康莱特软胶囊联合吉西他滨方案用于一线老年晚期胰腺癌的疗效  

Efficacy of Kanglaite Soft Capsules plus gemcitabine regimen vs gemcitabine alone in first-line chemotherapy among elderly patients with advanced pancreatic cancer

作　　者：孙玮[1] 崔灵芝[1] 张丽皎[1] Sun Wei;Cui Lingzhi;Zhang Lijiao(Department of Targeted Therapy,Shanxi Provincial Cancer Hospital,Shanxi Hospital Affliated to Cancer Hospital,Chinese Academy of Medical Sciences,Cancer Hospital Affiliated to Shanxi Medical University,Taiyuan,Shanxi 030013,China)

机构地区：[1]山西省肿瘤医院、中国医学科学院肿瘤医院山西医院、山西医科大学附属肿瘤医院肿瘤分子靶向治疗病区,山西太原030013

出　　处：《中国药物与临床》2023年第4期243-246,共4页Chinese Remedies & Clinics

摘　　要：目的观察康莱特软胶囊在一线老年晚期胰腺癌的治疗作用。方法将2013年1月至2018年8月在山西省肿瘤医院肿瘤分子靶向治疗病区收治的晚期胰腺癌患者45例纳入研究,按治疗意愿非随机入组试验组及对照组,试验组22例,用康莱特软胶囊(每次2.7 g,每天4次),联合吉西他滨方案,吉西他滨1000 g/m^(2),每3周1个周期,每4周重复;对照组23例单纯给予吉西他滨化疗。疗效评价采用螺旋CT或磁共振成像(MRI)观察病灶大小,按实体瘤疗效评价标准RECIST 1.1版评价疗效,分为完全缓解(CR)、部分缓解(PR)、稳定(SD)和进展(PD)。以CR+PR计算有效率(RR),CR+PR+SD为疾病控制率(DCR)。一般状态运用Karnofsky功能状态评分(KPS)。根据CD3+、CD4+值评价患者的免疫功能。不良反应按世界卫生组织(WHO)1998年标准,分为0~4度。结果试验组:CR 3例,PR 7例,客观缓解率(ORR)为46%(10/22),DCR 68%(15/22),无进展生存时间(PFS)≥3个月为59%(13/22);对照组:CR 1例,PR 1例,ORR为9%(2/23),DCR 26%(6/23),PFS≥3个月35%(8/23);2组疗效差异有统计学意义(P<0.05)。试验组不良作用较对照组明显减轻,且试验组治疗前后CD3+明显升高,CD4+降低,差异有统计学意义(P<0.05)。结论康莱特软胶囊配合化疗治疗老年胰腺癌有增效作用。Objective To investigate the therapeutic efficacy of Kanglaite Soft Capsulesas part of firstline treatment in elderly patients with advanced pancreatic cancer.Methods A total of 45 patients with advanced pancreatic cancer admitted to the targeted therapy wards of Shanxi Provincial Cancer Hospital between January 2013 and August 2018 were included in the study.According to their intention to treat,the patients were assigned to the study group and the control group in a non-randomized manner.The study group(n=22)received Kanglaite Soft Capsules(2.7 g,four times daily)plus gemcitabine regimen chemotherapy(1000 g/m^(2))given in 3-week cycle and repeated every 4 weeks.The control group(n=23)was given chemotherapy on gemcitabine regimen alone.Spiral CT or MRI was performed to follow up on the size of lesions.The therapeutic efficacy was evaluated according to the Response Evaluation Criteria in Solid Tumor(RECIST 1.1 edition),and classified as complete remission(CR),partial remission(PR),stable disease(SD)and progressive disease(PD).The response rate(RR)was calculated as the rate of CR+PR,and the disease control rate(DCR)as the rate of CR+PR+SD.Performance status was assessed by the Karnofsky(KPS)score.The immune function of the patients was evaluated according to the CD3+and CD4+levels.Adverse reactions were classified as grades 04 according to WHO criteria(1998).Results In the study group,there were 3 cases of CR and 7 of PR,corresponding to an objective response rate(ORR)of 46%(10/22),a DCR of 68%(15/22),and a≥3 month progression-free survival(PFS)of59%(13/22).In the control group,there were 1 case of CR and 1 of PR,corresponding to an ORR of 8.7%(2/23),a DCR of 26%(6/23),and a≥3 month PFS of 35%(8/23).There was a statistically significant difference in therapeutic efficacy between the two groups(P<0.05).Compared with the control group,the study group showed significantly less toxic and side effects,and elevated immune function(P<0.05).Conclusion Kanglaite Soft Capsules added on chemotherapy leads to efficacy sy

关 键 词：胰腺 管癌 康莱特注射液 疗效比较研究 

分 类 号：R735.9[医药卫生—肿瘤]