Repsher L H
Occupational and Environmental Lung Disease Program, Lutheran Medical Center, Wheat Ridge, Colorado.
J Clin Pharmacol. 1993 Sep;33(9):856-60. doi: 10.1002/j.1552-4604.1993.tb01963.x.
In a double-blind trial, 29 patients were treated for stable, chronic bronchitis with iodinated glycerol (Organidin, 60 mg four times daily; n = 16) or placebo (n = 13). The study consisted of a 2-week single-blind lead-in period, followed by a 6-week double-blind treatment period, and assessed a total of 50 response variables. In this set of patients, treatment with iodinated glycerol was associated with statistically significant (P < 0.05) and/or positive trend (P < 0.1) toward improvement in cough frequency, cough severity, difficulty in raising sputum, sputum thickness, sputum stickiness, forced expiratory flow at FVC25%-75%, cell concentration in sputum, and several measures of physician assessment of patient condition. Iodinated glycerol was well tolerated during the 6-week treatment period; no adverse effects were reported and no patient receiving iodinated glycerol withdrew from the study prematurely. In conclusion, this study demonstrates that iodinated glycerol, 60-mg tablets given in a total daily dose of 240 mg, is safe and effective therapy for reducing symptoms in patients with stable, chronic bronchitis.
在一项双盲试验中,29例稳定期慢性支气管炎患者接受碘化甘油(Organidin,每日4次,每次60毫克;n = 16)或安慰剂(n = 13)治疗。该研究包括为期2周的单盲导入期,随后是为期6周的双盲治疗期,并评估了总共50个反应变量。在这组患者中,碘化甘油治疗与咳嗽频率、咳嗽严重程度、咳痰困难、痰液厚度、痰液黏稠度、用力肺活量25%-75%时的呼气流量、痰液中的细胞浓度以及医生对患者病情评估的多项指标的改善具有统计学意义(P < 0.05)和/或呈阳性趋势(P < 0.1)。在为期6周的治疗期间,碘化甘油耐受性良好;未报告不良反应,且没有接受碘化甘油治疗的患者提前退出研究。总之,本研究表明,每日总剂量为240毫克的60毫克碘化甘油片是治疗稳定期慢性支气管炎患者症状的安全有效疗法。