目的:观察清肺散结丸与长春瑞滨(vinorelbine,NVB)和顺铂(cisplatin,DDP)联合治疗晚期非小细胞肺癌的近期疗效及毒副作用,为临床用药提供参考。方法:选取2010年11月-2012年3月我院收治的晚期非小细胞肺癌患者146例,随机分为对照组和联合组,每组各73例。对照组常规给予长春瑞滨和顺铂(NP方案)治疗,联合组在对照组基础上加以清肺散结丸治疗。观察两组患者的客观有效率、疾病控制率、生活质量改善率和毒副反应的发生情况。结果:对照组患者的客观有效率为42.5%,联合组为46.6%,差异无统计学意义(P>0.05);联合组疾病控制率为85.0%,明显高于对照组的65.8%(P<0.05);联合组生活质量改善情况为68.5%,明显高于对照组的41.1%(P<0.05);联合组Ⅱ度以上白细胞减少的发生率为54.8%,对照组为75.3%;联合组Ⅲ度以上白细胞减少的发生率为17.8%,对照组为37.0%,差异显著具有统计学意义(P<0.05);联合组恶心呕吐的发生率为24.7%,显著优于对照组的49.3%(P<0.05)。结论:NP方案联用清肺散结丸治疗晚期NSCLC能够使患者获益并提高患病期间生活质量,降低骨髓移植和消化系统毒副反应发生。 OBJECTIVE: To observe the short-term curative effect and side effects of Qingfei Sanjie Pill combined with vinorelbine (NVB) and cisplatin (DDP) in the treatment of advanced non-small cell lung cancer (NSCLC) and provide reference for clinical use. Methods: A total of 146 patients with advanced non-small cell lung cancer admitted to our hospital from November 2010 to March 2012 were randomly divided into control group and combination group, with 73 cases in each group. Control group routinely given Vinorelbine and cisplatin (NP regimen) treatment, the combined group in the control group based on the Qingfei Sanjie pill treatment. Observed the two groups of patients objective efficiency, disease control rate, quality of life improvement rate and the occurrence of toxic reactions. Results: The objective effective rate was 42.5% in the control group and 46.6% in the combined group, with no significant difference (P> 0.05). The control rate of the combined group was 85.0%, which was significantly higher than that of the control group (65.8%, P < 0.05). The improvement of quality of life in the combination group was 68.5%, which was significantly higher than that in the control group (41.1%, P <0.05). The incidence of leukopenia of grade Ⅱ or higher was 54.8% in the combination group and 75.3% in the control group The incidence of leukopenia was 17.8% in the control group and 37.0% in the control group, with significant difference (P <0.05). The incidence of nausea and vomiting was 24.7% in the combination group, which was significantly better than that in the control group (49.3%, P <0.05). Conclusion: The combination of NP and Qingfei Sanjie pill in the treatment of advanced NSCLC can benefit patients and improve the quality of life during the illness, reduce the incidence of bone marrow transplantation and digestive toxicity.