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背景:近年关于已完成治疗周期的瘤灶稳定的非小细胞肺癌(non-small-cell lung cancer,NSCLC)患者的维持治疗问题,引起医学界普遍兴趣。开展中医药在中晚期恶性肿瘤维持治疗领域的研究可能是目前综合治疗措施有益的补充。目的:观察中药复方肺泰胶囊维持治疗对NSCLC患者生存质量的影响,并评价其安全性。设计、场所、受试者和干预措施:按标准入选南京军区福州总医院中晚期NSCLC患者62例,按信封法随机分为治疗组和对照组,每组各31例。治疗组给予肺泰胶囊维持治疗,对照组不给予任何干预。两组患者均定期随访。主要结局指标:定期评估临床证候疗效、体力状况、生存质量和安全性。组间临床特征、症状缓解率、体力状况和生活质量评分分别采用方差分析、非参数检验和协方差分析进行统计。安全性评价采用描述性统计。结果:入组62例,治疗组和对照组各1例出组,可评价疗效病例60例。治疗前两组基线资料分布均衡(P>0.05)。治疗组治疗后临床证候评估以及体力状况改善率分别提高了36.6%(Z=-2.632,P=0.008)和26.7%(Z=-2.182,P=0.029),两指标间存在显著正相关(r=0.917,P<0.001);治疗组生活质量得以改善,治疗期间未见明显药物相关的不良反应。结论:中药复方肺泰胶囊维持治疗可改善中晚期非小细胞肺癌患者的生存质量。
BACKGROUND: In recent years, there has been widespread medical interest in the maintenance of non-small-cell lung cancer (NSCLC) patients who have completed the treatment cycle. To carry out traditional Chinese medicine in the treatment of advanced malignant tumor in the field of research may be a useful complement to the current comprehensive treatment. Objective: To observe the effect of traditional Chinese medicine compound Fei Tai Capsule on the quality of life of patients with NSCLC, and evaluate its safety. DESIGN, SETTING, TRIALS AND INTERVENTIONS: Sixty-two patients with moderate to advanced NSCLC were enrolled in the Fuzhou General Hospital of Nanjing Military Region according to the standards. They were randomly divided into treatment group and control group according to the envelope method, with 31 cases in each group. The treatment group was given the treatment of lung Thai capsule, the control group did not give any intervention. Both groups were followed up regularly. MAIN OUTCOME MEASURES: Regular assessment of the efficacy of clinical syndromes, physical status, quality of life and safety. Clinical characteristics, symptom relief rate, physical status and quality of life scores were analyzed by variance analysis, nonparametric test and covariance analysis respectively. Safety evaluation using descriptive statistics. Results: In the group of 62 cases, the treatment group and the control group of 1 case out of the group, evaluation of 60 cases of curative effect. The baseline data of the two groups before treatment were evenly distributed (P> 0.05). After treatment, the clinical syndromes assessment and physical improvement rate in treatment group increased by 36.6% (Z = -2.632, P = 0.008) and 26.7% (Z = -2.182, P = 0.029) respectively. There was a significant positive correlation between the two indexes r = 0.917, P <0.001). The quality of life of the treatment group was improved, and no obvious drug-related adverse reactions were observed during the treatment. Conclusion: The maintenance of traditional Chinese medicine compound lungta capsule can improve the quality of life of patients with advanced non-small cell lung cancer.