既往研究显示环孢素能减少急性心肌梗死的面积和再灌注损伤。多国学者们近期对环孢素是否能改善临床结局以及是否能够预防不良左心室重塑进行了研究，结果表明，与安慰剂相比，经皮冠脉介入治疗(PCI)术前静脉注射环孢素未能改善急性前壁ST段抬高心肌梗死(STEMI)的临床预后，也并未防止1年时不良左心室重塑。相关论文近期在线发表于《新英格兰医学杂志》(N Engl J Med)。

        该研究为一项多中心、双盲随机试验，纳入970例罪犯血管完全闭塞的急性前臂STEMI患者，在患者症状发作的12小时内、冠脉再通前，随机给予其静脉注射环孢素(2.5mg/kg)或安慰剂。主要终点为1年内的全因死亡率，住院期间心衰加重或因心衰再入院和左室重塑(定义为左室舒张末容积增加15%及以上)。

        结果显示，1年后，环孢素治疗组和安慰剂组分别有395例和396例患者有足够数据，以进行评估分析。治疗组和对照组主要终点事件发生率分别为59%和58.1%(OR 1.04;95%CI：0.78-1.39;P=0.77)。进一步分析显示，环孢素未减少主要终点或其他事件的单个临床事件发生率，包括再梗死、不稳定心绞痛和卒中。两组间安全性无显著差异。

        参考文献：Cung TT ,et al. N Engl J Med.2015 Aug 30. [Epub ahead of print]

N Engl J Med. 2015 Aug 30. [Epub ahead of print]
Cyclosporine before PCI in Patients with Acute Myocardial Infarction.
Cung TT1, Morel O, Cayla G, Rioufol G, Garcia-Dorado D, Angoulvant D, Bonnefoy-Cudraz E, Guérin P, Elbaz M, Delarche N, Coste P, Vanzetto G, Metge M,Aupetit JF, Jouve B, Motreff P, Tron C, Labeque JN, Steg PG, Cottin Y, Range G, Clerc J, Claeys MJ, Coussement P, Prunier F, Moulin F, Roth O, Belle L, Dubois P, Barragan P, Gilard M, Piot C, Colin P, De Poli F, Morice MC, Ider O, Dubois-Randé JL, Unterseeh T, Le Breton H, Béard T, Blanchard D, Grollier G, Malquarti V, Staat P, Sudre A, Elmer E, Hansson MJ, Bergerot C, Boussaha I, Jossan C, Derumeaux G, Mewton N, Ovize M.
Author information
• 1From Centre Hospitalier Universitaire (CHU) Arnaud de Villeneuve (T.-T.C.) and Clinique du Millénaire (C.P.), Montpellier, Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg (O.M.), CHU de Nimes, Nimes (G.C.), Hôpital Cardiovasculaire Louis Pradel (G. Rioufol, E.B.-C., C.B., I.B., C.J., G.D., N.M., M.O.), Claude Bernard University (G. Rioufol, E.B.-C., C.B., I.B., C.J., G.D., N.M., M.O.), Centre Hospitalier Saint-Joseph et Saint-Luc (J.-F.A.), Clinique de la Sauvegarde (V.M.), Clinique du Tonkin (P.S.), Clinical Investigation Center and Explorations Fonctionnelles Cardiovasculaires (C.B., I.B., C.J., G.D., N.M., M.O.), Lyon, CHU de Tours (D.A.) and Clinique Saint-Gatien (D.B.), Tours, Hôpital Guillaume et René Laennec, Nantes (P.G.), CHU de Rangueil, Toulouse (M.E.), Centre Hospitalier de Pau, Pau (N.D.), Hôpital Haut Lévèque, Bordeaux (P. Coste), Hôpital A. Michallon-CHU de Grenoble, Grenoble (G.V.), Hôpital Henri Duffau, Avignon (M.M.), Centre Hospitalier du Pays d'Aix, Aix-en-Provence (B.J.), Hôpital Gabriel Montpied, Clermont Ferrand (P.M.), Hôpital Charles Nicolle, Rouen (C.T.), Clinique de la Fourcade, Bayonne (J.-N.L.), Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris (P.G.S.), Hôpital du Bocage, Dijon (Y.C.), Centre Hospitalier General, Chartres (G. Range), Centre Hospitalier de Compiègne, Compiègne (J.C.), CHU d'Angers, Angers (F.P.), CHU de Nancy-Brabois, Vandœuvre-lès-Nancy (F.M.), CHU de Mulhouse (O.R.) and Clinique du Diaconat (O.I.), Mulhouse, Centre Hospitalier d'Annecy, Annecy (L.B.), Polyclinique des Fleurs, Ollioules (P.B.), Hôpital de La Cavale Blanche, Brest (M.G.), Clinique Esquirol, Agen (P. Colin, F.D.P.), Institut Jacques Cartier, Massy (M.-C.M.), Centre Hospitalier Henri Mondor, Créteil (J.-L.D.-R.), Hôpital Claude Galien, Quincy sous Sénat (T.U.), Hôpital Pontchaillou, Rennes (H.L.B.), Clinique de l'Ormeau, Tarbes (T.B.), Hôpital de la Côte de Nacre, Caen (G.G.), and Hôpital Cardiologique Calmette, Lille (A.S.) - all in France; Hospital Universitari Vall d'Hebron, Barcelona (D.G.-D.); University Hospital Antwerp, Edegem (M.J.C.), Algemeen Ziekenhuis Sint Jan, Brugge (P. Coussement), and CHU de Charleroi, Charleroi (P.D.) - all in Belgium; and Department of Clinical Sciences, Lund University, Lund, Sweden (E.E., M.J.H.).
Abstract
Background Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size.
We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling.
Methods In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary recanalization. The primary outcome was a composite of death from any cause, worsening of heart failure during the initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year. Adverse left ventricular remodeling was defined as an increase of 15% or more in the left ventricular end-diastolic volume.
Results A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year. The rate of the primary outcome was 59.0% in the cyclosporine group and 58.1% in the control group (odds ratio, 1.04; 95% confidence interval [CI], 0.78 to 1.39; P=0.77). Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events, including recurrent infarction, unstable angina, and stroke. No significant difference in the safety profile was observed between the two treatment groups.
Conclusions In patients with anterior STEMI who had been referred for primary PCI, intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year. (Funded by the French Ministry of Health and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials.gov number, NCT01502774 ; EudraCT number, 2009-013713-99 .).