既往研究顯示環孢素能減少急性心肌梗死的麵積和再灌注損傷。多國學者們近期對環孢素是否能改善臨床結局以及是否能夠預防不良左心室重塑進行了研究，結果表明，與安慰劑相比，經皮冠脈介入治療(PCI)術前靜脈注射環孢素未能改善急性前壁ST段抬高心肌梗死(STEMI)的臨床預後，也並未防止1年時不良左心室重塑。相關論文近期在線發表於《新英格蘭醫學雜誌》(N Engl J Med)。

        該研究為一項多中心、雙盲隨機試驗，納入970例罪犯血管完全閉塞的急性前臂STEMI患者，在患者症狀發作的12小時內、冠脈再通前，隨機給予其靜脈注射環孢素(2.5mg/kg)或安慰劑。主要終點為1年內的全因死亡率，住院期間心衰加重或因心衰再入院和左室重塑(定義為左室舒張末容積增加15%及以上)。

        結果顯示，1年後，環孢素治療組和安慰劑組分別有395例和396例患者有足夠數據，以進行評估分析。治療組和對照組主要終點事件發生率分別為59%和58.1%(OR 1.04;95%CI：0.78-1.39;P=0.77)。進一步分析顯示，環孢素未減少主要終點或其他事件的單個臨床事件發生率，包括再梗死、不穩定心絞痛和卒中。兩組間安全性無顯著差異。

        參考文獻：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 .).