中国感染与化疗杂志
中國感染與化療雜誌
중국감염여화료잡지
CHINESE JOURNAL OF INFECTION AND CHEMOTHERAPY
2014年
6期
493-502
,共10页
赵旭%吴菊芳%修清玉%王辰%张德平%黄建安%谢灿茂%孙圣华%吕晓菊%司斌%肖组克%张婴元
趙旭%吳菊芳%脩清玉%王辰%張德平%黃建安%謝燦茂%孫聖華%呂曉菊%司斌%肖組剋%張嬰元
조욱%오국방%수청옥%왕신%장덕평%황건안%사찬무%손골화%려효국%사빈%초조극%장영원
社区获得性肺炎%左氧氟沙星%短程疗法%临床试验%有效性%安全性
社區穫得性肺炎%左氧氟沙星%短程療法%臨床試驗%有效性%安全性
사구획득성폐염%좌양불사성%단정요법%림상시험%유효성%안전성
community-acquired pneumonia%levofloxacin%short-course treatment%clinical trial%efficacy%safety
目的：比较左氧氟沙星750 mg注射液5 d短程疗法与500 mg注射液7～14 d常规疗法治疗社区获得性肺炎（CAP）疗效和安全性差异。方法本临床试验为随机对照、开放、非劣效性多中心临床试验。CAP患者被随机分配到左氧氟沙星750 mg组治疗5 d或500 mg组治疗7～14 d ，两组均接受静脉给药治疗，观察其临床表现、实验室检查、影像学改变及微生物学检查等，比较两组安全性和疗效差异。结果10个研究中心共入选病例241例。其中全分析集（FAS ）223例，包括750 mg组111例，500 mg组112例。符合方案分析集（PPS）211例，包括750 mg组107例，500 mg组104例。安全性分析集（SS）241例，包括750 mg组121例，500 mg组120例。FAS 750 mg组疗程中位数为5．0 d ，500 mg组疗程中位数为9．0 d。750 mg组总剂量中位数为3750 mg ，500 mg组总剂量中位数为4500 mg。FAS第4次随访750 mg组有效率为86．2％，500 mg组有效率为84．7％，两组综合疗效评价相比为非劣效。FAS 750 mg组可进行微生物疗效评价者共40例，获病原菌41株，500 mg组可行微生物疗效评价者共49例，获病原菌51株，两组细菌清除率均为100％。另外，750 mg组和500 mg组的非典型病原体的临床有效率均为100％。对750 mg组安全性观察结果显示，临床不良反应最常见为注射部位瘙痒、疼痛和充血等，其次为失眠、恶心、皮疹等。较常见的实验室指标异常为中性粒细胞比率降低、白细胞总数降低、ALT升高、AST升高等。以上不良反应多属轻微，患者可耐受，与500 mg组相比，因药物中止试验和不良反应发生率差异无统计学意义，提示两组安全性相仿。结论左氧氟沙星750 mg注射液5 d短程疗法治疗CAP与左氧氟沙星500 mg注射液7～14 d常规疗程相比，其临床和微生物疗效相仿，不良反应发生率相仿，均较轻微，患者耐受性好。
目的：比較左氧氟沙星750 mg註射液5 d短程療法與500 mg註射液7～14 d常規療法治療社區穫得性肺炎（CAP）療效和安全性差異。方法本臨床試驗為隨機對照、開放、非劣效性多中心臨床試驗。CAP患者被隨機分配到左氧氟沙星750 mg組治療5 d或500 mg組治療7～14 d ，兩組均接受靜脈給藥治療，觀察其臨床錶現、實驗室檢查、影像學改變及微生物學檢查等，比較兩組安全性和療效差異。結果10箇研究中心共入選病例241例。其中全分析集（FAS ）223例，包括750 mg組111例，500 mg組112例。符閤方案分析集（PPS）211例，包括750 mg組107例，500 mg組104例。安全性分析集（SS）241例，包括750 mg組121例，500 mg組120例。FAS 750 mg組療程中位數為5．0 d ，500 mg組療程中位數為9．0 d。750 mg組總劑量中位數為3750 mg ，500 mg組總劑量中位數為4500 mg。FAS第4次隨訪750 mg組有效率為86．2％，500 mg組有效率為84．7％，兩組綜閤療效評價相比為非劣效。FAS 750 mg組可進行微生物療效評價者共40例，穫病原菌41株，500 mg組可行微生物療效評價者共49例，穫病原菌51株，兩組細菌清除率均為100％。另外，750 mg組和500 mg組的非典型病原體的臨床有效率均為100％。對750 mg組安全性觀察結果顯示，臨床不良反應最常見為註射部位瘙癢、疼痛和充血等，其次為失眠、噁心、皮疹等。較常見的實驗室指標異常為中性粒細胞比率降低、白細胞總數降低、ALT升高、AST升高等。以上不良反應多屬輕微，患者可耐受，與500 mg組相比，因藥物中止試驗和不良反應髮生率差異無統計學意義，提示兩組安全性相倣。結論左氧氟沙星750 mg註射液5 d短程療法治療CAP與左氧氟沙星500 mg註射液7～14 d常規療程相比，其臨床和微生物療效相倣，不良反應髮生率相倣，均較輕微，患者耐受性好。
목적：비교좌양불사성750 mg주사액5 d단정요법여500 mg주사액7～14 d상규요법치료사구획득성폐염（CAP）료효화안전성차이。방법본림상시험위수궤대조、개방、비렬효성다중심림상시험。CAP환자피수궤분배도좌양불사성750 mg조치료5 d혹500 mg조치료7～14 d ，량조균접수정맥급약치료，관찰기림상표현、실험실검사、영상학개변급미생물학검사등，비교량조안전성화료효차이。결과10개연구중심공입선병례241례。기중전분석집（FAS ）223례，포괄750 mg조111례，500 mg조112례。부합방안분석집（PPS）211례，포괄750 mg조107례，500 mg조104례。안전성분석집（SS）241례，포괄750 mg조121례，500 mg조120례。FAS 750 mg조료정중위수위5．0 d ，500 mg조료정중위수위9．0 d。750 mg조총제량중위수위3750 mg ，500 mg조총제량중위수위4500 mg。FAS제4차수방750 mg조유효솔위86．2％，500 mg조유효솔위84．7％，량조종합료효평개상비위비렬효。FAS 750 mg조가진행미생물료효평개자공40례，획병원균41주，500 mg조가행미생물료효평개자공49례，획병원균51주，량조세균청제솔균위100％。령외，750 mg조화500 mg조적비전형병원체적림상유효솔균위100％。대750 mg조안전성관찰결과현시，림상불량반응최상견위주사부위소양、동통화충혈등，기차위실면、악심、피진등。교상견적실험실지표이상위중성립세포비솔강저、백세포총수강저、ALT승고、AST승고등。이상불량반응다속경미，환자가내수，여500 mg조상비，인약물중지시험화불량반응발생솔차이무통계학의의，제시량조안전성상방。결론좌양불사성750 mg주사액5 d단정요법치료CAP여좌양불사성500 mg주사액7～14 d상규료정상비，기림상화미생물료효상방，불량반응발생솔상방，균교경미，환자내수성호。
