Department of Pharmacology, Institute of Postgraduate Medical Education & Research (IPGMER), 244B, Acharya J. C. Bose Road, Kolkata, West Bengal, India.
Indian J Pharmacol. 2011 Apr;43(2):126-30. doi: 10.4103/0253-7613.77341.
Conventional polyethoxylated castor oil (PCO)-based paclitaxel is associated with major adverse drug reactions (ADRs). Nanoxel, a nanoparticle-based formulation, may improve its tolerability by removing the need for PCO vehicle, and also permit its use in a higher dose. We conducted intensive monitoring of the ADR profile of Nanoxel in comparison with conventional paclitaxel in a public tertiary care set-up.
ADR data were collected from 10 patients receiving Nanoxel and 10 age-matched controls receiving conventional paclitaxel in this longitudinal observational study, conducted in a medical oncology ward over 18 months. Severity was graded as per US National Cancer Institute Common Terminology Criteria for Adverse Events.
The groups had comparable demography at baseline. The median disease duration and per cycle median dose of paclitaxel were greater in the Nanoxel arm. Total 119 ADRs were noted with Nanoxel and 123 with conventional paclitaxel. Of these, 25 (21.0%, 95% CI 13.69-28.33%) in the Nanoxel and 20 (16.2%, 95% CI 9.74-22.78%) in paclitaxel group were of grade 3/4 severity. Common events included myalgia, nausea, anemia, paresthesia, alopecia, diarrhea, and vomiting with Nanoxel, and paresthesia, anemia, myalgia, anorexia, alopecia, vomiting, diarrhea, stomatitis, and nausea with paclitaxel. Of the less common events (<5%), grade 2 or 3 arthralgia was seen exclusively with Nanoxel while motor neuropathy with muscular weakness was more frequent and severe with conventional paclitaxel. Hypersensitivity reactions were not encountered in either arm, although no antiallergy premedication was employed for Nanoxel.
Despite its ADR profile being statistically comparable to conventional paclitaxel, this observational study suggests that Nanoxel tolerability could be better, considering that a significantly higher dose was employed. This hypothesis needs confirmation through an interventional study.
常规聚氧乙烯蓖麻油（PCO）基紫杉醇会引起严重的药物不良反应（ADR）。纳米载体是一种基于纳米颗粒的制剂，通过去除 PCO 载体，可以提高其耐受性，还可以允许使用更高的剂量。我们在一个公共三级保健机构中对纳米载体与常规紫杉醇的 ADR 谱进行了密集监测。
在这项为期 18 个月的纵向观察性研究中，我们在肿瘤科病房中对 10 名接受纳米载体治疗的患者和 10 名年龄匹配的接受常规紫杉醇治疗的患者进行了 ADR 数据收集。严重程度根据美国国立癌症研究所不良事件常用术语标准进行分级。
两组患者的基线人口统计学特征相似。纳米载体组的中位疾病持续时间和每个周期的中位紫杉醇剂量均较高。使用纳米载体记录了 119 例 ADR，使用常规紫杉醇记录了 123 例 ADR。其中，纳米载体组 25 例（21.0%，95%CI 13.69-28.33%）和紫杉醇组 20 例（16.2%，95%CI 9.74-22.78%）为 3/4 级严重程度。常见事件包括肌痛、恶心、贫血、感觉异常、脱发、腹泻和呕吐，纳米载体组出现感觉异常、贫血、肌痛、厌食、脱发、呕吐、腹泻、口腔炎和恶心，紫杉醇组出现感觉异常、贫血、肌痛、厌食、脱发、呕吐、腹泻、口腔炎和恶心。不太常见的事件（<5%），纳米载体组仅出现 2 级或 3 级关节炎，而常规紫杉醇组更常见且更严重的是运动神经病变伴肌无力。两种药物均未出现过敏反应，尽管纳米载体未使用抗过敏药物。
尽管其 ADR 谱与常规紫杉醇统计学上相似，但这项观察性研究表明，考虑到使用了更高的剂量，纳米载体的耐受性可能更好。这一假设需要通过干预性研究来证实。
