不同疗程地塞米松联合阿瑞匹坦、托烷司琼预防蒽环类药物引起乳腺癌患者恶心及呕吐的临床研究

Clinical study of different courses of dexamethasone combined with aprepitantand tropisetron in the prevention of nausea and vomiting in breast cancer patients induced by anthracycline drugs

目的:探讨不同疗程的地塞米松联合5-HT3受体拮抗剂和NK-1受体拮抗剂对预防乳腺癌患者接受蒽环类药物和环磷酰胺化疗方案(AC或EC)引起高度恶心呕吐(CINV)的疗效。方法:采用前瞻性研究方法选择2018年1月1日-2018年6月30日接收AC或EC的乳腺癌患者84例,随机分为对照组48例(第1~3天受地塞米松10 mg),观察组36例(第1天接受地塞米松10 mg)。在整个研究期间通过患者研究日志记录其对治疗的反应。主要研究终点为完全缓解率(CR),次要研究终点包括急性期CR、延迟期CR;完全控制率(CC)、急性期CC、延迟期CC,以及这种止吐治疗的安全性。结果:2组患者均接受6个化疗周期,且其一般临床资料均无显著性学差异。观察组与对照组急性期及延迟期CINV的CR分别是(94.4%vs 87.5%,P>0.05),(88.9%vs 91.7%,P>0.05);CINV的总CR为(80.6%vs 81.3%,P>0.05);观察组与对照组急性期及延迟期CINV的CC分别是(55.6%vs 60.4%,P>0.05),(63.9%vs 68.8%,P>0.05);CINV的总CR为(47.2%vs 54.2%,P>0.05);且各组间无显著性差异。治疗期间2组不良反应均为轻度,观察组头痛,关节酸痛的发生率(8.3%)稍低于对照组(14.6%),有显著性差异(P<0.05);便秘及皮疹的发生率无显著性差异。且期间未出现与止吐方案相关的严重不良反应。结论:阿瑞匹坦及托烷司琼联合地塞米松(第1天)的预防性止吐作用可实现与地塞米松(第1~3天)相似的疗效,特别是对于延迟性化疗相关性恶心呕吐疗效更佳,且安全性更好,值得临床推广。

OBJECTIVE To investigate the efficacy of different courses of dexamethasone combined with 5-HT3 receptor antagonists and NK-1 receptor antagonists in preventing high-grade nausea and vomiting(CINV) caused by anthracycline and cyclophosphamide chemotherapy regimens(AC or EC) in breast cancer patients.METHODS A prospective study was conducted in 84 patients with breast cancer who received AC or EC on June 30, 2018. The patients were randomly divided into control group(n=48) treated with dexamethasone 10 mg on Day 1-3 and observation group(n=36) treated with dexamethasone 10 mg on Day 1.Their response to treatment was recorded throughout the study via patient study diary.The primary study endpoint was complete response(CR), and secondary study endpoints included acute CR, delayed CR;complete control(CC), acute CC, delayed CC, and the safety of this antiemetic therapy. RESULTS Patients in both groups received 6 cycles of chemotherapy, and their general clinical data showed no statistically significant difference. The CR of CINV in acute phase and delayed phase in control group was(94.4% vs 87.5%, P>0.05),(88.9% vs 91.7%, P>0.05);the total CR of CINV was(80.6% vs 81.3%, P>0.05);the CC of CINV in acute phase and delayed phase in control group was(55.6% vs 60.4%, P>0.05),(63.9% vs 68.8%, P>0.05);the total CR of CINV was(47.2% vs 54.2%, P>0.05);and there was no statistical difference between the groups. During the treatment, the adverse reactions in the two groups were mild. The incidence rate of headache and arthralgia in the observation group(8.3%) was slightly lower than that in the control group(14.6%), with statistical significance(P<0.05);there was no statistical significance in the incidence rate of constipation and rash.There were no serious adverse reactions related to the antiemetic regimen during this period. CONCLUSION The preventive antiemetic effects of aprepitant and tropisetron combined with dexamethasone(Day 1) can be similar to dexamethasone(Days 1-3), especially for delayed chemotherapy-associated nausea and vomiting with better efficacy and safety, which is worthy of clinical promotion.