Kaiser L, Lew D, Hirschel B, Auckenthaler R, Morabia A, Heald A, Benedict P, Terrier F, Wunderli W, Matter L, Germann D, Voegeli J, Stalder H
Division of Infectious Diseases, University Hospital of Geneva, Switzerland.
Lancet. 1996 Jun 1;347(9014):1507-10. doi: 10.1016/s0140-6736(96)90670-4.
Upper-respiratory-tract infection is one of the main causes of overuse of antibiotics. We have found previously that bacteria such as Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae can be isolated from the nasopharyngeal secretions of a substantial proportion of adults with upper-respiratory-tract infections. We have assessed the efficacy of co-amoxiclav in patients with common colds but no clinical signs of sinusitis or other indications for antibiotics.
Between January, 1992 and March, 1994, 314 patients who presented to our outpatient clinic with common colds were enrolled in the double-blind, placebo-controlled study. They were randomly assigned 5 days' treatment with co-amoxiclav (375 mg three times daily) or identical placebo. Clinical examinations were done at enrolment and on day 5-7 to assess outcome (cured, persistent symptoms, worse symptoms). Seven patients were excluded after randomisation, seven did not have nasopharyngeal aspiration, and 12 did not return for followup assessment.
Of 300 patients with nasopharyngeal aspirates, 72 had negative bacterial cultures, 167 had cultures positive only for bacteria unrelated to respiratory infections, and 61 had cultures positive for H influenzae, M catarrhalis, or S pneumoniae. At 5-day follow-up of these culture-positive patients, the distribution of outcome was significantly better among co-amoxiclav-treated (n=30) than placebo-treated (n=28) patients (cured 27 vs 4%; persistent symptoms 70 vs 60%; worse symptoms 3 vs 36%; p=0.001). Patients on co-amoxiclav also scored their symptoms significantly lower than patients on placebo (p=0.008). Among culture-negative patients (n=230), the outcome distribution did not differ between the treatment groups (p=0.392).
The majority of patients with upper-respiratory-tract infection do not benefit from antibiotics and side-effects are frequent. However, for the subgroup whose nasopharyngeal secretions contain H influenzae, M catarrhalis, or S pneumoniae, antibiotics are clinically beneficial.
上呼吸道感染是抗生素过度使用的主要原因之一。我们之前发现，在相当一部分患有上呼吸道感染的成年人的鼻咽分泌物中，可以分离出流感嗜血杆菌、卡他莫拉菌和肺炎链球菌等细菌。我们评估了阿莫西林克拉维酸在普通感冒但无鼻窦炎临床症状或其他抗生素使用指征患者中的疗效。
1992年1月至1994年3月期间，314名因普通感冒前来我们门诊就诊的患者被纳入这项双盲、安慰剂对照研究。他们被随机分配接受5天的阿莫西林克拉维酸治疗（375毫克，每日三次）或相同的安慰剂。在入组时以及第5至7天进行临床检查，以评估结果（治愈、症状持续、症状加重）。随机分组后有7名患者被排除，7名患者未进行鼻咽抽吸，12名患者未返回进行随访评估。
在300名进行了鼻咽抽吸的患者中，72名细菌培养结果为阴性，167名仅培养出与呼吸道感染无关的细菌，61名培养出流感嗜血杆菌、卡他莫拉菌或肺炎链球菌。在这些培养阳性患者的5天随访中，接受阿莫西林克拉维酸治疗的患者（n = 30）的结果分布明显优于接受安慰剂治疗的患者（n = 28）（治愈：27%对4%；症状持续：70%对60%；症状加重：3%对36%；p = 0.001）。接受阿莫西林克拉维酸治疗的患者对症状的评分也显著低于接受安慰剂治疗的患者（p = 0.008）。在培养阴性的患者（n = 230）中，治疗组之间的结果分布没有差异（p = 0.392）。
大多数上呼吸道感染患者无法从抗生素治疗中获益，且副作用频繁。然而，对于鼻咽分泌物中含有流感嗜血杆菌、卡他莫拉菌或肺炎链球菌的亚组患者，抗生素具有临床益处。
