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目的:评价国产与进口头孢吡肟在治疗中、重度细菌性感染的有效性和安全性。方法:随机将139例患者分为国产头孢吡肟组(试验组)70例,进口头孢吡肟组(对照组)69例。给药方案均为每次2g,1次/12h,疗程7~14d。结果:治疗后1~3d,试验组与对照组痊愈率分别为67.69%和63.33%,有效率分别为92.31%和91.67%,对不同致病菌感染的细菌阴转率分别为96.15%和98.08%,细菌清除率分别为94.44%和100%,差异均无统计学意义。治疗后7~10d,试验组与对照组痊愈率分别为80.00%和73.33%,两组比较差异无统计学意义;有效率分别为92.31%和100%,两组差异有统计学意义(P<0.05)。两药对不同致病菌感染的细菌阴转率分别为94.23%和100%,细菌清除率分别为94.23%和100%,差异均无统计学意义(P>0.05)。纸片法药敏试验显示,致病菌对试验药和对照药的敏感率均为96.42%。两组不良反应发生率分别为8.57%和5.80%,差异无统计学意义(P>0.05)。结论:国产与进口头孢吡肟在临床疗效、细菌学疗效、不良反应等方面差异无统计学意义(P>0.05),是一种安全有效的抗感染药物。
Objective: To evaluate the efficacy and safety of domestic and imported cefepime in the treatment of moderate and severe bacterial infections. Methods: Seventy-nine patients were randomly divided into domestic cefepime group (experimental group) 70 cases, imported cefepime group (control group) 69 cases. Dosing regimens are 2g each time, 1 time / 12h, course of treatment 7 ~ 14d. Results: The cure rates of the experimental group and the control group were 67.69% and 63.33% respectively after 1 ~ 3 days of treatment, the effective rates were 92.31% and 91.67% respectively. The negative rates of bacterial infection to different pathogenic bacteria were 96.15% and 98.08 %, The bacterial clearance rates were 94.44% and 100%, respectively, with no significant difference. After 7 ~ 10 days of treatment, the cure rates of the experimental group and the control group were 80.00% and 73.33% respectively, with no significant difference between the two groups; the effective rates were 92.31% and 100% respectively, with significant difference between the two groups (P < 0.05). The negative conversion rate of the two drugs to different pathogenic bacteria was 94.23% and 100% respectively, and the bacterial clearance rate was 94.23% and 100% respectively, with no significant difference (P> 0.05). Susceptibility test of paper method showed that the sensitivity of pathogenic bacteria to test drug and reference drug were both 96.42%. The incidence of adverse reactions in both groups were 8.57% and 5.80%, respectively, with no significant difference (P> 0.05). Conclusion: Domestic and imported cefepime have no significant difference in clinical curative effect, bacteriological efficacy and adverse reaction (P> 0.05), which is a safe and effective anti-infective drug.