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001-es BibID:BIBFORM103936
035-os BibID:(WoS)000868254300009 (Scopus)85143055930
Első szerző:Aggarwal, Rohit
Cím:Trial of Intravenous Immune Globulin in Dermatomyositis / Aggarwal Rohit, Charles-Schoeman Christina, Schessl Joachim, Bata-Csörgő Zsuzsanna, Dimachkie Mazen M., Griger Zoltan, Moiseev Sergey, Oddis Chester, Schiopu Elena, Vencovsky Jiri, Beckmann Irene, Clodi Elisabeth, Bugrova Olga, Dankó Katalin, Ernste Floranne, Goyal Namita A., Heuer Marvin, Hudson Marie, Hussain Yessar M., Karam Chafic, Magnolo Nina, Nelson Ronald, Pozur Nataliia, Prystupa Liudmyla, Sárdy Miklós, Valenzuela Guillermo, van der Kooi Anneke J., Vu Tuan, Worm Margitta, Levine Todd, ProDERM Trial Group
Dátum:2022
ISSN:0028-4793
Megjegyzések:Background: Intravenous immune globulin (IVIG) for the treatment of dermatomyositis has not been extensively evaluated. Methods: We conducted a randomized, placebo-controlled trial involving patients with active dermatomyositis. The patients were assigned in a 1:1 ratio to receive IVIG at a dose of 2.0 g per kilogram of body weight or placebo every 4 weeks for 16 weeks. The patients who received placebo and those without confirmed clinical deterioration while receiving IVIG could enter an open-label extension phase for another 24 weeks. The primary end point was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score reflecting the change in a core set of six measures of myositis activity over time; scores range from 0 to 100, with higher scores indicating greater improvement. Key secondary end points included at least moderate improvement (TIS ?40) and major improvement (TIS ?60), and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index. Results: A total of 95 patients underwent randomization: 47 patients were assigned to the IVIG group, and 48 to the placebo group. At 16 weeks, 79% of the patients in the IVIG group (37 of 47) and 44% of those in the placebo group (21 of 48) had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<0.001). The results with respect to the secondary end points, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary end-point analysis, except for the change in creatine kinase level (an individual core measure of the TIS), which did not differ meaningfully between the two groups. Over 40 weeks, 282 treatment-related adverse events occurred in the IVIG group, including headache (in 42% of patients), pyrexia (in 19%), and nausea (in 16%). A total of 9 serious adverse events that were considered to be related to IVIG occurred, including 6 thromboembolic events. Conclusions: In this 16-week trial involving adults with dermatomyositis, the percentage of patients with a response of at least minimal improvement based on a composite score of disease activity was significantly greater among those who received IVIG than among those who received placebo. IVIG was associated with adverse events, including thromboembolism. (Funded by Octapharma Pharmazeutika; ProDERM ClinicalTrials.gov number, NCT02728752.).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal Of Medicine. - 387 : 14 (2022), p. 1264-1278. -
További szerzők:Charles-Schoeman, Christina Schessl, Joachim Bata-Csörgő Zsuzsanna Dimachkie, Mazen M. Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Moiseev, Sergey Oddis, Chester V. Schiopu, Elena Vencovsky, Jiri Beckmann, Irene Clodi, Elisabeth Bugrova, Olga Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Ernste, Floranne Goyal, Namita A. Heuer, Marvin Hudson, Marie Hussain, Yessar M. Karam, Chafic Magnolo, Nina Nelson, Ronald Pozur, Nataliia Prystupa, Liudmyla Sárdy Miklós Valenzuela, Guillermo van der Kooi, Anneke J. Vu, Tuan Worm, Margitta Levine, Todd ProDERM Trial Group
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2.

