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海玫瑰对慢性支气管炎患者痰液生化成分的影响:与安慰剂对比的双盲研究

Effects of seaprose on sputum biochemical components in chronic bronchitic patients: a double-blind study vs placebo.

作者信息

Moretti M, Bertoli E, Bulgarelli S, Testoni C, Guffanti E E, Marchioni C F, Braga P C

机构信息

Istituto di Tisiologia e Malattie dell' Apparato Respiratorio, Università di Modena, Italy.

出版信息

Int J Clin Pharmacol Res. 1993;13(5):275-80.

PMID:8200722
Abstract

Seaprose is a semialkaline proteinase endowed with proteolytic effect and antiinflammatory activity tested in different clinical trials. There is clinical evidence that seaprose reduces sputum viscoelastic properties in chronic hypersecretory bronchitis. The present study evaluated (in a double-blind design vs. placebo) the activity of seaprose on bronchial inflammation, mucus glycoprotein secretion and bronchial humoral defence mechanism in chronic bronchitic patients clinically stable (10 per group). Markers of bronchial inflammation (albumin, albumin/total protein ratio) and bronchial infection (DNA), of mucus glycoproteins (fucose and N-acetylneuraminic acid) and of humoral defence mechanism (secretory-IgA) were tested in sputum. We found that ten-day treatment with seaprose (90 mg/day) reduced sputum albumin during the observation period, the difference being statistically significant at the 18th day. The sputum albumin/total protein ratio also decreased by 50% at the end of the study. In the same group, sputum DNA, secretory-IgA, fucose and N-acetylneuraminic acid remained unchanged after treatment. The placebo group did not show any significant changes in the sputum marker substances. This study provides experimental evidence for the antiinflammatory activity of seaprose on bronchial mucosa in chronic bronchitic patients studied in a stable phase of their disease. Furthermore the drug does not seem to affect mucus glycoprotein secretion or secretory-IgA production.

摘要

海普罗斯是一种半碱性蛋白酶,在不同的临床试验中已证实其具有蛋白水解作用和抗炎活性。有临床证据表明,海普罗斯可降低慢性分泌过多性支气管炎患者痰液的粘弹性。本研究(采用双盲设计,与安慰剂对照)评估了海普罗斯对临床病情稳定的慢性支气管炎患者(每组10例)支气管炎症、黏液糖蛋白分泌及支气管体液防御机制的作用。检测了痰液中支气管炎症标志物(白蛋白、白蛋白/总蛋白比值)、支气管感染标志物(DNA)、黏液糖蛋白标志物(岩藻糖和N - 乙酰神经氨酸)及体液防御机制标志物(分泌型免疫球蛋白A)。我们发现,用海普罗斯(90毫克/天)治疗10天可使观察期内痰液白蛋白减少,在第18天时差异具有统计学意义。在研究结束时,痰液白蛋白/总蛋白比值也降低了50%。在同一组中,治疗后痰液DNA、分泌型免疫球蛋白A、岩藻糖和N - 乙酰神经氨酸均未改变。安慰剂组痰液标志物物质未显示任何显著变化。本研究为海普罗斯在慢性支气管炎患者疾病稳定期对支气管黏膜的抗炎活性提供了实验证据。此外,该药物似乎不影响黏液糖蛋白分泌或分泌型免疫球蛋白A的产生。

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