白血病药物被证明长期安全有效

2007-11-20 17:16:40 文字大小：【大】【中】【小】

(WASHINGTON, November 7, 2007) – The drug imatinib mesylate, more commonly known as Gleevec®, proves safe and effective over the long term in patients with an advanced form of chronic myeloid leukemia (CML), according to a study prepublished online in Blood, the official journal of the American Society of Hematology.
（华盛顿 2007年11月7日）一项在美国血液学会官方刊物《血液》网站预发表的研究称，甲磺酸伊马替尼，更广泛地被人称作格列卫，被证明对于慢性粒细胞性白血病的患者长期安全有效。

A team of researchers from the U.S. and Europe, including the drug’s creator, Brian Druker, MD, followed 454 patients with chronic-phase CML taking imatinib for more than six years. Prior to enrollment, all study participants had experienced either treatment failure or intolerance with interferon alpha, which was the standard of care for CML at the time the study was initiated.
包括药物的发明者Brian Druker博士在内的一个由来自美国和欧洲的研究人员组成的团队跟踪研究了454位慢性粒细胞性白血病慢性期患者，这些患者使用伊马替尼已经超过6年。在参与研究前，所有的研究对象都已经经历了干扰素α治疗失败或者耐受，这是研究开始时对慢粒的标准治疗。

“The long-term follow-up results of imatinib in CML post interferon failure reassure us of the high efficacy of the drug and its safety,” stated Hagop Kantarjian, MD, the lead author on the study and Chairman and Professor of the Leukemia Department at the University of Texas M.D. Anderson Cancer Center. “With a six-year follow-up, the estimated six-year survival rate is 76 percent. In historical data, after interferon failure the average survival was about three to four years.”
“这项研究是对伊马替尼对干扰素失败后慢粒患者效果的长期跟踪。这项研究的结果给了我们信心：这个药物是高效而安全的。”Hagop Kantarjian博士说。他是研究的主持人，是德克萨斯州立大学M.D.Anderson癌症研究中心白血病研究中心的教授。“6年跟踪研究的结果显示，六年生存率大约为76%。历史数据表明，干扰素治疗失败后的患者平均生存时间曾经是大约3~4年。

Imatinib dosage began at 400 milligrams per day and was escalated to 600 mg/d or 800 mg/d in patients who did not achieve positive treatment responses within set time periods or whose disease relapsed.
伊马替尼的剂量开始时是400毫克每天。对于在预定时间内没有明显疗效或病情复发的病人，剂量可以逐渐上升到600毫克到800毫克每天

The best possible treatment outcome – a complete cytogenetic response, which is the elimination of the genetic abnormality associated with the disease – occurred in 57 percent of the study participants and was achieved in a median time of eight months. Overall survival rates and avoidance of disease progression were strongly correlated with cytogenetic response by 12 months; those with a minimal or no cytogenetic response within the first year faired poorly.
最好的可能治疗结果是完全细胞遗传学缓解，即疾病相关基因异常的排除，在57%的研究对象身上出现，出现的中位时间为8个月。总体生存率和病情恶化停止与患者服药12个月后细胞遗传学反应密切相关，那些在第一年里没有或只有很小细胞遗传学反应的患者预后较差。

The incidence of serious side effects was low and, although 15 cases of heart dysfunction were reported in study participants, only four cases were considered to be drug-related. During the study, 35 patients discontinued the drug because of adverse events or abnormal test results.
严重副作用的发生率较低。尽管在研究对象中有15例心脏功能障碍的报告，但是只有4例被认为与药物有关。研究中有35位患者因为出现不良反应或者异常的测试结果而中断药物治疗。

“About half of the patients on the study continue to receive imatinib and 40 percent are in complete cytogenetic response,” said Dr. Kantarjian. “No long-term new toxicities have been observed. In particular, the drug-related cardiac toxicity, which was reported to be of concern last year, was quite rare.”
“研究中大约半数的病人继续使用伊马替尼，40%的患者获得完全细胞遗传学缓解。”Kantarjian 博士说。“没有观察到新的长期毒性。特别地，去年所报告的引人关注的由药物引发的心脏毒性是相当罕见的。”

This clinical trial was the basis for the first approval of imatinib for CML, which has since become the standard of care for the disease.
临床实验是最初批准伊马替尼用于慢性粒细胞性白血病的基础，后来伊马替尼成为了治疗这种疾病的标准。