右雷佐生注射剂预防蒽环类药物引起乳腺癌患者心脏毒性的临床研究  

Clinical trial of dexrazoxane injection in preventing anthracycline induced cardiotoxicity in breast cancer patients

作　　者：虞敏晶[1] 杨荣华[1] YU Min-jing;YANG Rong-hua(Department of Breast Surgery,Changzhou Fourth People's Hospital,Changzhou 213000,Jiangsu Province,China)

机构地区：[1]常州市第四人民医院乳腺外科,江苏常州213000

出　　处：《中国临床药理学杂志》2022年第7期627-630,共4页The Chinese Journal of Clinical Pharmacology

基　　金：江苏省研究生科研与实践创新计划基金资助项目(KYCX191243)。

摘　　要：目的观察右雷佐生注射剂预防蒽环类药物引起乳腺癌患者心脏毒性的效果.方法将102例患者按随机数表法分为对照组51例和试验组51例.试验组首先给予右雷佐生(右雷佐生与表柔比星的剂量比为10:1),在30 min内静脉滴注完毕.30 min后,2组患者均给予600 mg·m^(-2)环磷酰胺,静脉滴注,第1天+90 mg·m^(-2)表柔比星,静脉滴注,第1天.2组患者均治疗4个周期,每个周期21 d.比较2组患者的心功能情况,心脏不良事件和药物不良反应的发生情况.结果试验期间有2例患者脱落.治疗后,试验组和对照组的肌钙蛋白T分别为(4.85±0.83)和(6.48±0.94)μg·L^(-1),左心室射血分数分别为(55.93±5.68)%和(49.89±6.35)%,总心脏不良事件发生率分别为10.00%和26.00%,差异均有统计学意义(均P<0.05).试验组的药物不良反应主要有消化道反应、脱发、皮疹、白细胞降低、血小板减少和口腔黏膜炎,对照组的药物不良反应主要有消化道反应、皮疹、白细胞降低、脱发、血小板减少、口腔黏膜炎和肝功能异常.试验组和对照组的总药物不良反应发生率分别为30.00%和40.00%,差异无统计学意义(P>0.05).结论右雷佐生注射剂可预防蒽环类药物引起的心脏毒性,减轻心脏损伤,且安全性良好.Objective To observe the effect of dexrazoxane injection in preventing anthracycline induced cardiotoxicity in breast cancer patients.Methods A total of 102 patients were divided into control group and treatment group according to the random number table,51 cases in each group.The treatment group was given dexrazoxane(the dose ratio of dexrazoxane to epirubicin was 10∶1),and the intravenous infusion was completed within 30 minutes.Thirty minutes later,both groups were given an intravenous infusion of 600 mg·m^(-2)cyclophosphamide on the first day and an intravenous infusion of 90 mg·m^(-2)epirubicin on the first day.Patients in both groups were treated for 4 cycles,each cycle was 21 days.The cardiac function,the occurrence of adverse cardiac events and adverse drug reactions of the two groups of patients were compared.Results During the trial,2 patients fell off.After treatment,the troponin T of the treatment and control groups was(4.85±0.83)and(6.48±0.94)μg·L^(-1),the left ventricular ejection fraction(LVEF)was(55.93±5.68)%and(49.89±6.35)%,the total incidences of adverse cardiac events were 10.00%and 26.00%,the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were digestive tract reactions,hair loss,skin rash,leukopenia,thrombocytopenia and oral mucositis,which in control group were digestive tract reactions,skin rash,leukopenia,alopecia,thrombocytopenia,oral mucositis and abnormal liver function.The total incidences of adverse drug reaction rates in treatment and control groups were 30.00%and 40.00%without significant difference(P>0.05).Conclusion Dexrazoxane injection can prevent cardiotoxicity caused by anthracyclines,reduce heart damage,and has good safety.

关 键 词：右雷佐生注射剂 乳腺癌 心脏毒性 安全性评价 

分 类 号：R97[医药卫生—药品]