康艾注射液联合单药化疗治疗老年晚期非小细胞肺癌的有效性和安全性

Effectiveness and safety of Kang′ai injection combined with single agent chemotherapy in treatment of elderly patients with advanced NSCLC

目的观察康艾注射液联合多西他赛或吉西他滨单药化疗治疗老年晚期非小细胞肺癌(NSCLC)的有效性和安全性。方法采用多中心、随机、平行对照的研究方法将3所医院在2013年6月至2014年8月期间收治的150例老年晚期NSCLC患者随机分成含铂组(含铂两药的联合化疗)与康艾组(康艾注射液联合单药化疗)。观察并比较两组患者的临床疗效及不良反应。结果康艾组患者有效率明显高于含铂组(P<0.05);治疗后康艾组患者临床症状改善有效率明显高于含铂组(P<0.05);治疗后康艾组患者PS评分提高率明显高于含铂组(P<0.05);治疗到第二疗程后康艾组患者生活质量评分明显高于含铂组患者(P<0.05);康艾组患者不良反应情况明显少于含铂组患者(P<0.05)。结论康艾注射液联合单药化疗治疗老年NSCLC能有效的缓解患者临床症状,缩小瘤体,安全性较高。

Objective To observe the effectiveness and safety of Kang＇ai injection combined with docetaxel or gemcitabine chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer （NSCLC）. Methods A multi-center, randomized and parallel control study was carried out in 150 elderly patients with ad- vanced NSCLC treated in 3 hospitals during the period from June 2013 to August 2014. The patients were randomly divided into platinum-based group （platinum-based doublet chemotherapy） and Kang＇ai group （Kang＇ai injection combined with single agent chemotherapy）. The clinical efficacy, quality of fife and adverse reactions were ob- served and compared between the two groups. Results There was no significant difference in the disease control rate between the two groups group （79.66% vs 81.82% ） （X2 = 0.101, P = 0.751 ） while the effective rate of Kang＇ ai group was significantly higher than that of platinum-based group （30.51% vs 14.29% ） （X2=5.240, P = 0.022）. The effective rate of clinical symptom relief in Kang＇ ai group after treatment was significantly higher than that in platinum-based group （69.49% vs 48.05%） （X2 = 6.278, P = 0.012）, and the increase rate of PS score in Kang＇ai group after the treatment was also significantly higher than that in platinum-based group （18.64% vs 3.90%） （X2 = 7.868, P = 0.005 ）. There was no significant difference in quality of life between two groups （P 〉 0.05 ）. The quali- ty of life score of Kang＇ai group was significantly higher than that of platinum-based group at the second course of treatment （P 〈 0.05）. The incidence of adverse reactions in Kang＇ai group was significantly lower than that in the platinum-based group （47.46% vs 71.42% ） （X2 = 8.070, P 〈 0.05）. Conclusion Kang＇ai injection combined with single agent chemotherapy can effectively relieve clinical symptoms and reduce the tumor size in elderly patients with advanced NSCLC, with high safety.