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目的:对接受紫杉醇联合顺铂3周方案的非小细胞肺癌患者药代动力学差异进行研究,分析非小细胞肺癌患者中紫杉醇关键药代动力学参数Tc>0.05(血浓度0.05μM以上时间)与临床毒性的相关性,为紫杉醇的治疗药物监测提供依据。方法:应用纳米增强免疫比浊法检测非小细胞肺癌患者紫杉醇化疗后(24±6)h的血药浓度,采用群体药物动力学模型计算出Tc>0.05值,同时观察化疗后出现的不良反应,按照NCI-CTC v4.0毒副反应评价标准进行分级、结果:全组16例患者共进行32次化疗,有效周期29次(可测算出Tc>0.05),共发生不良反应25例次,包括骨髓抑制、胃肠道反应,无因不良反应而中断治疗者。将患者按照紫杉醇在体内暴露情况分为两组:正常暴露组和高暴露组。骨髓抑制的发生率在两组中存在显著差异(P=0.003),恶心呕吐的发生率无显著性差异(P=0.483)。对两组Ⅲ度以上骨髓抑制的发生率进行比较,发现两组间存在差异,但无统计学意义(P=0.052)。结论:通过测算紫杉醇Tc>0.05值可以了解紫杉醇在患者体内的暴露情况,从而判断患者发生骨髓抑制的风险。但由于本研究中样本量有限,尚需大样本的临床研究进一步证实上述结论。
AIM: To investigate the pharmacokinetics of non-small cell lung cancer (NSCLC) patients receiving paclitaxel plus cisplatin for 3 weeks. The key pharmacokinetic parameters of paclitaxel (Tc> 0.05) were determined in non-small cell lung cancer patients (serum concentration> 0.05 μM) And clinical relevance of toxicity for the treatment of paclitaxel to provide the basis for drug monitoring. Methods: The plasma concentration of paclitaxel in patients with non-small cell lung cancer (24 ± 6 h) was measured by nano-enhanced immunoturbidimetry. Tc> 0.05 was calculated by population pharmacokinetic model. The adverse reaction , According to NCI-CTC v4.0 toxic and side effects evaluation criteria for grading, Results: The whole group of 16 patients with a total of 32 chemotherapy, the effective period of 29 times (Tc> 0.05), a total of 25 cases of adverse reactions, Including myelosuppression, gastrointestinal reactions, no interruption of treatment due to adverse reactions. The patients were divided into two groups according to the in vivo exposure of paclitaxel: the normal exposure group and the high exposure group. There was a significant difference in the incidence of myelosuppression between the two groups (P = 0.003) and no significant difference in the incidence of nausea and vomiting (P = .483). The incidence of myelosuppression above grade Ⅲ was compared between the two groups and found no significant difference between the two groups (P = 0.052). CONCLUSIONS: The paclitaxel exposure in patients can be assessed by measuring the Tc> 0.05 value of paclitaxel in order to determine the patient’s risk of myelosuppression. However, due to the limited sample size in this study, a large sample of clinical studies is needed to confirm the above conclusion.