论文部分内容阅读
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 4×106u/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PR 1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~k,),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?
Objective To investigate the efficacy and adverse reactions of rmhTNF in combination with systemic chemotherapy in the treatment of advanced malignancies by prospective randomized controlled clinical trial. Methods A total of 105 patients with advanced malignant tumor were randomly divided into experimental group (69 cases) and control group (36 cases). The characteristics of the two groups were comparable (P> 0.05). The experimental group were given rmhTNF 4 × 106u / m2, intramuscular injection, d1-d7, d11-d17, combined with chemotherapy. Control group 36 patients given chemotherapy alone, chemotherapy and test group. Efficacy evaluation according to WHO standard, divided into complete remission (CR), partial remission (PR), improvement (MR), stability (SD), progress (PD). To CR + PR for efficiency. Toxicity According to WHO anti-cancer drugs acute and sub-acute toxicity grading standards. Results In the experimental group, the CR was 1 and the PR was 12, the effective rate was 13/69 (18.84%). In the control group, the effective rate was only 1/36 (2.78%) in the PR group. The effective rate in the experimental group was significantly higher than that in the control group (P = 0.022). The curative effect of different diseases showed that the effective rate of lung cancer in trial group was 8/17 (47.06 ~ k), which was significantly higher than that in control group (1/6) (16.67%). The effective rate of gastric cancer and colorectal cancer in experimental group was also higher than that of corresponding group The control group, but the difference was not statistically significant. After treatment, the general condition score (KPS) was 89.00 ± 9.92 in the test group and 84.17 ± 8.84 in the control group, which was significantly higher in the test group than in the control group (P = 0.028). Adverse reactions of rmhTNF intramuscular injection were mainly injection of local pain, cold chills, injection of local inflamed sclerosis, fever, bone muscle pain, cold-like symptoms, but to a lesser extent, patients can tolerate. Conclusion rmhTNF intramuscular injection combined with systemic chemotherapy for advanced malignancies is effective and safe?