临床肿瘤学杂志
臨床腫瘤學雜誌
림상종류학잡지
Chinese Clinical Oncology
2015年
9期
819-824
,共6页
张伟京%克晓燕%王杰军%王梅%朱军%张树才%张巧花%于丁%饶智国%于世英%谢丛华
張偉京%剋曉燕%王傑軍%王梅%硃軍%張樹纔%張巧花%于丁%饒智國%于世英%謝叢華
장위경%극효연%왕걸군%왕매%주군%장수재%장교화%우정%요지국%우세영%사총화
重组改构人肿瘤坏死因子-NC(rhTNF-NC)%肿瘤%胸腹水%生活质量
重組改構人腫瘤壞死因子-NC(rhTNF-NC)%腫瘤%胸腹水%生活質量
중조개구인종류배사인자-NC(rhTNF-NC)%종류%흉복수%생활질량
Recombinant human tumor necrosis factor-NC(rhTNF-NC)%Malignant tumors%Malignant pleural effusions and ascites%Life quality
目的:观察重组改构人肿瘤坏死因子?NC( rhTNF?NC)注射液单药治疗恶性肿瘤的临床疗效、不良反应以及对患者生活质量的影响。方法入组的320例患者中,可进行疗效评价310例,脱落9例,剔除1例。310例患者中,恶性淋巴瘤71例,恶性胸腹水169例,恶性黑色素瘤18例,肺癌20例,肝癌12例,乳腺癌10例,结肠癌7例和肾癌3例。恶性淋巴瘤、恶性黑色素瘤、肺癌等实体肿瘤患者给予静脉注射rhTNF?NC 60万~90万 IU/m2,最大剂量≤100万 IU/m2,1次/d,连用4周;恶性胸腹水患者予以胸腹腔注射rhTNF?NC,剂量为200万~300万IU/次,1~2次/周,连用2~3周;体表肿瘤(主要为恶性黑色素瘤)患者在rhTNF?NC静脉给药的同时予以瘤体内或瘤床注射,推荐注射剂量为50万~100万IU/次,2~3次/周。结果可评价的患者310例,其中恶性胸腹水169例,实体肿瘤141例。实体瘤患者中获CR 2例,PR 21例,有效率( RR)为16?3%(23/141),疾病控制率( DCR)为79?4%(112/141)。恶性淋巴瘤的RR为28?2%(20/71),DCR为84?5%(60/71);恶性黑色素瘤的RR为11?1%(2/18),DCR为83?3%(15/18);肺癌无CR病例,获PR 1例,MR 2例;肾癌获MR 1例;肝癌、结肠癌、乳腺癌均未见明显疗效。恶性胸腹水病例中获CR 15例,PR 102例,RR为69?2%(117/169),DCR为98?8%(167/169);其中,恶性胸水的RR为74?5%(105/141),恶性腹水为42?9%(12/28)。全组患者治疗后的 KPS 评分较治疗前有显著提高(P=0?013),特别是恶性胸水患者提高更为明显。主要不良反应为发热(38?8%)和寒战(23?5%),绝大多数为1、2级。结论注射用rhTNF?NC治疗恶性淋巴瘤和恶性胸腹水疗效明确,对肺癌、恶性黑色素瘤也有一定疗效,并能够明显改善各种癌症患者的生活质量,安全性良好。
目的:觀察重組改構人腫瘤壞死因子?NC( rhTNF?NC)註射液單藥治療噁性腫瘤的臨床療效、不良反應以及對患者生活質量的影響。方法入組的320例患者中,可進行療效評價310例,脫落9例,剔除1例。310例患者中,噁性淋巴瘤71例,噁性胸腹水169例,噁性黑色素瘤18例,肺癌20例,肝癌12例,乳腺癌10例,結腸癌7例和腎癌3例。噁性淋巴瘤、噁性黑色素瘤、肺癌等實體腫瘤患者給予靜脈註射rhTNF?NC 60萬~90萬 IU/m2,最大劑量≤100萬 IU/m2,1次/d,連用4週;噁性胸腹水患者予以胸腹腔註射rhTNF?NC,劑量為200萬~300萬IU/次,1~2次/週,連用2~3週;體錶腫瘤(主要為噁性黑色素瘤)患者在rhTNF?NC靜脈給藥的同時予以瘤體內或瘤床註射,推薦註射劑量為50萬~100萬IU/次,2~3次/週。結果可評價的患者310例,其中噁性胸腹水169例,實體腫瘤141例。實體瘤患者中穫CR 2例,PR 21例,有效率( RR)為16?3%(23/141),疾病控製率( DCR)為79?4%(112/141)。噁性淋巴瘤的RR為28?2%(20/71),DCR為84?5%(60/71);噁性黑色素瘤的RR為11?1%(2/18),DCR為83?3%(15/18);肺癌無CR病例,穫PR 1例,MR 2例;腎癌穫MR 1例;肝癌、結腸癌、乳腺癌均未見明顯療效。噁性胸腹水病例中穫CR 15例,PR 102例,RR為69?2%(117/169),DCR為98?8%(167/169);其中,噁性胸水的RR為74?5%(105/141),噁性腹水為42?9%(12/28)。全組患者治療後的 KPS 評分較治療前有顯著提高(P=0?013),特彆是噁性胸水患者提高更為明顯。主要不良反應為髮熱(38?8%)和寒戰(23?5%),絕大多數為1、2級。結論註射用rhTNF?NC治療噁性淋巴瘤和噁性胸腹水療效明確,對肺癌、噁性黑色素瘤也有一定療效,併能夠明顯改善各種癌癥患者的生活質量,安全性良好。
목적:관찰중조개구인종류배사인자?NC( rhTNF?NC)주사액단약치료악성종류적림상료효、불량반응이급대환자생활질량적영향。방법입조적320례환자중,가진행료효평개310례,탈락9례,척제1례。310례환자중,악성림파류71례,악성흉복수169례,악성흑색소류18례,폐암20례,간암12례,유선암10례,결장암7례화신암3례。악성림파류、악성흑색소류、폐암등실체종류환자급여정맥주사rhTNF?NC 60만~90만 IU/m2,최대제량≤100만 IU/m2,1차/d,련용4주;악성흉복수환자여이흉복강주사rhTNF?NC,제량위200만~300만IU/차,1~2차/주,련용2~3주;체표종류(주요위악성흑색소류)환자재rhTNF?NC정맥급약적동시여이류체내혹류상주사,추천주사제량위50만~100만IU/차,2~3차/주。결과가평개적환자310례,기중악성흉복수169례,실체종류141례。실체류환자중획CR 2례,PR 21례,유효솔( RR)위16?3%(23/141),질병공제솔( DCR)위79?4%(112/141)。악성림파류적RR위28?2%(20/71),DCR위84?5%(60/71);악성흑색소류적RR위11?1%(2/18),DCR위83?3%(15/18);폐암무CR병례,획PR 1례,MR 2례;신암획MR 1례;간암、결장암、유선암균미견명현료효。악성흉복수병례중획CR 15례,PR 102례,RR위69?2%(117/169),DCR위98?8%(167/169);기중,악성흉수적RR위74?5%(105/141),악성복수위42?9%(12/28)。전조환자치료후적 KPS 평분교치료전유현저제고(P=0?013),특별시악성흉수환자제고경위명현。주요불량반응위발열(38?8%)화한전(23?5%),절대다수위1、2급。결론주사용rhTNF?NC치료악성림파류화악성흉복수료효명학,대폐암、악성흑색소류야유일정료효,병능구명현개선각충암증환자적생활질량,안전성량호。
