| Purpose:To evaluate the objectivity and comprehensiveness of "Oncologic Curative Effect Evaluation Criteria of Chinese Medicine in Solid Tumor(draft)" (hereinafter referred to as "the draft"),which is applied to the advanced malignant tumor,and to validate the applicability of "the draft" in curative effect evaluation of Chinese medicine treatment to advanced non-small cell Lung Cancer.Methods:Using retrospective clinical research methods,collect a total of 104 cases of non-small cell lung cancer atⅢ～Ⅳstages,of which 53 cases are in Chinese medicine group,51 cases in Western medicine group,collect tumor size, clinical symptoms,KPS scoring,survival time and other curative effect targets,adopt "the draft" criteria[the total curative effect(100%)=tumor size(30%)+clinical symptoms(15%)+physical condition(15%)+survival time(40%),scoring 75～100 into excellence,50～74 into utility,25～49 into stabilization,＜25 into inefficacy]and response evaluation criteria in solid tumor(RECIST)to the two groups,analyze and compare the different results of the two criteria applied in appraisaling curative effect,then evaluate the objectivity and comprehensiveness of "the draft" in curative effect evaluation of Chinese medicine treatment to advanced non-small cell Lung Cancer.Results: ①In regard of the size of the tumor,according to RECIST,the tumor effective rate,stable rate of the Chinese Medicine group were 1.89%and 71.70%,while Western medicine group were 17.65%and 72.55%.The difference of the tumor effective rates between the two groups was significant(P＜0.05),but the tumor stable rates showed no significant difference(P＞0.05).②In regard of clinical symptoms,it showed no significant difference between the two groups in alleviating cough,hemoptysis,chest pain,fever and shortness of breath(P＞0.05),but the symptoms of fatigue was markedly improved in the Chinese medicine group,showing very significant difference(P＜0.01).③The KPS scoring,the effective rate and stable rate were 50.94%and 88.68% in the Chinese medicine group,while 23.53%and 52.83%in the Western medicine group.The differences of both effective rate and stable rate were very significant between the two groups(P＜0.01).④The status of survival,the median survival time of the Chinese medicine group was 8.0±1.2 months,and six months survival rate,one-year survival rate,two-year survival rate were 60.38%,24.53%,3.77%,while the median survival time of the Western medicine group was 5.9±0.4months,six months survival rate,one-year survival rate,two-year survival rate were 41.18%, 15.69%,1.96%.⑤According to "the draft",the total effective rate and stable rate of the Chinese group were 39.62%and 88.68%,while 29.41%and 80.39%in the Western medicine group.Both the total effective rate and stable rate of the Chinese group were slightly higher than those of the Western medicine group,but there was no significant difference(P＞0.05).⑥Comparing the curative effect evaluation results of the two criteria,by RECIST,there was 1 case of complete response(CR),9 cases of partial response (PR),65 cases of stable disease(SD),29 cases of progressive disease(PD) in a total of 104 cases,the total effective rate(ORR)and stable rate(OSD) were 9.62%and 72.12%;according to "the draft",the comprehensive curative effect of 104 cases was:4 markedly effective cases,32 effective cases,52 stable cases and 16 invalid cases,the total effective rate and stable rate were 34.62%and 84.62%.The curative effect evaluation results of the two criteria were very significantly different(P＜0.01).⑦Consistency of the curative effect evaluation results of the two criteria: Kappa valued 0.237,P＜0.01,showing that there was consistency between the two evaluation results,which was however,not ideal.Conclusion:①Adopting "the draft" criteria to evaluating curative effect of Chinese medicine treatment to advanced non-small cell lung cancer,the result can better reflect Chinese medicine therapy's curative effect characteristics and advantages which improve the quality of life,stable the tumor and prolong survival time.②Compared with the RECIST,"the draft" in curative effect evaluation of Chinese medicine treatment to advanced non-small cell Lung Cancer was more objective and comprehensive;③"the draft" is applicable to evaluate curative effect of Chinese medicine treatment to advanced non-small cell Lung,and its Clinical application can be proposed after gradual improvement.
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