中药手足宁方外用治疗阿帕替尼所致3级手足皮肤反应的临床研究

作者	单位
陈佳露,邵田娱,张瑶,寿柳梅,舒琦瑾	1.浙江中医药大学第一临床医学院（杭州 310053）；2.浙江中医药大学附属第一医院肿瘤科（杭州 310003）

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中文摘要:

目的探讨中药手足宁方外用治疗阿帕替尼所致3级手足皮肤反应（HFSR）的临床疗效。方法本研究采用前瞻性、自身前后对照的临床试验方法，将纳入的50例患者在维持原阿帕替尼治疗强度不变的基础上，予手足宁方浸泡治疗1~2个疗程。观察治疗有效率、平均降级时间、疼痛评分（NRS）、手足生活质量评分（HF-QoLS）、血清血管内皮生长因子A（VEGF-A）表达水平及不良反应。结果 50例患者脱落5例，最终45例纳入统计分析。手足宁方有效率为84.4%（38/45），治疗后HFSR降至2级的平均时间为（4.00 ± 1.14）天，降至1级的平均时间为（9.20 ± 2.12）天；初治患者的有效率、平均降级时间与经治患者比较，差异均无统计学意义（P>0.05）。用手足宁方治疗有效患者NRS、HF-QoLS、血清VEGF-A表达水平较治疗前均显著降低（P<0.01）；无效患者NRS、HF-QoLS、血清VEGF-A表达水平与治疗前比较，差异无统计学意义（P>0.05）。结论中药手足宁方外用治疗阿帕替尼所致3级HFSR具有良好的临床疗效，可降低HFSR分级，有效缓解疼痛，改善生活质量。

英文摘要:

Objective To study the clinical efficacy of Shouzuning Decoction （SZND） in the treatment of apatinib-associated grade 3 hand-foot skin reaction （HFSR）. Methods This study adopted a prospective， self-controlled clinical trial method. A total 50 patients were included in this trial and received SZND treatment for 1-2 courses， while Apatinib dosage was kept constantly throughout this study. The effective rate， average HFSR grade reduction time， pain intensity （numerical rating scale， NRS）， hand-foot quality of life scale （HF-QoLS）， serum vascular endothelial growth factor A （VEGF-A） levels， and adverse reactions were observed. Results Totally 5 cases dropped and 45 cases were included in statistical analysis. The response rate of the SZND treatment was 84.4% （38/45 cases）. The average time from grade 3 to grade 2 was （4.00 ± 1.14） days， and the average time from grade 3 to grade 1 was （9.20 ± 2.12） days. There were no significant differences in the effective rate and average degradation time between newly treated patients and treated patients （P>0.05）. The NRS score， HF-QoLS score， and the expression levels of serum VEGF-A decreased significantly after SND treatment only in effective patients （P<0.01）， but there were no significant differences in these aspects of ineffective patients （P>0.05）. Conclusion The external application of SZND showed good clinical efficacy in the treatment of apatinib induced grade 3 HFSR， lowered HFSR grading， effectively alleviated pain， improved quality of life.

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