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中医肿瘤疗效评价标准在晚期非小细胞肺癌的应用           
中医肿瘤疗效评价标准在晚期非小细胞肺癌的应用

【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);中医组乏力症状明显改善,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。

【关键词】  肺肿瘤/中药疗法;非小细胞肺癌/中药疗法;评价研究

  Abstract:ObjectiveTo 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).MethodsA 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).ResultsThe 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) month

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