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16. Modified-Release Recombinant Human TSH (MRrhTSH) Augments the Effect of 131I Therapy in Benign Multinodular Goiter: Results from a Multicenter International, Randomized, Placebo-Controlled Study

Author

Graf, H., Fast, S., Pacini, F., Pinchera, A., Leung, A., Vaisman, M., Reiners, C., Wemeau, J. L., Huysmans, D., Harper, W., Driedger, A., de Souza, H. Noemberg, Castagna, M. G., Antonangeli, L., Braverman, L., Corbo, R., Düren, C., Proust-Lemoine, E., Edelbroek, M. A., Marriott, C., Rachinsky, I., Grupe, P., Watt, T., Magner, J., and Hegedus, L.

Published
2011

23. Effect of hormone replacement on exercise cardiopulmonary reserve and recovery performance in subclinical hypothyroidism

Author

Teixeira,P.F.S., Oliveira,F.P., and Vaisman,M.

Subjects
Subclinical hypothyroidism, Thyroid dysfunction, Exercise physiology, Levothyroxine, Ergospirometry
Abstract

Subclinical hypothyroidism (SH) patients present cardiopulmonary, vascular and muscle dysfunction, but there is no consensus about the benefits of levothyroxine (L-T4) intervention on cardiopulmonary performance during exercise. The aim of the present study was to investigate the effects of L-T4 on cardiopulmonary exercise reserve and recovery in SH patients. Twenty-three SH women, 44 (40-50) years old, were submitted to two ergospirometry tests, with an interval of 6 months of normalization of thyroid-stimulating hormone (TSH) levels (L-T4 replacement group) or simple observation (TSH = 6.90 μIU/mL; L-T4 = 1.02 ng/dL). Patients with TSH >10 μIU/mL were excluded from the study to assure that they would receive treatment in this later stage of SH. Twenty 30- to 57-year-old women with no thyroid dysfunction (TSH = 1.38 μIU/mL; L-T4 = 1.18 ng/dL) were also evaluated. At baseline, lower values of gas exchange ratio reserve (0.24 vs 0.30; P < 0.05) were found for SH patients. The treated group presented greater variation than the untreated group for pulmonary ventilation reserve (20.45 to 21.60 L/min; median variation = 5.2 vs 25.09 to 22.45 L/min; median variation = -4.75, respectively) and for gas exchange ratio reserve (0.19 to 0.27; median variation = 0.06 vs 0.28 to 0.18; median variation = -0.08, respectively). There were no relevant differences in cardiopulmonary recovery for either group at baseline or after follow-up. In the sample studied, L-T4 replacement improved exercise cardiopulmonary reserve, but no modification was found in recovery performance after exercise during this period of analysis.

Published
2010

31. Modified-release recombinant human TSH (MRrhTSH) augments the effect of 131I therapy in benign multinodular goiter:Results from a multicenter international, randomized, placebo-controlled study

Author

Graf, Hans, Fast, S., Pacini, F., Pinchera, A., Leung, A., Vaisman, M., Reiners, C., Wemeau, J. L., Huysmans, D., Harper, W., Driedger, A., Noemberg De Souza, H., Castagna, M. G., Antonangeli, L., Braverman, L., Corbo, R., Düren, C., Proust-Lemoine, E., Edelbroek, M. A., Marriott, C., Rachinsky, I., Grupe, P., Watt, T., Magner, J., Hegedus, L., Graf, Hans, Fast, S., Pacini, F., Pinchera, A., Leung, A., Vaisman, M., Reiners, C., Wemeau, J. L., Huysmans, D., Harper, W., Driedger, A., Noemberg De Souza, H., Castagna, M. G., Antonangeli, L., Braverman, L., Corbo, R., Düren, C., Proust-Lemoine, E., Edelbroek, M. A., Marriott, C., Rachinsky, I., Grupe, P., Watt, T., Magner, J., and Hegedus, L.

Abstract

Background: Recombinant human TSH (rhTSH) can be used to enhance 131I therapy for shrinkage of multinodular goiter (MG). Objective, Design, and Setting: The objective of the study was to compare the efficacy and safety of 0.01 and 0.03 mg modified-release (MR) rhTSH as an adjuvant to 131I therapy, vs. 131I alone, in a randomized, placebo-controlled, international, multicenter study. Patients and Intervention: Ninety-five patients (57.2 ± 9.6 yr old, 85% females, 83% Caucasians) with MG (median size 96.0, range 31.9-242.2 ml) were randomized to receive placebo (group A, n = 32), MRrhTSH 0.01 mg (group B, n = 30), or MRrhTSH 0.03 mg (group C, n = 33) 24 h before a calculated activity of 131I. Main Outcome Measures: The primary end point was a change in thyroid volume (by computerized tomography scan, at 6 months). Secondary end points were the smallest cross-sectional area of the trachea; thyroid function tests; Thyroid Quality of Life Questionnaire; electrocardiogram; and hyperthyroid symptom scale. Results: Thyroid volume decreased significantly in all groups. The reduction was comparable in groups A and B (23.1 ± 8.8 and 23.3 ± 16.5%, respectively; P = 0.95). In group C, the reduction (32.9±20.7%) wasmorepronounced than in groupsA(P=0.03) and B. The smallest cross-sectional area of the trachea increased in all groups: 3.8 ± 2.9% in A, 4.8 ± 3.3% in B, and 10.2 ± 33.2% in C, with no significant difference among the groups. Goiter-related symptoms were effectively reduced and there were no major safety concerns. Conclusion: In this dose-selection study, 0.03 mg MRrhTSH was the most efficacious dose as an adjuvant to 131I therapy of MG. It was well tolerated and significantly augmented the effect of 131I therapy in the short term. Larger studies with long-term follow-up are warranted.

