Block S L, McCarty J M, Hedrick J A, Nemeth M A, Keyserling C H, Tack K J
Kentucky Pediatric Research, Bardstown, USA.
Pediatr Infect Dis J. 2000 Dec;19(12 Suppl):S159-65. doi: 10.1097/00006454-200012001-00005.
Two dosage regimens of cefdinir were compared with amoxicillin/clavulanate for the treatment of suppurative acute otitis media (AOM) in children.
This was an investigator-blinded, randomized, comparative, multicenter trial, in which tympanocentesis was performed in 384 patients, ages 6 months to 12 years, who had nonrefractory AOM. Patients were randomized to receive one of three 10-day treatment regimens: cefdinir 14 mg/kg daily (QD; n = 128); cefdinir 7 mg/kg twice a day (BID; n = 128); or amoxicillin/clavulanate 40/10 mg/kg/day divided for use three times a day (TID; n = 128).
Of the 384 enrolled patients 303 were evaluable for clinical efficacy. Clinical success rates were statistically equivalent for the 3 treatment groups at the end of therapy: 85 of 102 (83.3%) for cefdinir QD; 81 of 101 (80.2%) for cefdinir BID; 86 of 100 (86%) for amoxicillin/clavulanate. Of the 197 evaluable patients from whom a susceptible pathogen was recovered, presumptive eradication rates at end of therapy were equivalent: 55 of 65 (84.6%), 54 of 66 (81.8%) and 55 of 66 (83.3%) for cefdinir QD-, cefdinir BID- and amoxicillin/clavulanate-treated patients, respectively. However, presumptive eradication rates for Streptococcus pneumoniae were significantly lower for cefdinir BID (55.2%) than for amoxicillin/clavulanate (89.5%; P = 0.0019) and marginally lower than for cefdinir QD (80%; P = 0.054). Diarrhea was the most common treatment-associated adverse reaction in all groups but was significantly more common in amoxicillin/clavulanate-treated patients (35%) than in patients who had been treated with cefdinir QD (10%, P<0.001) or cefdinir BID (13%, P<0.001).
A 10-day regimen of cefdinir 14 mg/kg QD or 7 mg/kg BID was as clinically effective overall as a 10-day regimen of amoxicillin/ clavulanate 40/10 mg/kg/day divided TID in the treatment of tympanocentesis-confirmed, nonrefractory AOM in children. These data suggest that cefdinir QD may be a better alternative than cefdinir BID for refractory AOM. Both dosing regimens of cefdinir were associated with significantly fewer gastrointestinal adverse reactions than was amoxicillin/clavulanate.
比较头孢地尼的两种给药方案与阿莫西林/克拉维酸治疗儿童化脓性急性中耳炎（AOM）的效果。
这是一项研究者设盲、随机、对照、多中心试验，对384例6个月至12岁患有非难治性AOM的患者进行了鼓膜穿刺术。患者被随机分配接受三种10天治疗方案中的一种：头孢地尼每日14mg/kg（QD；n = 128）；头孢地尼7mg/kg每日两次（BID；n = 128）；或阿莫西林/克拉维酸40/10mg/kg/天，分三次服用（TID；n = 128）。
384例入组患者中，303例可评估临床疗效。治疗结束时，3个治疗组的临床成功率在统计学上相当：头孢地尼QD组102例中的85例（83.3%）；头孢地尼BID组101例中的81例（80.2%）；阿莫西林/克拉维酸组100例中的86例（86%）。在197例培养出敏感病原体的可评估患者中，治疗结束时推测的根除率相当：头孢地尼QD组65例中的55例（84.6%），头孢地尼BID组66例中的54例（81.8%），阿莫西林/克拉维酸组66例中的55例（83.3%）。然而，头孢地尼BID组肺炎链球菌的推测根除率（55.2%）显著低于阿莫西林/克拉维酸组（89.5%；P = 0.0019），略低于头孢地尼QD组（80%；P = 0.054）。腹泻是所有组中最常见的与治疗相关的不良反应，但在阿莫西林/克拉维酸治疗的患者中（35%）明显比头孢地尼QD治疗的患者（10%，P<0.001）和头孢地尼BID治疗的患者（13%，P<0.001）更常见。
在治疗鼓膜穿刺术确诊的儿童非难治性AOM时，10天的头孢地尼14mg/kg QD或7mg/kg BID方案在临床效果上与10天的阿莫西林/克拉维酸40/10mg/kg/天TID方案相当。这些数据表明，对于难治性AOM，头孢地尼QD可能比头孢地尼BID是更好的选择。与阿莫西林/克拉维酸相比，头孢地尼的两种给药方案引起的胃肠道不良反应明显更少。
