A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results
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A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results (129 visite)

Saccà F, Quarantelli M, Rinaldi C, Tucci T, Piro R, Perrotta G, Carotenuto B, Marsili A, Palma V, De Michele G, Brunetti A, Brescia Morra V, Filla A, Salvatore M

J Neurol (ISSN: 1432-1459, 0340-5354, 1432-1459electronic), 2012 Jan; 259(1): 132-138.



Tipo di articolo: Journal Article, Clinical Trial, Phase Ii, Randomized Controlled Trial, Research Support, Non-U. S. Gov'T,

Impact factor: 3.578, Impact factor a 5 anni: 3.598

Url: http://www.scopus.com/inward/record.url?eid=2-s2.0-84856701376&partnerID=40&md5=9adf7ccdcb1d74076ea7dad4ceb8723a

Parole chiave: Amyotrophic Lateral Sclerosis, Growth Hormone, Homa-Ir, Igf-I, Igfbp-3, Insulin, Arginine, Choline, Creatine, Gonadorelin, Human Growth Hormone, N Acetylaspartic Acid, Placebo, Riluzole, Somatomedin Binding Protein 3, Adult, Aged, Amyotrophic Lateral Sclerosis Functional Rating Scale Revised, Clinical Article, Controlled Study, Disease Course, Disease Duration, Disease Severity, Double Blind Procedure, Drug Dose Increase, Female, Glucose Blood Level, Growth Hormone Deficiency, Hormone Determination, Hypertension, Injection Site Reaction, Insulin Resistance, Joint Stiffness, Joint Swelling, Limb Weakness, Mortality, Motor Cortex, Motor Performance, Neuroimaging, Nuclear Magnetic Resonance Spectroscopy, Peripheral Edema, Phase 2 Clinical Trial, Priority Journal, Randomized Controlled Trial, Side Effect, 80 And Over, Double-Blind Method, Endpoint Determination, Image Processing, Computer-Assisted, Insulin-Like Growth Factor Binding Protein 3, Magnetic Resonance Imaging, Middle Aged, Neuroprotective Agents, Recombinant Proteins,

Affiliazioni:

*** IBB - CNR ***
Department of Neurological Sciences, University Federico II, Via Pansini, 5, 80131 Naples, NA, Italy. francesco.sacca@unina.it
Biostructure and Bioimaging Institute, National Research Council, Naples, Italy
U.O.C. Neurofisiopatologia, PO S. Gennaro ASL Napoli 1, Naples, Italy
U. O. C. Neurofisiopatologia, PO S. Gennaro ASL Napoli 1, Naples, Italy


