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

External Application of Shouzuning Decoction in the Treatment of Grade 3 Hand-foot Skin Reaction Caused by Apatinib

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。

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.