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多米多醇治疗小儿支气管肺部疾病:与安慰剂对照的双盲临床试验

Domiodol treatment for bronchopulmonary diseases in the paediatric age group: a double-blind controlled clinical trial versus placebo.

作者信息

Fiocchi A, Grasso U, Zuccotti G, Arancio R, Riva E, Giovannini M

机构信息

Fifth Paediatric Clinic, University of Milan, Institute of Biomedical Sciences, San Paolo, Italy.

出版信息

J Int Med Res. 1988 Jan-Feb;16(1):31-8. doi: 10.1177/030006058801600103.

Abstract

Thirty children (25 males, five females), mean age 9.33 +/- 2.57 years, with acute infectious pulmonary diseases or acute flare-ups of chronic bronchitis, were randomly treated with either domiodol or placebo. The study was conducted between November 1986 and February 1987. Domiodol was administered orally for 14 days in doses of 0.5 mg/kg three times daily. Subjective symptoms (cough, sputum viscosity, difficulty in raising sputum and sputum characteristics) were assessed semi-quantitatively. They were all reduced significantly in the group treated with domiodol compared to those given placebo. Spirometric measures of vital capacity and peak expiratory flow rate were also improved in patients given domiodol compared with placebo. Conversely, no differences were noted in forced expiratory volume in 1 s, Tiffenau index, or mid-expiratory flow. There were no clinical side-effects and no changes in any other parameters measured; in particular, levels of thyroid hormone and thyroid stimulating hormone were unchanged. Thus, domiodol proved effective in reducing the symptoms of infection of the lower respiratory tract and in improving the consistency of mucus in children.

摘要

30名儿童(25名男性,5名女性),平均年龄9.33±2.57岁,患有急性感染性肺部疾病或慢性支气管炎急性发作,被随机给予多米澳多或安慰剂治疗。该研究于1986年11月至1987年2月进行。多米澳多口服给药14天,剂量为0.5mg/kg,每日3次。对主观症状(咳嗽、痰液黏稠度、咳痰困难和痰液特征)进行半定量评估。与给予安慰剂的组相比,多米澳多治疗组的所有症状均显著减轻。与安慰剂相比,给予多米澳多的患者肺活量和呼气峰值流速的肺量计测量值也有所改善。相反,在1秒用力呼气量、蒂费瑙指数或呼气中期流速方面未发现差异。没有临床副作用,所测量的任何其他参数也没有变化;特别是,甲状腺激素和促甲状腺激素水平未改变。因此,多米澳多被证明对减轻儿童下呼吸道感染症状和改善黏液黏稠度有效。

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