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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
【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。
【Abstract】 Objective: To observe the clinical ei cacy 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℃), 20 minutes once time, 2 times a day, 7 days as an observation period. Results: The NRS was used to evaluate the ef ects 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 dif erences in two groups had statistical signii cance(P<0.01). The ef ective rate of pain relief was 85.07% in trial group while 44.12% in control group. The dif erences in two groups had statistical signii cance(P<0.05). The total ef ective rate of peripheral neurotoxicity systematics was 75.0% in trial group while 35.29% in control group. The dif erences in two groups had statistical signii cance(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 ef ectively reduced the systematics, improved the quality of life, with good safety.
【Key words】 External treatment of TCM; Peripheral neurotoxicity; Wenjing Tongluo treatment;
- 【文献出处】 中华中医药杂志 ,China Journal of Traditional Chinese Medicine and Pharmacy , 编辑部邮箱 ,2014年08期
- 【分类号】R273
- 【被引频次】63
- 【下载频次】816