001-es BibID:BIBFORM033332
Első szerző:Alexander, John H.
Cím:Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome / Alexander John H., Lopes Renato D., James Stefan, Kilaru Rakhi, He Yaohua, Mohan Puneet, Bhatt Deepak L., Goodman Shaun, Verheugt Freek W., Flather Marcus, Huber Kurt, Liaw Danny, Husted Steen E., Lopez-Sendon Jose, De Caterina Raffaele, Jansky Petr, Darius Harald, Vinereanu Dragos, Cornel Jan H., Cools Frank, Atar Dan, Leiva-Pons Jose Luis, Keltai Matyas, Ogawa Hisao, Pais Prem, Parkhomenko Alexander, Ruzyllo Witold, Diaz Rafael, White Harvey, Ruda Mikhail, Geraldes Margarida, Lawrence Jack, Harrington Robert A., Wallentin Lars, for the APPRAISE-2 Investigators
Dátum:2011
ISSN:0028-4793
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:New England Journal Of Medicine. - 365 : 8 (2011), p. 699-708. -
További szerzők:Lopes, Renato D. James, Stefan Kilaru, Rakhi He, Yaohua Mohan, Puneet Bhatt, Deepak L. Goodman, Shaun Verheugt, Freek W. Flather, Marcus Huber, Kurt Liaw, Danny Husted, Steen Lopez-Sendon, Jose De Caterina, Raffaele Jansky, Petr Darius, Harald Vinereanu, Dragos Cornel, Jan H. Cools, Frank Atar, Dan Leiva-Pons, Jose Luis Keltai Mátyás (1942-) (kardiológus) Ogawa, Hisao Pais, Prem Parkhomenko, Alexander Ruzyllo, Witold Diaz, Rafael White, Harvey Ruda, Mikhail Geraldes, Margarida Lawrence, Jack Harrington, Robert A. Wallentin, Lars Soltész Pál (1961-) (belgyógyász, kardiológus) for the APPRAISE-2 Investigators
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3.

001-es BibID:BIBFORM020688
Első szerző:Barrett-Connor, Elizabeth
Cím:Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women / Barrett-Connor E., Mosca L., Collins P., Geiger M. J., Grady D., Kornitzer M., McNabb M. A., Wenger N. K., the Raloxifene Use for The Heart (RUTH) Trial Investigators
Dátum:2006
Megjegyzések:The effect of raloxifene, a selective estrogen-receptor modulator, on coronary heart disease (CHD) and breast cancer is not established. METHODS: We randomly assigned 10,101 postmenopausal women (mean age, 67.5 years) with CHD or multiple risk factors for CHD to 60 mg of raloxifene daily or placebo and followed them for a median of 5.6 years. The two primary outcomes were coronary events (i.e., death from coronary causes, myocardial infarction, or hospitalization for an acute coronary syndrome) and invasive breast cancer. RESULTS: As compared with placebo, raloxifene had no significant effect on the risk of primary coronary events (533 vs. 553 events; hazard ratio, 0.95; 95 percent confidence interval, 0.84 to 1.07), and it reduced the risk of invasive breast cancer (40 vs. 70 events; hazard ratio, 0.56; 95 percent confidence interval, 0.38 to 0.83; absolute risk reduction, 1.2 invasive breast cancers per 1000 women treated for one year); the benefit was primarily due to a reduced risk of estrogen-receptor-positive invasive breast cancers. There was no significant difference in the rates of death from any cause or total stroke according to group assignment, but raloxifene was associated with an increased risk of fatal stroke (59 vs. 39 events; hazard ratio, 1.49; 95 percent confidence interval, 1.00 to 2.24; absolute risk increase, 0.7 per 1000 woman-years) and venous thromboembolism (103 vs. 71 events; hazard ratio, 1.44; 95 percent confidence interval, 1.06 to 1.95; absolute risk increase, 1.2 per 1000 woman-years). Raloxifene reduced the risk of clinical vertebral fractures (64 vs. 97 events; hazard ratio, 0.65; 95 percent confidence interval, 0.47 to 0.89; absolute risk reduction, 1.3 per 1000). CONCLUSIONS: Raloxifene did not significantly affect the risk of CHD. The benefits of raloxifene in reducing the risks of invasive breast cancer and vertebral fracture should be weighed against the increased risks of venous thromboembolism and fatal stroke. (ClinicalTrials.gov number, NCT00190593 [ClinicalTrials.gov].).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:The New England Journal of Medicine. - 355 : 2 (2006), p. 125-137. -
További szerzők:Mosca, Lori Collins, Peter Geiger, Mary Jane Grady, Deborah Kornitzer, Marcel McNabb, Michelle A. Wenger, Nanette K. Czuriga István (1948-2018) (kardiológus) the Raloxifene Use for The Heart (RUTH) Trial Investigators
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4.

