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安灭菌(augmentin)是英国Beecham公司生产的羟氨苄青霉素(amoxicillin)与棒酸(clavulanic acid)的联合制剂。本项研究所用临床样品由华北制药厂提供,系用Beecham公司进口原料,由该厂生产的安灭菌静脉针剂(每支含安灭菌1g,棒酸0.2g)。本项多中心临床研究由北京医科大学临床药理研究所负责组织,包括二个临床试验。一个为128例随机对照试验,试验药安灭菌与对照药头孢拉定各64例。另一个为38例安灭菌无对照开放试验。随机对照试验在呼吸道感染与泌尿道感染病人中进行。剂量与疗程为:安灭菌每次1.2g,头孢拉定每次1g或2g均采用静脉给药,每日3—4次,每次溶于50ml生理盐水,静脉滴注30min,疗程10—14天。安灭菌与头孢拉定二组痊愈显效率分别为92.2与85.9%,二组细菌清除率分别为86.4%与81%。临床疗效与细菌清除率二组之间均无显著性差异。二组不良反应平均为10.94%。用安灭菌治疗总例数为102例,包括对照试验中64例与开放试验中38例,临床治愈率56.9%,显效率35.3%,进步率6.9%,失败率0.98%,治愈显效率为92.2%,细菌清除率86.7%,不良反应率8.82%。本组临床分离菌株对安灭菌、羟氨苄青霉素、四环素、头孢拉定、头孢唑啉敏感试验结果表明,安灭菌是所测药物中作用最强的一种。。临床分离菌株对安灭菌的敏感率为85.7～88%。本项研究还证实了本组病例中分离的产酶耐药菌均对安灭菌高敏,产酶耐药菌引起的感染患者用安灭菌治疗均取得了满意的疗效。根据以上研究结果,可以认为安灭菌是治疗呼吸道感染、泌尿道感染及其他系统感染的较好的药物之一。
Augmentin is a combination of amoxicillin and clavulanic acid produced by the British company Beecham. The clinical samples used in this study were supplied by North China Pharmaceutical Factory. The raw materials imported by Beecham Company were sterilized intravenous injection (each containing 1 g of antibacterial bacteria and 0.2 g of clavulanic acid). This multicenter clinical study is organized by the Institute of Clinical Pharmacology, Beijing Medical University, including two clinical trials. A randomized controlled trial of 128 cases, the experimental drug safety and control cephradine 64 cases. The other one is 38 cases of anaerobic non-controlled open-label test. Randomized controlled trials in patients with respiratory tract infections and urinary tract infections. The dosage and course of treatment were as follows: 1.2g of sterilizing bacteria and 1g or 2g of cefradine were administered intravenously 3-4 times per day in 50ml of normal saline, intravenously for 30min, and the course of treatment was 10-14 days . An effective sterilization and cefradine were cured two effective rates were 92.2 and 85.9%, two groups of bacterial clearance rates were 86.4% and 81%. There was no significant difference between the two groups in clinical efficacy and bacterial clearance rate. Two groups of adverse reactions averaged 10.94%. The total number of cases treated with An sterilization was 102, including 64 cases in the control trial and 38 cases in the open trial. The clinical cure rate was 56.9%, the markedly effective rate was 35.3%, the progressive rate was 6.9% and the failure rate was 0.98% 92.2%, bacterial clearance rate 86.7%, adverse reaction rate 8.82%. The clinical isolates of this group of bacteria on the safety of amoxicillin, amoxicillin, tetracycline, cefradine, cefazolin sensitive test results show that the safety of the tested drugs in the most effective one. . The sensitivity rate of clinical isolates to Ann bacteria was 85.7-88%. This study also confirmed that the isolates in this group of patients with drug-resistant strains of bacteria are highly sensitive to An sterilization, enzyme-resistant bacteria caused by infection with An sterilization sterilization have achieved satisfactory results. Based on the above findings, it can be considered An sterilization is one of the better drugs for the treatment of respiratory infections, urinary tract infections and other systemic infections.