甲磺酸帕珠沙星注射液治疗急性细菌感染的多中心随机对照研究

目的评价甲磺酸帕珠沙星注射液治疗呼吸系统和泌尿系统急性细菌性感染的临床疗效和安全性。方法采用多中心、随机双盲、平行阳性药对照试验方法。试验组用甲磺酸帕珠沙星注射液500mmg，ivgtt，bid；对照组用左氧氟沙星200mg，iv gtt，bid，疗程7。14d。结果本研究共入组287例，试验组144例，对照组143例。细菌培养阳性病例193例，试验组94例，对照组99例，试验组总痊愈率和有效率分别为59．57％和90．43％，对照组分别为59．60％和87．88％。其中呼吸系统感染试验组的痊愈率和有效率分别为57．45％和91．49％，对照组分别为61．22％和83．67％；泌尿系统感染试验组的痊愈率和有效率分别为61．70％和89．36％，对照组分别为58．00％和92．00％，2组比较差异均无统计学意义（P〉0．05）。试验组细菌清除率为95．74％（90／94），对照组为93．94％（93／99），2组比较差异无统计学意义（P〉0．05）。试验组和对照组不良反应发生率分别为10．42％（15／144）和13．29％（19／143），主要表现为轻至中度的恶心、腹泻、头痛、皮疹、注射部位疼痛、静脉炎、ALT升高、BUN升高、Cr升高等，2组比较差异无统计学意义（P〉0．05）。结论甲磺酸帕珠沙星注射液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。

Multiple center clinical studies of pazufloxacin mesilate sodium chloride injection in the treatment of patients with acute bacterial infections

AIM To evaluate the efficacy and safety of pazufloxacin mesilate sodium injection in the treatment of patients with acute bacterial infections of respiratory tract and urinary reproductive tract. METHODS It was a randomized,double-blind,parallel controlled and multiple center trial design. Patients in test group were given 500 mg pazufloxacin mesilate sodium injection, iv gtt, bid for 7 - 14 d. Patients in control group were given 200 mg levofloxacin injection, iv gtt, bid for 7 - 14 d. RESULTS Two hundred and eighty-seven patients with acute bacterial infections of respiratory tract and urinary reproductive tract were selected. One hundred and ninty-three cases were positive in bacteriological test,of which 94 cases in test group and 97 cases in control group. One hundred and forty-four patients in test group were given 500 mg pazufloxacin mesilate sodium injection, iv gtt, bid for 7 - 14 d, while 143 patients in control group were given 200 mg levofloxacin injection, iv gtt, bid for 7 - 14 d. In the 193 cases of bacteriological positive cases, the total effec- tive rates of test group and control group were 90.43 % and 87.88% , and the recovery rates were 59.57% and 59.60%, respectively. The bacterial clearance rates were 95.74% （90/94）and 93.94% （93/99）, respectively. The adverse drug reaction rates were 10.42% （15/144） and 13.29% （19/143）, respectively. The main adverse drug reactions inclluded nausea, diarrhea, headache, rash, injection site pain, phlebitis, the increase of ALT, BUN and Cr.The two groups were similar in the efficacy and safety （ P 〉 0.05）. CONCLUSION Pazufloxacin mesilate sodium injection is an effective and safe drug in the treatment of patients with acute infections of respiratory tract and urinary reproductive tract.