中华全科医师杂志
中華全科醫師雜誌
중화전과의사잡지
CHINESE JOURNAL OF GENERAL PRACTITIONERS
2008年
1期
19-21
,共3页
杨静%葛庚芝%夏天%陈宝元%韩晓雯%刘冰%何礼贤%丁小强%黄仲义%邱忠民%马骏%沈策%汪年松
楊靜%葛庚芝%夏天%陳寶元%韓曉雯%劉冰%何禮賢%丁小彊%黃仲義%邱忠民%馬駿%瀋策%汪年鬆
양정%갈경지%하천%진보원%한효문%류빙%하례현%정소강%황중의%구충민%마준%침책%왕년송
喹诺酮类%细菌感染%随机对照试验
喹諾酮類%細菌感染%隨機對照試驗
규낙동류%세균감염%수궤대조시험
Quinolones%Bacterial infections%Randomized controlled trials
目的 评价国产甲磺酸帕珠沙星氯化钠注射液治疗呼吸道感染和泌尿道感染的临床疗效和安全性.方法 采用多中心随机、双盲、阳性药物平行对照设计.共入选244例,脱落4例.试验组120例,使用甲磺酸帕珠沙星氯化钠注射液,每次300 mg,每日2次静脉滴注;对照组120例,使用盐酸左氧氟沙星葡萄糖注射液,每次200 mg,每日2次静脉滴注;疗程均为7～14 d.安全性评价244例.结果 试验组和对照组呼吸道感染治疗的临床总有效率分别为77.0%和80.6%,泌尿道感染治疗的总有效率分别为93.5%和89.6%.试验组总细菌清除率为91.5%,其中呼吸道感染及泌尿道感染细菌清除率分别为89.6%和94.1%.对照组总细菌清除率为93.4%,其中呼吸道感染及泌尿道感染细菌清除率分别为97.3%和89.7%.试验组和对照组不良反应率分别为4.88%和7.44%,差异无统计学意义(P＞0.05).结论 国产甲磺酸帕珠沙星氯化钠注射液治疗呼吸道感染和泌尿道感染安全、有效.
目的 評價國產甲磺痠帕珠沙星氯化鈉註射液治療呼吸道感染和泌尿道感染的臨床療效和安全性.方法 採用多中心隨機、雙盲、暘性藥物平行對照設計.共入選244例,脫落4例.試驗組120例,使用甲磺痠帕珠沙星氯化鈉註射液,每次300 mg,每日2次靜脈滴註;對照組120例,使用鹽痠左氧氟沙星葡萄糖註射液,每次200 mg,每日2次靜脈滴註;療程均為7～14 d.安全性評價244例.結果 試驗組和對照組呼吸道感染治療的臨床總有效率分彆為77.0%和80.6%,泌尿道感染治療的總有效率分彆為93.5%和89.6%.試驗組總細菌清除率為91.5%,其中呼吸道感染及泌尿道感染細菌清除率分彆為89.6%和94.1%.對照組總細菌清除率為93.4%,其中呼吸道感染及泌尿道感染細菌清除率分彆為97.3%和89.7%.試驗組和對照組不良反應率分彆為4.88%和7.44%,差異無統計學意義(P＞0.05).結論 國產甲磺痠帕珠沙星氯化鈉註射液治療呼吸道感染和泌尿道感染安全、有效.
목적 평개국산갑광산파주사성록화납주사액치료호흡도감염화비뇨도감염적림상료효화안전성.방법 채용다중심수궤、쌍맹、양성약물평행대조설계.공입선244례,탈락4례.시험조120례,사용갑광산파주사성록화납주사액,매차300 mg,매일2차정맥적주;대조조120례,사용염산좌양불사성포도당주사액,매차200 mg,매일2차정맥적주;료정균위7～14 d.안전성평개244례.결과 시험조화대조조호흡도감염치료적림상총유효솔분별위77.0%화80.6%,비뇨도감염치료적총유효솔분별위93.5%화89.6%.시험조총세균청제솔위91.5%,기중호흡도감염급비뇨도감염세균청제솔분별위89.6%화94.1%.대조조총세균청제솔위93.4%,기중호흡도감염급비뇨도감염세균청제솔분별위97.3%화89.7%.시험조화대조조불량반응솔분별위4.88%화7.44%,차이무통계학의의(P＞0.05).결론 국산갑광산파주사성록화납주사액치료호흡도감염화비뇨도감염안전、유효.
Objective To evaluate efficacy and safety of locally-produced pazufloxacin mesilate sodium chloride injection in the treatment of bacterial infections of respiratory and urinary tract.Methods A multi-center double-blind randomized controlled clinical trial was carried out to evaluate efficacy and safety of pazufloxacin mesilate sodium chloride in treatment for acute bacterial infection, as compared to those of levofloxacin hydrochloride and glucose injection as control treatment.A total of 244 patients with acute bacterial infection of respiratory and urinary tract were enrolled in the studies.120 in trial group and 120 in control group, with four withdrawals.Pazufloxacin mesilate and levofloxacin were administered intravenously by drip at a dose of 300 mg and 200 mg, every 12 hours for 7 to 14 days for trial and control groups, respectively.Resuits Overall efficacy of pazufloxacin mesilate was 77.0 percent and 93.5 percent in treatment for acute bacterial infections of respiratory and urinary tract.respectively, and that of levofloxacin was 80.6 percent and 89.6 percent, respectively.Overall bacterial clearance rate WaS 91.5 percent for pazufloxacin mesilate, 89.6 percent for respiratory tract infection and 94.1 percent for urinary tract infection, respectively.and 93.4 percent for levofloxacin, 97.3 percent for respiratory tract infection and 89.7 percent for urinary tract infection, respectively.No significant difference in adverse drug reactions between the two groups(P＞0.05)was found, with 4.88 percent and 7.44 percent for trial and control groups, respectively.Conclusions Pazufloxacin mesilate sodium chloride injection produced locally is a safe and effective antibiotic in treatment for acute infections of respiratory and urinary tract.
