重组改构人肿瘤坏死因子治疗恶性腹腔积液的多中心临床研究  

A multicenter clinical study of recombinant mutant human tumor necrosis factor in treating malignant peritoneal effusion

作　　者：鲍扬漪[1] 顾康生[2] 庞东生[3] 程先平 杨维春[5] 史清明 孟水平[7] 朱爱萍[8] 曾永蕾[9] 

机构地区：[1]合肥市第一人民医院肿瘤科,安徽230061 [2]安徽医科大学第一附属医院肿瘤科,安徽合肥230022 [3]海军安庆医院肿瘤科,安徽安庆246004 [4]安徽省第二人民医院肿瘤科,合肥230041 [5]淮南朝阳医院肿瘤科,安徽232007 [6]安徽省胸科医院肿瘤科,合肥230022 [7]安徽省肿瘤医院肿瘤科,合肥230001 [8]安庆市第一人民医院肿瘤科,安徽246004 [9]安徽中医药大学第二附属医院肿瘤科,安徽合肥230061

出　　处：《现代医药卫生》2018年第1期15-17,共3页Journal of Modern Medicine & Health

摘　　要：目的观察重组改构人肿瘤坏死因子(rmh TNF)治疗恶性腹腔积液的疗效和安全性。方法选取2013年5月至2015年5月安徽省抗癌协会临床肿瘤协作专业委员会9个临床研究中心收治的经病理检查确诊为恶性肿瘤伴腹腔积液患者38例,于第1、4、7、10天分别经腹腔引流的中心静脉导管注入rmh TNF 300万单位,腹腔注入药物3次以上者评估疗效和不良反应。结果 38例患者平均腹腔注射药物(3.68±0.85)次,完全缓解(CR)5例,部分缓解(PR)13例,稳定(SD)17例,进展(PD)3例,客观缓解率(ORR)为47.37%(18/38);38例患者中初治12例,CR 3例,PR 3例,SD 1例,PD 5例,ORR为50.00%(6/12);复治26例,CR 2例,PR 10例,SD 12例,PD 2例,ORR为46.15%(12/26);初治患者治疗后的SD例数明显少于复治患者,差异有统计学意义(χ~2=9.600,P=0.002)。38例患者中腹腔注入rmh TNF前给予吲哚美辛栓100 mg纳肛预处理23例,未给予预处理15例;38例患者中低于38.5℃发热4例(10.53%),乏力2例(5.26%),未发生腹腔感染、腹痛、低血压、电解质紊乱等;未观察到白细胞和血小板减少。结论腹腔注入rmh TNF治疗恶性腹腔积液疗效满意,不良反应轻微,值得临床进一步推广应用。Objective To observe the efficacy and safety of recombinant mutant human tumor necrosis factor(rmh TNF)in the treatment of malignant peritoneal effusion.Methods Thirty-eight patients with malignant tumor complicating peritoneal effusion definitely diagnosed by pathologic examination in 9 clinical study centers of the Clinical Tumor Collaboration Specialized Committee of Anhui Provincial Anti-Cancer Association from May 2013 to May 2015 were selected.Three million units of rmh TNF were injected by the central venous catheter in peritoneal drainage on 1,4,7 10 d respectively.The efficacy and adverse reactions in the patients with drugs peritoneal injection more than 3 times were evaluated.Results All the 38 patients were treated with average(3.68 ±0.85)times of intraperitoneal injection,5 cases were complete remission(CR),13 cases were partial remission(PR),17 cases were stable disease(SD),3 cases were progress disease(PD),the objective remission rate(ORR)was 47.37%(18/38);among 38 cases,there were 12 cases of initial treatment,3 cases of CR,3 cases of PR,5 case of SD,1 cases of PD,ORR was 50.00%(6/12);there were 26 cases of re-treatment,2 cases of CR,10 cases of PR,12 cases of SD,2 cases of PD,ORR was 46.15%(12/26);the SD cases number after treatment in the patients with initial treatment was significantly lower than that in the patients with re-treatment,the difference was statistically significant(χ2=9.600,P=0.002).In this group of23 patients with rmh TNF before injection of anti-inflammatory analgesic 100 mg pretreatment,15 cases were not pretreated;among 38 cases,there were 4 cases(8.33%)of fever under 38.5 °C,2 cases(4.17%)of fatigue,no abdominal infection,abdominal pain,hypotension and electrolytes imbalance occurred;no reduction of white blood cells and platelets were observed.Conclusion Intraperitoneal injection of rmh TNF has satisfactory effect in the treatment of malignant peritoneal effusion with mild adverse reactions and deserves further clinical promotion and application.

关 键 词：肿瘤坏死因子α/治疗应用 重组蛋白质类/治疗应用 腹水/药物疗法 多中心研究 

分 类 号：R730.5[医药卫生—肿瘤]