中药复方肺泰胶囊对ⅢB/Ⅳ期非小细胞肺癌化疗患者化疗延迟率和化疗通过率影响的随机对照研究

Influence of Chinese herbal medicine Feitai Capsule on completion or delay of chemotherapy in patients with stage ⅢB/Ⅳ non-small-cell lung cancer:a randomized controlled trial

背景:化疗通过率可间接反映患者对化疗的耐受性和依从性。患者耐受性或依从性差,会影响整个综合治疗计划,从而影响肿瘤治疗的疗效。因此,如何提高化疗通过率及减少延迟化疗率在肿瘤治疗领域中越来越引起人们的重视。中医药联合化疗在减毒增效、提高中晚期非小细胞肺癌(non-small-celllungcancer,NSCLC)患者的生存质量方面有一定优势。目的:观察中药复方肺泰胶囊对ⅢB/Ⅳ期NSCLC化疗患者化疗延迟率和化疗通过率的影响。设计、场所、对象和干预措施:采用前瞻性、随机、对照的临床研究方法,收集南京军区福州总医院肿瘤科的NSCLC患者60例。将60例ⅢB/Ⅳ期NSCLC患者随机分为治疗组(肺泰胶囊联合化疗)和对照组(单纯化疗),治疗4个周期。主要结局指标:观察每个周期化疗通过率、化疗延迟率和4个周期后的治疗效果。结果:入组60例,其中5例被剔除(治疗组2例,对照组3例),55例可评价疗效。治疗前,两组基线资料分布均衡(P>0.05)。治疗组和对照组第4周期的化疗通过率分别为96.42%和74.07%,化疗延迟率分别为3.57%和14.8%(P=0.007)。4个周期后治疗组疾病控制率为78.6%,对照组疾病控制率为59.3%,两组比较,差异无统计学意义(P=0.1739)。结论:中药复方肺泰胶囊可提高ⅢB/Ⅳ期NSCLC化疗患者化疗通过率,增强化疗疗效。

BACKGROUND： Chemotherapy completion rate can reflect the tolerance and compliance of patients to chemotherapy. Poor tolerance may result in delay or suspension of the comprehensive treatment plan, thus affect the efficacy of cancer treatment. Evaluating methods to improve the completion rate of chemotherapy and reduce the occurrence of delayed chemotherapy has gained increasing attention and is the significant area of study in the field of cancer treatment. Studies have shown that Chinese medicine combined with chemotherapy could improve the quality of life in patients with stage ⅢB/Ⅳ non-small-cell lung cancer （NSCLC）. OBJECTIVE： To observe the effects of Feitai Capsule, a Chinese patent herbal drug, combined with chemotherapy in patients with stage ⅢB/Ⅳ NSCLC. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： A total of 60 diagnosed stage IIIB/IV NSCLC patients from the Department of Oncology, Fuzhou General Hosipital of Najing Military Region were randomly divided into treatment group （30 cases） and control group （30 cases）. Patients in the treatment group were treated with chemotherapy plus Feitai Capsule and patients in the control group only received chemotherapy. Both groups of patients were treated for 4 therapeutic cycles. MAIN OUTCOME MEASURES： The chemotherapy completion rate and the chemotherapy delay rate were observed in each cycle of treatment. The therapeutic efficacy was evaluated after 4 cycles. RESULTS： The chemotherapy completion rate was 96.42% in the treatment group, while that of the control group was 74.07%. The chemotherapy delay rate was 3.57% in the treatment group, while that of the control group was 14.8% （P=0.007 0）. The disease control rate was 78.6% in the treatment group, while that of the control group was 59.3% （P=0.173 9）. CONCLUSION： Feitai Capsule can increase the chemotherapy completion rate in patients with stage ⅢB/Ⅳ NSCLC.