Ineffectiveness of oral terfenadine in natural colds: evidence against histamine as a mediator of common cold symptoms.
Ineffectiveness of oral terfenadine in natural colds: evidence against histamine as a mediator of common cold symptoms.
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DOI：
10.1097/00006454-198803000-00032
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发表时间：
1988-03
期刊：
影响因子：
--
通讯作者：
M. Gaffey;D. Kaiser;F. Hayden
中科院分区：
文献类型：
--
作者：
M. Gaffey;D. Kaiser;F. Hayden
组胺在感染性鼻炎发病机制中的作用尚不清楚，抗组胺药治疗普通感冒的疗效也不清楚。本研究评估了口服特非那定（Seldane）治疗普通感冒的短期疗效。在5周的时间里，作者招募了250名在入组前6至48小时内出现感冒症状的成年人。志愿者的主诉是流鼻涕或鼻塞；至少一种其他呼吸道症状；无发热、渗出性咽炎；入组1周内无特应性、鼻窦炎史或使用感冒药史。在符合条件的受试者中，126人随机分配特非那定（60毫克），124人接受安慰剂。志愿者在第1、2和3天每天两次自行服用特非那定或安慰剂，在第4天早上服用最后一剂。他们还在症状卡上记录了临床症状的严重程度（流鼻涕、流鼻涕、打喷嚏、鼻后滴涕、咳嗽和喉咙痛）。两组在整个治疗期间报告的严重程度评分相似。两组的平均症状负担几乎以相同的速度下降。特非那定耐受性好，副作用发生率低。根据受试者评价，特非那定并不比安慰剂更有效。特非那定组总体疗效的平均+/- SD评分为2.2 +/- 1.1，安慰剂组为2.1 +/- 1.3 （P = NS）。特非那定接受者（41%）比安慰剂接受者（48%）表示他们会再次使用研究药物治疗感冒症状的人数略少。（摘要删节250字）
The role of histamine in the pathogenesis of infectious rhinitis is unclear, as is the efficacy of antihistaminic drugs in the treatment of the common cold. This study evaluated the short-term efficacy of oral terfenadine (Seldane) in the treatment of the common cold. Over a 5-week period, the authors recruited 250 adults who had developed cold symptoms within 6 to 48 hours prior to enrollment. Volunteers had a primary complaint of runny or stuffy nose; at least one other respiratory symptom; no fever or exudative pharyngitis; and no history of atopy, sinusitis, or use of cold preparations within 1 week of enrollment. Out of the eligible subjects, 126 were randomly assigned terfenadine (60 mg), and 124 received placebo. Volunteers self-administered either terfenadine or placebo twice a day on Days 1, 2 and 3, and a final dose on the morning of Day 4. They also recorded the severity of their clinical symptoms (runny nose, sniffles, sneezing, postnasal drip, cough and sore throat) on symptom cards. Both groups reported similar severity scores throughout the treatment period. Average symptom burdens declined at almost identical rates for both groups. Terfenadine was well tolerated and had a low incidence of side effects. According to subject evaluation, terfenadine was no more effective than placebo. The mean +/- SD score of global efficacy was 2.2 +/- 1.1 in the terfenadine group and 2.1 +/- 1.3 in the placebo group (P = NS). Slightly fewer terfenadine recipients (41%) than placebo recipients (48%) said they would use the study medication again for treating cold symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)