消癌平注射液联合化疗治疗晚期非小细胞肺癌的临床观察

Xiaoaiping Injection Combined with Cisplatin and Gemcitabine for Non-Small Cell Lung Cancer: A Clinical ObservationΔ

目的:观察消癌平注射液联合吉西他滨+顺铂化疗方案(GP方案)治疗晚期非小细胞肺癌(NSCLC)的近期临床疗效、生存质量与不良反应。方法:将符合标准的晚期NSCLC患者以随机抽样法分配至GP组和GP+消癌平注射液组,分别按世界卫生组织(WHO)实体瘤客观疗效评价通用标准、WHO抗肿瘤药物急性与亚急性毒性分级标准和肺癌症状量表观察者量表(LCSS)评价疗效、不良反应和生活质量,并以Kaplan-Meier法和寿命表法进行生存分析。结果:2组患者中位生存期、1年和1年半生存率比较,差异均无统计学意义。单用GP组患者,Ⅲ～Ⅳ度白细胞计数减少发生率为48.8%,血红蛋白减少发生率为39.5%,血小板计数减少发生率为37.2%,Ⅲ～Ⅳ度恶心、呕吐发生率为23.3%;而GP+消癌平注射液组各项指标分别为16.3%、20.9%、18.6%和7.0%(P<0.05)。LCSS评分表明单用GP化疗后患者呼吸困难、咳血症状改善不明显,而GP+消癌平注射液组患者放疗后所有症状均有改善,差异具有统计学意义(P<0.05)。结论:消癌平注射液作为GP方案的辅助用药,在减轻化疗的毒性程度、改善患者身体机能状况方面是安全、有效的,相对于单用GP方案更容易被晚期NSCLC患者所接收,因此值得临床推广应用。

OBJECTIVE：To evaluate the efficacy and safety of Xiaoaiping injection combined with cisplatin plus gemcitabine（regimen of GP） for patients with non-small cell lung cancer（NSCLC） and the quality of life of the NSCLC patients treated with the this combined therapy.METHODS： A total of 86 patients with advanced NSCLC meeting the inclusion criteria were randomly assigned to receive either GP alone or GP plus Xiaoaiping injection.The objective evaluation criteria for solid tumors as recommended by WHO,the grading criteria for acute/subacute toxicity of chemotherapeutic drugs as recommended by WHO,and the observer score of lung cancer symptom scale（LCSS） were used for evaluation of the efficacy and safety of the chemotherapy and the quality of life of the patients.Kaplan-Meier and Life-time Table were used for survival analysis.RESULTS： The differences between two groups in median survival time,1-year and 1.5-year survival rates were not significant.The incidence rates of leucopenia of grade Ⅲ-Ⅳ reduction of hemoglobin,reduction of blood platelet count,and nausea vomiting of grade Ⅲ-Ⅳ were 48.8%,39.5%,37.2% and 23.3%,respectively in GP group as compared with 16.3%,20.9%,18.6% and 7.0% respectively in GP plus Xiaoaiping injection group（P0.05）.LCSS score indicated that in patients treated with GP therapy alone,there was little improvement in symptoms of dyspnea and hemoptysis;however in those treated with GP plus Xiaoaiping injection,all the symptoms had improvement after chemotherapy（P0.05）.CONCLUSION： Xiaoaiping injection as the adjuvant therapy for GP regimen was proved to be safe and effective for improving body function while attenuating the toxic side effect of GP chemotherapy in NSCLC patients.As compared with the GP therapeutic regimen alone,the GP plus Xiaoaiping injection regimen was more acceptable in patients with advanced NSCLC hence it is worthy of clinical popularization and application.