Bender Bruce G, Berning Shaun, Dudden Rosalind, Milgrom Henry, Tran Zung Vu
National Jewish Medical and Research Center, Denver, CO 80206, USA.
J Allergy Clin Immunol. 2003 Apr;111(4):770-6. doi: 10.1067/mai.2003.1408.
Antihistamines are among the most frequently used medications in the United States. Despite dramatically higher cost, second-generation antihistamines are replacing diphenhydramine because of the perception that they are not constrained by its sedating effects.
We sought to examine, through meta-analytic procedures, the collective evidence regarding the sedating and performance-impairing effects of diphenhydramine relative to placebo and second-generation antihistamines.
A search that began with the MEDLINE database was limited to those studies that included patients with atopic disease and control subjects, were blinded and randomized clinical trials, objectively examined alertness and psychomotor performance, reported means and variances, and were written in English. Information was systematically abstracted from the resulting 18 articles, and effect size was calculated.
Diphenhydramine impaired performance relative to placebo control and second-generation antihistamines, including acrivastine, astemizole, cetirizine, fexofenadine, loratadine, and terfenadine. However, results were quite varied, the average sedating effect of diphenhydramine was modest, and in some instances results of tests of performance in the diphenhydramine group showed less sedation than in the control or second-generation antihistamine groups. A significant (P <.05) average effect size indicated a mild sedating effect caused by second-generation antihistamines in comparison with placebo.
The absence of a consistent finding of diphenhydramine-induced sedation is surprising given that most studies have been designed to increase the probability of this outcome, including administering a 50-mg dose. On the basis of this meta-analysis of performance-impairment trials, a clear and consistent distinction between sedating and nonsedating antihistamines does not exist.
抗组胺药是美国最常用的药物之一。尽管第二代抗组胺药成本大幅提高，但由于人们认为其不受第一代抗组胺药镇静作用的限制，正逐渐取代苯海拉明。
我们试图通过荟萃分析程序，收集有关苯海拉明相对于安慰剂和第二代抗组胺药的镇静和损害行为表现作用的综合证据。
从MEDLINE数据库开始检索，仅限于那些纳入特应性疾病患者和对照受试者、采用盲法和随机临床试验、客观检测警觉性和精神运动表现、报告均值和方差且用英文撰写的研究。从检索到的18篇文章中系统提取信息，并计算效应量。
相对于安慰剂对照和第二代抗组胺药（包括阿伐斯汀、阿司咪唑、西替利嗪、非索非那定、氯雷他定和特非那定），苯海拉明损害行为表现。然而，结果差异很大，苯海拉明的平均镇静作用适中，在某些情况下，苯海拉明组的行为表现测试结果显示其镇静作用低于对照组或第二代抗组胺药组。显著（P<.05）的平均效应量表明，与安慰剂相比，第二代抗组胺药有轻微的镇静作用。
鉴于大多数研究旨在提高出现这一结果的可能性，包括给予50毫克剂量，苯海拉明诱导镇静作用缺乏一致的研究结果令人惊讶。基于对损害行为表现试验的这项荟萃分析，镇静性和非镇静性抗组胺药之间不存在明确和一致的区分。
