Barrow G I, Higgins P G, al-Nakib W, Smith A P, Wenham R B, Tyrrell D A
MRC Common Cold Unit, Harvard Hospital, Salisbury, U.K.
Clin Exp Allergy. 1990 Jan;20(1):45-51. doi: 10.1111/j.1365-2222.1990.tb02774.x.
Two studies involving double-blind group comparative trials in human volunteers compared the effects of intranasal nedocromil sodium (2.6 mg active drug per nostril, q.i.d.) with placebo on clinical symptoms and performance impairment associated with the common cold. In the first study volunteers were challenged with rhinoviruses (RV9 and RV14), and in the second study with respiratory coronavirus. In both studies, active and placebo groups of volunteers were demographically similar. Infection rates in both groups were also similar. There were no withdrawals resulting from unusual symptoms related to either treatment. In the rhinovirus study (19, placebo; 20, nedocromil sodium) daily symptom scores and daily mean nasal secretion weights were significantly lower in the nedocromil sodium-treated group. In the coronavirus study (26, placebo; 27, nedocromil sodium) there was little difference in the severity of colds between the active and placebo-treated groups, but trends favoured nedocromil sodium. In both studies the impairment of performance in volunteers who developed a cold was significantly less in those treated with nedocromil sodium than in those treated with placebo.
两项针对人类志愿者的双盲组对比试验研究,比较了每侧鼻孔使用2.6毫克活性药物奈多罗米钠(每日四次)与安慰剂对普通感冒相关临床症状及功能损害的影响。在第一项研究中,志愿者感染鼻病毒(RV9和RV14);在第二项研究中,志愿者感染呼吸道冠状病毒。在两项研究中,活性药物组和安慰剂组志愿者在人口统计学特征上相似。两组的感染率也相似。未出现因与任何一种治疗相关的异常症状而导致的退出试验情况。在鼻病毒研究中(19人使用安慰剂;20人使用奈多罗米钠),奈多罗米钠治疗组的每日症状评分和每日平均鼻分泌物重量显著更低。在冠状病毒研究中(26人使用安慰剂;27人使用奈多罗米钠),活性药物治疗组和安慰剂治疗组感冒严重程度差异不大,但趋势上更倾向于奈多罗米钠。在两项研究中,感冒的志愿者中,使用奈多罗米钠治疗的人功能损害明显小于使用安慰剂治疗的人。