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Amyotrophic lateral sclerosis (ALS) is a fatal neurological disease with motor neuron degeneration. Riluzole is the only available treatment. Two-thirds of ALS patients present with growth hormone (GH) deficiency. The aim of this study is to determine if add-on of GH to riluzole, with an individually regulated dose based on Insulin-like growth factor 1 (IGF-I) production, was able to reduce neuronal loss in the motor cortex, reduce mortality, and improve motor function of ALS patients. Patients with definite/probable ALS, in treatment with riluzole, aged 40-85 years, and with disease duration ≥3 years were enrolled. The study was randomized, placebo controlled, and double blind. Before treatment, patients were tested with a GH releasing hormone (GHRH) + arginine test. The initial dose of GH was 2 IU s.c. every other day, and was progressively increased to a maximum of 8 IU. Primary endpoint was N-acetylaspartate/(creatine + choline) (NAA/Cre + Cho) ratio in motor cortex assessed by magnetic resonance spectroscopy performed at months 0, 6, and 12. Secondary endpoints were mortality and ALS functional rating scale revised (ALSFRS-R). The NAA/(Cre + Cho) ratio decreased in all patients who completed the trial. No significant difference was noted between treated and placebo group. At baseline, although IGF-I levels were within the normal range, 73% of patients had GH deficiency, being severe in half of them. Compared with bulbar onset, spinal-onset patients showed more depressed GH response to the GHRH + arginine stimulation test (10.4 ± 7.0 versus 15.5 ± 8.1 ng/mL; p < 0.05). Insulin resistance [homeostasis model assessment of insulin resistance (HOMA-IR)] increased from 2.1 ± 1.0 at baseline to 4.6 ± 1.9 at 12 months (p < 0.001). Insulin-like growth factor (IGF) binding protein 3 (IGFBP-3) decreased from 8,435 ± 4,477 ng/mL at baseline to 3,250 ± 1,780 ng/mL at 12 months (p < 0.001). The results show that GH exerted no effect on cerebral NAA or clinical progression assessed by ALSFRS-R. Two-thirds of ALS patients had GH deficit, with higher levels in the bulbar-onset group. During follow-up, patients showed progressive increase in HOMA-IR and decrease in IGFBP-3 levels. © 2011 Springer-Verlag.
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Milardi D, Pappalardo M, Grasso DM, La Rosa C
* Unveiling the unfolding pathway of FALS associated G37R SOD1 mutant: A computational study (105 visite)
Mol Biosyst (ISSN: 1742-206x), 2010; 6(6): 1032-1039.
Impact Factor: 3.825
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Cittadini A, Saldamarco L, Marra AM, Arcopinto M, Carlomagno G, Imbriaco M, Del Forno D, Vigorito C, Merola B, Oliviero U, Fazio S, Sacca L
* Growth Hormone Deficiency in Patients with Chronic Heart Failure and Beneficial Effects of Its Correction (137 visite)
Journal Of Clinical Endocrinology & Metabolism (ISSN: 0021-972x), 2009 Sep; 94(9): 3329-3336.
Impact Factor: 6.202
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D'Ambrosio K, Limauro D, Pedone E, Galdi I, Pedone C, Bartolucci S, De Simone G
* Insights into the catalytic mechanism of the Bcp family: functional and structural analysis of Bcp1 from Sulfolobus solfataricus (152 visite)
Proteins (ISSN: 1097-0134, 0887-3585, 1097-0134electronic), 2009 Sep; 76(4): 995-1006.
Impact Factor: 3.085
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Carriero MV, Longanesi-cattani I, Bifulco K, Maglio O, Lista L, Barbieri A, Votta G, Masucci MT, Arra C, Franco R, De Rosa M, Stoppelli MP, Pavone V
* Structure-based design of an urokinase-type plasminogen activator receptor-derived peptide inhibiting cell migration and lung metastasis (136 visite)
Mol Cancer Ther Molecular Cancer Therapeutics (ISSN: 1535-7163, 1538-8514electronic, 1535-7163linking), 2009 Sep; 8(9): 2708-2717.
Impact Factor: 4.953
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Sacca F, Quarantelli M, Rinaldi C, Tucci T, Piro R, Carotenuto B, Marsili A, Palma V, Bresciamorra V, Brunetti A, De Michele G, Filla A, Salvatore M
* A Double-Blind, Placebo-Controlled, Randomized Trial of Growth Hormone as Add-On Therapy to Riluzole in Patients with Amyotrophic Lateral Sclerosis: Preliminary MRS, Hormonal, and Population Analysis (169 visite)
Neurology (ISSN: 0028-3878, 1526-632x, 1526-632xelectronic), 2009 Mar 17; 72(11): N/D-N/D.
Impact Factor: 8.172
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Sacca F, Quarantelli M, Rinaldi C, Tucci T, Piro R, Carotenuto B, Marsili A, Palma V, Bresciamorra V, Brunetti A, De Michele G, Filla A, Salvatore M
* A Randomized Trial of Growth Hormone as Add. On Therapy to Riluzole in Patients with Amyotrophic Lateral Sclerosis (117 visite)
Neurology (ISSN: 0028-3878, 1526-632x, 1526-632xelectronic), 2009 Mar 17; 76(9): N/D-N/D.
