尿多酸肽注射液治疗晚期肿瘤的临床研究

Multicenter phase Ⅱ clinical trial of uroacitides injection in the treatment for advanced malignant tumors

目的观察尿多酸肽注射液单药治疗晚期恶性肿瘤的近期疗效、不良反应以及对患者生活质量的影响。方法人组的160例患者中，非小细胞肺癌33例，原发性肺癌45例，乳腺癌17例，食管癌11例，胃癌18例，大肠癌19例，脑胶质瘤10例，肾癌4例，胰腺癌3例，均为常规治疗无效的患者。其中中止治疗21例，死亡1例，可评价疗效者138例，可评价毒副反应者160例。尿多酸肽注射液300ml经锁骨下静脉置管给药，每天1次，连续用药4～8周。结果在可评价客观疗效的138例患者中，总有效率为5．8％，总肿瘤控制率为65．2％，临床受益率为57．2％。患者不良反应轻，主要有恶心呕吐（21．9％）和疼痛（6．3％），大多为Ⅰ～Ⅱ度，可自行恢复。结论尿多酸肽注射液单药治疗乳腺癌、原发性肝癌、非小细胞肺癌、大肠癌、脑胶质瘤等晚期恶性肿瘤有较高的肿瘤控制率，能明显改善晚期癌症患者生活质量，且不良反应轻微，患者耐受性好，值得进一步研究。

Objective To investigate the efficacy, safety and the life quality improvement of uroacitides injection in the treatment for patients with advanced malignant tumors. Methods A total of 160 patients with advanced stage cancers were enrolled into this multicenter, open and non-randomized phase I1 clinical trial, including cancers of the lung （33 cases）, liver （45 cases）, breast （17 cases）, esophagus （11 cases）, stomach （18 cases）, colon （19 cases）, pancreas （3 cases） and kidney （4 cases）, and glioma （10 cases）. Uroacitides was administrated in a dose of 300 ml daily via the superior vena cava catheter for consecutive 4-8 weeks. Results Of the 160 patients, 21 dropped out and one patient died during the trial. Efficacy could be evaluated in 138 patients and safety in 160. The total objective response rate （ ORR, CR ＋ PR） ） and tumor control rate （ CR ＋ PR ＋ MR ＋ SD） of the 138 evaluable patients were 5.8% and 65.2%, respectively. Clinical benefit response（CBR） rate was 57.2%. Major adverse effects were grade I -II and reversible nausea/vomiting （21.9%） and pain （6.3%）. Conclusion Uroacitides injection is effective in the control for various kinds of advanced cancers with mild, reversible and tolerable adverse effects, and can also improve the patient＇s quality of life. It is worth being studied further.