例死亡。经检测，患病儿童服用的药物中检出超标的二甘醇（diethylene glycol, DEG）与乙二醇（ethylene glycol, EG）。本研究旨在明确本次AKI暴发的潜在病因及相关危险因素。

材料与方法
本研究在冈比亚7个区域中的6个区域开展队列病例研究。病例组为研究期间居住于上述6个区域、年龄≤8岁且同期被确诊为AKI的儿童；对照组为与病例组年龄范围一致、居住于同一社区但未被诊断为AKI的儿童。本研究共招募321名儿童组成亚队列，从中选取对照个体。数据分析采用针对点治疗场景的边际结构模型（Marginal Structural Models），使用治疗权重逆概率（inverse probability of treatment weights, IPTW）估计量；最终模型采用显著性水平为5%的多变量logistic回归分析，以识别AKI的危险因素。

结果
本研究共纳入63例病例与258例对照。其中63例病例中，58例为确诊病例，5例为疑似病例。儿童AKI与服用掺假药物存在因果关联（比值比OR=1.76，95%置信区间1.60–1.92；p<0.0001）。AKI的危险因素包括服用掺假药物、合并用药以及年龄偏小。

结论
2022年6月至9月冈比亚儿童暴发的AKI疫情，与服用掺假药物存在因果关联；合并用药与低龄会进一步升高患病风险。二甘醇掺假儿科药物事件在多个国家均曾频繁发生。