Tack K J, Henry D C, Gooch W M, Brink D N, Keyserling C H
Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan 48105, USA.
Antimicrob Agents Chemother. 1998 May;42(5):1073-5. doi: 10.1128/AAC.42.5.1073.
A multicenter, randomized, controlled, investigator-blind study was performed to evaluate the safety and efficacy of oral cefdinir versus oral penicillin V for the treatment of pharyngitis due to group A beta-hemolytic streptococci (GABHS). Patients 13 years of age and older were randomized to receive either oral cefdinir (300 mg twice a day) for 5 days followed by placebo for 5 days or oral penicillin V (250 mg four times a day) for 10 days. Throat cultures were obtained, and signs and symptoms of pharyngitis were recorded at study admission and follow-up visits on study days 11 to 15, 16 to 20, and 25 to 31. Patients kept a diary to record medication intake and their assessment of throat pain at admission and at each day of study treatment. Five hundred fifty-eight patients were enrolled, of whom 432 (77.4%) were clinically and microbiologically evaluable. The GABHS eradication rates 5 to 10 days after completion of therapy were 193 of 218 (88.5%) in the cefdinir group and 176 of 214 (82.2%) in the penicillin group (P = 0.053). Clinical cure rates were 89.0 and 84.6%, respectively (P = 0.80). By the time of the long-term follow-up visit, 2 to 3 weeks after completion of treatment, 156 of 191 (81.7%) of the assessable cefdinir patients and 152 of 195 (77.9%) of the penicillin patients remained free of GABHS. Both treatments were well tolerated, with adverse reaction rates of 18.3% in the cefdinir study arm and 15.0% in the penicillin study arm (P = 0.278). Five-day treatment with cefdinir is safe and effective therapy for GABHS pharyngitis. Based on its twice-a-day dosage and shorter course of therapy, leading to potentially greater patient compliance, cefdinir may be considered for use in the treatment of pharyngitis caused by GABHS.
开展了一项多中心、随机、对照、研究者设盲的研究，以评估口服头孢地尼与口服青霉素V治疗A组β溶血性链球菌（GABHS）所致咽炎的安全性和疗效。13岁及以上患者被随机分组，分别接受口服头孢地尼（每日两次，每次300mg），共5天，随后接受5天安慰剂治疗；或口服青霉素V（每日四次，每次250mg），共10天。在研究入组时以及研究第11至15天、第16至20天和第25至31天的随访时采集咽拭子培养标本，并记录咽炎的体征和症状。患者记录日记，以记录药物摄入情况以及入组时和研究治疗期间每天对咽痛的评估。共纳入558例患者，其中432例（77.4%）可进行临床和微生物学评估。治疗完成后5至10天，头孢地尼组218例中有193例（88.5%）GABHS清除，青霉素组214例中有176例（82.2%）GABHS清除（P=0.053）。临床治愈率分别为89.0%和84.6%（P=0.80）。到治疗完成后2至3周的长期随访时，可评估的头孢地尼组患者191例中有156例（81.7%）、青霉素组患者195例中有152例（77.9%）无GABHS感染。两种治疗的耐受性均良好，头孢地尼研究组的不良反应发生率为18.3%，青霉素研究组为15.0%（P=0.278）。头孢地尼5天疗程治疗GABHS咽炎安全有效。基于其每日两次给药且疗程较短，可能使患者依从性更高，头孢地尼可考虑用于治疗GABHS所致咽炎。
