目的 观察喘可治注射液联合化疗治疗Ⅲ、Ⅳ期老年非小细胞肺癌（NSCLC）的近期疗效。方法 采用前瞻性、随机、对照的临床研究方法，将62例老年NSCLC病例按1∶1比例分为试验组（喘可治注射液+中医辨证论治+化疗）和对照组（中医辨证论治+化疗），其中试验组32例，对照组30例。观察喘可治注射液联合化疗对瘤体大小、临床症状、体力状况（PS）评分、体质量的影响及化疗副反应。结果 试验组、对照组瘤体大小疗效评价：有效率（ORR）分别为31.3 %、16.7 %，稳定率（DCR）分别为84.4 %、73.3 %，两组比较差异均无统计学意义（P＞0.05）。试验组咳嗽、咯痰、夜尿频多、畏寒肢冷等临床症状缓解率优于对照组（P＜0.05）；试验组的PS评分改善优于对照组（P＜0.05）；试验组治疗后体质量增加率及稳定率均高于对照组（P＜0.05）；试验组骨髓抑制程度较对照组轻，其中白细胞及中性粒细胞变化有统计学意义（P＜0.05）。结论 喘可治注射液应用于Ⅲ、Ⅳ期老年NSCLC化疗患者具有增效减毒的协同作用，能明显改善临床症状、提高PS评分，维持体质量及有效减轻骨髓抑制。

Objective To observe the short-term therapeutic effect of Chuankezhi injection（CI） combined with chemotherapy for the treatment of senile patients with non-small cell lung cancer（NSCLC） at the stage III or IV. Methods A prospective，randomized，and controlled trial was carried out in 62 senile patients with NSCLC. The patients were randomly divided into two groups at the proportion of 1∶1. The test group had 32 patients，and were given CI combined with chemotherapy，and the control group had 30 patients and were treated with chemotherapy alone. The outcomes included tumor size，clinical symptoms，physical state（PS） scores，body mass and adverse reactions of chemotherapy. Results Objective response rate（ORR） was 31.3 %，16.7 %，disease control rate（DCR） was 84.4 %，73.3 % in the test group and the control group respectively，and the differences were not statistically significant（P＞0.05）. The relief of clinical symptoms such as cough，expectoration，frequent nocturnal micturition of the test group was better than that of the control group（P＜0.05）. The test group had better effect on improving PS scores，increasing body mass increase rate and stability rate，improving bone marrow depression and the changes of white blood cells and neutrophil（P＜0.05）. Conclusion For the treatment of senile patients with NSCLC at the stage of III or IV，CI has synergistic effects on enhancing efficacy and reducing toxicity of chemotherapy，it can significantly improve the clinical symptoms and PS scores，maintaining body weight，and reduce chemotherapy- induced bone marrow suppression.

R285.6

广东省教育部产学研结合项目（2012B091100051）；广东省中医药局科研课题（20132182）。