Shrmeka Mukerem Sultan, Semman Mubarik Fetu, Moges Biruk Tafese, Dereja Feki Nekir, Garedo Aster Wakjira
Department of Pharmacy, College of Medicine and Health Science, Wolkite University, Wolkite, Ethiopia.
Department of Clinical Pharmacy, School of Pharmacy, College of Medicine and Health Science, Jimma University, Jimma, Ethiopia.
PLoS One. 2025 May 16;20(5):e0321785. doi: 10.1371/journal.pone.0321785. eCollection 2025.
In 2017, reports of adverse drug reactions worldwide reached an estimated 35 million.Chemotherapeutic agents were one of the most often implicated pharmacological classes in inducing adverse drug reactions. Adverse drug reactions increase the overall expense and mortality. Adverse drug reactions increase morbidity, mortality, hospitalization rate and financial expenses. Therefore, this study intended to assess chemotherapy-related adverse drug reactions and associated factors among adult cancer patients.
A facility-based prospective observational study was conducted from July 2022 to October 2022 at Jimma Medical Center's oncology unit. A standard data collection tool (Naranjo's algorithm, modified Hartwig's severity scale, and modified Schumock-Thornton criteria) was used for assessment of causality, severity, and preventability of adverse reactions, respectively. Socio-demographic profile and any adverse drug reactions reported were collected separately. The data was collected by one pharmacist and two nurses after giving training. Data was entered into Epidata version 4.6.0 and analyzed by SPSS version 25. Bivariate and multivariable logistic regression was conducted to identify independent predictors of the pattern of adverse drug reaction occurrence. A P-value of 0.05 was taken as statistically significant.
Out of 154 patients enrolled in the study, 66.2% were female. The mean age of patients was 41.20 ± 13.54 years. From the total, 98 (63.6%) cases developed a total of 198 adverse drug reactions. Out of them, 59.2% were female. The most commonly encountered adverse drug reactions were nausea and vomiting (33.8%) and hair loss (29.3%). Most of the reactions were probable (61.1%) in causality, mild (66.2%) in severity, and not preventable (43.9%) in nature. Female sex (AOR = 1.054; 95% CI= (1.021-1.087); P = 0.001), number of chemotherapy treatments (AOR = 3.33; 95% CI= (1.301-8.52); P = 0.012), and elderly age (AOR = 3.065; 95% CI= (1.01-9.296); P = 0.048) were associated with occurrences of adverse drug reactions.
We can deduce from the data that adverse drug reactions are a significant concern for patients undergoing chemotherapy, with nearly two-thirds experiencing ADRs. The most common reactions are nausea and vomiting, which are mostly mild and probable. Age, gender, and the use of several chemotherapy drugs were associated with an increased risk of adverse drug reactions. Hence all concerned bodies should make an effort for early detection and take preventive measure of chemotherapy-related adverse drug reactions. Where feasible, use chemotherapy protocols with alower risk of ADRs. Evaluate dose adjustments for elderly patients. Implement protocols for risk assessment before initiating chemotherapy.
2017年，全球药物不良反应报告估计达3500万例。化疗药物是引发药物不良反应最常见的药物类别之一。药物不良反应增加了总体费用和死亡率。药物不良反应增加了发病率、死亡率、住院率和经济费用。因此，本研究旨在评估成年癌症患者中与化疗相关的药物不良反应及相关因素。
2022年7月至2022年10月在吉马医疗中心肿瘤科开展了一项基于机构的前瞻性观察研究。分别使用标准数据收集工具（纳伦霍算法、改良的哈特维希严重程度量表和改良的舒莫克-桑顿标准）评估不良反应的因果关系、严重程度和可预防性。分别收集社会人口学资料和报告的任何药物不良反应。一名药剂师和两名护士在接受培训后收集数据。数据录入Epidata 4.6.0版本，并使用SPSS 25版本进行分析。进行双变量和多变量逻辑回归以确定药物不良反应发生模式的独立预测因素。P值为0.05被视为具有统计学意义。
在纳入研究的154例患者中，66.2%为女性。患者的平均年龄为41.20±13.54岁。总共98例（63.6%）患者发生了198例药物不良反应。其中，59.2%为女性。最常见的药物不良反应是恶心和呕吐（33.8%）以及脱发（29.3%）。大多数反应在因果关系上可能（61.1%），严重程度为轻度（66.2%），本质上不可预防（43.9%）。女性（比值比=1.054；95%置信区间=（1.021-1.087）；P=0.001）、化疗疗程数（比值比=3.33；95%置信区间=（1.301-8.52）；P=0.012）和老年（比值比=3.065；95%置信区间=（1.01-9.296）；P=0.048）与药物不良反应的发生有关。
从数据中我们可以推断，药物不良反应是接受化疗患者的一个重大问题，近三分之二的患者会出现药物不良反应。最常见的反应是恶心和呕吐，大多为轻度且可能发生。年龄、性别和多种化疗药物的使用与药物不良反应风险增加有关。因此，所有相关机构应努力进行早期检测，并采取预防化疗相关药物不良反应的措施。在可行的情况下，使用药物不良反应风险较低的化疗方案。评估老年患者的剂量调整。在开始化疗前实施风险评估方案。
