Sánchez-Gundín Julia, Torres-Suárez Ana Isabel, Fernández-Carballido Ana María, Barreda-Hernández Dolores
Pharmacy Service, Hospital Virgen de la Luz, Cuenca Department of Pharmacy and Food Technology, Universidad Complutense de Madrid, Madrid.
Department of Pharmacy and Food Technology, Universidad Complutense de Madrid, Madrid Industrial Pharmacy Institute, Universidad Complutense de Madrid, Madrid.
Farm Hosp. 2019 Sep 1;43(5):158-162. doi: 10.7399/fh.11161.
To analyze adverse reactions in patients with nonmetastatic colorectal cancer due to treatment with either innovative or generic capecitabine and/or to the chemotherapeutic regimen employed, to the capecitabine alone, or in combination with oxaliplatin (XELOX).
Descriptive retrospective study carried out in a secondary level hospital in two study periods (November 2013-April 2014 and August 2016-May 2017). The collected variables were: exposure (chemotherapy scheme and/or received medication), control (demographics, disease and treatment data), and response (adverse reactions). The statistical analysis of data was performed with the SPSS® 15.0 program. Results: Fifty patients were included. According to the administered chemotherapeutic scheme, statistically significant differences were found in the appearance of palmar-plantar erythrodysesthesia, which is more frequent with monotherapy (p < 0.05), and neurotoxicity, thrombocytopenia and neutropenia, which is more frequent with XELOX (p < 0.05). Concerning the capecitabine drug administered, no statistically significant differences were found in the studied adverse reactions.
The safety profile of two capecitabine formulations - innovative and generic- appears to be associated with the chemotherapy scheme employed, and not the drug itself. Most palmar- plantar erythrodysesthesia for monotherapy is likely due to the higher dose of capecitabine used in said scheme. The increase in neurotoxicity, thrombocytopenia and neutropenia for XELOX is probably due to cumulative toxicity of two antineoplastic drugs.
分析非转移性结直肠癌患者使用创新型或仿制型卡培他滨治疗和/或采用的化疗方案（单独使用卡培他滨或与奥沙利铂联合使用的XELOX方案）所引起的不良反应。
在一家二级医院进行描述性回顾性研究，研究分为两个阶段（2013年11月至2014年4月和2016年8月至2017年5月）。收集的变量包括：暴露因素（化疗方案和/或所接受的药物）、对照因素（人口统计学、疾病和治疗数据）以及反应因素（不良反应）。使用SPSS® 15.0程序对数据进行统计分析。
纳入50例患者。根据所给予的化疗方案，发现手足红斑感觉异常的出现存在统计学显著差异，单药治疗时更常见（p < 0.05），而神经毒性、血小板减少症和中性粒细胞减少症在XELOX方案中更常见（p < 0.05）。关于所给予的卡培他滨药物，在所研究的不良反应中未发现统计学显著差异。
创新型和仿制型两种卡培他滨制剂的安全性似乎与所采用的化疗方案有关，而非药物本身。单药治疗中大多数手足红斑感觉异常可能是由于该方案中使用的卡培他滨剂量较高。XELOX方案中神经毒性、血小板减少症和中性粒细胞减少症的增加可能是由于两种抗肿瘤药物的累积毒性。
