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Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine

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




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












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。



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)。


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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