| 引用本文:周岱翰1 林丽珠1 田华琴2 吴万垠3 贾英杰4 张军一5 刘魁凤6 邓 力7 胡作为8 徐天舒9 谢 强10 邓运宗11 林 清12 谢德荣13 王树堂1.益气化痰法为主中医药治疗方案对老年非小细胞肺癌中位生存期的影响：一项多中心、前瞻性临床队列研究[J].世界中医药,2014,9(07):. |
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| 益气化痰法为主中医药治疗方案对老年非小细胞肺癌中位生存期的影响：一项多中心、前瞻性临床队列研究 |
| Effect on the survival of elderly patients with non-small cell lung cancer treated by the tradiotional Chinese medicine treatment based on Yiqi Huatan method ：a multicenter，clinically prospective cohort study |
| 投稿时间：2014-06-19 |
| DOI：10.3969/j.issn.1673-7202.2014.07.003 |
| 中文关键词: 中医药治疗 益气除痰法 非小细胞肺癌 临床队列研究 |
| English Keywords:Elderly Non-Small Cell Lung Cancer Yiqi Chutan method Traditional Chinese Medicine Chemotherapy |
| 基金项目:国家科技部“十一·五”科技支撑计划重大疾病项目（“老年非小细胞肺癌的中医药综合治疗方案研究”，编号：2006BAI04A05-3）资助 |
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| 目的：观察以益气化痰法为主的中医综合治疗方案在延长III、IV期老年非小细胞肺癌（NSCLC）生存期中的作用，建立老年晚期非小细胞肺癌的中医药综合治疗方案。方法：采用多中心、临床前瞻性队列研究的临床研究方法，以Ⅲ、Ⅳ期老年NSCLC患者作为研究对象，采用益气除痰法为主治疗，针药并用，辨病与辨证相结合治疗，用K-M法分析中位疾病进展时间、中位生存期，并按既往接受过抗肿瘤治疗与否及不同病理类型等进行分层分析。结果：共纳入合格病例315例，其中中医队列完成纳入167例，化疗队列148例。采用K-M法进行生存分析，中医队列、化疗队列中位生存期分别为385 d、305 d（P=0.331）；中位TTP分别为114.0 d、116.5 d（P=0.452）。进一步分层分析表明，对于初治患者中医队列、化疗队列中位生存期分别为291 d、331 d（P=0.308），对于复治患者分别为477 d、264 d（P=0.025）；对于鳞癌患者中医队列、化疗队列中位生存期分别为267 d、389 d（P=0.042），腺癌患者分别为428 d、234 d（P=0.150），其他肺癌患者分别为287 d、146 d（P=0.050）。结论：益气化痰法为主的中医药综合治疗在延长III、IV期老年NSCLC的中位生存期与控制肿瘤进展方面，均与化疗作用相当，对于老年晚期非小细胞肺癌患者是一种有效替代治疗方案。分层分析提示对于复治患者和非鳞癌患者，中医药治疗有可能较化疗具有更好的疗效，值得进一步研究。 |
| English Summary: |
| This prospective cohort study is to observe the effects of the tradiotional Chinese medicine treatment based on Yiqi Chutan method in prolonging survival time of elderly patients with advanced stage non-small cell lung cancer(NSCLC)，to search a regimen for old NSCLC.Methods：A prospective cohort study was carried out in 13 clinical centers.315 cases of eldly patients （PS≤2）with III/IV stage of NSCLC were enrolled into two group according to the treatment the patients acceived，that is，Study Group I(TCM) was treated with Chinese herbal decoction based on Yiqi Chutan method，Study Group II(chemotherapy) with chemotherapy.Data analyses were performed using SPSS for windows Ver16.0 software.Long-term therapeutic effect was analyzed by Kaplan-Meier statistical method.Results：With a median follow-up of 16 months after treatment，the median survival(MST) was 385 days in Group I，305 days in Group II（P=0.331）.The median TTP of Group II or I was 114 days and 116.5 days respectively（P=0.452）.For those without chemotherapy before enrolment，the MST was 477 days vs 264 days（P=0.308）.While for those with chemotherapy before enrolment，the MST was 477 days and 264 days respectively（P=0.025）.Stratified analysis showed that for patients with squamous cell carcinoma，adenocarcinoma or other pathological type，the MST was 267 days vs 389 days（P=0.042），428 days vs 234 days（P=0.150） and 287 days vs 146 days （P=0.050） respectively.Conclusion：The tradiotional Chinese medicine treatment based on Yiqi Chutan method is an effective alternative treatment options for elderly patients with III/IV stage of stage NSCLC，the effect of which in prolonging survival time is equal to or more better than that of chemotherapy.The tradiotional Chinese medicine treatment may be bemore helpful than chemotherapy as a better survival advantage according to Stratified analysis，which conclusions need longer follow-up time and further studies. |
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