摘要
[目的]探讨《实体瘤的中医肿瘤疗效评定（草案）》（简称《草案》）在中医药治疗晚期非小细胞肺癌（NSCLC）疗效评价应用中的客观性和全面性。[方法]采用回顾性临床对照研究方法，收集Ⅲ～Ⅳ期NSCLC病例共104例，其中中医组53例，西医组51例，同时采用《草案》和实体瘤疗效评价标准（RECIST）对2组进行疗效评定，分析、比较两种不同标准评定的结果。[结果]（1）按照《草案》标准，中医组瘤体缓解有效率明显低于西医组（P〈0．05），瘤体稳定率2组无显著性差异（P〉0．05）；中医纽乏力症状明显改善，疗效优于西医组（P〈0．01）；中医组卡氏评分疗效显著优于西医组（P〈0．01）；总疗效方面，中医组总有效率、总稳定率略高于西医组，但无显著性差异（P〉0．05）。（2）生存情况方面，中医组中位生存期为（8．0±1．2）个月，半年、1年、2年生存率分别为60．38％、24．53％、3．77％，西医组中位生存期为（5．9±0．4）个月，半年、1年、2年生存率分别为41．18％、15．69％、1．96％。（3）两种标准评定结果，按照RECIST标准总有效率为9．62％，总稳定率为72．12％；按照《草案》标准总有效率为34．62％，总稳定率为84．62％，两种标准评定结果比较，差异有显著性意义（P〈0．01）。两种标准评定结果的一致性分析表明其评价结果存在一致性，但一致程度不够理想。[结论]以《草案》标准评价中医药治疗晚期NSCLC疗效，其结果能较好地反映中医疗效特点和优势，较之RECIST标准更为客观和全面，建议逐步完善后在临床推广应用。
Objective To investigate the objectivity and comprehensiveness of Response Evaluation Criteria of Traditional Chinese Medicine for Solid Tumor （REC-TCM-ST） in the therapeutic effect evaluation of Chinese medicine for late non-small-cell lung cancer （NSCLC）. Methods A retrospective study was carried out in 104 NSCLC patients in the stages of Ⅲ - Ⅳ. Of 104 patients, 53 received traditional Chinese medicine （TCM group） , and 51 received western medicine （WM group）. The therapeutic effect in the two groups was evaluated with both REC-TCM-ST and Response Evaluation Criteria in Solid Tumor （RECIST）. Results The REC-TCM-ST evaluation results showed that the effective rate on relieving tumor mass in TCM group was lower than that in WM group （P 〈 0. 05 ）, the difference of tumor-mass stable rate was insignificant between the two groups （ P 〉 0. 05 ） ; the symptom of weakness was much relieved, and effect on Karnofsky score was good in TCM group as compared with that in WM group （P 〈 0. 01 ）. The total effective rate and total stable rate in TCM group were a littler higher than those in WM group, but the difference was insignificant （ P 〉 0. 05 ）. As for the survival patients, TCM group had a median survival period of （8.0 ± 1.2 ） months, and survival rates for half a year, one year and two years were 60. 38% , 24.53% and 3.77% respectively; WM group had a median survival period of （5.9 ±0. 4） months, and survival rates for half a year, one year and two years were 41.18%, 15.69% and 1.96% respectively. The RECIST evaluation results showed that the total effective rate and the total stable rate were 9.62% and 72. 12% respectively, while were 34.62% and 84.62% respectively when evaluated with REC-TCM- ST, the difference being significant （ P 〈 0. 01 ）. There has certain consistency between the evaluation result of REC-TCM-ST and that of RECIST, but the degree of consistency was not satisfactory. Conclusion Therapeutic effect evaluation of TCM for late NSCLC with REC-TCM-ST can show the effectiveness of TCM more objectively and comprehensively than RECIST, and REC-TCM-ST is worth of further improvement and expansion in clinic.
出处
《广州中医药大学学报》
CAS
2009年第2期108-112,共5页
Journal of Guangzhou University of Traditional Chinese Medicine
关键词
肺肿瘤/中药疗法
非小细胞肺癌/中药疗法
评价研究
LUNG NEOPLASMS/TCD therapy
CARCINOMA, NON-SMALL-CELL LUNG/TCD therapy
EVALUATION STUDIES
