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学科主题: 临床医学
题名:
Paraplegia and Paraparesis From Intrathecal Methotrexate and Cytarabine Contaminated With Trace Amounts of Vincristine in China During 2007
作者: Zeng, Guang1; Ma, Huilai; Wang, Xiangbo; Yan, Huifang; Wan, Xinhua; Jiang, Bin; Fontaine, Robert E.; Wu, Zhenglai; Lin, Shaobin; Ruan, Feng; Liu, Huihui
刊名: JOURNAL OF CLINICAL ONCOLOGY
发表日期: 2011-05-01
DOI: 10.1200/JCO.2010.32.7072
卷: 29, 期:13, 页:1765-1770
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology
研究领域[WOS]: Oncology
关键词[WOS]: ACUTE LYMPHOBLASTIC-LEUKEMIA ; CHEMOTHERAPY ; INJECTION ; MYELOPATHY
英文摘要:

Purpose The production and administration of drugs used intrathecally requires special care to prevent contamination with neurotoxic agents. In 2007, we investigated a widespread outbreak of paraplegia and paraparesis among Chinese patients who received intrathecal drugs to identify the presumed contaminant and its source to prevent further cases.

Patients and Methods We defined a case as onset from January 1 to October 31, 2007, of bilateral flaccid paraparesis or paraplegia or retention and incontinence of stool or urine, in a patient receiving intrathecal drugs. Using a retrospective cohort approach, we selected 12 hospitals from all hospitals that had reported cases. In these hospitals, we identified all 448 patients (including 107 cases) who received intrathecal chemotherapy or chemoprophylaxis in 2007. We calculated attack rates and Mantel-Haenszel adjusted risk ratios for intrathecal drug type and lot.

Results All 12 hospitals used intrathecal methotrexate or cytarabine produced by one pharmaceutical plant. Only two lots of each drug were associated with cases. Lot-specific attack rates ranged from 42% to 100% (risk ratio, infinity; lower confidence bounds, 1.8 to 7.3). Vincristine production had immediately preceded production of the implicated lots on the same equipment. By using ultra performance liquid chromatography, we detected vincristine (0.28 to 18 mu g) in unused vials from implicated lots of methotrexate and cytarabine.

Conclusion Trace amounts of vincristine that contaminated intrathecal drugs caused a large outbreak of severe neurologic damage. Vincristine and other neurotoxic drugs should not be produced on any equipment that is also used for producing drugs that are to be administered intrathecally.

语种: 英语
WOS记录号: WOS:000290090400034
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/63508
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
2.Ctr Dis Control & Prevent, Atlanta, GA USA
3.Natl Inst Occupat Hlth & Poison Control, Beijing, Peoples R China
4.Capital Med Univ, Xuan Wu Hosp, Beijing, Peoples R China
5.Chinese Ctr Dis Control & Prevent, Chinese Field Epidemiol Training Program, Beijing 100050, Peoples R China
6.Natl Inst Environm Hlth & Related Product Safety, Beijing, Peoples R China
7.Peking Union Med Coll, Beijing 100021, Peoples R China

Recommended Citation:
Zeng, Guang,Ma, Huilai,Wang, Xiangbo,et al. Paraplegia and Paraparesis From Intrathecal Methotrexate and Cytarabine Contaminated With Trace Amounts of Vincristine in China During 2007[J]. JOURNAL OF CLINICAL ONCOLOGY,2011,29(13):1765-1770.
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