Mizoguchi H, Wilson A, Jerdack G R, Hull J D, Goodale M, Grender J M, Tyler B A
The Procter & Gamble Company, Health Care Research Center, Mason, OH, USA.
Int J Clin Pharmacol Ther. 2007 Apr;45(4):230-6. doi: 10.5414/cpp45230.
The aim of this study was to evaluate the efficacy of a single night-time dose of a syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple cold symptoms.
A syrup containing 15 mg dextromethorphan hydrobromide, 7.5 mg doxylamine succinate, 600 mg paracetamol and 8 mg ephedrine sulfate (Wick MediNait produced by WICK Pharma, Germany, a subsidiary of Procter & Gamble GmbH; test syrup) or placebo (placebo syrup) for oral administration.
This was a randomized, double-blind, placebo-controlled, multi-center, parallel design study. At enrollment, eligible subjects had to have at least moderate nasal congestion and a runny nose, at least mild cough and at least mild pain with one or more of the following: sore throat, sore chest, headache or body pain/aches. Subjects were randomized into either Group T (test syrup) or Group P (placebo syrup). On the evening of enrollment, subjects rated baseline symptoms, ingested the assigned study product and completed symptom-relief assessments at 3 hours post-dosing. Within one hour of awakening the following morning, subjects completed night-time symptom relief and sleep satisfaction assessments. All symptoms were recorded using an Interactive Voice Response system. Treatment comparisons were made after adjusting for the severity of baseline symptom using analysis of covariance.
Of 485 subjects who took the study product, 432 (224 in Group T; 208 in Group P) were evaluable for analysis. For the primary endpoint (composite of nasal congestion/runny nose/cough/pain relief scores 3 hours post-dosing), subjects in Group T had clinically and statistically significantly greater relief than Group P (p = 0.0002). Each individual symptom score also showed statistically significant improvement at this time point (p < or = 0.017). The next morning, Group T continued to show clinically and statistically significant benefits over Group P on the composite score and each of the individual symptoms (p < or = 0.003). Evidence of benefit with the test syrup was also seen in the higher score for overall night-time relief (p < 0.0001) and greater satisfaction on sleep (p = 0.002) compared to placebo syrup. Improvement in individual symptoms after 3 hours was obtained in 16-42% more subjects in Group T than in Group P, whereas the percentage of subjects in Group T having Good or Very Good relief the morning after dosing increased by 25-68% compared to subjects in Group P. 14 subjects (5 in Group T; 9 in Group P) reported AEs but none of these occurred with an incidence greater than 1%. There were no serious AEs.
The results confirm the multisymptom benefit of a single dose of the test syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate and support its role as an effective and convenient therapy for symptoms of nasal congestion, runny nose, cough and pain/body aches associated with the common cold and for increasing sleep quality disturbed by the common cold.
本研究旨在评估含对乙酰氨基酚、氢溴酸右美沙芬、琥珀酸多西拉敏和硫酸麻黄碱的糖浆在单一夜间剂量给药时，对患有多种感冒症状的受试者的疗效。
一种口服糖浆，含有15毫克氢溴酸右美沙芬、7.5毫克琥珀酸多西拉敏、600毫克对乙酰氨基酚和8毫克硫酸麻黄碱（Wick MediNait，由德国WICK制药公司生产，宝洁公司的子公司；试验糖浆）或安慰剂（安慰剂糖浆）。
这是一项随机、双盲、安慰剂对照、多中心、平行设计研究。入选时，符合条件的受试者必须至少有中度鼻塞和流涕，至少有轻度咳嗽，并且至少有轻度疼痛，伴有以下一种或多种症状：喉咙痛、胸痛、头痛或身体疼痛。受试者被随机分为T组（试验糖浆组）或P组（安慰剂糖浆组）。入选当晚，受试者对基线症状进行评分，服用指定的研究产品，并在给药后3小时完成症状缓解评估。在次日早晨醒来后一小时内，受试者完成夜间症状缓解和睡眠满意度评估。所有症状均使用交互式语音应答系统记录。使用协方差分析对基线症状的严重程度进行调整后，进行治疗比较。
在485名服用研究产品的受试者中，432名（T组224名；P组208名）可进行分析评估。对于主要终点（给药后3小时鼻塞/流涕/咳嗽/疼痛缓解评分的综合指标），T组受试者在临床和统计学上的缓解程度均显著高于P组（p = 0.0002）。此时，每个个体症状评分在统计学上也显示出显著改善（p≤0.017）。次日早晨，T组在综合评分和各个个体症状方面，在临床和统计学上仍显著优于P组（p≤0.003）。与安慰剂糖浆相比，试验糖浆在总体夜间缓解评分更高（p < 0.0001）以及睡眠满意度更高（p = 0.002）方面也显示出有益证据。给药后3小时，T组中个体症状得到改善的受试者比P组多16% - 42%，而给药次日早晨，T组中症状得到良好或非常良好缓解的受试者百分比比P组增加了25% - 68%。14名受试者（T组5名；P组9名）报告了不良事件，但这些事件的发生率均未超过1%。没有严重不良事件发生。
结果证实了含对乙酰氨基酚、氢溴酸右美沙芬、琥珀酸多西拉敏和硫酸麻黄碱的试验糖浆单剂量给药对多种症状的益处，并支持其作为一种有效且方便的疗法，用于治疗与普通感冒相关的鼻塞、流涕、咳嗽和疼痛/身体疼痛症状，以及改善因普通感冒而受干扰的睡眠质量。
