Deaths Associated with Hypocalcemia from Chelation Therapy, Texas, Pennsylvania, and Oregon, 2003–2005与死亡相关的低钙血症，从螯合疗法，德克萨斯州，宾夕法尼亚州，和俄勒冈州， 2003年至2005年

Chelating agents bind lead in soft tissues and are used in the treatment of lead poisoning to enhance urinary and biliary excretion of lead, thus decreasing total lead levels in the body ( 1 ).螯合剂约束导致在软组织，并用来在铅中毒的治疗，以提高尿和胆汁排泄的铅，从而降低总铅含量在人体中（ 1 ） 。 During the past 30 years, environmental and dietary exposures to lead have decreased substantially, resulting in a considerable decrease in population blood lead levels (BLLs) ( 2 ) and a corresponding decrease in the number of patients requiring chelation therapy.在过去的30年，环境和膳食暴露的铅大幅下跌，导致在相当人口的减少血中铅浓度（ blls ） （ 2 ）和相应的数目减少了病人的需要螯合疗法。 Chelating agents also increase excretion of other heavy metals and minerals, such as zinc and, in certain cases, calcium ( 1 ).螯合剂也增加排泄的其他重金属和矿物质，如锌，在某些情况下，钙（ 1 ） 。 This report describes three deaths associated with chelation-therapy–related hypocalcemia that resulted in cardiac arrest.本报告介绍了三人死亡相关的螯合疗法有关的低钙血症，导致在心脏骤停。 Several drugs are used in the treatment of lead poisoning, including edetate disodium calcium (CaEDTA), dimercaperol (British anti-Lewisite), D-penicillamine, and meso-2,3-dimercaptosuccinic acid (succimer).几种药物使用在铅中毒的治疗，包括edetate二钠钙（ caedta ） ， dimercaperol （英国反路易氏剂） ， D -青霉胺，细观-2,3 - dimercaptosuccinic酸（ succimer ） 。 Health-care providers who are unfamiliar with chelating agents and are considering this treatment for lead poisoning should consult an expert in the chemotherapy of lead poisoning.卫生保健提供者谁不熟悉螯合剂，并正在考虑这个治疗铅中毒，应征询专家在化疗铅中毒。 Hospital pharmacies should evaluate whether continued stocking of Na ₂ EDTA is necessary, given the established risk for hypocalcemia, the availability of less toxic alternatives, and an ongoing safety review by the Food and Drug Administration (FDA).医院药房应评估是否需要继续放养的Na ₂的EDTA是必要的，由于建立了风险低血钙症，可供使用的毒性较低的替代品，并进行安全审查，然后再由美国食品和药物管理局（ FDA ） 。 Health-care providers and pharmacists should ensure that Na ₂ EDTA is not administered to children during chelation therapy.保健提供者和药剂师应确保娜₂的EDTA是没有管理的儿童在螯合疗法。

Chelating agents, especially those intended for use in children, should be effective in reducing lead and other heavy metals from the body without producing substantial adverse effects on levels of critical serum electrolytes, such as calcium.螯合剂，特别是那些打算用于在儿童，应能有效减少铅和其他重金属，从体内没有产生实质性的负面影响水平的关键血清电解质，如钙。 The only agent recommended for intravenous (IV) chelation therapy for children is CaEDTA ( 1 ).唯一的代理人建议静脉（四）螯合疗法的儿童是caedta （ 1 ） 。 However, hospital formularies usually stock multiple chelation agents.不过，医院的处方通常股票多个螯合代理商。 One such agent, Na ₂ EDTA, was formerly used for treatment of hypercalcemia, but its use has become infrequent because of concerns regarding nephrotoxicity and because of the availability of less toxic alternatives ( 3 ).这样一个代理人，钠₂的EDTA ，前身是用于治疗高血钙症，但它的使用，已成为屡见不鲜，因为担心对于肾毒性和因供应毒性较低的替代品（ 3 ） 。 Furthermore, Na ₂ EDTA contains a warning stating, “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy.” According to the package insert, Na ₂ EDTA is “indicated in selected patients for the emergency treatment of hypercalcemia and for the control of ventricular arrhythmias associated with digitalis toxicity.” According to FDA and CDC, the safety and effectiveness of Na ₂ EDTA in pediatric patients has not been established, and its use is not recommended because it induces hypocalcemia and possibly fatal tetany ( 1 ).此外，娜₂的EDTA包含一个警告，说明“ ，使用这种药物在任何特定的病人是建议，只有当严重的临床状况证明侵略性的措施，与此相关类型的疗法” 。根据该方案，插入，钠_二的EDTA是“表示，在选定的病人的急诊处理高血钙症，并为控制室性心律失常与洋地黄毒性。 ： ”根据FDA和疾病防治中心，安全性和有效性的Na ₂的EDTA在儿科病人尚未建立，其使用不推荐，因为它诱使低血钙症，并可能致命的手足搐搦（ 1 ） 。

