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为评价头孢托仑酯(ME1207)治疗细菌性感染的有效性和安全性,采用随机双盲对照试验和开放试验方法共治疗80例患者,其中ME1207(A药)与头孢克肟(B药)随机双盲各治疗20例(呼吸系统和泌尿系统各10对),ME1207开放试验治疗40例(呼吸系统20例、泌尿系统10例、皮肤软组织感染10例)。每日400mg,疗程7~14d。ME1207痊愈率和有效率在对照试验中为80%和95%,在开放试验中为75%和92.5%,总痊愈率为76.7%,总有效率为93.3%,细菌培养阳性率为100%,细菌清除率在对照试验和开放试验中分别为95%和92.5%。纸片法药敏试验中ME1207敏感株百分率为100%,与头孢哌酮相同,而优于头孢克肟和头孢克洛,明显优于阿莫西林(48.8%)。ME120760例中6例出现不良反应,表现为消化道反应3例,转氨酶升高2例,凝血酶原时间延长1例。与对照药头孢克肟相比在痊愈率、有效率、细菌清除率及不良反应发生方面均无显著性差异(P>0.05)。ME1207在每日400mg剂量下治疗轻、中度细菌感染安全、有效。
To evaluate the efficacy and safety of cefditoren pivoxil (ME1207) in the treatment of bacterial infections, 80 patients were treated with a randomized, double-blind, controlled trial and an open trial, in which ME1207 (drug A) and cefixime Randomized double-blind treatment of 20 cases (10 pairs of respiratory and urinary system), ME1207 open trial treatment of 40 cases (respiratory system in 20 cases, urinary system in 10 cases, 10 cases of skin and soft tissue infections). Daily 400mg, treatment 7 ~ 14d. The cure rate and effective rate of ME1207 were 80% and 95% in the control trial, 75% and 92.5% in the open trial, the total cure rate was 76.7% and the total effective rate was 93.3%. The bacterial culture The positive rate was 100% and the bacterial clearance was 95% and 92.5% respectively in the control and open trials. The susceptibility test of ME1207 in paper method was 100% sensitive to cefoperazone, which was superior to cefixime and cefaclor and significantly superior to amoxicillin (48.8%). In the 120 cases of ME120760, 6 cases showed adverse reactions, which showed digestive tract reaction in 3 cases, elevated transaminase in 2 cases and prothrombin time in 1 case. Compared with the control drug cefixime, there was no significant difference in cure rate, effective rate, bacterial clearance and adverse reactions (P> 0.05). ME1207 in the daily 400mg dose of light and moderate bacterial infections safe and effective.