甲磺酸帕珠沙星注射液治疗急性细菌感染的疗效研究

Clinical Study of Pazufloxacin Mesilate in Treatment of Acute Bacterial Infection

目的 评价帕珠沙星治疗急性细菌感染的临床疗效和安全性。方法 采用随机、双盲、对照试验的方法，治疗组为甲磺酸帕珠沙星注射液，对照组为左氧氟沙星，每组各20例，纳入对象为呼吸道、泌尿道感染，甲磺酸帕珠沙星用量：轻度感染500mg Qd静滴；中度感染500mgBid静滴。左氧氟沙星用量：轻度感染200mgQd静滴；中度感染200mgBid静滴。疗程均为7～14d。结果 甲磺酸帕珠沙星的临床治愈率70．0％（14／20），有效率90．0％（18／20），细菌清除率87．5％（14／16）；对照组左氧氟沙星分别为65．0％（13／20），90．0％（18／20），86．7％（13／15）。帕珠沙星和左氧氟沙星不良反应发生率均为8．7％。以上结果经统计学处理，差异均无统计学意义（P均〉0．05）。结论 甲磺酸帕珠沙星是治疗轻中度呼吸道、泌尿道感染有效、安全的抗菌药物。

Objective To evaluate efficacy and safety of pazufloxacin mesilate in treatment of acute bacterial infections. Method A randomized, double blind and controlled trial with 20 pairs of patients with respiratory and urinary tract bacterial infection were treated with pazufloxacin mesilate（ treatment group）and levofloxacin （con- trol group）respectively. The dosage of pazufloxacin mesilate in treating low grade infection and midrange infec- tion was 500 mg once daily and twice daily intravenous drop infusion respectively for 7-14 days. And the dosage of levofloxacin in treating low grade infection and midrange infection was 200 mg once daily and twice daily in- travenous drop infusion respectively for 7-14 days. Result The results showed that the cure rate of pazufloxacin mesilate was 70. 0% （14/20）, the effective rate was 90. 0% （18/20）and the bacterial clearance rate was 87.5% （14/16） ,while in levofloxacin group they were 65.0% （13/20） ,90. 0% （18/20） and 86.7% （13/15） respectively. The adverse reaction rates of both pazufloxacin mesilate and levofloxacin were 8.7%. There were no statistical significant differences（ P 〉 0. 05 ）between pazufloxacin mesilate and levofloxacin in overall results. Conclusion The study demonstrated pazufloxacin mesilate was an antibiotic of efficacy and safety in treating respiratory and urinary tract bacterial infection.