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目的探讨接受3周紫杉醇化疗方案的实体瘤患者紫杉醇血药浓度>0.05μmol/L的时间(T_c>0.05)与不良反应间的相关性。方法 200例实体瘤患者,均接受3周以紫杉醇为基础的化疗方案,于每周期化疗静脉滴注紫杉醇后18~30h采集外周血2~3mL,检测紫杉醇血药浓度并测定T_c>0.05值,比较T_c>0.05值≤35h者和T_c>0.05值>35h者不良反应发生情况,并基于T_c>0.05的剂量调整模型进行剂量调整。结果 200例患者紫杉醇血药浓度为13~194μg/L,T_c>0.05值为11~55h;T_c>0.05值在性别、年龄、TNM分期上差异均无统计学意义(P>0.05);T_c>0.05值>35h组Ⅲ~Ⅳ级中性粒细胞减少发生率(87.5%)及血小板减少发生率(75.0%)明显高于T_c>0.05值≤35h组(2.7%、4.3%)(P<0.05),Ⅲ~Ⅳ级胃肠道反应、神经毒性、肝功能损害发生率(12.5%、6.3%、18.8%)与T_c>0.05值≤35h组(19.6%、1.6%、4.3%)比较差异无统计学意义(P>0.05)。结论接受紫杉醇为基础的3周化疗方案的实体瘤患者紫杉醇T_c>0.05与严重中性粒细胞减少及血小板减少明显相关,将T_c>0.05控制在35h以下可减少血液学不良反应。
Objective To investigate the correlation between adverse reactions and time of paclitaxel plasma concentration> 0.05μmol / L (T_c> 0.05) in patients with solid tumors receiving paclitaxel chemotherapy for 3 weeks. Methods Totally 200 patients with solid tumors received paclitaxel-based chemotherapy for 3 weeks. Peripheral blood was collected at 2 to 3 mL 18 to 30 hours after chemotherapy and intravenous infusion of paclitaxel. The plasma concentration of paclitaxel was measured and T_c> 0.05 was determined. The incidence of adverse reactions was compared between T_c> 0.05 values≤35h and T_c> 0.05 values> 35h, and the dosage was adjusted based on the dose adjustment model with T_c> 0.05. Results The plasma concentration of paclitaxel was 13 ~ 194μg / L in 200 patients, while the value of T_c> 0.05 was 11 ~ 55h. There was no significant difference of T_c> 0.05 in sex, age and TNM stage (P> 0.05) The incidence of grade Ⅲ-Ⅳ neutropenia (87.5%) and thrombocytopenia (75.0%) were significantly higher than those with T_c> 0.05 (≤ 2.7%, 4.3%, P <0.05) ), Grade Ⅲ ~ Ⅳ gastrointestinal tract reaction, neurotoxicity, the incidence of liver damage (12.5%, 6.3%, 18.8%) and T_c> 0.05≤35h group (19.6%, 1.6%, 4.3% Statistical significance (P> 0.05). CONCLUSIONS: Taxol Tc> 0.05 in patients with solid tumors receiving paclitaxel-based 3-week chemotherapy regimen is significantly associated with severe neutropenia and thrombocytopenia. Tc> 0.05 for less than 35 h may reduce the adverse reactions of hematology.