001-es BibID:BIBFORM099099
Első szerző:Bonaca, Marc P.
Cím:Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction / Bonaca Marc P., Bhatt Deepak L., Cohen Marc, Steg Philippe Gabriel, Storey Robert F., Jensen Eva C., Magnani Giulia, Bansilal Sameer, Fish M. Polly, Im Kyungah, Bengtsson Olof, Ophuis Ton Oude, Budaj Andrzej, Theroux Pierre, Ruda Mikhail, Hamm Christian, Goto Shinya, Spinar Jindrich, Nicolau José Carlos, Kiss Robert G., Murphy Sabina A., Wiviott Stephen D., Held Peter, Braunwald Eugene, Sabatine Marc S., PEGASUS-TIMI 54 Steering Committee and Investigators
Dátum:2015
ISSN:0028-4793
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:New England Journal Of Medicine. - 372 : 19 (2015), p. 1791-1800. -
További szerzők:Bhatt, Deepak L. Cohen, Marc A. Steg, Philippe Gabriel Storey, Robert F. Jensen, Eva C. Magnani, Giulia Bansilal, Sameer Fish, M. Polly Im, Kyungah Bengtsson, Olof Ophuis, Ton Oude Budaj, Andrzej Theroux, Pierre Ruda, Mikhail Hamm, Christian Goto, Shinya Špinar, Jindrich Nicolau, José Carlos Kiss Róbert Gábor Murphy, Sabina A. Wiviott, Stephen D. Held, Peter Braunwald, Eugene Sabatine, Marc S. Jenei Csaba (1976-) (kardiológus) PEGASUS-TIMI 54 Steering Committee and Investigators
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5.

001-es BibID:BIBFORM013545
Első szerző:Boztug, Kaan
Cím:Stem-cell gene therapy for the Wiskott-Aldrich syndrome / Kaan Boztug, Manfred Schmidt, Adrian Schwarzer, Pinaki P. Banerjee, Inés Avedillo Díez, Ricardo A. Dewey, Marie Böhm, Ali Nowrouzi, Claudia R. Ball, Hanno Glimm, Sonja Naundorf, Klaus Kühlcke, Rainer Blasczyk, Irina Kondratenko, László Maródi, Jordan S. Orange, Christof von Kalle, Christoph Klein
Dátum:2010
ISSN:0028-4793
Megjegyzések:The Wiskott-Aldrich syndrome (WAS) is an X-linked recessive primary immunodeficiency disorder associated with thrombocytopenia, eczema, and autoimmunity. We treated two patients who had this disorder with a transfusion of autologous, genetically modified hematopoietic stem cells (HSC). We found sustained expression of WAS protein expression in HSC, lymphoid and myeloid cells, and platelets after gene therapy. T and B cells, natural killer (NK) cells, and monocytes were functionally corrected. After treatment, the patients' clinical condition markedly improved, with resolution of hemorrhagic diathesis, eczema, autoimmunity, and predisposition to severe infection. Comprehensive insertion-site analysis showed vector integration that targeted multiple genes controlling growth and immunologic responses in a persistently polyclonal hematopoiesis. (Funded by Deutsche Forschungsgemeinschaft and others; German Clinical Trials Register number, DRKS00000330.).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:New England Journal of Medicine. - 363 : 20 (2010), p. 1918-1927. -
További szerzők:Schmidt, Manfred Schwarzer, Adrian Banerjee, Pinaki P. Avedillo Díez, Inés Dewey, Ricardo A. Böhm, Marie Nowrouzi, Ali Ball, Claudia Regina Glimm, Hanno Naundorf, Sonja Kühlcke, Klaus Blasczyk, Rainer Kondratenko, Irina Maródi László (1949-) (gyermekgyógyász infektológus, immunológus) Orange, Jordan S. Kalle, Christof, von Klein, Christoph
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6.

001-es BibID:BIBFORM077367
035-os BibID:(WoS)000423233400006 (Scopus)85041389324
Első szerző:Connors, Joseph M.
Cím:Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin's Lymphoma / J. M. Connors, W. Jurczak, D. J. Straus, S. M. Ansell, W. S. Kim, A. Gallamini, A. Younes, S. Alekseev, Á. Illés, M. Picardi, E. Lech-Maranda, Y. Oki, T. Feldman, P. Smolewski, K. J. Savage, N. L. Bartlett, J. Walewski, R. Chen, R. Ramchandren, P. L. Zinzani, D. Cunningham, A. Rosta, N. C. Josephson, E. Song, J. Sachs, R. Liu, H. A. Jolin, D. Huebner, J. Radford, ECHELON-1 Study Group
Dátum:2018
ISSN:0028-4793
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal of Medicine. - 378 : 9 (2018), p. 331-344. -
További szerzők:Jurczak, Wojciech Straus, David J. Ansell, Stephen M. Kim, Won Seog Gallamini, Andrea Younes, Anas Alekseev, Sergey Illés Árpád (1959-) (belgyógyász, haematológus, onkológus) Picardi, Marco Lech-Maranda, Ewa Oki, Yasuhiro Feldman, Tatyana Smolewski, Piotr Savage, Kerry J. Bartlett, Nancy L. Walewski, Jan Chen, Robert Ramchandren, Radhakrishnan Zinzani, Pier Luigi Cunningham, David Rosta András Josephson, Neil C. Song, Eric Sachs, Jessica Liu, Rachael Jolin, Hina A. Huebner, Dirk Radford, John ECHELON-1 Study Group
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7.

