Belachew Sewunet Admasu, Erku Daniel Asfaw, Mekuria Abebe Basazn, Gebresillassie Begashaw Melaku
Department of Clinical Pharmacy.
Department of Pharmaceutical Sciences.
Drug Healthc Patient Saf. 2016 Dec 8;8:83-90. doi: 10.2147/DHPS.S116924. eCollection 2016.
Adverse drug reactions (ADRs) are a global problem and constitute a major clinical problem in terms of human suffering. The high toxicity and narrow therapeutic index of chemotherapeutic agents makes oncology pharmacovigilance essential. The objective of the present study was to assess the pattern of ADRs occurring in cancer patients treated with chemotherapy in a tertiary care teaching hospital in Ethiopia.
A cross-sectional study over a 2-year period from September 2013 to August 2015 was conducted on cancer patients undergoing chemotherapy at Gondar University Referral Hospital Oncology Center. Data were collected directly from patients and their medical case files. The reported ADRs were assessed for causality using the World Health Organization's causality assessment scale and Naranjo's algorithm. The severities of the reported reactions were also assessed using National Cancer Institute Common Terminology CTCAE version 4.0. The Pear-son's chi-square test was employed to examine the association between two categorical variables.
A total of 815 ADRs were identified per 203 patients included in the study. The most commonly occurring ADRs were nausea and vomiting (18.9%), infections (16.7%), neutropenia (14.7%), fever and/or chills (11.3%), and anemia (9.3%). Platinum compounds (31.4%) were the most common group of drugs causing ADRs. Of the reported ADRs, 65.8% were grades 3-4 (severe level), 29.9% were grades 1-2 (mild level), and 4.3% were grade 5 (toxic level). Significant association was found between age, number of chemotherapeutic agents, as well as dose of chemotherapy with the occurrence of grades 3-5 toxicity.
The high incidence of chemotherapy-related ADRs among cancer patients is of concern. Setting up an effective ADR monitoring and reporting system (onco-pharmacovigilance) and creating awareness among health care professionals regarding the importance of ADR reporting may help prevent the problem.
药物不良反应（ADR）是一个全球性问题，就人类痛苦而言，它构成了一个主要的临床问题。化疗药物的高毒性和窄治疗指数使得肿瘤药物警戒至关重要。本研究的目的是评估埃塞俄比亚一家三级护理教学医院中接受化疗的癌症患者发生药物不良反应的模式。
在2013年9月至2015年8月的两年期间，对贡德尔大学转诊医院肿瘤中心接受化疗的癌症患者进行了一项横断面研究。数据直接从患者及其医疗病例档案中收集。使用世界卫生组织的因果关系评估量表和纳兰霍算法对报告的药物不良反应进行因果关系评估。还使用美国国立癌症研究所通用术语标准CTCAE第4.0版评估报告反应的严重程度。采用Pearson卡方检验来检验两个分类变量之间的关联。
在纳入研究的203名患者中，共识别出815例药物不良反应。最常发生的药物不良反应是恶心和呕吐（18.9%）、感染（16.7%）、中性粒细胞减少（14.7%）、发热和/或寒战（11.3%）以及贫血（9.3%）。铂类化合物（31.4%）是引起药物不良反应最常见的药物类别。在报告的药物不良反应中，65.8%为3 - 4级（严重程度），29.9%为1 - 2级（轻度程度），4.3%为5级（毒性程度）。发现年龄、化疗药物数量以及化疗剂量与3 - 5级毒性的发生之间存在显著关联。
癌症患者中化疗相关药物不良反应的高发生率令人担忧。建立有效的药物不良反应监测和报告系统（肿瘤药物警戒）并提高医护人员对药物不良反应报告重要性的认识可能有助于预防该问题。
