安灭菌与头孢拉定随机对照临床试验

RAND0MIZED CONTROLLED CLINICAL TRIAL ON AUGMENTIN COMPARED WITH CEPHRADINE

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 (AUG), a product of the Beecham Company,is a combination of amoxicillin (AMO) and clavulanic acid (CA) with formulation of AMO lg + CA 0 .2G. Test compounds for clinical trials was provided by Huabei Pharmaceutical Factory, using import raw materials from the Beecham Company. The multiple-centre clinical study, including a randomized controlled clinical trial on AUG compared with cephradine (CPH) and an open trial on AUG only, was conducted by the Institute of Clinical Pharmacology, Beijing Medical University. In the controlled trial, 128 patients with respiratory tract or urinary tract infections were randomized to receive either AUG (64 patients) or CPH (64 patients). The dosage and therapeutic duration were as follows:AUG 1.2g, CPH 1g or 2g, intravenously, 3 to 4 times per day for 10 to 14 days. The cure rate plus excellence rate of AUG and CPH were 92.2%and 85.9% respectively. The bacterial clearance rate of the two groups was 86.4% and 81% respectively. There was no statistically significant difference between the two groups on the clinical efficacy and bacterial clearance rate. The adverse drug reactions (ADR) of both groups were mild with the rate of 10.94% either. The total number of patients treatcd by AUG was 102 cases (64 patients in controlled study and 38 patients in open trial) with a cure rate of 56.9%, excellence rate of 35.3%, improvement rate of 6.9% and failure rate of 0.98%, The cure rate plus excellence rate, bacterial clearance rate and ADR rate of 102 cases treated with AUG were 92.2%, 86.7% and 8.28%, respectively. Results from the comparison of the susceptibility of clinical isolatesto AUG, AMO, tetracycline, CPH and cephazolin showed that AUG wasthe most effective antibiotic among the test compounds. The rate of sus-ceptibility of clinical isolates to AUG was 85.7-88%, and it was shownthat all of the beta-lactamase producing resistant strains isolated from thepatients were highly sensitive to AUG and its use in the treatment of pa-tients infected by enzyme-producing resistant strains has attained satisfac-tory therapeutic effect. The above study showed that AUG is one of the useful drugs in thetreatment of respiratory tract and urinary tract infections, as well as othersystemic infections.