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

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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: The chemotherapy pass rate indirectly reflects the patient’s tolerance to chemotherapy and compliance. Patient tolerance or poor compliance can affect the overall treatment plan, which affects the efficacy of cancer treatment. Therefore, how to improve the rate of chemotherapy and reduce the rate of delayed chemotherapy has drawn more and more attention in the field of cancer treatment. Traditional Chinese medicine combined chemotherapy has some advantages in reducing the toxicity and improving the efficiency and improving the quality of life of patients with advanced non-small-cell lung cancer (NSCLC). OBJECTIVE: To observe the effect of compound Taifentai capsule on the delay rate of chemotherapy and the chemotherapy pass rate in patients with stage ⅢB / Ⅳ NSCLC. DESIGN, SETTING, ARTICLES AND INTERVENTIONS: A prospective, randomized, controlled clinical study was conducted to collect 60 NSCLC patients from Department of Oncology, Fuzhou General Hospital of Nanjing Military Region. Sixty patients with stage ⅢB / Ⅳ NSCLC were randomly divided into treatment group (Lung Tai Capsule combined with chemotherapy) and control group (chemotherapy alone) for 4 cycles. MAIN OUTCOME MEASURES: The rate of chemotherapy pass through each cycle, the delay in chemotherapy, and the effect of treatment after 4 cycles were observed. Results: 60 cases were enrolled, of which 5 cases were excluded (2 cases in the treatment group and 3 cases in the control group) and 55 cases could be evaluated. Before treatment, the two groups of baseline data were evenly distributed (P> 0.05). The chemotherapy pass rates in the fourth cycle of the treatment group and the control group were 96.42% and 74.07%, respectively, and the delayed rates of chemotherapy were 3.57% and 14.8%, respectively (P = 0.007). After 4 cycles, the disease control rate was 78.6% in the treatment group and 59.3% in the control group. There was no significant difference between the two groups (P = 0.1739). Conclusion: The traditional Chinese medicine compound lung tai capsule can improve the chemotherapy pass rate and enhance the curative effect of ⅢB / Ⅳ NSCLC chemotherapy.
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