生命质量与中医药治疗恶性肿瘤临床疗效评价标准探讨

中医药治疗肿瘤疗效确切,在综合治疗中有独特的地位和优势.中医药治疗肿瘤是一种多途径、多层次、多渠道及多靶点的整体综合治疗,"带瘤生存"和生命质量提高是其显著特点.中医治疗肿瘤的理想疗效应是在满意的生命质量和较长的生存时间基础上的一定程度的肿瘤的反应性.因此,应当把生命质量、证候(症状体征量化)及证候标准化引入到中医药治疗恶性肿瘤领域中,使其疗效评价能够客观化、定量化、标准化.要全面客观地评价中医药治疗肿瘤的疗效,必须制定一个既能体现中医治疗肿瘤的特色及优势,又能适应现代医学肿瘤临床疗效评价的要求及发展趋势的标准.我们认为,疗效＝质量调整生命年(生命质量×生存时间)十证候缓解率十肿瘤缓解率.但质量调整生命年、证候缓解率、肿瘤缓解率三者在疗效评价中各自所占的比重(权重)与不同的肿瘤分期及治疗方法密切相关.

Discussion of relationship between quality of life and clinical effect assessment of malignant tumor treated with traditional Chinese medicine

Traditional Chinese Medicine (TCM) therapy is effective in treating malignant tumor. TCM therapy is a multi-way, multi-layer and multi-target integrated treatment characterized by "survival with tumor" and improvement of life quality. An ideal result of the TCM therapy for cancer should be a positive response of the patient with satisfactory quality of life (QOL) and longer survival time. So it is necessary to introduce the QOL, quantification of symptoms and signs and standardization of TCM syndromes to the objective, quantitative and standardized effect assessment of TCM therapy for cancer. A criterion for evaluating the effect of TCM therapy on tumors should be established, which reflects the characteristics and advantages of the TCM therapy, and meets the requirement of the developing effect assessment of modern medicine in cancer treatment. It is suggested that the treatment effect should be the sum of quality adjusted life years (QALYs) (equal to QOL multiplied by time of survival), syndrome remission rate and tumor remission rate. But the proportion of each of the three is variable, which has close relationships with the different tumor stages and corresponding treatments.