【摘要】：目的比較左氧氟沙星750 mg注射液5 d短程療法與500 mg注射液7~14 d常規(guī)療法治療社區(qū)獲得性肺炎(CAP)療效和安全性差異。方法本臨床試驗(yàn)為隨機(jī)對照、開放、非劣效性多中心臨床試驗(yàn)。CAP患者被隨機(jī)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,觀察其臨床表現(xiàn)、實(shí)驗(yàn)室檢查、影像學(xué)改變及微生物學(xué)檢查等,比較兩組安全性和療效差異。結(jié)果 10個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。符合方案分析集(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。FAS750 mg組療程中位數(shù)為5.0d,500 mg組療程中位數(shù)為9.0d。750 mg組總劑量中位數(shù)為3 750 mg,500 mg組總劑量中位數(shù)為4 500 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%,兩組綜合療效評價(jià)相比為非劣效。FAS750 mg組可進(jìn)行微生物療效評價(jià)者共40例,獲病原菌41株,500 mg組可行微生物療效評價(jià)者共49例,獲病原菌51株,兩組細(xì)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(jié)果顯示,臨床不良反應(yīng)最常見為注射部位瘙癢、疼痛和充血等,其次為失眠、惡心、皮疹等。較常見的實(shí)驗(yàn)室指標(biāo)異常為中性粒細(xì)胞比率降低、白細(xì)胞總數(shù)降低、ALT升高、AST升高等。以上不良反應(yīng)多屬輕微,患者可耐受,與500 mg組相比,因藥物中止試驗(yàn)和不良反應(yīng)發(fā)生率差異無統(tǒng)計(jì)學(xué)意義,提示兩組安全性相仿。結(jié)論左氧氟沙星750 mg注射液5 d短程療法治療CAP與左氧氟沙星500 mg注射液7~14 d常規(guī)療程相比,其臨床和微生物療效相仿,不良反應(yīng)發(fā)生率相仿,均較輕微,患者耐受性好。
[Abstract]:Objective to compare the efficacy and safety of levofloxacin 750mg injection in the treatment of community-acquired pneumonia (CAP). Methods the patients in this clinical trial were randomly assigned to levofloxacin 750 mg group for 5 days or 500 mg group for 7 days. Both groups were given intravenous administration and their clinical manifestations were observed. Laboratory examination, imaging changes and microbiological examination were used to compare the safety and efficacy between the two groups. Results 241 patients were enrolled in 10 research centers. The total analysis set (FAS) was 223 cases, including 111 cases in 750 mg group and 112 cases in 500 mg group. There were 211 cases of PPS, including 107 cases in 750 mg group and 104 cases in 500 mg group. Safety analysis set (SS) 241 cases, The median course of treatment of 500mg group including 750mg group was 120 cases. The median course of treatment of FAS750mg group was 5.0dago 500mg group, the median of total dose of 9.0d.750 group was 3 750mg / 500mg group, the median of total dose of 500mg group was 4 500mg.FAS, the effective rate of 750mg group was 86.2mg / 500mg group. The effective rate was 84.7. Compared with the non-inferior effect. FAS750mg group, 40 cases could be evaluated by microorganism. A total of 49 patients with 41 strains of pathogenic bacteria and 51 strains of pathogenic bacteria were obtained in the 500 mg group. The bacterial clearance rates of both groups were 100. In addition, the clinical effective rate of atypical pathogens in 750mg group and 500mg group was 100%. The safety observation of 750mg group showed that the most common adverse reactions were pruritus, pain and congestion at injection site, followed by insomnia, nausea, rash and so on. The more common laboratory indexes were decreased neutrophil ratio, decreased leukocyte count, elevated alt, and increased AST, etc. Most of the adverse reactions were mild and tolerable. Compared with the 500mg group, there was no significant difference in the incidence of drug termination test and adverse reaction between the two groups, suggesting that the safety of the two groups was similar. Conclusion the clinical efficacy of levofloxacin 750mg injection is similar to that of levofloxacin 500mg injection for 714 days compared with that of levofloxacin injection for 714 days. The incidence of adverse reactions is similar and mild, and the patient has good tolerance.
【作者單位】： 復(fù)旦大學(xué)附屬華山醫(yī)院抗生素研究所 衛(wèi)生部抗生素臨床藥理重點(diǎn)實(shí)驗(yàn)室;上海長征醫(yī)院;首都醫(yī)科大學(xué)附屬朝陽醫(yī)院;南京大學(xué)附屬鼓樓醫(yī)院;蘇州大學(xué)附屬第一醫(yī)院;中山大學(xué)附屬第一醫(yī)院;中南大學(xué)附屬湘雅三院;四川大學(xué)附屬華西醫(yī)院;廣州軍區(qū)武漢總醫(yī)院;江西省人民醫(yī)院;
【基金】：國家科技部“重大新藥創(chuàng)制”科技重大專項(xiàng)(2012ZX09303004001)
【分類號】：R563.1

