恶性胶质瘤患者应用替莫唑胺治疗的临床研究

目的:研究替莫唑胺治疗恶性胶质瘤的有效性和安全性。方法:选择68例经病理学证实为恶性胶质瘤的患者随机进入替莫唑胺(TMZ)组和卡氮芥(BCNU)组,分别给予TMZ或BCNU治疗。以28d为1个疗程,每例患者进行2～6个疗程的治疗。所有患者均定期随访,进行实体肿瘤客观疗效、未进展存活率、生活质量和药物安全性的评定。结果:头颅强化CT或MRI所示的实体肿瘤治疗有效率TMZ组为44.12%,而BCNU组为20.59%,差异具有统计学意义(P<0.01);TMZ组患者在第6个疗程末的未进展存活率(47.06%)较BCNU组(23.53%)明显提高,差异具有统计学意义(P<0.05)。TMZ组患者生活质量的改善情况优于BCNU组,且不良反应的发生率低于BCNU组(P<0.05)。结论:TMZ较之传统的烷化剂类化疗药BCNU,能够明显延长恶性胶质瘤患者的未进展存活时间,客观缓解率高,耐受性良好且安全性较高。

A Clinical Study of Temozolomide in Patients with Malignant Glioma

Objective:To study the efficacy and security of temozolomide(TMZ) in patients with malignant glioma.Methods:Sixty-eight patients,certified to have malignant glioma by pathology,were randomly divided into TMZ group and carmustine(BCNU) group,and TMZ or BCNU was administered respectively.There were 28 days in one treatment course,and 2-6 treatment courses were performed in these cases.All patients were followed up periodically.Image based tumor response,the progression free survival(PFS),quality of life,and security were evaluated respectively.Results:Image based tumor response rate was 44.12% in TMZ group and 20.59% in BCNU group with significant difference(P<0.01).The progression free survival rate of patients in TMZ group after the sixth course(47.06%) was higher than that in BCNU group(23.53%) with significant difference(P<0.05).Patients with TMZ treatment experienced better quality of life and fewer adverse drug events than those with BCNU treatment(P<0.05).Conclusion:TMZ can evidently prolong the progression free survival time of patients with malignant glioma compared with that of BCNU(traditional alkylating antineoplastics)group.TMZ showed more efficient tumor response rate with good tolerability and safety.