In 2005 , the Texas Department of Health childhood lead poisoning surveillance program reported a death attributable to chelation-associated hypocalcemia to CDC.在2005年，得克萨斯州卫生署儿童铅中毒监察计划报告的死亡是由于螯合相关的低血钙症，以课程发展议会。 Subsequently, CDC queried state and local lead-surveillance programs regarding chelation-related fatalities; additional deaths were identified in Pennsylvania and Oregon.随后，议会质疑，国家和地方的铅监察程序方面的螯合有关的死亡;额外的死亡确定在宾夕法尼亚州和俄勒冈州。

Case Reports 病例报告

Texas. In February 2005, a girl aged 2 years who was tested for blood lead during routine health surveillance had a capillary BLL of 47 µ g/dL. 德克萨斯州。在2005年2月，一名女童年龄二年谁测试血铅在进行例行健康监测了毛细管bll 47 μ克/ dl 。 A venous BLL of 48 µ g/dL obtained 12 days later confirmed the elevated BLL. 1静脉bll 48 μ克/ dl获得12天稍后证实高架bll 。 A complete blood count and iron study conducted concurrently revealed low serum iron levels and borderline anemia.一个完整的血液计数和铁所进行的研究同时显示，低血清铁水平和边缘性贫血。 On February 28, 2005, the girl was admitted to a local medical center for combined oral and IV chelation therapy. 2月28日， 2005年，该女童被承认了当地的医疗中心，结合口腔和第四螯合疗法。

The patient’s blood electrolytes at admission were within normal limits.病人的血液中电解质入院时均在正常范围内。 Initial medication orders included IV Na ₂ EDTA and oral succimer (an agent primarily used for treatment of lead poisoning).初次服药定单包括四娜₂ EDTA和口头succimer （一剂，主要用于治疗铅中毒） 。 The medication order subsequently was corrected by the pediatric resident to IV CaEDTA.药物，以便随后被纠正小儿驻地至四caedta 。 At 4:00 pm on the day of admission, the patient received her first dose of IV CaEDTA (300 mg in 100 mL normal saline at 25 mL/hr).在下午四点就一天入院，病人接受她的第一剂四caedta （ 300毫克， 100毫升生理盐水25毫升/小时） 。 At 4:35 pm, she was administered 200 mg of oral succimer.在下午4时35分，她被管理的200毫克口服succimer 。 Her vital signs remained normal throughout the night.她的生命体征一直保持正常整个晚上。 At 4:00 am the next day, a dose of IV Na ₂ EDTA (instead of IV CaEDTA) was administered.在上午04点，第二天，剂量四娜₂的EDTA （而不是四caedta ）管理。 An hour later, the patient’s serum calcium had decreased to 5.2 mg/dL (normal value for pediatric patients: 8.5–10.5 mg/dL).一小时后，病人的血清钙下降到5.2毫克/ dl （正常值为儿科病人： 8月5日至10月5日毫克/ dl ） 。 At 7:05 am, the child’s mother noticed that the child was limp and not breathing.在上午07时05分，孩子的母亲看到孩子蹒跚而不是呼吸。 Bedside procedures did not restore a normal cardiac rhythm, and a cardiac resuscitation code was called at 7:25 am The child had no palpable pulse or audible heartbeat.床边程序并没有恢复正常的心脏节律和心脏复苏的代码被称为在上午07时25分儿童没有明显的脉搏或心跳发声。 Repeat laboratory values for serum drawn at 7:55 am indicated that the serum calcium level was <5.0 mg/dL despite repeated doses of calcium chloride.重复实验室值为血清得出在上午07时55分表明，血清中钙水平是< 5.0毫克/ dl屡禁不止剂量的氯化钙。 All attempts at resuscitation failed, and the girl was pronounced dead at 8:12 am所有试图在复苏失败，该名女童伤重不治，在上午08时12分

An autopsy revealed no results of toxicologic significance.验尸报告显示，没有结果的毒理学意义。 A postmortem radiologic bone survey indicated areas of sclerosis at the metaphyses (growth arrest and recovery lines compatible with lead exposure).一死后骨放射学调查表明，地区性硬化症在metaphyses （增长逮捕和复苏线兼容与铅暴露） 。 The cause of death was recorded as sudden cardiac arrest resulting from hypocalcemia associated with chelation therapy.死亡原因记录为心脏骤停而造成低血钙症相关的螯合疗法。 The hospital’s child mortality review board findings indicated that a dose of IV Na ₂ EDTA was unintentionally administered to the child.该医院的儿童死亡率审查委员会的调查结果显示，剂量四娜₂的EDTA是有意无意地管理，以儿童。

