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目的 :评价注射用阿莫西林 舒巴坦治疗常见致病菌引起的中、重度急性下呼吸道细菌感染性疾病的临床疗效和安全性。方法 :通过以氨苄西林 舒巴坦为对照药 ,采用双盲随机对照平行试验设计 ,入选病例 4 4例 ,剔除 3例 ,中辍 1例 ,共完成4 0例。其中急性支气管炎 2 2例 ,肺炎 1 8例。试验组 (1 9例 )应用注射用阿莫西林 舒巴坦 ,2 .2 5 g/次 ,2 /d静脉滴注 ,对照组(2 1例 )应用氨苄西林 舒巴坦 ,2 .2 5g/次 ,2 /d静脉滴注 ,疗程均为 7～ 1 4d。结果 :试验组与对照组入选病例基本情况、病情程度差异无统计学意义。阿莫西林 舒巴坦治疗组的痊愈率和有效率分别为 6 8.4 %、89.5 % ,与氨苄西林 舒巴坦对照组差异无统计学意义 (痊愈率和有效率分别为 4 2 .9%、95 .2 % ,P >0 .0 5 )。阿莫西林 舒巴坦对分离细菌的清除率为 87.5 % ,氨苄西林 舒巴坦组为 90 .0 % ,两组细菌清除率的差异无显著性。应用注射用阿莫西林 舒巴坦未见严重不良反应 ,仅发生皮疹 3例、恶心 1例 ,发生率为 1 9.1 % (4 /2 1 ) ,对照组皮疹 1例、恶心 1例 ,8.7% (2 /2 3) ,其差异无显著性 (P >0 .0 5 )。结论 :阿莫西林 舒巴坦对临床常见致病菌引起的中、重度下呼吸道感染 ,尤其是产酶菌引起的严重感染 ,临床疗效较好 ,使用安全 ,有较高
Objective: To evaluate the clinical efficacy and safety of amoxicillin and sulbactam for the treatment of moderate and severe bacterial infections of lower respiratory tract caused by common pathogenic bacteria. Methods: Ampicillin sulbactam was used as a reference drug, and a double-blind randomized controlled trial was designed. Four forty-four cases were selected, three cases were excluded, one case was discontinued, and 40 cases were completed. There were 22 cases of acute bronchitis and 18 cases of pneumonia. In the test group (19 cases), amoxicillin and sulbactam for injection was used, and the rats in the control group (21 cases) were treated with ampicillin sulbactam (2.52g / / Times, 2 / d intravenous infusion, treatment were 7 ~ 14d. Results: The experimental group and the control group were selected the basic conditions, the degree of illness was no significant difference. Amoxicillin and sulbactam treatment group, the cure rate and effective rate were 8.42%, 89.5%, and ampicillin sulbactam control group, the difference was not statistically significant (cure rate and effective rate were 42.9% 95.2%, P> 0.05). The clearance rate of amoxicillin and sulbactam to the isolated bacteria was 87.5% and that of the ampicillin and sulbactam group was 90.0%. There was no significant difference in the bacterial clearance rate between the two groups. Application of amoxicillin and sulbactam for injection showed no serious adverse reactions, only 3 cases of rash and 1 case of nausea, with a rate of 1 9.1% (4/21), 1 case of rash in control group, 1 case of nausea and 8.7% (2/2 3), the difference was not significant (P> 0.05). Conclusion: Amoxicillin and sulbactam are effective in the treatment of moderate and severe lower respiratory tract infections caused by common pathogenic bacteria in clinical practice, especially those caused by enzyme-producing bacteria. The clinical efficacy is good, safe to use, and high