001-es BibID:BIBFORM105335
035-os BibID:(WoS)000888836400009 (Scopus)85144448744
Első szerző:Das Pradhan, Aruna
Cím:Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk / Das Pradhan Aruna, Glynn Robert J., Fruchart Jean-Charles, MacFadyen Jean G., Zaharris Elaine S., Everett Brendan M., Campbell Stuart E., Oshima Ryu, Amarenco Pierre, Blom Dirk J., Brinton Eliot A., Eckel Robert H., Elam Marshall B., Felicio Joao S., Ginsberg Henry N., Goudev Assen, Ishibashi Shun, Joseph Jacob, Kodama Tatsuhiko, Koenig Wolfgang, Leiter Lawrence A., Lorenzatti Alberto J., Mankovsky Boris, Marx Nikolaus, Nordestgaard Børge G., Páll Dénes, Ray Kausik K., Santos Raul D., Soran Handrean, Susekov Andrey, Tendera Michal, Yokote Koutaro, Paynter Nina P., Buring Julie E., Libby Peter, Ridker Paul M., PROMINENT Investigators
Dátum:2022
ISSN:0028-4793
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal Of Medicine. - 387 : 21 (2022), p. 1923-1934. -
További szerzők:Glynn, Robert J. Fruchart, Jean-Charles MacFadyen, Jean G. Zaharris, Elaine S. Everett, Brendan M. Campbell, Stuart E. Oshima, Ryu Amarenco, Pierre Blom, Dirk J. Brinton, Eliot A. Eckel, Robert H. Elam, Marshall B. Felicio, Joāo S. Ginsberg, Henry N. Goudev, Assen Ishibashi, Shun Joseph, Jacob Kodama, Tatsuhiko Koenig, Wolfgang Leiter, Lawrence A. Lorenzatti, Alberto J. Mankovsky, Boris N. Marx, Nikolaus Nordestgaard, Børge G. Páll Dénes (1967-) (belgyógyász, kardiológus) Ray, Kausik K. Santos, Raul D. Soran, Handrean Susekov, Andrey Tendera, Michal Yokote, Koutaro Paynter, Nina P. Buring, Julie E. Libby, Peter Ridker, Paul M. PROMINENT Investigators
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8.

001-es BibID:BIBFORM013825
Első szerző:Decousus, Hervé
Cím:Fondaparinux for the Treatment of Superficial-Vein Thrombosis in the Legs / Hervé Decousus, Paolo Prandoni, Patrick Mismetti, Rupert M. Bauersachs, Zoltán Boda, Benjamin Brenner, Silvy Laporte, Lajos Matyas, Saskia Middeldorp, German Sokurenko, Alain Leizorovicz, The CALISTO Study Group
Dátum:2010
Megjegyzések:The efficacy and safety of anticoagulant treatment for patients with acute, symptomaticsuperficial-vein thrombosis in the legs, but without concomitant deep-veinthrombosis or symptomatic pulmonary embolism at presentation, have not been established.MethodsIn a randomized, double-blind trial, we assigned 3002 patients to receive either fondaparinux,administered subcutaneously at a dose of 2.5 mg once daily, or placebo for45 days. The primary efficacy outcome was a composite of death from any cause orsymptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomaticextension to the saphenofemoral junction or symptomatic recurrence ofsuperficial-vein thrombosis at day 47. The main safety outcome was major bleeding.The patients were followed until day 77.ResultsThe primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinuxgroup and 88 of 1500 patients (5.9%) in the placebo group (relative riskreduction with fondaparinux, 85%; 95% confidence interval [CI], 74 to 92; P<0.001).The incidence of each component of the primary efficacy outcome was significantlyreduced in the fondaparinux group as compared with the placebo group, except forthe outcome of death (0.1% in both groups). The rate of pulmonary embolism ordeep-vein thrombosis was 85% lower in the fondaparinux group than in the placebogroup (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions wereobserved at day 77. A total of 88 patients would need to be treated to prevent oneinstance of pulmonary embolism or deep-vein thrombosis. Major bleeding occurredin one patient in each group. The incidence of serious adverse events was 0.7% withfondaparinux and 1.1% with placebo.ConclusionsFondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatmentof patients with acute, symptomatic superficial-vein thrombosis of the legsand did not have serious side effects.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:The New England Journal of Medicine. - 363 : 13 (2010), p. 1222-1232. -
További szerzők:Prandoni, Paolo Mismetti, Patrick Bauersachs, Rupert M. Boda Zoltán (1947-) (belgyógyász, haematologus, klinikai onkológus) Brenner, Benjamin Laporte, Silvy Mátyás Lajos Middeldorp, Saskia Sokurenko, German Leizorovicz, Alain The CALISTO Study Group
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elektronikus változat
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9.

