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| 复方斑蝥胶囊预防 III期结直肠癌患者术后复发转移的多中心临床研究 |
| 郑佳彬,王应天,关靓,李冰雪,李奇,林洪生,侯炜,刘杰,刘云鹏,张瑞明,刘牧林,田峰 |
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| 中国中医科学院广安门医院 北京 100053;中国医科大学附属第一医院 沈阳 110001;四川大学华西医院 成都 610041;蚌埠医学院第一附属医院 蚌埠 233004;北京天创明达医药科技有限公司 北京 100190 |
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| 摘要: |
| 目的:研究复方斑蝥胶囊预防Ⅲ期结直肠癌患者术后复发转移的安全性与有效性。方法:采用多中心随机双盲安慰剂对照的临床研究方法，将 141例Ⅲ期结直肠癌术后完成辅助化疗 4个周期以上患者分为观察组 68例，对照组 73例，观察组予以复方斑蝥胶囊口服，对照组予以安慰剂口服。干预 6个月后，评价两组复发转移情况，临床症状、生存质量及安全性。结果:中位随访 36.5个月，观察组 8例(11.8%)、对照组 15例(20.6%)发生复发转移。观察组的 2年无病生存率为 95%，高于对照组的 82%(HR=0.24，95%CI 0.07～ 0.85，P=0.02)；与对照组相比，观察组总生活质量评分、疲乏、疼痛、气促明显改善。观察期间两组不良反应事件无明显差异，且均无严重不良反应发生。结论:复方斑蝥胶囊可延长Ⅲ期结直肠癌术后完成辅助化疗 4个周期以上患者的两年无病生存率，改善症状，提高生存质量。 |
| 关键词: 复方斑蝥胶囊 结直肠癌 术后复发转移 随机对照试验 |
| DOI：10.3969/j.issn.1007-6948.2020.01.007 |
| 投稿时间：2018-01-18 |
| 基金项目:国家自然基金面上项目:基于中医伏毒理论的扶正祛毒方对肿瘤干细胞依赖于 TF表达及 TF/FV Ⅱ a信号通路而促(QLQ-C 30 )进肿瘤转移的干预研究( 81273947)；中医药治疗晚期结直肠癌疗效与安全性评价 (SW2016-18) |
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| Prevention of Recurrence and Metastasis of Stage III Colorectal Cancer by Compound Cantharis Capsule: A Multicenter Clinical Study |
| ZHENG Jia-bin,WANG Ying-tian,GUAN Liang |
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| Abstract: |
| Objective To investigate the efficacy and safety of Compound Cantharis Capsule (CCC) on disease free survival (DFS) in curatively resected stage III colorectal cancer (CRC) patients. Methods Totally 141 curatively resected stage III CRC patients who completed adjuvant chemotherapy for more than 4 cycles were divided into observation group (68 cases) and control group (73 cases). The patients in observation group were orally given CCC, and the patients in control group were given placebo. After 6 months of intervention, the recurrence and metastasis, clinical symptoms, quality of life (QOL) and safety of the two groups were evaluated. Results After a median follow-up of 36.5 months, 8 patients (11.8%) in observation group and 15 cases (20.6%) in control group had relapse and metastasis events. The 2-year DFS was signi.cantly improved in the observation group (95%) compared with the control group (82%) (HR=0.24, 95%CI 0.07-0.85, P=0.02). Compared to the control group, patients in the observation group reported significantly greater improvement in global health status (P<0.0001), fatigue (P=0.002), pain (P=0.0003), and shortness of breath (P=0.005) as assessed by the European Organization for Research and Treatment of Cancer QOL questionnaire. There is no statistical difference in adverse events (AEs) between two groups, and no severe AEs (grade>=3) were observed in either group(P>0.05). Conclusions This study showed preliminary evidence of ef.cacy and safety that CCC could improve 2-year DFS and QOL for curatively resected stage III CRC patients who have completed 4 or more cycles of adjuvant chemotherapy. Further study should be conducted to con.rm the ef.cacy and safety on long term intervention and overall survival. |
| Key words: Compound cantharis capsule colorectal cancer postoperative recurrence and metastasis randomized controlled trial. |
