Eu2P European Programme in Pharmacovigilance and Pharmacoepidemiology, Université Bordeaux-Segalen, Bordeaux, France.
National Obesity Center and Endocrinology and Metabolic Diseases Unit, Yaoundé Central Hospital, Yaounde, Cameroon.
Eur J Clin Pharmacol. 2020 Nov;76(11):1601-1605. doi: 10.1007/s00228-020-02949-2. Epub 2020 Jun 30.
The study aimed to identify and describe adverse drug reactions and adherence to clinical guidelines in patients receiving treatment for type 2 diabetes mellitus (T2DM) in Cameroon.
The method used was a cross-sectional study at a tertiary diabetes care service in Yaoundé, Cameroon. Adult T2DM patients attending the diabetes clinic were interviewed using a pre-structured data collection form. Adverse drug reactions (ADRs) were self-reported by the patients. Naranjo's algorithm and Hartwig and Siegel's scale were used for assessment of causality and severity of ADRs, respectively. A blinded senior endocrinologist assessed whether treatment pattern of patients was "adherent" or not to local clinical guidelines for the management of diabetes.
Of a total of 350 patients enrolled into the study 61.1% were on oral hypoglycaemic agents only, 24.9% were on both oral hypoglycaemic agents and insulin, while 13.4% were on insulin alone. Metformin was used by 96.3% of the patients. Ninety patients reported 101 suspected ADRs. The proportion of ADRs among patients with poor adherence to clinical guidelines was higher than ADRs reported among adherent patients (Chi-square test = 7.3273; p = 0.007). Hypoglycaemia was more frequent ADR among non-adherent (25.7% of the suspected ADR) than adherent participants (11.6%). In the participants whose treatment pattern did not adhere to local clinical guidelines, ADRs were definite in 63.9%, probable in 16.6%, doubtful in 13.9% and possible in 5.6% of the cases. ADRs were moderate in 61.1% and severe in 19.4% of cases whose treatment pattern was non-adherent to clinical guidelines.
Adverse drug reactions may be frequent in type 2 diabetes patients whose treatment pattern does not adhere to local clinical guidelines in Cameroon. Therefore, the promotion of active pharmacovigilance and the design of training activities to promote the appropriate use of medicines at hospital level in Cameroon could help to improve the management of diabetes and reduce the incidence of avoidable ADRs in the future.
本研究旨在识别和描述在喀麦隆接受 2 型糖尿病（T2DM）治疗的患者中出现的药物不良反应（ADR）和对临床指南的遵循情况。
本研究采用横断面研究方法，在喀麦隆雅温得的一家三级糖尿病护理服务机构开展。通过使用预先设定的数据收集表，对参加糖尿病门诊的成年 T2DM 患者进行访谈。患者自行报告 ADR。分别使用 Naranjo 算法和 Hartwig 和 Siegel 量表评估 ADR 的因果关系和严重程度。一位盲法资深内分泌学家评估患者的治疗模式是否“遵循”当地糖尿病管理临床指南。
在总共纳入的 350 名患者中，61.1%仅接受口服降糖药治疗，24.9%同时接受口服降糖药和胰岛素治疗，13.4%仅接受胰岛素治疗。96.3%的患者使用二甲双胍。90 名患者报告了 101 例疑似 ADR。不遵循临床指南的患者发生 ADR 的比例高于遵循指南的患者（卡方检验=7.3273;p=0.007）。低血糖是不遵守（疑似 ADR 的 25.7%）和遵守（11.6%）临床指南的参与者中更常见的不良反应。在治疗模式不遵循当地临床指南的参与者中，ADR 被确定为 63.9%，可能为 16.6%，可疑为 13.9%，可能为 5.6%。不遵守临床指南的患者中，ADR 为中度的占 61.1%，严重的占 19.4%。
在喀麦隆，治疗模式不遵循当地临床指南的 2 型糖尿病患者可能会经常发生药物不良反应。因此，在喀麦隆推广积极的药物警戒并设计培训活动，以促进医院层面药物的合理使用，有助于改善糖尿病的管理，并减少未来可避免的 ADR 发生。