001-es BibID:BIBFORM091915
035-os BibID:(WoS)000562771200009 (Scopus)85089407724
Első szerző:DiNardo, Courtney D.
Cím:Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia / C. D. DiNardo, B. A. Jonas, V. Pullarkat, M. J. Thirman, J. S. Garcia, A. H. Wei, M. Konopleva, H. Döhner, A. Letai, P. Fenaux, E. Koller, V. Havelange, B. Leber, J. Esteve, J. Wang, V. Pejsa, R. Hájek, K. Porkka, Á. Illés, D. Lavie, R. M. Lemoli, K. Yamamoto, S.-S. Yoon, J. H. Jang, Su-Peng Yeh, M. Turgut, Wan-Jen Hong, Y. Zhou, J. Potluri, K. W. Pratz
Dátum:2020
ISSN:0028-4793
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal Of Medicine. - 383 : 7 (2020), p. 617-629. -
További szerzők:Jonas, Brian A. Pullarkat, Vinod Thirman, Michael J. Garcia, Jacqueline S. Wei, Andrew H. Konopleva, Marina Döhner, Hartmut Letai, Anthony Fenaux, Pierre Koller, Elizabeth Havelange, Violaine Leber, Brian Esteve, Jordi Wang, Jianxiang Pejsa, Vlatko Hájek, Roman Porkka, Kimmo Illés Árpád (1959-) (belgyógyász, haematológus, onkológus) Lavie, David Lemoli, Roberto M. Yamamoto, Kazuhito Yoon, Sung-Soo Jang, Jun Ho Yeh, Su-Peng Turgut, Mehmet Hong, Wan-Jen Zhou, Ying Potluri, Jalaja Pratz, Keith W.
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10.

001-es BibID:BIBFORM026616
Első szerző:Farid, Nadir R.
Cím:To the editor / Nadir R. Farid, Edit Bodolay, Csaba Balázs, Valeria Stenszky
Dátum:1987
Tárgyszavak:Orvostudományok Klinikai orvostudományok szerkesztői levél
Megjelenés:The New England journal of medicine. - 317 (1987), p. 248. -
További szerzők:Bodolay Edit (1950-) (belgyógyász, allergológus és klinikai immunológus) Balázs Csaba Stenszky Valéria
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11.

001-es BibID:BIBFORM072422
Első szerző:Feagan, Brian
Cím:Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease / Feagan B. G., Sandborn W. J., Gasink C., Jacobstein D., Lang Y., Friedman J. R., Blank M. A., Johanns J., Gao L. L., Miao Y., Adedokun O. J., Sands B. E., Hanauer S. B., Vermeire S., Targan S., Ghosh S., de Villiers W. J., Colombel J. F., Tulassay Z., Seidler U., Salzberg B. A., Desreumaux P., Lee S. D., Loftus E. V. Jr., Dieleman L. A., Katz S., Rutgeerts P., UNITI-IM-UNITI Study Group
Dátum:2016
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
ustekinumab, Crohn's disease
Megjelenés:The New England journal of medicine 375 : 20 (2016), p. 1946-1960. -
További szerzők:Sandborn, William J. Gasink, C. Jacobstein, D. Lang, Y. Friedman, J. Blank, Marion Johanns, Jewel Gao, L. L. Miao, Y. Adedokun, Omoniyi J. Sands, Bruce E. Hanauer, Stephen B. Vermeire, S. Targan, Stephan Ghosh, Subrata de Villiers, W. J. Colombel, J. F. Tulassay Zsolt (1944-) (belgyógyász, gasztroenterológus) Seidler, U. Salzberg, B. A. Desreumaux, P. Lee, S. D. Loftus, Edward V. Dieleman, L. A. Katz, Seymour Rutgeerts, Paul Altorjay István (1954-) (belgyógyász, gasztroenterológus, onkológus) UNITI-IM-UNITI Study Group
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12.

