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血管造影术围操作期接受碳酸氢钠和乙酰半胱氨酸患者的结局
Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine


Steven D. Weisbord ... 心脑血管疾病 其他 • 2018.02.15

注射碳酸氢钠、氯化钠和口服乙酰半胱氨酸预防造影剂诱发AKI

 

萧俐俐

Global Kidney Health Innovation Program, Renal Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

 

住院期间的急性肾损伤(AKI),包括造影剂引起的AKI,一直是相关患者死亡率升高的一个主要促发因素1。过去几年内,已有许多试验和荟萃分析评估了静脉注射碳酸氢钠、氯化钠和口服乙酰半胱氨酸预防造影剂诱发AKI的效果2-11,但是这些研究所得出的结论并不一致。尽管如此,临床上仍然经常给接受血管造影的患者使用这些药物。

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摘要


背景

临床上,静脉输注碳酸氢钠和口服乙酰半胱氨酸广泛用于血管造影后急性肾损伤及相关不良结局的预防,但目前尚无确切证据可证明其效果。

 

方法

本研究采用2×2析因设计,所招募的5,177例计划接受血管造影术的肾脏并发症高危患者被随机分组,分别接受静脉输注1.26%碳酸氢钠或0.9%氯化钠,以及口服乙酰半胱氨酸或安慰剂5日。其中,4,993例患者的数据被纳入改良意向性治疗分析。所采用的主要终点为复合终点,包括90日内死亡、透析需求或血清肌酐水平与基线相比持续升高至少50%。造影剂相关急性肾损伤为次要终点。

 

结果

该试验预先设定的中期分析结果明确后,申办方决定终止该试验。就主要终点而言,碳酸氢钠与乙酰半胱氨酸无交互作用(P=0.33)。碳酸氢钠组2,511例患者中有110例(4.4%)出现主要终点,氯化钠组2,482例患者中有116例(4.7%)(比值比[OR],0.93;95%置信区间[CI],0.72~1.22;P=0.62);乙酰半胱氨酸组2,495例患者中有114例(4.6%),安慰剂组2,498例患者中有112例(4.5%)(OR,1.02;95% CI,0.78~1.33;P=0.88)。此外,各组间造影剂相关急性肾损伤发生率无显著差异。

 

结论

对于接受血管造影的肾脏并发症高危患者,静脉输注碳酸氢钠与口服乙酰半胱氨酸和静脉输注氯化钠、口服安慰剂相比,前二者对90日内死亡、透析需求、肾功能持续下降,或造影剂相关急性肾损伤的预防并没有益处(由美国退伍军人事务部研究发展办公室[U.S. Department of Veterans Affairs Office of Research and Development]及澳大利亚国家健康与医学研究委员会[National Health and Medical Research Council of Australia]资助;PRESERVE 在ClinicalTrials.gov注册号为NCT 01467466)。





作者信息

Steven D. Weisbord, M.D., Martin Gallagher, M.D., Ph.D., Hani Jneid, M.D., Santiago Garcia, M.D., Alan Cass, M.D., Ph.D., Soe-Soe Thwin, Ph.D., Todd A. Conner, Pharm.D., Glenn M. Chertow, M.D., M.P.H., Deepak L. Bhatt, M.D., M.P.H., Kendrick Shunk, M.D., Ph.D., Chirag R. Parikh, M.D., Ph.D., Edward O. McFalls, M.D., PhD., et al., for the PRESERVE Trial Group*
From the Veterans Affairs (VA) Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh (S.D.W., P.M.P.); University of Sydney (M.G.) and the George Institute for Global Health, University of New South Wales (M.G., A.C.), Sydney, and the Menzies School of Health Research, Darwin, NT (A.C.) — all in Australia; Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston (H.J.); Minneapolis VA Health Care System and University of Minnesota, Minneapolis (S.G., E.O.M.); VA Cooperative Studies Program Coordinating Center (S.S.T., M.B., R.F., H.W., M.A., J.M., J.K.) and the Cardiology Section (D.L.B.), VA Boston Healthcare System, and Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School (D.L.B.) — all in Boston; VA Cooperative Studies Program Pharmacy Coordinating Center, Albuquerque, NM (T.A.C.); Stanford University Department of Medicine, Palo Alto (G.M.C.), and San Francisco VA Medical Center and University of California, San Francisco, San Francisco (K.S.) — all in California; and the VA Connecticut Healthcare System and Program of Applied Translational Research, Yale University, New Haven (C.R.P.). Address reprint requests to Dr. Weisbord at the Veterans Affairs Pittsburgh Healthcare System, Mailstop 111F-U, University Dr., Pittsburgh, PA 15240, or at steven.weisbord@va.gov. *A complete list of investigators in the PRESERVE trial group is provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.

 

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