国产吉西他滨联合铂类对晚期非小细胞肺癌患者生活质量的影响

Influences of china-made gemcitabine plus platinum regimen on the quality of life among patients with advanced non-small cell lung cancer

目的观察国产吉西他滨联合铂类治疗晚期非小细胞肺癌(NSCLC)的临床疗效,不良反应及生活质量。方法晚期NSCLC患者随机分为两组:吉西他滨联合卡铂(GC方案组),吉西他滨联合顺铂(GP方案组)。GC组采用吉西他滨1000 mg/m2,静脉滴注30 min,d1、8,卡铂300 mg/m2,d1;GP组采用顺铂30 mg/m2,d1～3,吉西他滨用法同GC组。每3周为1个周期。治疗2个周期评价疗效,每个周期评价不良反应。采用EORTC QLQ-C30和QLQ-LC13问卷对患者治疗前、后症状和生活质量进行评价,并对结果进行比较分析。结果总有效率、中位生存时间、中位疾病进展时间(TTP)、1年生存率、临床获益率两组对比差异无统计学意义(均P>0.05);两组主要不良反应为骨髓抑制和恶心呕吐,其中GC组反应较轻;两组生活质量各领域包括功能子领域及症状子领域评分治疗后明显改善,GC组改善更明显。结论吉西他滨联合铂类治疗晚期NSCLC疗效确切,两组化疗方案均能明显改善患者生活质量。其中GC方案耐受性更好,不良反应轻,在改善患者生活质量方面有一定的优势。

Objective To observe the clinical effect, toxicity and quality of life of gemcitabinc plus platinum regimen in treatment for advanced non-small cell lung cancer （NSCLC）. Methods Advanced NSCLC patients were randomly divided into GC group which dripped intravenously gemcitabine （1000 mg/ m^2 ,d1 ,d8 ） and Carboplatin （dl）, and GP group which dripped intravenously Cisplatin （30 mg/m^2 ,dl-d3 ） and gemcitabine（ 1000 mg/m^2 ,dl ,d8）. Three weeks of treatment were treated as one course, The toxicity was assessed after each course and the efficacy was evaluated per two courses. EORTC, QLQ-C30 and QLQ- LC13 questionnaires were employed to evaluate the changes of quality of life（QOL） and symptoms before and after treatment, and the evaluation results were compared and analyzed. Results There were no statistically significant differences between two groups in the total efficacy, median survival rate, median time to progres- sion（ TIP）, 1-year Survival Rate and Clinical Benefit Rate （ P 〉 0.05 ）. The main toxic and side-effect were myelosuppression, nausea and vomiting, which were comparatively mild in GC group. The QOL, including function sub-field and symptom sub-field, were significantly improved after treatment in two groups, particularly in GC group. Conclusion The efficacy of gemcitabine plus platinum regimen in treatment of advanced NSCLC is significant. The QOL of patients were obviously improved in the two groups, however, GC group was slightly better in improving QOL, tolerance and adverse reactions.