• 主管部门:
  • 中国科学院
  • 主办单位:
  • 中科院科技战略咨询研究院
  • 出版单位:
  • 世界科学技术杂志社
    科学出版社
  • 主编:
  • 陈凯先
  • 执行主编:
  • 胡镜清 陈士林 叶阳
  • 副主编:
  • (按姓氏笔划排列)王 伟 王 阶 王拥军 王喜军 孔令义 吕文亮 孙晓波 李 萍 李志刚 张卫东 陈立典 果德安 罗国安 赵军宁 徐宏喜 高秀梅 唐旭东 梁繁荣 葛金文
  • 名誉社长:
  • 徐伟宣
  • 社长:
  • 张志华
  • 编辑部主任:
  • 王 瑀
  • 编辑部:
  • 张娜娜 马雅静 方垚 王涵 何岸波 郭嫦娥
  • 责任译审:
  • 王晶
  • 国际刊号:
  • 1674-3849
  • 国内刊号:
  • 11-5699/R
  • 社址:
  • 北京市海淀区北四环西路4号中关村人才苑青年人才公寓4单元412房间
  • 邮编:
  • 100190
  • 电话:
  • 010-62616352
  • 网址:
  • www.wst.ac.cn
  • E-mail:
  • wst@casipm.ac.cn
  • 海外发行号:
  • M1644
  • 邮刊代号:
  • 2-534

加味黄芪桂枝五物配方颗粒防治奥沙利铂神经毒性多中心、随机、双盲、对照临床研究
Effects of Prevention and Treatment from Modified Huangqi Guizhi Wuwu Formula Granules on OIPN : A Multicenter, Randomized, Double-blind, Controlled Clinical Study
投稿时间:2019-04-24  修订日期:2019-04-24
DOI:
中文关键词:  加味黄芪桂枝五物配方颗粒,奥沙利铂,周围神经毒性,肠癌
英文关键词:Modified Huangqi Guizhi Wuwu Formula Granules, Oxaliplatin, peripheral neuropathy, intestinal cancer
基金项目:江苏省中医药局面上项目(NO.YB2015035):基于TRPs通道探讨当归四逆汤对奥沙利铂神经毒性作用的研究,负责人:霍介格;江苏省卫生厅(No:BRA2015493):益气温经复方中药对OXIN作用的临床研究,项目负责人:霍介格;江苏省常熟市科技局(No:CS201811),黄芪桂枝五物颗粒缓解奥沙利铂相关周围神经毒性的临床研究,主持人:陆屸
作者单位E-mail
马骏 南京中医药大学附属淮安中医院肿瘤科 rainyjun@126.com 
魏国利 南京中医药大学附属中西医结合医院  
朱梁军 江苏省肿瘤医院  
陆屸 常熟市第一人民医院  
李丹 南京中医药大学  
封革 南京市江北人民医院  
陈姗姗 上海市杨浦区市东医院  
许春明 南通市肿瘤医院  
胡镜清 中国中医科学院中医基础理论研究所  
霍介格 南京中医药大学附属中西医结合医院 huojiege@jsatcm.com 
摘要点击次数: 25
全文下载次数: 0
中文摘要:
      目的:本研究遵循多中心、随机、双盲、对照的原则,初步探索性观察加味黄芪桂枝五物配方颗粒对防治OIPN的临床疗效。方法:共计划入组60例肠癌根治术后辅助化疗患者,分为试验组和对照组,各30例。对照组采用mFOLFOX6、XELOX化疗方案作为基础治疗,并在化疗第1天起加用安慰剂(中药模拟剂)口服,每天1剂,分早晚两次口服。试验组在对照组化疗基础上加用加味黄芪桂枝五物配方颗粒口服,每天1剂,分早晚两次口服,直至化疗结束,共6个月。每一个月测定所有患者EORTC QLQ-CIPN20评分、KPS评分及EORTC QLQ-C30评分。在第1、4个月及治疗结束时进行肌电图测定,观察疗效。结果:①共入组60例患者,完成56例,脱落4例,余患者全部按计划完成研究,对照组与试验组各28例;②在生活质量评价方
英文摘要:
      Objective Following the principle of multi-center, randomized, double-blind and control, this study preliminarily explored the clinical efficacy of Modified Huangqi Guizhi Wuwu Formula Granules in the prevention and treatment of OIPN. Methods A total of 60 patients with intestinal cancer undergoing adjuvant chemotherapy after radical resection were divided into experimental group and control group, with 30 cases in each group. The control group was treated with mFOLFOX6 and XELOX as basic therapy, placebo (the simulator of traditional Chinese medicine) was administered orally on the first day of chemotherapy, 1 dose per day, twice a day. The experimental group was given Modified Huangqi Guizhi Wuwu Formula Granules for orally on the basis of chemotherapy in the control group, 1 dose per day, twice a day, until the end of chemotherapy, a total of 6 months. EORTC QLQ-CIPN20 scores, KPS scores and EORTC QLQ-C30 scores were measured every month. The EMG were determined at the first months, fourth months and the end of treatments. Results ①A total of 60 patients were enrolled in the group, 56 patients completed, 4 patients dropped off, the rest of the patients were completed the study as planned, 28 in the control group and 28 in the experimental group. ②In terms of quality of life evaluation, there were statistical differences in KPS scores and overall health scores of EORTC QLQ-C30 at 4, 5, 6 months and the end(P<0.05). The pain and fatigue dimensions in EORTC QLQ-C30 scores were better in the experimental group than in the control group from the 5th month to the end, with statistical significance(P<0.05).③In terms of CIPN20 scores, the difference between the two groups was more and more obvious from the 4th month to the end, with statistical significance(P<0.05).④In terms of EMG, in the fourth month, there were significant differences in latency, amplitude of right median nerve and amplitude of right posterior tibial nerve of motor nerve, and also significant differences in latency, amplitude, conduction velocity of right median nerve and amplitude of right ulnar nerve, amplitude of right posterior tibial nerve of sensory nerve between the two groups at the fourth month(P<0.05). At the end of the experiment, whether sensory or motor nerves, the degree of latency prolongation, amplitude reduction and conduction velocity reduction in the experimental group were better than those in the control group. ⑤There was no significant difference in liver and kidney function, routine blood test and cardiogram between the two groups (P>0.05), and also no progress of tumors was found in imaging examination. Conclusions Modified Huangqi Guizhi Wuwu Formula Granules can alleviate pain and fatigue symptoms caused by chemotherapy, alleviate OIPN symptoms, improve physical function of patients, overall health status and quality of life and enhance patients'tolerance to OIPN and delay the occurrence of chronic pain. Modified Huangqi Guizhi Wuwu Formula Granules can prevent and treat OIPN, reduce the extent of latency prolongation, amplitude reduction and slowdown of nerve conduction velocity, whether in upper limbs or lower limbs, sensory nerves or motor nerves. It has no obvious toxicity and side effects, and does not lead a progression of tumors. It is a safe and reliable drug for the prevention and treatment of OIPN.
  查看/发表评论  下载PDF阅读器
关闭