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儿童院内心脏停搏后的低温治疗
Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children


Frank W. Moler ... 心脑血管疾病 • 2017.01.26

儿童院内心肺复苏后低温疗法(THAPCA-IH)的再思考

 

李强强,张陈,顾虹*

首都医科大学附属北京安贞医院小儿心脏中心

* 通讯作者

 

心脏停搏的患者经过心肺复苏后常存在神经系统损害,早期研究认为低温治疗院外心肺复苏后昏迷的患者,会对大脑神经系统起到有效的保护作用1,2。但近年的研究表明,成人及儿童的常温治疗与低温治疗的效果没有显著差异3-5。鉴于院内心肺复苏患者与院外患者从病因到转归存在诸多差异,欧美国家联合进行了两项针对低温疗法在儿童院内、外心肺复苏患者的应用研究(THAPCA-IH和THAPCA-OH)。THAPCA-OH的研究结果显示对于院外复苏的儿童患者,应用常温治疗与低温治疗对比,一年随访时的效果是相同的6

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摘要


背景

对于院外心脏停搏后昏迷的成人和儿童,临床上推荐使用目标体温管理;然而,关于院内心脏停搏后体温管理的数据有限。


方法

在37家儿童医院进行的一项试验中,我们比较了两种体温干预措施在院内心脏停搏儿童中的作用。在循环恢复后6小时内,年龄为出生48小时至18岁的昏迷儿童被随机分配至低温治疗组(目标体温33.0℃)或常温治疗组(目标体温36.8℃)。研究者采用第二版文兰(Vinland)适应行为量表(VABS-Ⅱ,评分范围为20~160分,较高评分表明功能较好)评分估计患者的情况,并在心脏停搏前VABS-Ⅱ评分至少为70分的患者中评价主要疗效结局,即心脏停搏后VABS-Ⅱ评分≥70分的12个月时生存率。


结果

329例患者接受随机化后,试验由于无效而被终止。在257例心脏停搏前VABS-Ⅱ评分至少为70分且可评价的患者中,主要疗效结局的比例在低温组和常温组间无显著差异(分别为36% [48/133]和39% [48/124];相对危险为0.92;95%置信区间[CI]为0.67~1.27;P=0.63)。在317例神经行为功能变化情况可评价的患者中,从基线至12个月的VABS-Ⅱ评分变化在组间无显著差异(P=0.70)。在327例1年生存率可评价的患者中,1年生存率在低温组和常温组之间无显著差异(分别为49% [81/166]和46% [74/161];相对危险为1.07;95% CI为0.85~1.34;P0.56)。血液制品使用、感染、严重不良事件的发生率以及28日死亡率在组间亦无显著差异。


结论

在院内心脏停搏后生存的昏迷儿童患者中,与常温治疗相比,低温治疗对1年时功能结局良好的生存无显著获益(由美国国立心肺血液研究所[National Heart, Lung, and Blood Institute,NHLBI]资助;THAPCA-IH在ClinicalTrials.gov注册号为NCT00880087)。





