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目的:评价普卢利沙星片治疗呼吸系统和泌尿系统急性细菌性感染的安全性和有效性。方法:采用多中心、随机、双盲双模拟、阳性药平行对照方法。试验组用普卢利沙星片和左氧氟沙星模拟片各2片,2次/d,疗程7～14d;对照组用左氧氟沙星片和普卢利沙星模拟片各2片,2次/d,疗程7～14d。结果:本研究共入组265例,可进行疗效评价260例,试验组(普卢利沙星)131例,对照组(左氧氟沙星)129例。试验组和对照组的总有效率分别为89.47%和90.91%,细菌清除率分别为94.06%(95/101)和95.96%(95/99),两组比较差异均无统计学意义(P<0.05)。试验组和对照组不良反应发生率分别为5.26%(7/133)和3.79%(5/132),主要表现为轻中度的恶心、腹泻、头痛、皮疹、ALT升高、BUN升高、Cr升高等,两组比较差异无统计学意义(P<0.05)。结论:普卢利沙星片治疗呼吸系统和泌尿系统急性细菌感染,临床疗效明显,安全性较好。
PURPOSE: To evaluate the safety and efficacy of prulifloxacin in the treatment of acute bacterial infections of the respiratory and urinary systems. Methods: Multi-center, randomized, double-blind, double-dummy, positive drug parallel control method. The experimental group with prulifloxacin tablets and levofloxacin simulation tablets 2, 2 times / d, treatment 7 ~ 14d; control group levofloxacin tablets and prulifloxacin simulation tablets 2, 2 times / d, 7 ~ 14d. Results: A total of 265 patients were enrolled in this study. 260 patients were evaluated, 131 patients in trial group (prulifloxacin) and 129 in control group (levofloxacin). The total effective rates of the experimental group and the control group were 89.47% and 90.91% respectively, and the bacterial clearance rates were 94.06% (95/101) and 95.96% (95/99) respectively, with no significant difference between the two groups (P < 0.05). The incidence of adverse reactions in the experimental and control groups were 5.26% (7/133) and 3.79% (5/132) respectively. The main adverse reactions were mild to moderate nausea, diarrhea, headache, rash, elevated ALT, elevated BUN, Cr increased, the difference between the two groups was not statistically significant (P <0.05). Conclusion: Prulifloxacin tablets are effective in the treatment of acute bacterial infections of respiratory system and urinary system. The clinical effect is obvious and the safety is good.