CAJ | 학술논문

目的本研究通过前瞻性随机对照临床试验,观察注射用重组改构人肿瘤坏死因子(rmhTNF)联合全身化疗治疗晚期恶性肿瘤的疗效及不良反应.方法将105例晚期恶性肿瘤患者随机分为试验组69例,对照组36例,两组病例特征具有可比性(P＞0.05).试验组69例均给予rmhTNF 4×106 U/m2,肌注,d1～d7,d11～d17,联合化疗.对照组36例给予单纯化疗,化疗方案同试验组.疗效评价按WHO统一标准,分为完全缓解(CR)、部分缓解(PR)、好转(MR)、稳定(SD)、进展(PD).以CR+PR为有效率.毒性反应根据WHO抗癌药急性及亚急性毒性分级标准.结果试验组CR 1例,PR 12例,有效率为13/69(18.84%),而对照组PR1例,有效率仅为1/36(2.78%),试验组有效率显著高于对照组(P=0.022).不同病种的疗效分析显示,试验组肺癌的有效率8/17(47.06%),明显高于对照组1/6(16.67%),试验组胃癌、大肠癌的有效率亦高于相应的对照组,但其差别均无统计学意义.治疗后试验组一般状况评分(KPS)为89.00±9.92分,对照组为84.17±8.84分,试验组显著高于对照组(P=0.028).rmhTNF肌注给药的不良反应主要为注射局部疼痛、畏冷寒战、注射局部红肿硬结、发热、骨肌肉疼痛、感冒样症状等,但程度较轻,患者均可耐受.结论 rmhTNF肌注给药联合全身化疗治疗晚期恶性肿瘤是有效、安全的.
목적 본연구통과전첨성수궤대조림상시험,관찰주사용중조개구인종류배사인자(rmhTNF)연합전신화료치료만기악성종류적료효급불량반응.방법 장105례만기악성종류환자수궤분위시험조69례,대조조36례,량조병례특정구유가비성(P＞0.05).시험조69례균급여rmhTNF 4×106 U/m2,기주,d1～d7,d11～d17,연합화료.대조조36례급여단순화료,화료방안동시험조.료효평개안WHO통일표준,분위완전완해(CR)、부분완해(PR)、호전(MR)、은정(SD)、진전(PD).이CR+PR위유효솔.독성반응근거WHO항암약급성급아급성독성분급표준.결과 시험조CR 1례,PR 12례,유효솔위13/69(18.84%),이대조조PR1례,유효솔부위1/36(2.78%),시험조유효솔현저고우대조조(P=0.022).불동병충적료효분석현시,시험조폐암적유효솔8/17(47.06%),명현고우대조조1/6(16.67%),시험조위암、대장암적유효솔역고우상응적대조조,단기차별균무통계학의의.치료후시험조일반상황평분(KPS)위89.00±9.92분,대조조위84.17±8.84분,시험조현저고우대조조(P=0.028).rmhTNF기주급약적불량반응주요위주사국부동통、외냉한전、주사국부홍종경결、발열、골기육동통、감모양증상등,단정도교경,환자균가내수.결론 rmhTNF기주급약연합전신화료치료만기악성종류시유효、안전적.
Past studies showed that tumor necrosis factor (TNF) assisted anti-tumor treatment and intensified the sensitivity of chemotherapy. However its clinical application has been curbed because of its low purity, high dosage, and strong toxicity. The objective of present study is to evaluate the therapeutic effects and adverse reactions of recombinant mutant human tumor necrosis factor (rmhTNF) combined with chemotherapy in patients with advanced malignant tumor. Methods: 105 patients with advanced malignant tumor were randomly divided into trial group, 69 patients, and control group, 36 patients.rmhTNF was injected intramuscularly to the trial group at a dose of 4×106 U/m2, from the 1st to 7th days, the 11th to 17th days combined with chemotherapy course. The chemotherapy plan was as follows:CAP for patients with the NSCLC; FAM for patients with gastric cancer; FC for patients with colorectal cancer. One treatment cycle lasted for 21 days and two cycles were scheduled. The control group was given only the same chemotherapy as the trial group. Results: In the trial group there was 1 CR case and 12 PR cases, and the response rate was 13/69 (18.84%); in the control group 1 PR case, the response rate 1/36 (2.78%). The response rate in the trial group was significantly higher than that in the control group (P=0.022). The response rate for NSCLC in the trial group was 8/17 (47.06%), and 1/6 (16.67%) in the control group. The response rates for gastric cancer and colorectal cancer in the trial groups also were higher than those in the control groups. After the treatment the KPS was 89.00±9.92 in the trial group,and 84.17±8.84 in the control group, with a significant difference between the two groups (P=0.028). The adverse reactions of rmhTNF injection included: pain in the injection area, chill, hardening and swelling and redness in the injection area, fever, ostealgia and myosalgia, and cold-like symptoms. All these adverse reactions were mild and bearable. Conclusion: The administration of rmhTNF in combination with general chemotherapy is an effective and secure means in treating advanced malignant tumor.