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。%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.
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