1、8Clinical Research,Mar.2023,Vol.31 No.03基金项目：2021 年度山东省医学会临床科研资金(齐鲁专项)(YXH2022ZX02116)。作者简介：李京烨，男，副主任医师，本科。研究方向：恶性肿瘤诊治方面。*通讯作者：马德亮，副主任医师，。Stroke Scale,modified Rankin Scale,and modified Thrombolysis in Cerebral Infarction as autonomy predictive tools for stroke patientsJ.Rev Neurosci,2019,30(7):701-
2、708.17NAVIA P,SCHRAMM P,FIEHLER J.ADAPT technique in ischemic stroke treatment of M2 middle cerebral artery occlusions in comparison to M1 occlusions:post hoc analysis of the PROMISE studyJ.Interv Neuroradiol,2020,26(2):178-186.论著白蛋白结合型紫杉醇联合替吉奥胶囊一线治疗晚期胰腺癌的疗效及安全性分析李京烨1，许进荣2，马德亮1*(1.临沂市中心医院 肿瘤内科，山东 临沂
3、 276400；2.临沂市中心医院 老年医学科，山东 临沂 276400)摘要：目的 观察评价白蛋白结合型紫杉醇联合替吉奥胶囊一线治疗晚期胰腺癌的临床疗效及安全性，为临床治疗该病提供参考依据。方法 按照纳入排除标准选择 2021 年 10 月至 2022 年 10 月于临沂市中心医院住院的 83 例晚期胰腺癌患者为研究对象，将其随机分为观察组(N=41)和对照组(N=42)。对照组采用替吉奥单药治疗，观察组则在此基础上给予患者白蛋白结合型紫杉醇治疗，比较两组临床治疗效果、生存状况、毒副反应发生情况及生活质量。结果 治疗后，两组均无完全缓解患者，观察组治疗有效率为 58.54%，疾病控制率为 7
4、8.05%，对照组治疗有效率为33.33%，疾病控制率为 64.29%，差异有统计学意义(P 0.05)。观察组患者的生存期为(10.740.38)个月，中位生存期为(10.920.45)个月，对照组患者生存期为(7.420.15)个月，中位生存期为(7.650.24)个月，差异有统计学意义(P 0.05)。观察组发生白细胞减少、中性粒细胞减少及血小板减少患者多于对照组，发生呕吐和腹泻的患者少于对照组，但两组所有毒副反应发生率比较差异无统计学意义(P 0.05)。观察组患者生活质量量表(QLQ-C30)各项条目的得分高于对照组差异有统计学意义(P 0.05)。结论 晚期胰腺癌患者在替吉奥的基础
5、上应用白蛋白结合型紫杉醇一线治疗晚期的临床疗效优于单独使用替吉奥，证明其可有效提高治疗有效率和疾病控制率，改善患者的生存状态。但该治疗方法存在一定的毒副反应，临床应加强监测，预防毒副反应的发生，提高患者的生活质量。关键词：胰腺癌；紫杉醇；替吉奥；骨髓抑制；生存期中图分类号：R735.9文献标志码：A DOI：10.12385/j.issn.2096-1278(2023)03-0008-04Efficacy and safety of albumin-bound paclitaxel combined with Tijio capsule in first-line treatment of a
6、dvanced pancreatic cancerLI Jingye1,XU Jinrong2,MA Deliang1*(1.Department of medical oncology,Linyi Central Hospital,Linyi Shandong 276400,China;2.Department of Geriatrics,Linyi Central Hospital,Linyi Shandong 276400,China)Abstract:Objective To observe and evaluate the clinical efficacy and safety o
7、f albumin-bound paclitaxel combined with Tijio capsule in the first-line treatment of advanced pancreatic cancer,and to provide a reference for the clinical treatment of this disease.Methods According to the inclusion and exclusion criteria,83 patients with advanced pancreatic cancer admitted to Lin
8、yi Central Hospital from October 2021 to October 2022 were selected as subjects,and randomly divided into an observation group(N=41)and a control group(N=42).The control group was treated with Tijio monotherapy,and the observation group was treated with albumin-binding paclitaxel on this basis.The c