【共引文獻(xiàn)】

相關(guān)期刊論文 前10條

1 李文t ;吳詩品;陳洪濤;吳勁松;;血流感染575例病原菌分布及耐藥性分析[J];臨床合理用藥雜志;2011年31期

2 沈建人;;2003至2010年鮑曼不動桿菌感染的分布及耐藥性變遷[J];全科醫(yī)學(xué)臨床與教育;2012年03期

3 李文t ;吳詩品;陳洪濤;吳勁松;;血流感染575例病原菌分布及耐藥性分析[J];中國全科醫(yī)學(xué);2009年16期

4 錢進(jìn)先;陶唯益;吳健;趙華;;重癥監(jiān)護(hù)病房患者下呼吸道標(biāo)本非發(fā)酵菌構(gòu)成及耐藥性分析[J];齊齊哈爾醫(yī)學(xué)院學(xué)報(bào);2009年05期

5 許瑩瑩;楊小輝;王玉宇;;ICU患者呼吸機(jī)相關(guān)性肺炎耐藥菌分布的現(xiàn)狀及分析[J];齊齊哈爾醫(yī)學(xué)院學(xué)報(bào);2012年11期

6 葉伙梅;袁煒華;吳飛燕;梅超明;江炎章;李小藝;;銅綠假單胞菌的藥物敏感試驗(yàn)結(jié)果分析[J];熱帶醫(yī)學(xué)雜志;2010年06期

7 于國東;彭志允;;白虎加人參湯治療下呼吸道多重耐藥菌感染臨床觀察[J];新中醫(yī);2012年05期

8 王太森;呂潔;;兒童下呼吸道感染常見病原菌分布及耐藥分析[J];四川醫(yī)學(xué);2011年09期

9 欒耀芳;孔祥山;王軍;張玉倩;;銀翹散、桂枝湯對耐藥金黃色葡萄球菌的作用研究[J];山東中醫(yī)雜志;2011年11期

10 徐衛(wèi)剛;秦家榕;浦裕美;沈瑜;馬俊;;老年人尿路感染常見病原菌耐藥性分析[J];上海預(yù)防醫(yī)學(xué);2010年01期

相關(guān)會議論文 前10條

1 卓超;肖書念;邱桂霞;鐘南山;;哌拉西林-舒巴坦對非發(fā)酵菌體外抗菌活性研究[A];第二屆全國藥物性損害與安全用藥學(xué)術(shù)會議——抗感染藥物不良反應(yīng)與臨床安全應(yīng)用專題研討會論文匯編[C];2010年

2 尚靜;王培昌;李燕;白書媛;張麗麗;王育英;張曉耕;;2187株病原菌耐藥性分析[A];第二屆全國藥物性損害與安全用藥學(xué)術(shù)會議——抗感染藥物不良反應(yīng)與臨床安全應(yīng)用專題研討會論文匯編[C];2010年

3 梁蓓蓓;周家軍;裴廣勝;韓宇揚(yáng);白艷;白楠;蔡蕓;王睿;;利奈唑胺與萬古霉素對MRSA抗生素后效應(yīng)的研究[A];中華醫(yī)學(xué)會第七屆全國呼吸道感染學(xué)術(shù)大會暨第一屆多學(xué)科抗感染治療學(xué)術(shù)研討會論文匯編[C];2011年

4 劉金虹;;卡馬西平的不良反應(yīng)[A];2012年中國藥學(xué)大會暨第十二屆中國藥師周論文集[C];2012年

5 李巍;秦蘭;劉曉;吳雪琴;;自擬涼血化瘀湯治療血瘀火熱型免疫性血小板減少性紫癜臨床觀察[A];中華中醫(yī)藥學(xué)會第二屆岐黃論壇——血液病中醫(yī)藥防治分論壇論文集[C];2014年

6 朱章志;謝欣穎;王t熈，

本文編號：2127032