001-es BibID:BIBFORM010419
Első szerző:Giugliano, Robert P.
Cím:Early versus delayed, provisional eptifibatide in acute coronary syndromes / Giugliano, R. P., White, J. A., Bode, C., Armstrong, P. W., Montalescot, G., Lewis, B. S., van't Hof, A., Berdan, L. G., Lee, K. L., Strony, J. T., Hildemann, S., Veltri, E., Van de Werf, F., Braunwald, E., Harrington, R. A., Califf, R. M., Newby, L. K., The EARLY ACS Investigators, Keltai M.
Dátum:2009
ISSN:1533-4406 (Electronic)
Megjegyzések:Glycoprotein IIb/IIIa inhibitors are indicated in patients with acute coronary syndromes who are undergoing an invasive procedure. The optimal timing of the initiation of such therapy is unknown. METHODS: We compared a strategy of early, routine administration of eptifibatide with delayed, provisional administration in 9492 patients who had acute coronary syndromes without ST-segment elevation and who were assigned to an invasive strategy. Patients were randomly assigned to receive either early eptifibatide (two boluses, each containing 180 microg per kilogram of body weight, administered 10 minutes apart, and a standard infusion &gt; or = 12 hours before angiography) or a matching placebo infusion with provisional use of eptifibatide after angiography (delayed eptifibatide). The primary efficacy end point was a composite of death, myocardial infarction, recurrent ischemia requiring urgent revascularization, or the occurrence of a thrombotic complication during percutaneous coronary intervention that required bolus therapy opposite to the initial study-group assignment ("thrombotic bailout") at 96 hours. The key secondary end point was a composite of death or myocardial infarction within the first 30 days. Key safety end points were bleeding and the need for transfusion within the first 120 hours after randomization. RESULTS: The primary end point occurred in 9.3% of patients in the early-eptifibatide group and in 10.0% in the delayed-eptifibatide group (odds ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.23). At 30 days, the rate of death or myocardial infarction was 11.2% in the early-eptifibatide group, as compared with 12.3% in the delayed-eptifibatide group (odds ratio, 0.89; 95% CI, 0.79 to 1.01; P=0.08). Patients in the early-eptifibatide group had significantly higher rates of bleeding and red-cell transfusion. There was no significant difference between the two groups in rates of severe bleeding or nonhemorrhagic serious adverse events. CONCLUSIONS: In patients who had acute coronary syndromes without ST-segment elevation, the use of eptifibatide 12 hours or more before angiography was not superior to the provisional use of eptifibatide after angiography. The early use of eptifibatide was associated with an increased risk of non-life-threatening bleeding and need for transfusion.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Acute Coronary Syndrome
Aged
Angina Pectoris
Angioplasty, Transluminal, Percutaneous Coronary
Combined Modality Therapy
Coronary Angiography
Coronary Artery Bypass
Drug Administration Schedule
Drug Therapy, Combination
Electrocardiography
Female
Hemorrhage
Humans
Infusions, Intravenous
Kaplan-Meiers Estimate
Male
Middle Aged
Myocardial Infarction
Odds Ratio
Peptides
dosage
Platelet Aggregation Inhibitors
dosage
Platelet Glycoprotein GPIIb-IIIa Complex
inhibitors
Thrombosis
control
Treatment Failure
Megjelenés:The New England Journal of Medicine. - 360 : 21 (2009), p. 2176-2190. -
További szerzők:White, Jennifer A. Bode, Christoph Armstrong, Paul W. Montalescot, Gilles Lewis, Basil S. van't Hof, Arnoud Berdan, Lisa G. Lee, Kerry L. Strony, John T. Hildemann, Steven Veltri, Enrico Werf, Frans, van de Braunwald, Eugene Harrington, Robert A. Califf, Robert M. Newby, L. Kristin Keltai Mátyás (1942-) (kardiológus) The EARLY ACS Investigators
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
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