目的:观察中药联合吉西他滨化疗治疗晚期非小细胞肺癌(NSCLC)的临床疗效,探讨其对基质金属蛋白酶9(MMP-9)的影响。方法:60例Ⅲb~Ⅳ期NSCLC患者随机分为观察组和对照组。观察组采用参芪扶正注射液联合吉西他滨化疗治疗,对照组单用吉西他滨化疗治疗。两组均以21 d为1周期,治疗2周期后进行评价。结果:治疗后,观察组血清MMP-9水平显著降低,与治疗前和对照组比较均有显著性差异(P<0.05);治疗前Ⅳ期患者血清MMP-9水平显著高于Ⅲb期(P<0.05),治疗后Ⅳ期患者血清MMP-9水平显著低于Ⅲb期(P<0.05);观察组近期临床疗效有效率为56.7%,显著高于对照组(P<0.05);观察组1年生存率、平均随访时间和中位疾病进展时间显著高于对照组(P<0.05),Ⅲ~Ⅳ级毒副反应显著低于对照组(P<0.05)。结论:中药联合吉西他滨化疗治疗晚期NSCLC近期疗效明显,毒副反应低,并通过抑制MMP-9的活性来达到抑制肿瘤生长和转移。 Objective: To observe the clinical efficacy of traditional Chinese medicine combined with gemcitabine in the treatment of advanced non-small cell lung cancer (NSCLC), and to explore its effect on matrix metalloproteinase 9 (MMP-9). Methods: Sixty patients with stage Ⅲb-Ⅳ NSCLC were randomly divided into observation group and control group. The observation group was treated with Shenqi Fuzheng injection combined with gemcitabine chemotherapy, and the control group with gemcitabine chemotherapy alone. Both groups were 21 days for a period of 2 weeks after the treatment evaluation. Results: After treatment, the level of MMP-9 in the observation group was significantly lower than that in the control group (P <0.05). The level of serum MMP-9 in the pre-treatment stage Ⅳ was significantly higher than that in the stage Ⅲb <0.05). The serum level of MMP-9 in stage Ⅳ patients after treatment was significantly lower than that in stage Ⅲb (P <0.05). The effective rate of clinical efficacy in the observation group was 56.7%, significantly higher than that in the control group (P <0.05) The annual survival rate, average follow-up time and median disease progression time were significantly higher than those in the control group (P <0.05). The grade Ⅲ-Ⅳ toxicities were significantly lower than those in the control group (P <0.05). Conclusion: The combination of traditional Chinese medicine and gemcitabine in the treatment of advanced NSCLC has obvious curative effect in the short term, low toxic and side effects, and inhibits tumor growth and metastasis by inhibiting the activity of MMP-9.