Pennsylvania. In August 2005, a boy aged 5 years with autism died while receiving IV chelation therapy with Na ₂ EDTA in a physician’s office. During the chelation procedure, the mother noted that the child was limp. 宾夕法尼亚州。在2005年8月，一名男童年龄五年与自闭症死亡，而接受四，螯合疗法与Na ₂的EDTA在医生的办公室。期间，螯合程序，母亲指出，儿童是跛行。 The physician initiated resuscitation, and an emergency services team transported the child to the hospital.医生开始复苏，和紧急服务队运送儿童到医院去。 At the emergency department (ED), further resuscitation was attempted, including administration of at least 1 and possibly 2 doses of IV calcium chloride.在急诊部（教育） ，进一步复苏企图，包括政府当局的至少有1和2可能剂量的四氯化钙。 Subsequently, the boy’s blood calcium level was recorded in the ED as 6.9 mg/dL.随后，该名男童的血液中钙水平是记录在教育署为6.9毫克/ dl 。 The child did not regain consciousness.儿童没有恢复意识。 The coroner examination indicated cause of death as diffuse, acute cerebral hypoxic-ischemic injury, secondary to diffuse subendocardial necrosis.死因裁判官表示，考试的死亡原因为弥漫性，急性缺氧缺血性脑损伤，继发弥漫性心内膜下心肌坏死。 The myocardial necrosis resulted from hypocalcemia associated with administration of Na ₂ EDTA.心肌坏死所造成的低钙血症与政府当局的Na ₂的EDTA 。 The case is under investigation by the Pennsylvania State Board of Medicine.此案正在调查中，由宾夕法尼亚州立董事会中医药。

Oregon . 俄勒冈州 。 In August 2003, a woman aged 53 years with no evidence of coronary artery disease, intracranial disease, or injury was treated with 700 mg IV EDTA in a naturopathic practitioner’s clinic. 2003年8月，一女，年龄53岁，与没有证据显示有冠状动脉疾病，颅内病变，或伤害是治疗700毫克四的EDTA在一个naturopathic医生的诊所。 The EDTA was provided by a compounding laboratory (Creative Compounding, Wilsonville, Oregon) and was administered by the practitioner to remove heavy metals from the body.有关的EDTA提供了一个更为复杂的实验室（创造性的复合，俄勒冈州维尔森维尔市）是由医生，以消除重金属的身体。 The practitioner had provided a similar treatment to the patient on three previous occasions, once in June 2003 and twice in July 2003.医生提供了一个类似的治疗，病人对三前几次一样，一次是在2003年6月，两次在2003年7月。 Approximately 10–15 minutes after treatment began, the patient became unconscious.大约10-15分钟后开始治疗，病人昏迷。 Cardiopulmonary resuscitation was initiated, and an emergency services team was contacted.心肺复苏发起，并紧急服务队联络。 Attempts to revive the patient en route to and in the ED were unsuccessful.试图恢复病人的途中和在教育署均告失败。 The medical examiner determined the cause of death to be cardiac arrhythmia resulting from hypocalcemia associated with EDTA infusion and vascuolar cardiomyopathy.法医确定的死亡原因是心律失常造成的低钙血症相关的EDTA输液及vascuolar心肌病。 The patient’s ionized calcium level during code was 3.8 mg/dL (normal value for adult patients: 4.5–5.3 mg/dL) after one IV injection of calcium gluconate administered by emergency medical technicians en route to the hospital and another IV injection of calcium chloride in the ED.病人的离子钙水平期间，代码为3.8毫克/ dl （正常值为成人患者： 4月5日至5月3日毫克/ dl ）后，一静脉注射葡萄糖酸钙管理的紧急医疗救护技术员途中，医院和另一静脉注射的氯化钙在教育署。 The Oregon State Naturopath Licensing Board is conducting an investigation to determine whether Na ₂ EDTA or CaEDTA was administered to this patient.俄勒冈州国家naturopath牌局进行调查，以确定是否娜₂的EDTA或caedta管理，向这名病人。

The cases described in this report have been reported to FDA.所述案例在本报告已报FDA的。 FDA is performing a safety assessment of Na ₂ EDTA, including a review of the adverse event reporting system to determine whether other deaths related to use of chelating agents have been reported. FDA正执行一项安全评估的Na ₂的EDTA ，包括审查的不良事件报告制度，以确定是否其他有关的死亡使用螯合剂已报告。