Impact Factor: 8.172
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Cittadini A, Monti MG, Castiello MC, D'Arco E, Galasso G, Sorriento D, Saldamarco L, De Paulis A, Napoli R, Iaccarino G, Saccà L
* Insulin-like growth factor-1 protects from vascular stenosis and accelerates re-endothelialization in a rat model of carotid artery injury (111 visite)
J Thromb Haemost Journal Of Thrombosis And Haemostasis (ISSN: 1538-7933), 2009; 7(11): 1920-1928.
Impact Factor: 6.069
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Dudar GK, D'Andrea LD, Di Stasi R, Pedone C, Wallace JL
* A vascular endothelial growth factor mimetic accelerates gastric ulcer healing in an iNOS-dependent manner (147 visite)
Am J Physiol Gastrointest Liver Physiol American Journal Of Physiology Gastrointestinal And Liver Physiology (ISSN: 0193-1857), 2008 Sep; 295(2): G374-G374.
Impact Factor: 3.587
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De Simone A, Vitagliano L, Berisio R
* Role of hydration in collagen triple helix stabilization (119 visite)
Biochem Biophys Res Commun (ISSN: 0006-291x), 2008 Jul 18; 372(1): 121-125.
Impact Factor: 2.648
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Gallotta G, Palmieri V, Piedimonte V, Rendina D, De Bonis S, Russo V, Celentano A, Di Minno M, Postiglione A, Di Minno G
* Increased troponin I predicts in-hospital occurrence of hemodynamic instability in patients with sub-massive or non-massive pulmonary embolism independent to clinical, echocardiographic and laboratory information (94 visite)
Int J Cardiol (ISSN: 0167-5273, 1874-1754electronic, 0167-5273linking), 2008 Mar 14; 124(3): 351-357.
Impact Factor: 3.121
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Calabrese V, Mancuso C, Calvani M, Rizzarelli E, Butterfield DA, Stella AM
* Nitric oxide in the central nervous system: neuroprotection versus neurotoxicity (225 visite)
Nature Reviews Neuroscience (ISSN: 1471-0048), 2007 Oct; 8(10): 766-775.
Impact Factor: 24.52
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Ragno R, Simeoni S, Castellano S, Vicidomini C, Mai A, Caroli A, Tramontano A, Bonaccini C, Trojer P, Bauer I, Brosch G, Sbardella G
* Small molecule inhibitors of histone arginine methyltransferases: Homology modeling, molecular docking, binding mode analysis, and biological evaluations (151 visite)
J Med Chem (ISSN: 0022-2623, 1520-4804, 0022-2623print), 2007 Mar 22; 50(6): 1241-1253.
Impact Factor: 4.895
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D'Auria S, Varriale A, Gonnelli M, Saviano M, Staiano M, Rossi M, Strambini GB
* Tryptophan phosphorescence studies of the D-galactose/ D-glucose-binding protein from Escherichia coli provide a molecular portrait with structural and dynamics features of the protein (388 visite)
J Proteome Res (ISSN: 1535-3893), 2007; 6(4): 1306-1312.
Impact Factor: 5.675
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D'Andrea LD, Del Gatto A, Pedone C, Benedetti E
* Peptide-based molecules in angiogenesis (156 visite)
Chem Biol Drug Des Chemical Biology And Drug Design (ISSN: 1747-0277, 1747-0285), 2006 Feb; 67(2): 115-126.
Impact Factor: 2.507
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Cittadini A, Monti MG, Iaccarino G, Di Rella F, Tsichlis PN, Di Gianni A, Strömer H, Sorriento D, Peschle C, Trimarco B, Saccà L, Condorelli G
* Adenoviral gene transfer of Akt enhances myocardial contractility and intracellular calcium handling (122 visite)
Gene Ther (ISSN: 0969-7128, 0969-7128linking), 2006; 13(1): 8-19.
Impact Factor: 4.782
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Colao A, Di Somma C, Cuocolo A, Spinelli L, Acampa W, Spiezia S, Rota F, Savanelli MC, Lombardi G
* Does a gender-related effect of growth hormone (GH) replacement exist on cardiovascular risk factors, cardiac morphology, and performance and atherosclerosis? Results of a two-year open, prospective study in young adult men and women with severe GH deficiency (122 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2005 Sep; 90(9): 5146-5155.
Impact Factor: 6.02
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Di Costanzo L, Geremia S, Randaccio L, Nastri F, Maglio O, Lombardi A, Pavone V
* Miniaturized heme proteins: crystal structure of Co(III)-mimochrome IV (123 visite)
J Biol Inorg Chem (ISSN: 0949-8257, 1432-1327electronic, 0949-8257print), 2004 Dec; 9(8): 1017-1027.
Impact Factor: 3.3
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Colao A, Di Somma C, Cuocolo A, Filippella M, Rota F, Acampa W, Savastano S, Salvatore M, Lombardi G
* The severity of growth hormone deficiency correlates with the severity of cardiac impairment in 100 adult patients with hypopituitarism: An observational, case-control study (114 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2004 Dec; 89(12): 5998-6004.
Impact Factor: 5.778
