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外用复方丹参颗粒治疗靶向抗癌治疗所致皮肤毒性的疗效:一项随机、双盲、安慰剂对照试验。

Efficacy of Topical Compound Danxiong Granules for Treatment of Dermatologic Toxicities Induced by Targeted Anticancer Therapy: A Randomized, Double-Blind, Placebo-Controlled Trial.

作者信息

Tian Aiping, Zhou Aiping, Bi Xinyu, Hu Shangying, Jiang Zhichao, Zhang Wen, Huang Zhen, Shi Hongzhe, Yang Boyan, Chen Wei

机构信息

Department of Traditional Chinese Medicine, National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.

Department of Medical Oncology, National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.

出版信息

Evid Based Complement Alternat Med. 2017;2017:3970601. doi: 10.1155/2017/3970601. Epub 2017 Aug 6.

Abstract

Dermatologic toxicities resulting in dose reduction or discontinuation of treatment pose challenges for targeted anticancer therapies. We conducted this randomized, double-blind, placebo-controlled trial to investigate the efficacy of topical application of Compound Danxiong Granules (CDG) for treatment of dermatologic toxicities associated with targeted anticancer therapies. One hundred and ten patients with dermatologic toxicities induced by targeted anticancer therapies were randomly assigned to CDG or placebo group. Each crude herb ( Andr., L., and ) was prepared as an instant herbal powder. Application of the CDG via topical washes lasted 20 minutes, twice daily, for 10 days. The primary outcome was the total effective rate, defined as reduction in at least one grade of skin toxicity. The total effective rate was 77.61% (52/67) in the CDG group and 27.27% (9/33) in the placebo group ( < 0.0001). Compared to the placebo treatment, CDG treatment achieved a higher total effective rate for hand-foot skin reaction (95.45% versus 27.27%), acneiform eruption (69.23% versus 30.78%), and paronychia (68.42% versus 22.22%). Topical application of CDG can effectively attenuate dermatologic toxicities induced by targeted anticancer therapies. The effect of CDG was more pronounced in hand-foot skin reaction.

摘要

导致剂量减少或治疗中断的皮肤毒性给靶向抗癌治疗带来了挑战。我们开展了这项随机、双盲、安慰剂对照试验,以研究外用复方丹参颗粒(CDG)治疗与靶向抗癌治疗相关的皮肤毒性的疗效。110例由靶向抗癌治疗引起皮肤毒性的患者被随机分配至CDG组或安慰剂组。每种生药(丹参、黄芪和)制成速溶草药粉。通过局部冲洗应用CDG持续20分钟,每日两次,共10天。主要结局为总有效率,定义为皮肤毒性至少降低一个等级。CDG组总有效率为77.61%(52/67),安慰剂组为27.27%(9/33)(P<0.0001)。与安慰剂治疗相比,CDG治疗对手足皮肤反应(95.45%对27.27%)、痤疮样皮疹(69.23%对30.78%)和甲沟炎(68.42%对22.22%)的总有效率更高。外用CDG可有效减轻靶向抗癌治疗引起的皮肤毒性。CDG在手足皮肤反应中的效果更显著。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6fe/5563417/86b3e5b61de3/ECAM2017-3970601.001.jpg

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