Reported by: RA Beauchamp, MD, TM Willis, TG Betz, MD, J Villanacci, PhD, Texas Dept of State Health Svcs. 报道： 在Ra博乡广场（ Beauchamp ，海事处，技术备忘录，威力斯，甘油三酯贝茨，海事处， j villanacci ，博士，德州部国家健康svcs 。 RD Leiker, Oregon Childhood Lead Poisoning Prevention Program. 路leiker ，俄勒冈州的儿童铅中毒预防计划。 L Rozin, MD, Allegheny County, Pennsylvania Office of the Coroner. 升罗津，海事处，阿勒格尼县办公室的死因。 MJ Brown, ScD, DM Homa, PhD, TA Dignam, MPH, T Morta, Div of Emergency and Environmental Health Svcs, National Center for Environmental Health, CDC. 兆焦耳布朗，的SCD ，德国马克霍马，博士，电讯管理局局长dignam ，英里每小时，吨morta ，学的紧急情况和环境健康svcs中心，国家环境健康，疾病防治中心。

Editorial Note:编者按：

Both children and adults are subject to potentially lethal prescription errors involving “look-alike, sound-alike” substitutions (ie, confusion of drugs with similar names).儿童和成年人都受到潜在的致命的错误处方，涉及“外观类似，声音都”替换（即混乱，药品与类似的名称） 。 In a 1-year study of errors in a tertiary care teaching hospital, 11.4% of medication errors were found to have resulted from use of the wrong drug name, dosage form, or abbreviation ( 4 ).在1年的研究错误，在一个三级护理教学医院， 11.4 ％的药物发现错误已导致使用了错误的药物名称，剂型，或简称（ 4 ） 。 A review of medical records in the Texas case described in this report revealed that the brand names for the Na ₂ EDTA product, Endrate ^® (Hospira, Inc., Lake Forest, Illinois), and the CaEDTA product, Calcium Disodium Versenate ^® (3M Pharmaceuticals, St. Paul, Minnesota), were used interchangeably; this improper use of drug names likely resulted in the inappropriate administration of Na ₂ EDTA.检讨医疗纪录在得克萨斯州的情况介绍了在本报告中显示，该品牌名称的Na ₂的EDTA的产品， endrate ^® （ hospira ，公司，湖森林，伊利诺州） ，以及caedta产品，钙钠盐versenate ^® （ 3个月药品，圣保罗，明尼苏达州） ，被互换使用，这不当使用药物的名称，可能导致在不适当的政府当局的Na ₂的EDTA 。

Although CaEDTA and succimer were ordered for one patient and the form of EDTA administered to another remains under investigation, these drugs singly or in combination probably were not responsible for the low calcium levels. Hypercalcemia as a result of IV administration of CaEDTA has been reported ( 5 ).虽然caedta和succimer被勒令为其中一名病人和形式的EDTA管理的另一个仍在调查中，这些药物单独或联合应用可能不负责为低钙水平。高钙血症，由于四，行政caedta已报告（ 5 ） 。 Succimer by itself is a weak calcium binder but is not associated with a drop in essential minerals such as calcium ( 6 ). succimer由本身是一个薄弱钙粘结剂，但没有相关的下降，在必需的矿物质，如钙（ 6 ） 。 Moreover, the reported doses of CaEDTA and succimer in the Texas case were appropriate and within established safety limits.此外，报告剂量的caedta和succimer在得克萨斯州的情况是适当的和符合既定的安全范围内。

Medical center records and coroner reports indicate that Na ₂ EDTA was administered in at least two of the cases.医学中心的记录和死因裁判官报告表明，钠的EDTA _二是管理在至少两个的案件。 Na ₂ EDTA is often part of a standard hospital formulary; however, it should never be used for treating lead or other heavy metal poisoning in children because it induces hypocalcemia, which can lead to tetany and death ( 7 ).娜₂的EDTA的一部分，往往是一个标准的医院处方，但它绝不能用于治疗铅或其他重金属中毒的儿童，因为它诱使低血钙症，可导致手足搐搦和死亡（ 7 ） 。 The error that caused the death in Texas most likely resulted from miscommunication between the pharmacy and the pediatric unit.的错误所造成的死亡在德克萨斯州最有可能导致误传之间的药剂业及儿科单位。