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Galdiero S, Gouaux E
* High Resolution Crystallographic Studies Of Alpha-Hemolysin-Phospholipid Complexes Define Heptamer-Lipid Head Group Interactions: Implication For Understanding Protein-Lipid Interactions (108 visite)
Protein Sci (ISSN: 0961-8368, 1469-896xelectronic), 2004 Jun; 13(6): 1503-1511.
Impact Factor: 4.116
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Iaccarino G, Ciccarelli M, Sorriento D, Cipolletta E, Cerullo V, Iovino GL, Paudice A, Elia A, Santulli G, Campanile A, Arcucci O, Pastore L, Salvatore F, Condorelli G, Trimarco B
* AKT participates in endothelial dysfunction in hypertension (96 visite)
Circulationcirculation (ISSN: 0009-7322), 2004; 109(21): 2587-2593.
Impact Factor: 12.563
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Vitagliano L, Ruggiero A, Masullo M, Cantiello P, Arcari P, Zagari A
* The Crystal Structure Of Sulfolobus Solfataricus Elongation Factor 1 Alpha In Complex With Magnesium And Gdp (172 visite)
Biochemistry (ISSN: 0006-2960, 1520-4995, 1520-4995electronic), 2004; 43(21): 6630-6636.
Impact Factor: 4.008
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Spinelli L, Petretta M, Verderame G, Carbone G, Venetucci AA, Petretta A, Acampa W, Bonaduce D, Colao A, Cuocolo A
* Left ventricular diastolic function and cardiac performance during exercise in patients with acromegaly (115 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2003 Sep; 88(9): 4105-4109.
Impact Factor: 5.873
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De Luca S, Ulhaq S, Dixon M J, EssexJ, Bradley M
* Solid-phase synthesis of a focused library of trypanothione reductase inhibitors (112 visite)
Tetrahedron Lett (ISSN: 0040-4039), 2003 Apr 7; 44(15): 3195-3197.
Impact Factor: 2.326
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Colao A, Marzullo P, Cuocolo A, Spinelli L, Pivonello R, Bonaduce D, Salvatore M, Lombardi G
* Reversal of acromegalic cardiomyopathy in young but not in middle-aged patients after 12 months of treatment with the depot long-acting somatostatin analogue octreotide (124 visite)
Clin Endocrinol (ISSN: 0300-0664, 1365-2265, 1365-2265electronic), 2003 Feb; 58(2): 169-176.
Impact Factor: 2.767
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Leosco D, Iaccarino G, Cipolletta E, De Santis D, Pisani E, Trimarco V, Ferrara N, Abete P, Sorriento D, Rengo F, Trimarco B
* Exercise restores β-adrenergic vasorelaxation in aged rat carotid arteries (105 visite)
Am J Physiol Heart Circ Physiol American Journal Of Physiology Heart And Circulatory Physiology (ISSN: 0363-6135), 2003; 285(154-1): H369-H369.
Impact Factor: 3.658
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Esposito G, Ligresti A, Izzo AA, Bisogno T, Ruvo M, Di Rosa M, Di Marzo V, Iuvone T
* The endocannabinoid system protects rat glioma cells against HIV-1 Tat protein-induced cytotoxicity: Mechanism and regulation (107 visite)
J Biol Chem Journal Of Biological Chemistry (ISSN: 0021-9258, 1083-351x), 2002 Dec 27; 277(52): 50348-50354.
Impact Factor: 6.696
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Esposito G, Vitagliano L, Santamaria R, Viola A, Zagari A, Salvatore F
* Structural and functional analysis of aldolase B mutants related to hereditary fructose intolerance (105 visite)
Febs Lett (ISSN: 0014-5793, 0014-5793print, 1873-3468electronic), 2002 Nov 6; 531(2): 152-156.
Impact Factor: 3.912
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Colao A, Spinelli L, Cuocolo A, Spiezia S, Pivonello R, Di Somma C, Bonaduce D, Salvatore M, Lombardi G
* Cardiovascular consequences of early-onset growth hormone excess (126 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2002 Jul; 87(7): 3097-3104.
Impact Factor: 5.199
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Colao A, Di Somma C, Pivonello R, Cuocolo A, Spinelli L, Bonaduce D, Salvatore M, Lombardi G
* The cardiovascular risk of adult GH deficiency (GHD) improved after GH replacement and worsened in untreated GHD: A 12-month prospective study (122 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2002 Mar; 87(3): 1088-1093.
Impact Factor: 5.199
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Colao A, Di Somma C, Cuocolo A, Spinelli L, Tedesco N, Pivonello R, Bonaduce D, Salvatore M, Lombardi G
* Improved cardiovascular risk factors and cardiac performance after 12 months of growth hormone (GH) replacement in young adult patients, with GH deficiency (123 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2001 May; 86(5): 1874-1881.
Impact Factor: 5.16
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Colao A, Cuocolo A, Marzullo P, Nicolai E, Ferone D, Morte A, Pivonello R, Salvatore M, Lombardi G
