Kumar A, Murray D L, Hanna C B, Kreindler T G, Jacobson K D, Bundy J M, Waxman K, Finnerty E F, Folan D W, Drucker W R
Department of Pediatrics and Human Development, Michigan State University, East Lansing 48824-1317.
Antimicrob Agents Chemother. 1988 Jun;32(6):882-5. doi: 10.1128/AAC.32.6.882.
In two prospective, randomized multicenter double-blind studies with a dosage of either 250 mg given four times a day (study A) or 500 mg given two times a day (study B), the comparative efficacy and safety of cephalexin hydrochloride (LY061188; Keftab) and cephalexin monohydrate (Keflex) for treatment of skin and soft tissue infections were determined. In study A, 97 patients received cephalexin hydrochloride and 101 patients received cephalexin monohydrate. In study B, 75 patients received cephalexin hydrochloride and 70 patients received cephalexin monohydrate. Diagnoses included abscesses, cellulitis, wound infections, and infected dermatitis, and were comparable in the different treatment groups. Pathogens were isolated from 82% of patients enrolled; the majority of isolates were of Staphylococcus aureus, Streptococcus pyogenes, other staphylococcal species, and a few gram-negative bacteria. In study A, 68 of 71 (95.7%) evaluable patients who received cephalexin hydrochloride responded satisfactorily; 73 of 81 (90%) patients who received cephalexin monohydrate also responded satisfactorily. In study B, 56 of 58 (96.5%) evaluable patients who received cephalexin hydrochloride responded satisfactorily; 47 of 50 (94%) patients who received cephalexin monohydrate also responded satisfactorily. An adverse clinical event leading to discontinuation of the treatment drug developed in 17 of 343 (4.95%) patients in both studies. No differences were noted between the two drugs. Skin eruptions, pruritus, and mild gastrointestinal symptoms were the common adverse effects. These data suggest that cephalexin hydrochloride, a new formulation of cephalexin, is a safe and effective antimicrobial agent for treatment of a variety of skin and subcutaneous infections in a dosage of either 250 mg four times a day or 500 mg twice a day.
在两项前瞻性、随机、多中心双盲研究中，一项研究（研究A）给予盐酸头孢氨苄（LY061188；凯复定）剂量为每日4次，每次250毫克，另一项研究（研究B）给予头孢氨苄一水合物（凯福乐）剂量为每日2次，每次500毫克，以此确定盐酸头孢氨苄和头孢氨苄一水合物治疗皮肤及软组织感染的相对疗效和安全性。在研究A中，97例患者接受盐酸头孢氨苄治疗，101例患者接受头孢氨苄一水合物治疗。在研究B中，75例患者接受盐酸头孢氨苄治疗，70例患者接受头孢氨苄一水合物治疗。诊断包括脓肿、蜂窝织炎、伤口感染和感染性皮炎，不同治疗组的诊断情况具有可比性。从82%的入组患者中分离出病原体；分离出的病原体大多数为金黄色葡萄球菌、化脓性链球菌、其他葡萄球菌属菌种，以及少数革兰氏阴性菌。在研究A中，接受盐酸头孢氨苄治疗的71例可评估患者中有68例（95.7%）反应良好；接受头孢氨苄一水合物治疗的81例患者中有73例（90%）反应也良好。在研究B中，接受盐酸头孢氨苄治疗的58例可评估患者中有56例（96.5%）反应良好；接受头孢氨苄一水合物治疗的50例患者中有47例（94%）反应也良好。两项研究中，343例患者中有17例（4.95%）出现导致停用治疗药物的不良临床事件。两种药物之间未发现差异。皮疹、瘙痒和轻度胃肠道症状是常见的不良反应。这些数据表明，头孢氨苄的新剂型盐酸头孢氨苄，以每日4次、每次250毫克或每日2次、每次500毫克的剂量治疗各种皮肤和皮下感染时，是一种安全有效的抗菌药物。
