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目的评价国产吉西他滨(誉捷)联合铂类方案治疗非小细胞肺癌的安全性及短期疗效。方法61例非小细胞肺癌患者采用誉捷+顺铂方案40例,誉捷+卡铂方案21例;化疗使用常规剂量及用法,每3周循环,至少完成2周期。以0~Ⅳ级记录化疗期间不良反应,化疗前及2周期后分别进行生活质量(QOL)评分,同时评估非手术患者化疗前后肿瘤大小变化。结果本组患者化疗后最主要的不良反应为白细胞下降、中性粒细胞下降和恶心呕吐,发生率分别为59.0%、41.0%和41.0%,其余不良反应发生率较低;中重度不良反应(Ⅲ+Ⅳ度)同样以白细胞下降、中性粒细胞下降和恶心呕吐为主,发生率分别为13.1%、14.8%和11.5%。全组患者化疗期间出现4例心脏相关事件,3例出血事件,1例患者出现中枢神经系统症状,经及时处理后患者均顺利出院。化疗后生活质量稳定和提高的患者占全组患者的68.9%;化疗前后患者生活质量分别为46.79±4.637和45.66±6.416,两者比较无统计学差异(P=0.312)。22例非手术患者化疗2周期后疗效为:10例SD,3例M R,8例PR,1例CR,治疗有效率(CR+PR)为40.9%。结论国产吉西他滨(誉捷)与铂类联合方案治疗非小细胞肺癌在用药安全性及短期疗效上与国外文献报道无明显差异,绝大多数患者能够良好耐受。
Objective To evaluate the safety and short-term efficacy of domestic gemcitabine (Yu Jie) combined with platinum regimen in the treatment of non-small cell lung cancer. Methods Totally 61 patients with non-small cell lung cancer (NSCLC) were enrolled in this study. Forty patients were treated with Fudan plus cisplatin and 21 patients with Fudan plus carboplatin. Chemotherapy was given every 3 weeks with at least 2 cycles. Adverse reactions during chemotherapy were recorded on a scale of 0 to 4 and quality of life (QOL) scores were assessed before and 2 weeks after chemotherapy. Changes in tumor size before and after non-surgical treatment were also evaluated. Results The main adverse reactions after chemotherapy in this group were leukopenia, neutropenia and nausea and vomiting. The incidence rates were 59.0%, 41.0% and 41.0%, respectively. The incidence of other adverse reactions was low. The moderate and severe adverse reactions Ⅲ + Ⅳ degrees) the same leukopenia, neutropenia and nausea and vomiting, the incidence rates were 13.1%, 14.8% and 11.5%. During the chemotherapy in the whole group, there were 4 cardiac-related events and 3 bleeding events. One patient developed central nervous system symptoms. All patients were discharged after timely treatment. After chemotherapy, the quality of life of stable and improved patients accounted for 68.9% of the total patients; before and after chemotherapy, the quality of life of patients were 46.79 ± 4.637 and 45.66 ± 6.416, respectively, there was no significant difference (P = 0.312). The efficacy of two cycles of 22 non-surgical patients after chemotherapy was 10 cases of SD, 3 cases of M R, 8 cases of PR, and 1 case of CR. The response rate (CR + PR) was 40.9%. Conclusion The combination of domestic gemcitabine (Platinum Fitch) with platinum in the treatment of non-small cell lung cancer in drug safety and short-term efficacy of no significant difference with the foreign literature, the vast majority of patients with good tolerance.