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Low-dose l-isoproterenol versus salbutamol in hospitalized pediatric patients with severe acute exacerbation of asthma: A double-blind, randomized controlled trial.
Katsunuma, Toshio; Fujisawa, Takao; Maekawa, Takanobu; Akashi, Kenichi; Ohya, Yukihiro; Adachi, Yuichi; Hashimoto, Koji; Mizuno, Mihoko; Imai, Takanori; Oba, Mari S; Sako, Mayumi; Ohashi, Yasuo; Nakamura, Hidefumi.
Afiliación
  • Katsunuma T; Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan. Electronic address: tkatsunuma@jikei.ac.jp.
  • Fujisawa T; Allergy Center, Mie National Hospital, Mie, Japan.
  • Maekawa T; Department of General Pediatrics and Interdisciplinary Medicine, National Center for Child Health and Development, Tokyo, Japan.
  • Akashi K; Department of Pediatrics, The Jikei University School of Medicine, Tokyo, Japan.
  • Ohya Y; Division of Allergy, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan.
  • Adachi Y; Department of Pediatrics, Graduate School of Medicine and Pharmaceutical Science, University of Toyama, Toyama, Japan.
  • Hashimoto K; Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan.
  • Mizuno M; Mihoko Mizuno, Department of Pediatrics, Social Medical Corporation Kojunkai Daido Hospital, Aichi, Japan.
  • Imai T; Takanori Imai, Department of Pediatrics, The Showa University School of Medicine, Tokyo, Japan.
  • Oba MS; Department of Medical Statistics, Faculty of Medicine, Toho University, Tokyo, Japan.
  • Sako M; Division for Clinical Trials, Department of Clinical Research, Center for Clinical Research and Development, National Center for Child Health and Development, Tokyo, Japan.
  • Ohashi Y; Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.
  • Nakamura H; Department of Development Strategy, Center for Clinical Research and Development, National Center for Child Health and Development, Tokyo, Japan.
Allergol Int ; 68(3): 335-341, 2019 Jul.
Article en En | MEDLINE | ID: mdl-30846304
BACKGROUND: Although the guidelines in most countries do not recommend continuous inhalation of l-isoproterenol to treat pediatric patients with acute severe exacerbation of asthma, lower dose of l-isoproterenol has been widely used in Japan. To determine whether the efficacy of low-dose l-isoproterenol was superior to that of salbutamol, we conducted a double-blind, randomized controlled trial. METHODS: Hospitalized patients aged 1-17 years were eligible if they had severe asthma exacerbation defined by the modified pulmonary index score (MPIS). Patients were randomly assigned (1:1) to receive inhalation of l-isoproterenol (10 µg/kg/h) or salbutamol (500 µg/kg/h) for 12 hours via a large-volume nebulizer with oxygen. The primary outcome was the change in MPIS from baseline to 3 hours after starting inhalation. Trial registration number UMIN000001991. RESULTS: From December 2009 to October 2013, 83 patients (42 in the l-isoproterenol group and 41 in the salbutamol group) were enrolled into the study. Of these, one patient in the l-isoproterenol group did not receive the study drug and was excluded from the analysis. Compared with salbutamol, l-isoproterenol reduced MPIS more rapidly. Mean (SD) changes in MPIS at 3 hours were -2.9 (2.5) in the l-isoproterenol group and -0.9 (2.3) in the salbutamol group (difference -2.0, 95% confidence interval -3.1 to -0.9; P < 0.001). Adverse events occurred in 1 (2%) and 11 (27%) patients in the l-isoproterenol and salbutamol groups, respectively (P = 0.003). Hypokalemia and tachycardia occurred only in the salbutamol group. CONCLUSIONS: Low-dose l-isoproterenol has a more rapid effect with fewer adverse events than salbutamol.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Asma / Broncodilatadores / Albuterol / Isoproterenol Tipo de estudio: Clinical_trials Límite: Child / Child, preschool / Female / Humans / Infant / Male Idioma: En Revista: Allergol Int Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2019 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Asma / Broncodilatadores / Albuterol / Isoproterenol Tipo de estudio: Clinical_trials Límite: Child / Child, preschool / Female / Humans / Infant / Male Idioma: En Revista: Allergol Int Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2019 Tipo del documento: Article Pais de publicación: Reino Unido