* Is the acromegalic cardiomyopathy reversible? Effect of 5-year normalization of growth hormone and insulin-like growth factor I levels on cardiac performance (97 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2001 Apr; 86(4): 1551-1557.
Impact Factor: 5.16
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Colao A, Marzullo P, Ferone D, Spinelli L, Cuocolo A, Bonaduce D, Salvatore M, Boerlin V, Lancranjan I, Lombardi G
Cardiovascular effects of depot long-acting somatostatin analog sandostatin LAR in acromegaly (122 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2000 Sep; 85(9): 3132-3140.
Impact Factor: 5.447
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Marzullo P, Cuocolo A, Ferone D, Pivonello R, Salvatore M, Lombardi G, Colao A
Cardiac effect of thyrotoxicosis in acromegaly (109 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2000 Apr; 85(4): 1426-1432.
Impact Factor: 5.447
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Colao A, Cuocolo A, Di Somma C, Cerbone G, Della Morte A, Pivonello R, Nicolai E, Salvatore M, Lombardi G
Does the age of onset of growth hormone deficiency affect cardiac performance? A radionuclide angiography study (100 visite)
Clin Endocrinol (ISSN: 0300-0664, 1365-2265, 1365-2265electronic), 2000 Apr; 52(4): 447-455.
Impact Factor: 2.922
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Colao A, Cuocolo A, Di Somma C, Cerbone G, Della Morte A, Nicolai E, Lucci R, Salvatore M, Lombardi G
Impaired cardiac performance in elderly patients with growth hormone deficiency (92 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 1999 Nov; 84(11): 3950-3955.
Impact Factor: 5.805
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Colao A, Cuocolo A, Marzullo P, Nicolai E, Ferone D, Della Morte A, Petretta M, Salvatore M, Lombardi G
Impact of patient's age and disease duration on cardiac performance in acromegaly: A radionuclide angiography study (101 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 1999 May; 84(5): 1518-1523.
Impact Factor: 5.805
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Colao A, Lastoria S, Ferone D, Varrella P, Marzullo P, Pivonello R, Cerbone G, Acampa W, Salvatore M, Lombardi G
The pituitary uptake of In-111-DTPA-D-Phe(1)-octreotide in the normal pituitary and in pituitary adenomas (117 visite)
J Endocrinol Invest (ISSN: 0391-4097, 1720-8386electronic), 1999 Mar; 22(3): 176-183.
Impact Factor: 0.957
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Colao A, Cuocolo A, Marzullo P, Nicolai E, Ferone D, Florimonte L, Salvatore M, Lombardi G
Effects of 1-year treatment with octreotide on cardiac performance in patients with acromegaly (87 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 1999 Jan; 84(1): 17-23.
Impact Factor: 5.805
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Lombardi A, De Simone G, Nastri F, Galdiero S, Della Morte R, Staiano N, Pedone C, Bolognesi M, Pavone V
The Crystal Structure Of Alpha-Thrombin-Hirunorm Iv Complex Reveals A Novel Specificity Site Recognition Mode (119 visite)
Protein Sci (ISSN: 0961-8368, 1469-896xelectronic), 1999 Jan; 8(1): 91-95.
Impact Factor: 4.457
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Longobardi S, Cuocolo A, Merola B, Di Rella F, Colao A, Nicolai E, Cardei S, Salvatore M, Lombardi G
Left ventricular function in young adults with childhood and adulthood onset growth hormone deficiency (88 visite)
Clin Endocrinol (ISSN: 0300-0664, 1365-2265, 1365-2265electronic), 1998 Feb; 48(2): 137-143.
Impact Factor: 3.101
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Ferone D, Lastoria S, Colao A, Varrella P, Cerbone G, Acampa W, Merola B, Salvatore M, Lombardi G
Correlation of scintigraphic results using 123I-methoxybenzamide with hormone levels and tumor size response to quinagolide in patients with pituitary adenomas (103 visite)
J Clin Endocrinol Metab (ISSN: 0021-972x), 1998 Jan; 83(1): 248-252.
Impact Factor: 5.641
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Lombardi G, Colao A, Cuocolo A, Longobardi S, Di Somma C, Orio F, Merola B, Nicolai E, Salvatore M
Cardiological aspects of growth hormone and insulin-like growth factor- (94 visite)
J Pediatr Endocrinol Metab (ISSN: 0334-018x), 1997 Nov; 10(6): 553-560.
Impact Factor: 0.481
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Sijens PE, Knopp MV, Brunetti A, Wicklow K, Alfano B, Bachert P, Sanders JA, Stillman AE, Kett H, Sauter R
1H MR spectroscopy in patients with metastatic brain tumors: A multicenter study (106 visite)
Magn Reson Med (ISSN: 0740-3194, 1522-2594electronic), 1995 Jun; 33(6): 818-826.
Impact Factor: 3.012
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74 Records (70 escludendo Abstract e Conferenze).
Impact factor totale: 353.468 (337.124 escludendo Abstract e Conferenze).
Impact factor a 5 anni totale: 323.912 (309.514 escludendo Abstract e Conferenze).







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