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中药外治转移性乳腺癌患者化疗手足综合征的临床研究

Study on External Chinese Medicine Treating Capecitabine-Induced hand-foot Syndrome in Metastatic Breast Cancer

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【作者】 娄彦妮贾立群张明霞谭煌英朱世杰

【Author】 LOU Yanni,JIA Liqun,ZHANG Mingxia,TAN Huangying,ZHU Shijie (Department of TCM Oncology,China-Japan Friendship Hospital,Beijing 100029,China)

【机构】 卫生部中日友好医院中医肿瘤科

【摘要】 背景随着卡培他滨在转移性乳腺癌中的广泛应用,其常见不良反应手足综合征已引起人们重视。严重的手足综合征可引起剧烈疼痛,影响患者生活质量并可能造成治疗中断或永久性停药,目前尚缺乏明确有效的治疗方法。目的观察中药外用治疗化疗致手足综合征的临床疗效和安全性。方法选取使用卡培他滨化疗后出现2级以上手足综合征不良反应的转移性乳腺癌患者为观察对象,采用中药外用(洗/浸),连用7天为1个观察周期。疗效评价方法:参照NCI常见毒性分级标准比较治疗前、后的症状和体征,用药后降至0级为治愈、较用药前下降1级以上为有效、无改善为无效,并采用FACT-B(V4.0)生活质量问卷评估患者治疗前、后生活质量。结果入组42例患者中,手足综合征1级8例,2级19例,3级15例,治疗有效率83.3%(35/42)、其中治愈率38.1%(16/42),疼痛缓解的平均起效时间为1.8±0.8天。FACT-B(V4.0)生活质量评分在治疗前后分别为(77.24±25.69)和(109.17±20.53),(P<0.01)。所有患者中未观察到皮肤过敏等副反应。结论中药外用可有效治疗卡培他滨致手足综合征,能够迅速减轻疼痛、提高患者生活质量,且使用安全。

【Abstract】 Background:With the capecitabine being increasingly used in the treatment of metastatic breast cancer(MBC),the common side effect of capecitabine,hand-foot syndrome (HFS) has become a main problem which can distress both physicians and patients.Severe HFS such as severe pain can have a negative impact on quality of life (QOL) of these patients and cause reduced dosage or even stopping chemotherapy.No effective treatment for HFS can be available at present.Objective:To evaluate the efficacy and safety of external use of Chinese herbs in patients with MBC and HSF.Methods:Eligible patients includes patients with MBC,who had HFS (NCI-CTC grade ≥1) after receiving single capecitabine chemotherapy(1250 mg/m2,PO,twice daily,cycled days 1-14,every 21 days).The patients soaked their feet and hands in the Chinese herbal lotion for 20 minutes,twice daily for 7 days.Evaluation criteria,CR as symptom disappearing completely,PR as NCI-CTC grade for HFS decreasing by more than 1 level after treatment,the total response rate as CR+PR.The QOL of these patients were also evaluated before and after treatment using a FACT-B questionnaire (Version 4.0-Chinese).Results:42 patients(pts) have been enrolled in this study.Grade 1 for HFS was seen in 8 pts,G2 in 19 pts and G3 in 15 pts.The total response rate was 83.3%(35/42),CR 38.1%(16/42),PR45.2%(19/42).The average time from therapy to pain relieve was 1.8±0.8 days,The QOL scores before and after treatment were 77.24±25.69 and 109.17±20.53,respectively (P<0.01).No side effects such as skin allergies related to the treatment was found in this study.Conclusions:In the treatment of capecitabine-induced HFS,the external Chinese medicine is fast effective for relieving pain,and it has the features of easy use and no skin allergies.Thus it can improve the QOL of patients with MBC and HFS.

【基金】 “十一五”国家科技支撑计划中医临床研究课题,编号:2008BAI53B023
  • 【会议录名称】 自主创新与持续增长第十一届中国科协年会论文集(3)
  • 【会议名称】自主创新与持续增长第十一届中国科协年会
  • 【会议时间】2009-09-08
  • 【会议地点】中国重庆
  • 【分类号】R273
  • 【主办单位】中国科学技术协会、重庆市人民政府
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