作者信息

Frank W. Moler, M.D., Faye S. Silverstein, M.D., Richard Holubkov, Ph.D., Beth S. Slomine, Ph.D., James R. Christensen, M.D., Vinay M. Nadkarni, M.D., Kathleen L. Meert, M.D., Brittan Browning, M.S., R.D., C.C.R.C., Victoria L. Pemberton, R.N.C., M.S., Kent Page, M.Stat., Marianne R. Gildea, B.S.N., M.S., Barnaby R. Scholefield, M.B., B.S., Ph.D., Seetha Shankaran, M.D., Jamie S. Hutchison, M.D., John T. Berger, M.D., George Ofori-Amanfo, M.B., Ch.B., Christopher J.L. Newth, M.D., Alexis Topjian, M.D., Kimberly S. Bennett, M.D., M.P.H., Joshua D. Koch, M.D., Nga Pham, M.D., Nikhil K. Chanani, M.D., Jose A. Pineda, M.D., Rick Harrison, M.D., Heidi J. Dalton, M.D., Jeffrey Alten, M.D., Charles L. Schleien, M.D., Denise M. Goodman, M.D., Jerry J. Zimmerman, M.D., Ph.D., Utpal S. Bhalala, M.D., Adam J. Schwarz, M.D., Melissa B. Porter, M.D., Samir Shah, M.D., Ericka L. Fink, M.D., Patrick McQuillen, M.D., Theodore Wu, M.D., Sophie Skellett, M.B., B.S., M.R.C.P., Neal J. Thomas, M.D., Jeffrey E. Nowak, M.D., Paul B. Baines, M.D., Ph.D., John Pappachan, M.B., B.S., Mudit Mathur, M.D., Eric Lloyd, M.D., Elise W. van der Jagt, M.D., M.P.H., Emily L. Dobyns, M.D., Michael T. Meyer, M.D., Ronald C. Sanders, Jr., M.D., Amy E. Clark, M.S., and J. Michael Dean, M.D., for the THAPCA Trial Investigators*
From the University of Michigan, Ann Arbor (F.W.M., F.S.S.), and Wayne State University, Detroit (K.L.M., S. Shankaran) — both in Michigan; University of Utah, Salt Lake City (R. Holubkov, B.B., K.P., M.R.G., K.S.B., A.E.C., J.M.D.); Kennedy Krieger Institute and Johns Hopkins University (B.S.S., J.R.C.) and Johns Hopkins Children’s Center (U.S.B.), Baltimore, and the National Heart, Lung, and Blood Institute, Bethesda (V.L.P.) — both in Maryland; Children’s Hospital of Philadelphia, Philadelphia (V.M.N., A.T.), University of Pittsburgh Medical Center, Pittsburgh (E.L.F.), and Penn State Children’s Hospital, Hershey (N.J.T.) — all in Pennsylvania; Birmingham Children’s Hospital, Birmingham (B.R.S.), Great Ormond Street Hospital, London (S. Skellett), Alder Hey Children’s Hospital, Liverpool (P.B.B.), and University Hospital Southampton, Southampton (J.P.) — all in the United Kingdom; Hospital for Sick Children, Toronto (J.S.H.); Children’s National Medical Center, Washington, DC (J.T.B.); Duke Children’s Hospital, Durham, NC (G.O.-A.); Children’s Hospital Los Angeles (C.J.L.N.) and Mattel Children’s Hospital UCLA (R. Harrison), Los Angeles, Children’s Hospital of Orange County, Orange (A.J.S.), University of California, San Francisco Benioff Children’s Hospital, San Francisco (P.M.), and Loma Linda University Children’s Hospital, Loma Linda (M.M.) — all in California; Children’s Medical Center Dallas, University of Texas Southwestern Medical School, Dallas (J.D.K.); University of Texas Health Sciences Center at San Antonio, San Antonio (T.W.); Children’s Healthcare of Atlanta, Atlanta (N.P., N.K.C.); Washington University, St. Louis (J.A.P.); Phoenix Children’s Hospital, Phoenix, AZ (H.J.D.); the Children’s Hospital of Alabama, Birmingham (J.A.); Children’s Hospital of New York, Columbia University Medical Center, New York (C.L.S.), and Golisano Children’s Hospital, University of Rochester Medical Center, Rochester (E.W.J.) — both in New York; Ann and Robert Lurie Children’s Hospital of Chicago, Chicago (D.M.G.); Seattle Children’s Hospital, Seattle (J.J.Z.); Kosair Children’s Hospital, University of Louisville, Louisville, KY (M.B.P.); University of Tennessee Health Science Center, Memphis (S. Shah); Children’s Hospital and Clinics of Minnesota, Minneapolis (J.E.N.); Nationwide Children’s Hospital, Columbus, OH (E.L.); Children’s Hospital Colorado, Aurora (E.L.D.); Medical College of Wisconsin, Milwaukee (M.T.M.); and Arkansas Children’s Hospital, Little Rock (R.C.S.). Address reprint requests to Dr. Moler at the University of Michigan Health System, F-6900 UH S., SPF 5243, 1500 E. Medical Center Dr., Ann Arbor, MI 48109-5243, or at fmoler@umich.edu. *A complete list of the Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trial investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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