Adding chloroquine to conventional treatment for glioblastoma multiforme -: A randomized, double-blind, placebo-controlled trial
Adding chloroquine to conventional treatment for glioblastoma multiforme -: A randomized, double-blind, placebo-controlled trial
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DOI：
10.7326/0003-4819-144-5-200603070-00008
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发表时间：
2006-03-07
影响因子：
39.2
通讯作者：
López-González, MA
中科院分区：
文献类型：
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作者：
Sotelo, J;Briceño, E;López-González, MA
背景：恶性细胞克隆对化疗和放疗的耐药经常导致多形性胶质母细胞瘤患者治疗失败。初步研究表明，在常规治疗中加入氯喹可能改善治疗效果。目的：探讨在常规治疗基础上加用氯喹治疗多形性胶质母细胞瘤的疗效。设计：随机、双盲、安慰剂对照试验。单位：墨西哥国家神经病学和神经外科研究所。患者：手术证实的胶质母细胞瘤患者30例，局限于1个大脑半球，Karnofsky评分大于70，无合并症，年龄小于60岁。干预措施：从术后clay 5或安慰剂开始，口服氯喹150mg /d，持续12个月。所有患者均接受常规化疗和放疗。测量：主要结局是术后生存；对存活患者进行随访至2005年10月。所有患者均采用Karnofsky评分和影像学检查、血液学检查和眼科检查进行定期评估。结果：接受氯喹治疗的患者术后中位生存期为24个月，对照组为11个月。观察结束时，使用氯喹治疗的6例患者分别存活59、45、30、27、27、20个月；对照组3例患者分别存活32、25、22个月。虽然没有统计学上的显著差异，但服用氯喹的患者随时间的死亡率大约是服用安慰剂的患者的一半（风险比为0.52 [95% Cl， 0.21至1.26];P = 0.139）。局限性：观察到氯喹的优势可能是偶然的；由于样本量小，不能调整预处理特征和常规治疗方案的差异。结论：在常规治疗的基础上给予氯喹可提高多形性胶质母细胞瘤的中期生存率。这些结果表明，将氯喹作为胶质母细胞瘤辅助治疗的更大规模、更明确的研究是有必要的。
Background: Malignant cell clones resistant to chemotherapy and radiotherapy frequently lead to treatment failure in patients with glioblastoma multiforme. Preliminary studies suggest that adding chloroquine to conventional therapy may improve treatment outcomes.Objective: To examine the effect of adding chloroquine to conventional therapy for glioblastoma multiforme.Design: Randomized, double-blind, placebo-controlled trial.Setting: National Institute of Neurology and Neurosurgery of Mexico.Patients: 30 patients with surgically confirmed glioblastoma confined to 1 cerebral hemisphere, with a Karnofsky performance score greater than 70, no comorbid disease, and age younger than 60 years.Interventions: Oral chloroquine at 150 mg/d for 12 months beginning on postoperative clay 5 or placebo. All patients received conventional chemotherapy and radiotherapy.Measurements: Primary outcome was survival after surgery; surviving patients were followed up to October 2005. Periodic evaluation using the Karnofsky scale and imaging studies, as well as hematologic tests and ophthalmologic examinations, was done in all patients.Results: Median survival after surgery was 24 months for chloroquine-treated patients and 11 months for controls. At the end of the observation period, 6 patients treated with chloroquine had survived 59, 45, 30, 27, 27, and 20 months, respectively; 3 patients from the control group had survived 32, 25, and 22 months, respectively. Although not statistically significantly different, the rate of death with time was approximately half as large in patients receiving chloroquine as in patients receiving placebo (hazard ratio, 0.52 [95% Cl, 0.21 to 1.26]; P = 0.139).Limitations: The observed advantage of chloroquine may be due to chance; differences in pretreatment characteristics and conventional treatment regimens could not be adjusted for because of the small sample size.Conclusions: Chloroquine may improve mid-term survival when given in addition to conventional therapy for glioblastoma multiforme. These results suggest that larger, more definitive studies of chloroquine as adjuvant therapy for glioblastoma are warranted.