Chelation therapy with CaEDTA, dimercaperol, or succimer has been the mainstay of medical management for children with BLLs > 45 µ g/dL ( 1 ).螯合疗法与caedta ， dimercaperol ，或succimer一直是主体，医疗管理为儿童与blls > 45 μ克/ dl （ 1 ） 。 The effectiveness of chelation therapy in improving renal or nervous system symptoms of chronic mercury toxicity has not been established.的成效，螯合疗法在改善肾或中枢神经系统的症状，慢性汞毒性尚未建立。 Nonetheless, certain health-care practitioners have used chelation therapy for autism in the belief that mercury or other heavy metals are producing the symptoms ( 8 ).然而，某些保健医生用螯合疗法为自闭症在相信水银或其他重金属产生的症状（ 8 ） 。 Other practitioners have recommended chelation therapy for treatment of coronary artery disease, hoping to eliminate calcified atherosclerotic plaques that can lead to coronary artery occlusions and myocardial infarctions.其他从业人员已提出建议，螯合疗法治疗冠状动脉疾病，希望能消除钙化的动脉粥样硬化斑块可导致冠状动脉闭塞和心肌梗死。 These off-label uses of chelation therapy are not supported by accepted scientific evidence.这些小康标签使用螯合疗法是不支持接受的科学证据。 The Institute of Medicine found no scientific evidence that chelation is an effective therapy for autism spectrum disorder ( 8 ).该医学研究院发现，没有科学证据证明螯合是一种有效的治疗自闭症谱疾患（ 8 ） 。 Because limited consistent data exist on the use of chelation therapy to treat coronary artery disease, a clinical trial to assess the safety and effectiveness of chelation therapy is being conducted by the National Institutes of Health.*因为有限的一致的数据存在于使用螯合疗法治疗冠状动脉疾病，临床试验，以评估其安全性和有效性的螯合疗法是由美国国家卫生研究院的.*

Deaths associated with lead poisoning are rare ( 9 ), and childhood deaths caused by cardiac arrest associated with chelation therapy have not been documented previously ( 9 ).死亡相关的铅中毒是罕见的（ 9 ） ，和儿童造成的死亡心跳骤停与螯合疗法尚未记载以前（ 9 ） 。 As BLLs among children in the United States continue to decline ( 2 ), fewer children require chelation therapy.作为blls之间的儿童在美国继续下跌（ 2 ） ，少要孩子需要螯合疗法。 Primary care providers should consult experts in the chemotherapy of lead before using chelation drug therapy.基层医疗服务的提供者，应征询专家在化疗之前，率先使用螯合药物治疗。 If such an expert is not available, primary care providers should contact state or local childhood lead poisoning prevention programs or the Lead Poisoning Prevention Branch of the National Center for Environmental Health, CDC.如果这样的专家是无法使用，基层医疗服务的供应商应联系国家或地方的儿童铅中毒预防计划或铅中毒预防科的代表National Center for环境卫生，疾病防治中心。

CDC and its state and local partners will continue to educate health-care providers and pharmacists to ensure that Na ₂ EDTA is never administered to children during chelation therapy.疾病预防控制中心及国家和地方的合作伙伴将继续教育保健提供者和药剂师，以确保娜₂的EDTA是从来没有管理的儿童在螯合疗法。 CDC recommends that hospital pharmacies evaluate the need to keep Na ₂ EDTA in their formularies.课程发展议会建议，医院药房评估需要保持娜₂的EDTA在他们的处方。 Case reports of cardiac arrest or symptoms of hypocalcemia during chelation therapy should be reported to the CDC Lead Poisoning Prevention Branch (770-488-3300) or to MedWatch, the FDA adverse event reporting system, at http://www.fda.gov/medwatch .病例报告心跳骤停或症状的低钙血症期间，螯合疗法，应当报课程发展议会铅中毒预防科（ 770-488-3300 ）或以medwatch ，美国食品药品管理局的不良事件报告制度，在http://www.fda.gov / medwatch 。

Acknowledgments 认知

This report is based, in part, on contributions by M Markowitz, MD, Albert Einstein College of Medicine, New York, New York; SI Fisch, MD, Valley Baptist Hospital, Harlingen, Texas; and E Strimlan, Allegheny County, Pennsylvania Office of the Coroner.本报告是根据，这在部分上的贡献米马科维茨，海事处，艾伯特爱因斯坦医学院，纽约，纽约;硅fisch ，海事处，河谷浸信会医院，哈林根，得克萨斯州;和电子商务strimlan ，阿勒格尼县办事处的死因。

References参考

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* Additional information is available at http://nccam.nih.gov/news/2002/chelation/pressrelease.htm . *额外的信息可在http://nccam.nih.gov/news/2002/chelation/pressrelease.htm 。