Published
2011

34. Breakthrough pain characteristics and syndromes in patients with cancer pain. An international survey.

Author

Caraceni, A., Martini, C., Zecca, E., Portenoy, R.K., Ashby, M.A., Hawson, G., Jackson, K.A., Lickiss, N., Muirden, N., Pisasale, M., Moulin, D., Schulz, V.N., Rico Pazo, M.A., Serrano, J.A., Andersen, H.S., Henriksen, H.T., Mejholm, I., Sjogren, P.M., Heiskanen, T., Kalso, E., Pere, P., Poyhia, R., Vuorinen, E., Tigerstedt, I., Ruismaki, P., Bertolino, M., Larue, F., Ranchere, J.Y., Hege-Scheuing, G., Bowdler, I., Helbing, F., Kostner, E., Radbruch, L., Kastrinaki, K., Shah, S., Vijayaram, S., Sharma, K.S., Devi, P.S., Jain, P.N., Ramamani, P.V., Beny, A., Brunelli, C., Maltoni, M., Mercadante, S., Plancarte, R., Schug, S., Engstrand, P., Ovalle, A.F., Wang, X., Alves, M.F., Abrunhosa, M.R., Sun, W.Z., Zhang, L., Gazizov, A., Vaisman, M., Rudoy, S., Sancho, M.G., Vila, P., Trelis, J., Chaudakshetrin, P., Koh, M.L., Dongen, R.T.M. van, Vielvoye-Kerkmeer, A., Boswell, M.V., Elliott, T., Hargus, E., Lutz, L., Caraceni, A., Martini, C., Zecca, E., Portenoy, R.K., Ashby, M.A., Hawson, G., Jackson, K.A., Lickiss, N., Muirden, N., Pisasale, M., Moulin, D., Schulz, V.N., Rico Pazo, M.A., Serrano, J.A., Andersen, H.S., Henriksen, H.T., Mejholm, I., Sjogren, P.M., Heiskanen, T., Kalso, E., Pere, P., Poyhia, R., Vuorinen, E., Tigerstedt, I., Ruismaki, P., Bertolino, M., Larue, F., Ranchere, J.Y., Hege-Scheuing, G., Bowdler, I., Helbing, F., Kostner, E., Radbruch, L., Kastrinaki, K., Shah, S., Vijayaram, S., Sharma, K.S., Devi, P.S., Jain, P.N., Ramamani, P.V., Beny, A., Brunelli, C., Maltoni, M., Mercadante, S., Plancarte, R., Schug, S., Engstrand, P., Ovalle, A.F., Wang, X., Alves, M.F., Abrunhosa, M.R., Sun, W.Z., Zhang, L., Gazizov, A., Vaisman, M., Rudoy, S., Sancho, M.G., Vila, P., Trelis, J., Chaudakshetrin, P., Koh, M.L., Dongen, R.T.M. van, Vielvoye-Kerkmeer, A., Boswell, M.V., Elliott, T., Hargus, E., and Lutz, L.

Abstract

Contains fulltext : 57294.pdf (publisher's version ) (Closed access), Breakthrough pain (BKP) is a transitory flare of pain that occurs on a background of relatively well controlled baseline pain. Previous surveys have found that BKP is highly prevalent among patients with cancer pain and predicts more severe pain, pain-related distress and functional impairment, and relatively poor quality of life. An international group of investigators assembled by a task force of the International Association for the Study of Pain (IASP) evaluated the prevalence and characteristics of BKP as part of a prospective, cross-sectional survey of cancer pain. Fifty-eight clinicians in 24 countries evaluated a total of 1095 patients with cancer pain using patient-rated items from the Brief Pain Inventory (BPI) and observer-rated measures. The observer-rated information included demographic and tumor-related data, the occurrence of BKP, and responses on checklists of pain syndromes and pathophysiologies. The clinicians reported BKP in 64.8% of patients. Physicians from English-speaking countries were significantly more likely to report BKP than other physicians. BKP was associated with higher pain scores and functional interference on the BPI. Multivariate analysis showed an independent association of BKP with the presence of more than one pain, a vertebral pain syndrome, pain due to plexopathy, and English-speaking country. These data confirm the high prevalence of BKP, its association with more severe pain and functional impairment, and its relationship to specific cancer pain syndromes. Further studies are needed to characterize subtypes of BKP. The uneven distribution of BKP reporting across pain specialists from different countries suggests that more standardized methods for diagnosing BKP are needed.

Published
2004

36. Modified-Release Recombinant Human TSH (MRrhTSH) Augments the Effect of131I Therapy in Benign Multinodular Goiter: Results from a Multicenter International, Randomized, Placebo-Controlled Study

Author

Graf, H., primary, Fast, S., additional, Pacini, F., additional, Pinchera, A., additional, Leung, A., additional, Vaisman, M., additional, Reiners, C., additional, Wemeau, J. L., additional, Huysmans, D., additional, Harper, W., additional, Driedger, A., additional, de Souza, H. Noemberg, additional, Castagna, M. G., additional, Antonangeli, L., additional, Braverman, L., additional, Corbo, R., additional, Düren, C., additional, Proust-Lemoine, E., additional, Edelbroek, M. A., additional, Marriott, C., additional, Rachinsky, I., additional, Grupe, P., additional, Watt, T., additional, Magner, J., additional, and Hegedus, L., additional

Published
2011
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