Objective To compare the efficacy and safety of levofloxacin 750 mg for 5 days versus 500 mg for 7‐14 days intravenous (IV ) infusion in the treatment of community‐acquired pneumonia (CAP ) . Methods This study was a multi‐center , randomized , open‐label , non‐inferiority , controlled clinical trial .The CAP patients were randomized to receive levofloxacin 750 mg IV daily for 5 days or levofloxacin 500 mg IV daily for 7‐14 days .The clinical symptoms , laboratory tests , imaging results and microbiology data were collected and compared between the two treatment groups in terms of efficacy and safety .Results A total of 241 patients were enrolled in this clinical trial from 10 study centers .Among these patients ,223 were eligible for full analysis set (FAS) analysis ,including 111 in 750 mg group and 112 in 500 mg group .Of the 223 patients in FAS ,211 were eligible for per‐protocol set (PPS) analysis ,including 107 in 750 mg group and 104 in 500 mg group .Two hundred and forty‐one patients were included in safety set (SS) ,including 121 patients in 750 mg group and 120 in 500 mg group .The median treatment duration was 5 .0 days in 750 mg and 9 .0 days in 500 mg group .The median total dose was 3 750 mg in 750 mg group and 4 500 mg in 500 mg group .The overall efficacy rate was 86 .2% in 750 mg group and 84 .7% in 500 mg group in terms of FAS at visit 4 ,which suggested that the efficacy of 750 mg group was non‐inferior to 500 mg group .Of the 111 FAS patients in 750 mg group ,40 were bacteriological evaluable ,and 41 strains of pathogens were isolated .Forty‐nine of the 112 FAS patients in 500 mg group were bacteriological evaluable ,and 51 bacterial strains were obtained .The bacterial eradication rate was 100% in both groups .The clinical treatment efficacy rate for atypical pathogens was 100% in both groups .In 750 mg group ,the most common clinical adverse drug reactions (ADRs) were injection site adverse reactions including injection site pruritus ,pain and hyperemia .The other common ADRs were insomnia ,nausea ,skin rash .The most common drug‐related laboratory abnormalities were neutrophil percentage decreased , decreased white blood cell (WBC ) count , alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation .Most of the ADRs were mild in severity and well‐tolerated .The safety profile of the two treatments was comparable in terms of the drug‐related treatment discontinuation and the incidence of ADRs .Conclusions The short‐course regimen of levofloxacin 750 mg IV for 5 days is at least as effective and well tolerated as the long‐course regimen of 500 mg IV for 7‐14 days in treatment of CAP .
