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目的多西他赛广泛应用于多种癌症治疗,但由于其个体药代动力学差异较大和治疗窗狭窄,个体间疗效和不良反应差异较大。本研究探讨晚期食管癌患者应用多西他赛联合奈达铂方案化疗过程中,进行治疗药物监测的意义。方法收集2014-07-01-2015-12-31南通大学附属肿瘤医院晚期食管癌患者72例,给予多西他赛75mg/m2,静脉滴入d1;奈达铂80mg/m2,静脉滴入d1,21d为1个周期。多西他赛静脉滴入结束前10min和静脉滴入结束后30~60min各采集静脉2mL,采用胶乳免疫比浊法检测血药浓度,对血药浓度结果进行药代动力学分析,得出血药浓度-时间曲线下面积(area under concentration-time curve,AUC)。根据多西他赛AUC值,分为高AUC组、正常范围AUC组和低AUC组。比较3组近期疗效,每2个周期结束评价近期疗效,并观察不良反应发生情况。结果 3组有效率、临床获益率差异均无统计学意义,P>0.05。低AUC组Ⅲ+Ⅳ级白细胞减少发生率为11.76%,低于正常范围AUC组的42.86%,P=0.033;高AUC组Ⅲ+Ⅳ级血小板减少发生率为61.54%,明显高于正常范围AUC组23.81%,P=0.020。较正常范围AUC组贫血发生率52.27%,高AUC组贫血发生率(92.31%)明显升高,P=0.015。而恶心呕吐、口腔炎和体液潴留等不良反应发生率比较差异无统计学意义,P>0.05。结论多西他赛药代动力学参数AUC与晚期食管癌患者多西他赛联合奈达铂化疗所致血液学毒性严重程度密切相关,进行治疗药物监测值得在临床推广和应用。
Purpose Docetaxel is widely used in the treatment of a variety of cancers, but due to its large individual pharmacokinetic differences and narrow therapeutic windows, there are significant differences in efficacy and adverse reactions among individuals. This study was to explore the significance of the monitoring of therapeutic drugs in the treatment of advanced esophageal cancer patients with docetaxel combined with nedaplatin regimen. Methods Totally 72 patients with advanced esophageal cancer at the Affiliated Tumor Hospital of Nantong University were enrolled in 2014-07-01-2015-12-31. Docetaxel was given to 75 mg / m2, d1 was given intravenously, 80 mg / m2 of nedaplatin was intravenously injected into d1 , 21d for a period. Docetaxel intravenous infusion of 10min before the end and intravenous infusion of 30 ~ 60min each collected 2mL venous, latex immunoturbidimetric assay blood concentration, plasma concentration results of pharmacokinetic analysis, that blood medicine Area under concentration-time curve (AUC). According to docetaxel AUC value, divided into high AUC group, normal range AUC group and low AUC group. The short-term efficacy was compared between the three groups, and the short-term efficacy was evaluated at the end of each two cycles. The incidence of adverse reactions was also observed. Results There was no significant difference in the effective rate and clinical benefit rate between the three groups (P> 0.05). The incidence of grade Ⅲ + Ⅳ leukopenia in low AUC group was 11.76%, lower than 42.86% in AUC group, P = 0.033. The incidence of grade Ⅲ + Ⅳ thrombocytopenia in high AUC group was 61.54%, which was significantly higher than that in normal range Group 23.81%, P = 0.020. The incidence of anemia was 52.27% in the AUC group and 92.31% in the AUC group, P = 0.015. The incidence of nausea and vomiting, stomatitis and fluid retention and other adverse reactions was no significant difference (P> 0.05). Conclusion The docetaxel pharmacokinetic parameters AUC are closely related to the severity of hematological toxicities induced by docetaxel combined with nedaplatin in patients with advanced esophageal cancer. The monitoring of therapeutic drugs deserves clinical application and promotion.