Palaniappan Muthiah, Srinivasamurthy Sureshkumar, Dubashi Biswajit, Chandrasekaran Adithan
Technical Associate - Pharmacovigilance, Department of Clinical Pharmacology, JIPMER , Pondicherry, India .
D.M., Department of Clinical Pharmacology, JIPMER , Pondicherry, India .
J Clin Diagn Res. 2014 Oct;8(10):HC01-3. doi: 10.7860/JCDR/2014/9133.4975. Epub 2014 Oct 20.
Palmar plantar erythrodysesthesia (PPE) is a dose limiting toxicity of anticancer agents. In some cases it may mandate for discontinuation of anticancer agents. Evaluation of data of PPE among reported adverse drug reactions (ADRs) from the Department of Medical Oncology could quantify the burden.
To evaluate and analyse the PPE among reported ADRs from medical Oncology.
The data of all cases of reported PPE were collected during January 2012 to September 2013 and were analysed with WHO causality assessment scale. The severity was clinically graded. The follow-up data regarding outcome of ADRs were also noted.
During the study period of 21 months a total of 1418 ADRs have been reported from 1076 patients. Among them PPE was reported from 31 cases (2.9%). Majority (32.2%) of these patients were on chemotherapy for breast cancer. Patient's age ranged from 17 to 68 y and the median age was 50 y. There were 18 female (58%) and 13 male patients (42%). Capecitabine was the leading drug involved in PPE, reported with 20 cases (64.5%), and followed by docetaxel with 5 cases (16.1%). Majority (67.7%) of the reactions was categorized as certain and 64.5% was grade II severity clinically.
Our findings show that PPE accounts for 2.9% of total reported ADRs from Medical Oncology during 21 months. Majority of the reactions were classified as certain. Capecitabine is commonly implicated drug.
手足红斑性感觉异常(PPE)是抗癌药物的剂量限制性毒性。在某些情况下,可能需要停用抗癌药物。评估医学肿瘤学部门报告的药物不良反应(ADR)中PPE的数据可以量化其负担。
评估和分析医学肿瘤学报告的ADR中的PPE。
收集2012年1月至2013年9月期间所有报告的PPE病例数据,并使用WHO因果关系评估量表进行分析。临床对严重程度进行分级。还记录了关于ADR结果的随访数据。
在21个月的研究期间,共报告了1076例患者的1418例ADR。其中31例(2.9%)报告了PPE。这些患者中大多数(32.2%)正在接受乳腺癌化疗。患者年龄在17至68岁之间,中位年龄为50岁。有18名女性(58%)和13名男性患者(42%)。卡培他滨是导致PPE的主要药物,报告了20例(64.5%),其次是多西他赛,有5例(16.1%)。大多数(67.7%)反应被归类为肯定,临床严重程度为II级的占64.5%。
我们的研究结果表明,PPE占21个月期间医学肿瘤学报告的ADR总数的2.9%。大多数反应被归类为肯定。卡培他滨是常见的相关药物。