中医外治化疗性周围神经病变的多中心、随机、双盲、对照临床研究  

Randomized, multi-center, double-blinded, controlled clinical trial of external treatment of TCM on peripheral neuropathy caused by chemotherapy

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

机构地区：[1]中日友好医院,北京100029 [2]中国医学科学院肿瘤医院,北京100021 [3]北京军区总医院,北京100700 [4]中国中医科学院望京医院,北京100102

出　　处：《中华中医药杂志》2014年第8期2682-2685,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家"十一五"科技支撑计划项目(No.2008BAI53B023);国家"十二五"科技支撑计划项目(No.2012BAJ18B05)~~

摘　　要：目的:观察温经通络法外用治疗化疗性周围神经病变(CIPN)的临床疗效和安全性。方法:选取奥沙利铂化疗后出现CIPN不良反应者102例,按2∶1随机分为试验组68例与对照组34例,分别给予温经通络法外用治疗或安慰剂外用(洗/浸),温浴(35-40℃),20min/次,每日2次,连用7d为1个观察周期。结果:试验组与对照组治疗前后的数字评估法(NRS)评分试验组为(5.16±1.95)分和(2.40±2.40)分,对照组为(5.24±1.86)分和(4.35±2.39)分,组间差异有统计学意义(P<0.01);疼痛缓解有效率试验组与对照组分别为85.07%、44.12%,差异有统计学意义(P<0.05)。周围神经毒性分级的疗效总有效率试验组与对照组分别为75.00%、35.29%,差异有统计学意义(P<0.01)。治疗起效时间试验组和对照组分别为(4.49±0.25)d和(4.44±0.18)d。结论:温经通络法外用能够减轻CIPN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： To observe the clinical efficacy and safety of the external use of Wenjing Tongluo treatment for peripheral neuropathy caused by chemotherapy. Methods： 102 patients with peripheral neuropathy after oxaliplatin therapy were selected. The patients were randomly divided into the trial group （68 cases） and control group （34 cases） by assigned 2 ： 1. The two groups were given external use of Wenjing Tongluo treatment and placebo respectively, warm bath （35-40℃）, 20minutes once time, 2 times a day, 7 days as an observation period. Results： The NRS was used to evaluate the effects before and after treatment, the scores of NRS in trial group were respectively （5.16±1.95） and （2.40±2.40） before and after treatment, while the scores of NRS were （5.24±1.86） and （4.35±2.39） in control group. The differences in two groups had statistical significance （P〈0.01）. The effective rate of pain relief was 85.07% in trial group while 44.12% in control group. The differences in two groups had statistical significance （P〈0.05）. The total effective rate of peripheral neurotoxicity systematics was 75.0% in trial group while 35.29% in control group. The differences in two groups had statistical significance （P〈0.01）. The onset time of treatment in trial group and control group were （4.49±0.25） days and （4.44±0.18） days. Conclusion： The external use of Wenjing Tongluo treatment could reduce the pain of peripheral neurotoxicity induced by chemotherapy, which effectively reduced the systematics, improved the quality of life, with good safety.

关 键 词：中医外治 周围神经毒性 温经通络法 

分 类 号：R273[医药卫生—中西医结合]