9、linical efficacy,survival status,occurrence of toxic and side effects,and quality of life of the two groups were compared.Results After treatment,there was no complete remission in both group.The effective rate was 58.54%and the disease control rate was 78.05%in the observation group,and the effecti
10、ve rate was 33.33%and the disease control rate was 64.29%in the control group,with statistical significance(P 0.05).The survival time of patients in the observation group was(10.740.38)months,the median survival time was(10.920.45)months,the survival time of patients in the control group was(7.420.1
11、5)months,the median survival time(was 7.650.24)months,the difference was statistically significant(P 0.05).The incidence of leukopenia,neutropenia,and thrombocytopenia in the observation group was more than that in the control group,and the incidence of vomiting and diarrhea was less than that in th
12、e control group,but there was no statistical significance in the incidence of all toxic and side effects between the two groups(P 0.05).The scores of all items of the quality of life questionnaire core 30(QLQ-C30)in the observation group were higher than those in the control group,and the difference
13、 was statistically significant(P 0.05).Conclusion The clinical efficacy of Tijio combined with albumin-bound paclitaxel in the first-line treatment of advanced pancreatic cancer is better than that of Tijio alone,which proves that Tijio can effectively improve the treatment effective rate and diseas
14、e control rate,and improve the survival status of patients.However,this treatment method has certain toxic and side effects.Clinical monitoring should be strengthened to prevent the occurrence of toxic and side effects and improve the quality of life of patients.Key Words:pancreatic cancer;paclitaxe
15、l;Tijio;myelosuppression;survival period胰腺癌是消化系统常见的恶性肿瘤，恶性程度极高1。患者以 40 岁以上人群居多，且男性多于女性2。在全球范围内，胰腺癌的死亡率、发病率均呈升高趋势，其中我国胰腺癌的发病率和死亡率也在逐年升高3。9临床研究 2023 年 03 月第 31 卷第 03 期2019 年我国国家癌症中心调查显示，胰腺癌位发病率在恶性肿瘤排第 10 位，死亡率居第 6 位2。在男性和女性肿瘤相关死亡中居第 6 和 7 位。胰腺癌具有起病隐匿、进展快的特点，一旦发现多为晚期，已无法进行手术治疗，患者预后较差3。目前，胰腺癌患者的 5 年生存率约
16、为 2.0%，生存时间约为 6 个月4-5。对于晚期胰腺癌，大部分学者6-7推荐的主要治疗方法多为姑息性治疗，具体方案以化疗为主。目前临床常用的化疗药物主要有替吉奥胶囊、吉西他滨、伊利替康、白蛋白结合型紫杉醇、奥沙利铂等。其中吉西他滨是晚期胰腺的标准一线化疗药物，但疗效有限，且老年人难以耐受其副作用8。有研究显示9，含白蛋白结合型紫杉醇方案可显著改善晚期胰腺癌患者的生存期。同时，有学者指出10-11，胰腺癌应用白蛋白结合型紫杉醇治疗时多与其他化疗药物联合使用，其中常见是联合替吉奥胶囊。但目前关于白蛋白结合型紫杉醇联合替吉奥治疗晚期胰腺癌的安全性尚存在争议5,7,9。为此，本课题组选择临沂市中心医院近年收治的晚期胰腺癌开展研究，旨在观察并评估白蛋白结合型紫杉醇联合替吉奥胶囊一线治疗晚期胰腺癌的临床疗效及安全性，现报道如下。1资料与方法1.1临床资料分 析 2021 年 10 月 至 2022 年 10 月 临 沂 市 中 心 医院诊治的老年晚期胰腺癌患者 83 例，将根据入院顺序编号，按随机数字法分为观察组(41 例)和对照组(42例)。观 察 组 男 28 例，女 13 例；患 者 年