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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 ,抗菌活性较强
Aim To evaluate the safety and efficacy of amoxicillin sodium / sulbactam sodium in ampicillin with ampicillin / sulbactam sodium as the reference drug. Methods A prospective, single-blind, multicenter randomized parallel trial design was used. Moderate infection with amoxicillin sodium / sulbactam sodium was 4.5 g / d, severe infection was 15 0 mg / (kg · d), and ampicillin sodium / sulbactam sodium moderate infection was 4.5-5.9 g / d , Severe infection 9 ~ 12g / d, 2 to 3 times intravenous infusion, treatment of 7 to 14 days. Results The experimental group completed 61 cases, control group 59 cases. The test group was lower than the control group (P = 0.021). The total effective rates of the two groups were 88.5% and 89.83%, respectively (P = 0.769). The bacterial clearance rates were 92.16% and 94.12%, respectively (P = 0.62 2). Amoxicillin sodium / sulbactam sodium caused short-term dizziness, insomnia, mild gastrointestinal symptoms, rash and transient liver function abnormalities; ampicillin / sulbactam sodium caused similar adverse reactions and test drugs, only 1 case Due to rash withdrawal, given symptomatic treatment, most do not need to deal with, relieve itself, the incidence of adverse reactions were 11.48% and 18.33% (P = 0.328). The antibacterial activity of amoxicillin sodium / sulbactam sodium against Gram-positive bacteria was similar to that of ampicillin sodium / sulbactam sodium and cefuroxime, which was significantly better than that of amoxicillin and cefradine. The antibacterial activity against gram-negative bacteria Activity less than ampicillin sodium / sulbactam sodium and cefuroxime, better than amoxicillin and cephradine. Conclusions Amoxicillin sodium / sulbactam sodium injection is a kind of broad-spectrum antimicrobial drug with strong antibacterial activity