Objective To investigate the clinical efficacy, safety and life quality improvement of recombinant mutant human?NC( rhTNF?NC) in the treatment of malignant tumors or pleural effusions and ascites. Methods A total of 320 patients with malignant tumors or pleural effusions and ascites were enrolled into this multicenter, open and non?randomized phaseⅡ clinical trial, including malignant lymphoma( n=71) , malignant pleural effusions and ascites( n=169) , malignant melanoma( n=18) , lung cancer( n=20) , liver cancer( n=12) , breast cancer( n=10) , colon cancer( n=7) and renal cell carcinoma( n=3) . For malignant tumors, rhTNF?NC was intravenously dropped at a dose of 600?900 KU/m2 every day for 28 days. For malignant pleural effusions and ascites, rhTNF?NC was infused intralpeurally at a dose of 2000?3000 KU a time, 1?2 times per week for 2?3 weeks. For melanoma, intratumor injection was combined with intravenous injection at a dose of 500?1000 KU/time, 2?3 times per week. Results Three hundred and ten patients could be evaluated, including 169 cases of malignant pleural effusions and ascites, and 141 cases of solid tumors. In solid tumor pa?tients, 2 cases got CR, 21 in PR, with reponse rate(RR) of 16?3%(23/141) and disease control rate(DCR) of 79?4%(112/141). The malignant lymphoma?s RR was 28?2%(20/71), and DCR was 84?5%(60/71). Malignant melanoma?s RR was 11?1%(2/18), and DCR was 83?3%(15/18). In lung cancer, no one got CR, 1 in PR, and 2 in MR. 1 case of MR was in renal cell carcinoma. It showed no significant effect in liver cancer, colon cancer and breast cancer. In malignant pleural effusions and ascites, 15 got CR, 102 in PR with RR of 69?2%(117/169) and DCR of 98?8%(167/169). Among them, the malignant pleural effusions?s RR was 74?5%(105/141), and the malignant ascites?s RR was 42?9%(12/28).The KPS score of the whole group increased significantly after treat?ment(P=0?013), especially in the subgroup of malignant pleural effusion patients. The major adverse reaction was fever(38?8%) and shiver( 23?5%) mainly in grade 1 and 2. Conclusion The rhTNF?NC injection is effective in the control of various malignant tumors and malignant pleural effusions and ascites, with mild and tolerable adverse effects, and can dramatically improve the patients?quality of life.