格拉司琼透皮贴片在接受高致吐化疗女性乳腺癌患者中的疗效和安全性  

Efficacy and safety of the granisetron transdermal delivery system in female breast cancer patients receiving highly emetogenic chemotherapy

作　　者：曹恩颖 张剑[1] Cao Enying;Zhang Jian(Department of Medical Oncology,Fudan University Shanghai Cancer Center,Department of Oncology,Shanghai Medical College,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属肿瘤医院Ⅰ期临床试验病房,复旦大学上海医学院肿瘤学系,上海200032

出　　处：《肿瘤综合治疗电子杂志》2025年第1期102-107,共6页Journal of Multidisciplinary Cancer Management(Electronic Version)

基　　金：国家自然科学基金面上项目(82072915)。

摘　　要：目的探究格拉司琼透皮贴片(granisetron transdermal delivery system,GTDS)在接受高致吐化疗(highly emeto-genic chemotherapy,HEC)女性乳腺癌患者中的有效性和安全性。方法前瞻性选取2021年9月至2023年8月复旦大学附属肿瘤医院收治的100例使用GTDS防治恶心呕吐的女性乳腺癌患者作为研究对象,所有患者均接受HEC治疗,分析患者1个治疗周期GTDS防治恶心呕吐的情况和不良事件。主要疗效观察指标为延迟期(化疗开始后24~168 h)患者恶心呕吐达到完全缓解(completeresponse,CR)的比例。次要疗效观察指标包括急性期(化疗开始后0~<24h)和全程(化疗开始后0~168h)患者恶心呕吐达到CR的比例,急性期、延迟期和全程患者恶心呕吐达到完全控制(complete control,CC)的比例。采用Logistic回归模型进行风险差异计算,分析影响GTDS防治恶心呕吐CR的危险因素。结果延迟期有83.0%的患者达到恶心呕吐CR,65%的患者恶心呕吐达到CC。在急性期,CR率为92.0%,CC率为90.0%。整个治疗期间,CR率为81.0%,CC率为65.0%。此外,逐日CR率保持平稳,第1~7天的CR率均>90%,逐日CC率在第1~7天也>80%。单因素Logistic回归分析显示,年龄≤50岁、美国东部肿瘤协作组体力状态评分0分、有晕动症病史、有高血压病、有糖尿病、有手术史和化疗方案(蒽环类药物与环磷酰胺的联合方案)均是影响GTDS防治恶心呕吐CR的风险因素(均P<0.05)。进一步行多因素Logistic回归分析显示,以上因素均非影响GTDS治疗CR的独立危险因素(均P>0.05)。治疗过程中不良事件发生率为48.0%,常见的不良事件主要为乏力、便秘和头晕,但未报告严重不良事件。结论GTDS可有效预防女性乳腺癌患者接受HEC引起的恶心呕吐,且安全性较高。Objective To explore the efficacy and safety of the granisetron transdermal delivery system(GTDS)in female breast cancer patients receiving highly emetogenic chemotherapy(HEC).Method From September 2021 to August 2023,100 female breast cancer patients who used GTDS to prevent and treat nausea and vomiting in Fudan University Shanghai Cancer Center were prospectively selected as the research subjects.All patients underwent HEC,and the situation and adverse events of GTDS in preventing and treating nausea and vomiting in one treatment cycle were analyzed.The main efficacy observation index was the proportion of patients with nausea and vomiting reaching complete response(CR)in the delayed phase(24-168 hours after the start of chemotherapy).The secondary efficacy observation indicators included the proportion of patients with nausea and vomiting reaching CR in the acute phase(0-<24 hours after the start of chemotherapy)and the whole course(0-168 hours after the start of chemotherapy),and the proportion of patients with nausea and vomiting reaching complete control(CC)in the acute phase,delayed phase and whole course.Logistic regression model was used to calculate the risk difference and analyze the risk factors affecting the CR rate of GTDS in the prevention and treatment of nausea and vomiting.Result In the delayed phase,83.0%of patients achieved nausea and vomiting CR,and 65%of patients achieved nausea and vomiting CC.In the acute phase,the CR rate was 92.0%and CC was 90.0%.During the whole treatment period,the CR rate was 81.0%and the CC rate was 65.0%.In addition,the daily CR rate remained stable,with a CR rate of 90%from day 1 to day 7,and the daily CC rate exceeded 80%from day 1 to day 7.Univariate Logistic regression analysis showed that age≤50 years old,Eastern Cooperative Oncology Group physical status score was 0,history of motion sickness,history of hypertension,history of diabetes mellitus,history of surgery and chemotherapy regimen(anthracycline and cyclophosphamide combined regimen)were all risk fact

关 键 词：乳腺癌 格拉司琼透皮贴片 高致吐化疗 不良事件 

分 类 号：R73[医药卫生—肿瘤]