甲磺酸帕珠沙星注射液治疗急性细菌性感染有效性和安全性的多中心临床研究

Multiple center clinical studies of pazufloxacin mesylate injection in the treatment of patients with acute bacterial infections

目的评价甲磺酸帕珠沙星注射液治疗急性细菌性呼吸系统、泌尿生殖系统感染的有效性、安全性。方法采用随机单盲平行对照多中心试验方法。选择急性细菌性呼吸系统、泌尿生殖系统感染患者213例，可评价病例209例，随机编人试验组或对照组。试验组101例．每日1次给予甲磺酸帕珠沙星注射液300mg，iv，gtt，bid；对照组108例，每日1次给予加替沙星注射液200mg，iv，gtt，bid。疗程7～10d。结果甲磺酸帕珠沙星组、加替沙星组有效率分别为94．06％（95／101）和90．74％（98／108）；痊愈率分别为67．33％（68／101）和70．37％（76／108）；细菌清除率分别为94．62％（88／93）和93．62％（88／94）；不良反应发生率分别为7，69％（8／104）和5．50％（6／109）。两组有效性、安全性相似（P〉0．05）。结论甲磺酸帕珠沙星注射液治疗急性细菌性呼吸系统、泌尿生殖系统感染有效、安全，与加替沙星相当。

Objective To evaluate the efficacy and safety of pazufloxacin mesylate injection in the treatment of patients with acute bacterial infections of respiratory tract and urinary reproductive tract. Methods It was a randomized, single-blind, parallel controlled and multiple center trial design. Two hundred and thirteen patients with acute bacterial infections of respiratory tract and urinary reproductive tract were selected. Two hundred and nine patients that can be evaluated were randomly divided into test group and control group. One hundred and one patients in test group were given 300 mg pazufloxacin mesylate injection, iv, gtt, bid for 7-10d, while 108 patients in control group were given 200rag gatifloxacin injection, iv, gtt, bid for 7-10d. Results The total effective rates of pazufloxacin mesylate and gatifloxcin group were 94.06% （95/101） and 90.74% （98/108）, and the recovery rates were 67/33% （68/101） and 70.37% （76/108）, respectively. The bacterial clearance rates were 94.62% （88/93） and 93.62% （88/94）, respectively. The adverse reaction rates were 7.69% （8. 104） and 5.50% （6/109）, respectively. The two groups were similar in the efficacy and safety （P〉0.05）. Conclusion Pazufloxacin mesylate injection is effective and safe drug in the treatment of patients with acutc infections of respiratory tract and urinary-reproductive tract.