摘要
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： Recently the maintenance therapy of non-small-cell lung cancer （NSCLC） patients who completed required treatment cycles has caused widespread interests in the medical field. Traditional Chinese medicine may be a useful complement in maintenance treatment of mid-to-late stage NSCLC.
Objective： To observe the effects of Feitai Capsule, a compound traditional Chinese herbal medicine for expelling blood stasis and phlegm, on the quality of life of the NSCLC patients as a maintenance treatment. Design, setting, participants and interventions： A total of 62 mid-to-late stage NSCLC patients from Fuzhou General Hospital of Nanjing Military Region were included and randomly divided into treatment group （31 cases） and control group （31 cases）. Patients in the treatment group were treated with Feitai Capsule, and patients in the control group did not accept any intervention. Regular observations and follow-up were performed for patients in the two groups. Main outcome measures： Analysis of variance, nonparametric test, and analysis of covariance were used to compare clinical features, amelioration of clinical symptoms, physical constitution and energy, and quality of life. Results： There were two dropouts and 60 valid cases. The baseline characteristics of the two groups were similar. In the treatment group, symptom response and physical energy level were improved by 36.6% （Z= -2. 632, P =0. 008） and 26.7% （Z=-2. 182, P =0. 029）, respectively. There was a positive correlation between these two factors （r =0.917, P 〈0.001）. The patients in treatment group had a significantly improved quality of life after treatment, No serious adverse events were observed. Conclusion： Feitai Capsule as maintenance treatment can improve the quality of life of the patients with midto-late stage NSCLC.
出处
《中西医结合学报》
CAS
2009年第7期611-615,共5页
Journal of Chinese Integrative Medicine
基金
"十一五"军队中医药重大临床攻关课题(No.2006051002)
关键词
非小细胞肺癌
复方(中药)
生活质量
随机对照试验
non-small-cell lung carcinoma
compound （traditional Chinese drug）
quality of life
randomizedcontrolled trial
