Comparative safety and efficacy of cefdinir vs. amoxicillin/clavulanate for treatment of suppurative acute otitis media in children
Comparative safety and efficacy of cefdinir vs. amoxicillin/clavulanate for treatment of suppurative acute otitis media in children
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DOI：
10.1097/00006454-200012001-00005
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发表时间：
2000-12-01
影响因子：
3.6
通讯作者：
Tack, KJ
中科院分区：
文献类型：
--
作者：
Block, SL;McCarty, JM;Tack, KJ
Objective.比较头孢地尼与阿莫西林/克拉维汀治疗儿童急性化脓性中耳炎（AOM）的疗效。这是一项多中心、随机、对照、盲法试验，对384例年龄6个月至12岁的非难治性AOM患者进行了鼓室穿刺术。患者随机接受三种10天治疗方案之一：头孢地尼14 mg/kg/d（QD; n = 128）;头孢地尼7 mg/kg，每日两次（BID; n = 128）;或阿莫西林/克拉维汀40/10 mg/kg/天，每日三次（TID; n. = 128）。在384例入组患者中，303例可评价临床疗效。治疗结束时，3个治疗组的临床成功率在统计学上相当：85/102（83.3%）头孢地尼QD; 81/101头孢地尼BID组为80.2%; 86/100例（86%）阿莫西林/克拉维汀，在197例回收敏感病原体的可评价患者中，治疗结束时的假定根除率相当：头孢地尼QD、头孢地尼BID和阿莫西林/克拉维酸盐治疗患者分别为55/65（84.6%）、54/66（81.8%）和55/66（83.3%）。然而，头孢地尼BID的肺炎链球菌假定根除率显著较低（55.2%），而不是舒诺西林/克拉维酸（89.5%; P = 0.0019），略低于头孢地尼QD（80%; P = 0.054），腹泻是所有组中最常见的治疗相关不良反应，但在阿莫西林/克拉维酸治疗的患者中更常见（35%）与头孢地尼QD组（10%，P < 0.001）和头孢地尼BID组（13%，P < 0.001）比较，差异有统计学意义。头孢地尼14 mg/kg QD或7 mg/kg BID 10天方案与阿莫西林/克拉维汀40/10 mg/kg/天分次TID 10天方案治疗经鼓室穿刺术证实的非难治性AOM儿童的临床有效性总体相同。这些数据表明，对于难治性AOM，头孢地尼QD可能是比头孢地尼BID更好的替代方案。头孢地尼的两种给药方案与阿莫西林/克拉维汀相比，胃肠道不良反应显著较少。
Objective. Two dosage regimens of cefdinir were compared with amoxicillin/clavulanate for the treatment of suppurative acute otitis media (AOM) in children.Methods. 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 l0-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).Results. 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 sunoxicillin/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),Conclusions. A l0-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.