附桂管食通颗粒提高晚期食管癌生存率临床研究
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R735.1

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国家中医药百千万人才支持计划-岐黄学者(国中医药人教涵〔2018〕284号);全国名老中医药专家传承工作室建设项目(国中医药 人教函〔2022〕75号);国家中医临床研究基地科研专项(2019JDZX001,2019JDZX028)


Clinical Study on Fugui Guanshitong Granules Improving Survival Rates of Patients with Advanced Esophageal Cancer
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    摘要:

    目的:研究附桂管食通颗粒对脾肾阳虚、顽痰痼血型晚期食管癌患者治疗后42 d 生存率、T 细胞 亚群、食管癌相关肿瘤标志物的影响。方法:纳入9 个中心共120 例患者,利用区组随机法分为试验1 组、试 验2 组、对照组各40 例。试验1 组给予附桂管食通颗粒合丁香管食通含化丸;试验2 组给予丁香管食通含化 丸;对照组给予当归补血汤合桂枝人参汤颗粒,疗程为42 d。比较3 组治疗42 d 后的生存率、T 细胞亚 群(CD3+、CD4+、CD8+) 及癌胚抗原(CEA)、鳞状上皮细胞癌抗原(SCCA),并进行安全性评价。结果:试 验1 组生存率88.6%、试验2 组生存率86.8%、对照组生存率72.2%,3 组比较,差异无统计学意义(P> 0.05)。治疗后,3 组CD4+、CD8+、CEA 在时间上差异均有统计学意义(P<0.05),组间差异无统计学意 义(P>0.05)。3 组CD3+、SCCA 在组间和时间上差异均无统计学意义(P>0.05)。结论:附桂管食通颗粒可 一定程度提高晚期食管癌患者生存率,并提高机体免疫功能。

    Abstract:

    Abstract: Objective: To study the effect of Fugui Guanshitong Granules on survival rates, T lymphocytes and tumor markers related to esophageal cancer in patients with advanced esophageal cancer of spleen-kidney yang deficiency and lingering phlegm and obstinate blood type in 42 days after treatment. Methods:A total of 120 cases of patients from nine centers were included and divided into the trial group 1,the trial group 2 and the control group according to the block randomization method,with 40 cases in each group. The trial group 1 was treated with Fugui Guanshitong Granules and Dingxiang Guanshitong Hanhua Pills;the trial group 2 was treated with Dingxiang Guanshitong Hanhua Pills;the control group was treated with Danggui Buxue Decoction and Guizhi Renshen Decoction Granules. All the groups were treated for 42 days. The survival rates,T lymphocytes (CD3 +,CD4 +,CD8 + ),carcinoembryonic antigen (CEA), and squamous cell carcinoma antigen (SCCA) in the three groups were compared after 42 days of treatment,and the safety was evaluated. Results:The survival rate was 88.6% in the trial group 1,86.8% in the trial group 2,and 72.2% in the control group,there was no significant difference among the three goups (P>0.05). After treatment, the differences of CD4 + , CD8 + , and CEA in the three groups were significant in time (P<0.05), but there was no significant difference in the comparison among the three groups (P>0.05). There was no significant difference in CD3 + and SCCA among the three groups or the comparison of time (P>0.05). Conclusion: Fugui Guanshitong Granules for patients with advanced esophageal cancer can improve their survival rates and immune function.

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郑玉玲,陈建设,马纯政,许彦超,陈晓琦,林建州,李军赛,贺文龙,仝新朵,秦善文,张丽菡.附桂管食通颗粒提高晚期食管癌生存率临床研究[J].新中医,2023,55(18):124-130

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  • 在线发布日期: 2023-09-22
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