阿莫西林钠/舒巴坦钠随机单盲多中心临床与实验研究  

Randomized-controlled single-blind multicenter clinical trial and laboratory study on amoxicillin/sulbactam

作　　者：吕晓菊[1] 冯萍[1] 王文雅[1] 宗志勇[1] 俞汝佳[1] 辛建保[2] 金阳[2] 罗长清[2] 姚丽君[2] 张建初[2] 胡克[3] 胡云飞[3] 胡苏萍[3] 李耀华[3] 彭少华[3] 

机构地区：[1]四川大学华西医院,成都610041 [2]华中科技大学协和医院,武汉430022 [3]武汉大学人民医院,武汉430060

出　　处：《中国抗生素杂志》2002年第12期730-733,747,共5页Chinese Journal of Antibiotics

基　　金：国家药品监督管理局批准的新药研究课题 (批准号 2 0 0 0 - XL0 1 83)

摘　　要：目的　以氨苄西林钠 /舒巴坦钠为对照药 ,对国产阿莫西林钠 /舒巴坦钠进行多中心临床研究 ,评价后者的安全性与有效性。方法　采用前瞻性、单盲、多中心区组随机平行试验设计。阿莫西林钠 /舒巴坦钠中度感染 4 .5 g/ d,重度感染 15 0 mg/ (kg·d) ,氨苄西林钠 /舒巴坦钠中度感染 4 .5 g～ 9g/ d,重度感染 9～ 12g/ d,分 2～ 3次静脉滴注 ,疗程 7～ 14 d。结果　试验组完成 6 1例、对照组 5 9例。试验组用药量低于对照组 (P=0 .0 2 1)。两组各病种的临床总有效率分别为 88.5 2 %与 89.83% (P=0 .76 9) ;细菌清除率分别为 92 .16 %与94 .12 % (P=0 .6 92 )。阿莫西林钠 /舒巴坦钠可引起短暂头晕、失眠、轻微消化道症状、皮疹及短暂肝功能的异常 ;氨苄西林钠 /舒巴坦钠引起的不良反应类型与试验药相似 ,仅 1例因皮疹停药 ,给予对症治疗 ,大多无需处理 ,均自行缓解 ,两组不良反应发生率分别为 11.4 8%与 18.33% (P=0 .318)。阿莫西林钠 /舒巴坦钠对革兰氏阳性菌的抗菌活性与氨苄西林钠 /舒巴坦钠及头孢呋辛相似 ,明显优于阿莫西林与头孢拉定 ,对革兰氏阴性菌的抗菌活性稍逊于氨苄西林钠 /舒巴坦钠及头孢呋辛 ,优于阿莫西林与头孢拉定。结论　阿莫西林钠 /舒巴坦钠注射剂作为一种广谱抗菌药物 。Objective To evaluate the safety, efficacy and tolerance of amoxicillin/sulbactam (AMPC/SB). Method A multicenter single blind randomized comparative study was conducted for treatment of acute bacterial infection by amoxicillin/sulbactam (AMPC/SB). Ampicillin/sulbactam (ABPC/SB) was used as control. A total of 120 subjects were enrolled, 61 were randomly assigned to the AMPC/SB group [4 5g/d for moderate infection, 150mg/(kg·d) for sever infection] and 59 to the ABPC/SB (4 5~9g/d for moderate infection , 9~12mg/d for sever infection) intravenous for 7~10days. Results Clinical efficacy rates were 88 52% (54/61) in AMPC/SB group and 89 53% (53/59) in ABPC/SB group respectively ( P =0 769). The pathogens eradication rates were 92 16% (47/51) in the AMPC/SB group and 94 12% (48/51) in the ABPC/SB group( P =0 692). Side effect rates were 11 48% in AMPC/SB group and 18 33% in ABPC/SB group. Two patients in ABPC/SB group and 4 patients in AMPC/SB group developed minor abnormalities in labora tory safety parameters ( P =0 318). The in vitro activities of AMPC/SB against Gram positive cocci were similar to that of ABPC/SB and ceforuxime, more active than amoxicillin and cefradine. That against Gram negative bacilli were less than ABPC/SB and ceforuxime, more active than amoxicillin and cefradine. Conclusion The results suggested that amoxicillin/sulbactam, with wide antibacterial spectrum, satisfactory activity, is an effective and safe antibacterial agent in treatment of moderate to severe acute bacterial infections.

关 键 词：阿莫西林钠 舒巴坦钠 随机单盲 实验研究 多中心随机对照试验 

分 类 号：R969.4[医药卫生—药理学] R978.[医药卫生—药学]