Parathoduvil Abdul Aslam, Sisupalan Asha, Rema Padanayil Lekshmikutty
Assistant Professor, Department of Pharmacology, Travancore Medical College, Kollam, Kerala, India.
Professor and Head, Department of Pharmacology, Government Medical College, Manjeri, Kerala, India.
J Clin Diagn Res. 2017 May;11(5):FC10-FC14. doi: 10.7860/JCDR/2017/25129.9818. Epub 2017 May 1.
Chemotherapy Induced Nausea and Vomiting (CINV) is the most distressing side effect of cancer chemotherapy. It can seriously produce an impact on patient's quality of life. Prevention of CINV is far more effective than treatment of an established CINV. If the patient receives an optimal antiemetic regimen during the initial course of chemotherapy, the likelihood of developing emesis is greatly reduced. Although, all first generation 5HT3 antagonists demonstrate reasonable efficacy in preventing acute CINV, delayed CINV still remains a problem.
To compare the effectiveness and safety of palonosetron versus ondansetron as an antiemetic agent in patients receiving cancer chemotherapy.
A prospective observational study was conducted in 106 patients in each treatment arm. Study duration was 12 months from January 2013 to January 2014. Consecutive patients diagnosed with cancer satisfying inclusion criteria, who were about to receive moderately or highly emetogenic chemotherapy were enrolled into the study after getting informed written consent. Each patient received either Intravenous (IV) palonosetron 0.25 mg or ondansetron 8 mg half an hour before chemotherapy as antiemetic. Patients were followed up for a period of five days following chemotherapy. Number of episodes, severity of vomiting and nausea and antiemetic rescue given if any were recorded. The data were graded using NCI-CTCAE (VERSION 3.0). Proportion of patients with nausea and vomiting during acute (0-24 hours), delayed (24-120 hours) and overall period (0-120 hours) in both the study groups were compared. Outcome was assessed in terms of symptom control and response. Data were analysed using SPSS-16.0 statistical software (IBM). Chi-square test was used to compare the difference in clinical response.
Complete response during acute phase in ondansetron group was 80.2%, while for palonosetron it was 89.6%. During delayed phase, ondansetron and palonosetron produced complete response in 70.8% and 86.8% respectively. A total of 65.1% and 82.1% of subjects experienced complete response during the overall period in the ondansetron and palonosetron groups respectively. The difference in the response to antiemetic prophylaxis was statistically significant between the two groups for delayed (p-value = 0.006) and overall phase (p-value = 0.008).
Palonosetron is clinically more efficacious than ondansetron in controlling CINV especially in delayed phase and overall period of emesis.
化疗引起的恶心和呕吐（CINV）是癌症化疗最令人痛苦的副作用。它会严重影响患者的生活质量。预防CINV远比治疗已发生的CINV有效。如果患者在化疗初始疗程中接受最佳的止吐方案，发生呕吐的可能性会大大降低。虽然，所有第一代5 - HT3拮抗剂在预防急性CINV方面都显示出合理的疗效，但延迟性CINV仍然是一个问题。
比较帕洛诺司琼与昂丹司琼作为止吐药在接受癌症化疗患者中的有效性和安全性。
在每个治疗组中对106例患者进行了一项前瞻性观察研究。研究持续时间为2013年1月至2014年1月的12个月。连续诊断为癌症且符合纳入标准、即将接受中度或高度致吐性化疗的患者在获得知情书面同意后纳入研究。每位患者在化疗前半小时接受静脉注射帕洛诺司琼0.25mg或昂丹司琼8mg作为止吐药。化疗后对患者进行为期五天的随访。记录呕吐和恶心的发作次数、严重程度以及是否给予止吐解救药物。数据使用NCI - CTCAE（版本3.0）进行分级。比较两个研究组在急性（0 - 24小时）、延迟（24 - 120小时）和整个时期（0 - 120小时）出现恶心和呕吐的患者比例。根据症状控制和反应评估结果。使用SPSS - 16.0统计软件（IBM）分析数据。采用卡方检验比较临床反应的差异。
昂丹司琼组急性期的完全缓解率为80.2%，而帕洛诺司琼组为89.6%。在延迟期，昂丹司琼和帕洛诺司琼的完全缓解率分别为70.8%和86.8%。在整个时期，昂丹司琼组和帕洛诺司琼组分别有65.1%和82.1%的受试者实现了完全缓解。两组在延迟期（p值 = 0.006）和整个阶段（p值 = 0.008）的止吐预防反应差异具有统计学意义。
在控制CINV方面，尤其是在呕吐的延迟期和整个时期，帕洛诺司琼在临床上比昂丹司琼更有效。
