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听众
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发表于 2017-3-20 14:53:51
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第三个:
研究类型:
观察性研究
Study type:
Observational study
研究所处阶段:
回顾性研究
Study phase:
Retrospective study
研究目的:
(一)通过队列研究的方法,在晚期结直肠癌患者中,比较中西医治疗队列与西医治疗队列的生存结局,明确中西医结合治疗晚期结直肠癌的优势。 (二)初步筛选出与晚期结直肠癌患者预后有关的临床危险因子及有利因素,并结合与中医辨证、中医干预时间等因素,分析诸因素与预后的关系以及各因素间的交互作用,初步筛选出中医治疗晚期结直肠癌优势人群特征,为后续扩大样本量进行前瞻性研究验证工作及进一步制定中医治疗晚期结直肠癌优势人群模型奠定基础。
Objectives of Study:
(1) Cohort study of patients with metastatic colorectal cancer(mCRC), compared with the survival outcomes of combination of Traditional Chinese and Western Medicine treatment group and Western medicine treatment group, clear advantages of combination of Traditional Chinese and Western Medicine treatment of mCRC; (2) Combined with TCM syndrome differentiation, TCM intervention time and other factors, preliminary screening of clinical risk factors and favorable factors in the prognosis of patients with mCRC, analyse the relationship between factors and prognosis and the interaction between the factors, in order to screen out the superiority of Chinese medicine in the treatment of advanced colorectal cancer.
研究设计:
队列研究
Study design:
Cohort study
纳入标准:
(1)病理诊断明确、至少有一代测序包含KRAS、NRAS、BRAF其中一项基因状态的IV期结直肠癌患者;(2)卡氏评分≥70分;(3)年龄≥18岁
Inclusion criteria
(1) stage IV colorectal cancer patients with a genetic status of KRAS, NRAS, and BRAF were identified with a definite pathological diagnosis; (2) Karnofsky score more than 70 points; (3) 18 years of age or older.
排除标准:
(1)患者合并严重的心、肝、肺、肾等导致脏器功能不全的疾病;(2)完全性肠梗阻患者,或因各种原因不能口服药物者;(3)既往或合并其他恶性肿瘤病史,已治愈的皮肤基底细胞癌和宫颈原位癌除外;(4)患者信息严重缺失,影响疗效及安全性评价。
Exclusion criteria:
(1) patients with severe heart, liver, lung, kidney and other organs dysfunction caused by disease; (2) patients with complete intestinal obstruction, or those who cannot be taken orally for various reasons; (3) prior to or after the history of other malignancies, except for basal cell carcinoma and cervical carcinoma in situ; (4) patients with serious information loss, the impact of efficacy and safety evaluation.
研究实施时间:
Study execute time:
从From2017-01-28至To 2017-04-30
干预措施:
Interventions:
组别:
中西医组
样本量:
110
Group:
Traditional Chinese medicine and Western medicine group
Sample size:
干预措施:
中西医
干预措施代码:
Intervention:
Traditional Chinese medicine and Western medicine
Intervention code:
组别:
西医组
样本量:
225
Group:
Western medicine group
Sample size:
干预措施:
西医
干预措施代码:
Intervention:
Western medicine
Intervention code: |
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