参芪扶正注射液提高非小细胞肺癌化疗患者生存质量的随机对照多中心临床试验

Multi-center randomized clinical study on Shenqi-fuzheng injection combined with chemotherapy in the treatment for lung cancer

目的观察参芪扶正注射液对非小细胞肺癌(NSCLC)化疗患者生存质量的影响。方法采用多中心、随机、空白对照的研究方法,在全国11个分中心选取有明确病理诊断的232例NSCLC化疗患者,随机分为化疗组与参芪扶正注射液加化疗组。对两组患者的生存质量评价主要采用国际公认的欧洲癌症研究与治疗组织的生命质量核心量表(EORTC QLQ-C30)与癌症患者生活功能指标量表(FLIC)。结果参芪扶正注射液合并化疗可以明显改善NSCLC患者的躯体、心理、社会等多方面的生存质量,增加患者的体重,改善患者的神疲乏力、少气懒言、疼痛、胸胁胀满、痰多、咳嗽、面色恍白等临床症状,调节患者的免疫功能,还有提高肿瘤化疗客观有效率的趋势。参芪扶正注射液用药安全,无严重的不良反应。结论参芪扶正注射液可作为NSCLC化疗患者辅助用药,并能提高患者的生存质量。

Objective To investigate the effect of Shenqi-fuzheng injection combined with chemotherapy on the quality of life in lung cancer patient. Methods 232 pathologically confirmed non-small cell lung cancer patients were enrolled into this multi-center randomized trial. Of these 232 patients, 116 cases were treated with chemotherapy alone （chemotherapy group） , another 116 with chemotherapy combined with Shenqi-fuzheng injection produced by Lizhu Company （Shenqi-fuzheng group）. Life quality of these patients were evaluated using the QOL scale of European Organization for Research on Treatment of Cancer （QLQ-C30） and the functional living index-cancer. Results Compared with chemotherapy group, Life quality and symptoms were improved in the Shenqi-fuzheng group, which including lassitude, deficient in breath, pain, fullness in chest and hypochondrium, excessive phlegm, cough, complexion whiteness. Response rate to chemotherapy was also improved. No AE and SAE were observed in the Shenqi-fuzheng group. Conclusion Shenqi-fuzheng injection combined with chemotherapy is safe and effective in the treatment for non-samll cell lung cancer.