Catena E, Daffonchio L
Istituto di Clinica Tisiologica e Malattie Respiratorie, Seconda Università degli Studi, Napoli, Italy.
Pulm Pharmacol Ther. 1997;10(2):89-96. doi: 10.1006/pupt.1997.0083.
The results of a double-blind, randomized clinical trial involving 209 adult patients of either sex with moderate non-productive cough are reported. The therapeutic efficacy and the tolerability of levodropropizine syrup (60 mg t.i.d. for 5 days) was evaluated in comparison with dextromethorphan syrup (15 mg t.i.d. for 5 days). Efficacy was assessed by the number of coughing spells in a 6h period, the cough frequency classes, the cough intensity and the night awakenings due to cough. Tolerability was evaluated by laboratory results, vital signs and any adverse event occurred during the clinical trial, including presence or absence of somnolence. Independently from the underlying pathology and from the degree of baseline cough severity, the number of coughing spells was significantly (P < 0.05) reduced by both levodropropizine and dextromethorphan already after the 2nd day of treatment, the effect and its time of onset being similar for both drugs. Cough intensity was significantly (P < 0.01) reduced by both drugs throughout the treatment, at an earlier time with levodropropizine than with dextromethorphan. Concurrently with the relief of cough, the number of night awakenings was decreased remarkably and significantly (P < 0.05), with levodropropizine displaying an improvement significantly higher (P < 0.05) than dextromethorphan. No change in laboratory tests values was considered clinically relevant and vital signs were not clinically affected by the study drugs. The number of patients reporting adverse events was significantly higher (P < 0.05) in the dextromethorphan (12.1%) than in the levodropropizine (3.6%) group. Overall, somnolence was reported for a low percentage of patients with both drugs, with the percentage of patients experiencing this side effect being one half in the group treated with levodropropizine (4.6%) as compared with dextromethorphan (10.4%). These results confirm the antitussive effectiveness of levodropropizine and point out a more favourable benefit/risk profile when compared to dextromethorphan.
报告了一项双盲、随机临床试验的结果，该试验涉及209名患有中度干咳的成年男女患者。与右美沙芬糖浆（15毫克，每日三次，共5天）相比，评估了左羟丙哌嗪糖浆（60毫克，每日三次，共5天）的治疗效果和耐受性。通过6小时内的咳嗽发作次数、咳嗽频率分级、咳嗽强度以及因咳嗽导致的夜间觉醒情况来评估疗效。通过实验室检查结果、生命体征以及临床试验期间发生的任何不良事件（包括是否存在嗜睡）来评估耐受性。无论潜在病因和基线咳嗽严重程度如何，治疗第2天后，左羟丙哌嗪和右美沙芬均能显著（P<0.05）减少咳嗽发作次数，两种药物的效果及其起效时间相似。在整个治疗过程中，两种药物均能显著（P<0.01）降低咳嗽强度，左羟丙哌嗪比右美沙芬起效更早。随着咳嗽缓解，夜间觉醒次数显著减少（P<0.05），左羟丙哌嗪的改善程度显著高于右美沙芬（P<0.05）。实验室检查值的变化在临床上无相关性，研究药物对生命体征无临床影响。报告不良事件的患者数量在右美沙芬组（12.1%）显著高于左羟丙哌嗪组（3.6%）（P<0.05）。总体而言，两种药物报告嗜睡的患者比例均较低，与右美沙芬（10.4%）相比，左羟丙哌嗪治疗组出现这种副作用的患者比例为一半（4.6%）。这些结果证实了左羟丙哌嗪的镇咳效果，并指出与右美沙芬相比，其效益/风险比更有利。
