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中医外治化疗性手足痛的多中心、随机、对照临床研究 被引量:10

TCM external treatment for chemotherapy-induced hand-foot pain: a multi-center randomized controlled trial
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摘要 目的观察温经通络活血法外用治疗化疗性手足痛的临床疗效和安全性。方法选取化疗后出现手足痛不良反应者204例,包括奥沙利铂致周围神经毒性和卡培他滨致手足综合征各102例,按2:1随机分为试验组136例与对照组68例,分别给予温经通络活血法或安慰剂外用(洗/浸),温浴(35~40℃),20 min/次,每日2次,连用7天为1个观察周期。结果治疗前后的数字疼痛分级法(NRS)评分试验组为(5.51±1.99)和(2.20±2.20)分,对照组为(5.57±1.82)和(4.50±2.44)分,治疗后2组差异有统计学意义(P<0.01);疼痛缓解有效率试验组与对照组分别为88.06%、42.65%,差异有统计学意义(P<0.05)。手足痛分级的疗效总有效率试验组与对照组分别为81.34%、26.47%,差异有统计学意义(P<0.01)。试验组治疗起效时间为(4.10±0.22)天。结论温经通络活血法外用能减轻化疗性手足痛的疼痛程度,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 external application of warming-channel, dredging-collaterals and activating blood method on chemotherapy-induced hand-foot pain. Methods Two hundred and four patients with adverse reaction of hand-foot pain after chemotherapy were selected, including oxaliplatin-induced peripheral neurotoxicity(n=102) and capecitabine-induced hand-foot syndrome (n=102), which were randomly divided into a treatment group(n=136) and a control group (n=68) with the ratio of 2:1. The warming-channel, dredging-collaterals and activating-blood method and placebo were respectively applied for external use (washing or soaking), and warm bath (35~40~C), 20 min each time, twice each day and continuous seven days were taken as one observation period. Results The scores of numerical rating scales (NRS) before and after treatment were (5.51 + 1.99) and (2.20 + 2.20) in the treatment group while (5.57 ~ 1.82) and (4.50 ~ 2.44) in the control group, which had significant differences (P 〈 0.01); the effective rate of pain relief was 88.06 % in the treatment group and 42.65 % in the control group, respectively, which had significant differences (P 〈 0.05). The total effective rate of hand-foot pain grading was 81.34 % in the treatment group and 26.47 % in the control group, respectively, which had significant differences (P 〈 0.01). The onset time was (4.10 ± 0.22) days in the treatment group. Conclusion The external treatment of warming-channel, dredging-collaterals and activating-blood method can relieve the pain degree of chemotherapy-induced hand-foot pain, decrease the grading effectively, and improve the life quality of patients with favorable safety.
出处 《北京中医药》 2013年第4期261-265,共5页 Beijing Journal of Traditional Chinese Medicine
基金 国家"十一五"科技支撑计划资助项目(2008BAI53B023)
关键词 中医外治 周围神经毒性 手足综合征 温经通络活血法 TCM external treatment peripheral neurotoxicity hand-foot syndrome warming-channel, dredging-collaterals and activating-blood method
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参考文献11

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二级参考文献19

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