通络活血法外用治疗化疗性手足综合征临床研究  

External Use of Tongluo Huoxue Treatment in Hand-Foot Syndrome Caused by Capecitabine:A Clinical Study

作　　者：娄彦妮[1] 陈信义[2] 田爱平[3] 张侠[4] 冯利[5] 谭煌英[1] 朱世杰[1] 刘猛[1] 贾立群[1] 

机构地区：[1]卫生部中日友好医院,北京100029 [2]北京中医药大学东直门医院,北京100700 [3]中国医学科学院肿瘤医院,北京100021 [4]北京军区总医院,北京100700 [5]中国中医研究院望京医院,北京100102

出　　处：《辽宁中医药大学学报》2013年第4期68-70,共3页Journal of Liaoning University of Traditional Chinese Medicine

基　　金："十一五"国家科技支撑计划资助项目(2008BAI53B023)

摘　　要：目的:观察通络活血法外用治疗化疗性手足综合征的临床疗效和安全性。方法:选取卡培他滨化疗后出现手足综合征不良反应者为观察对象,2:1随机分为试验组与对照组,纳入患者共102例,分别给予通络活血法或安慰剂外用(洗/浸),温浴(35～38℃),20 min/次,每日2次,连用7天为1个观察周期。结果:手足综合征分级的疗效总有效率试验组与对照组分别为87.88%、20.59%,试验组治疗起效时间为(3.80±0.20)天;疼痛缓解有效率试验组与对照组分别为90.91%、41.18%,治疗前后的NRS评分试验组为5.89±1.97和2.12±2.20、对照组为5.91±1.76和4.88±2.38;组间差异有统计学意义。结论:通络活血法外用能够减轻化疗性手足综合征的疼痛程度、有效降低分级、改善患者的生活质量,且安全性良好。Objective： The randomized trial was designed to evaluate the efficacy and safety of the external use of Tongluo Huoxue treatment, versus placebo for hand-foot syndrome （ HFS ） caused by chemotherapy. Methods ： Eligible patients （ pts ） with HFS grade 〉~ 1 （ NCI-CTCAE v3.0 ） after capecitabine therapy were selected. Pts were randomly assigned 2 ： 1 to receive external compound Chinese herbal extract （ Arm 1 ） versus placebo （ Arm 2 ）. Pts soaked their hands and feet in Chinese herbal extract or placebo lotion for 20 minutes, twice a day for 7 days. Resuhs ： 102 pts from 4 centers were enrolled. Arms were well balanced. In Arm 1/Arm 2, total response rate for HFS Grade was 87.88%/20.59%. The average time from therapy beginning to pain relieves in Arm 1 was 3.80 ＋ 0.20 days. Total response rate for pain was 90.91%/41.18%, the mean score of pain measurement （ NRS scale of 0-10 ）before and after treatment were 5.89 ＋ 1.97 and 2.12 ＋ 2.20 in Arm 1,5.91 ＋ 1.76 and 4.88 ＋ 2.38 in Arm 2. Conclusions ： The external use of Tongluo Huoxue treatment can treat HFS, which is especially effective for relieving pain and improving QoL of pts, and it is easily used and safe.

关 键 词：中医外治 卡培他滨 手足综合征 通络活血法 

分 类 号：R269[医药卫生—中西医结合]