左氧氟沙星2种给药方案治疗老年人下呼吸道细菌感染的成本-效果分析

目的:为应用左氧氟沙星治疗老年人下呼吸道细菌感染寻找较佳的给药方案提供依据.方法:将82例下呼吸道细菌感染的老年患者分为2组,一组采用左氧氟沙星序贯疗法,为序贯组(43例),即先予左氧氟沙星注射液500 mg/d静脉滴注,每日1次,3日后改口服左氧氟沙星胶囊500 mg/d口服,每日1次,连用7日;另一组单纯采用左氧氟沙星静脉滴注治疗,为静脉组(39例),即左氧氟沙星注射液500 mg/d静脉滴注,每日1次,连用10日.疗程结束后对2组进行疗效比较及成本-效果分析.结果:序贯组和静脉组总有效率分别为86%和85%,细菌清除率分别为85%和83%,不良反应均轻;序贯组的成本-效果比为28.62,低于静脉组的39.51,比较差异有统计学意义(P＜0.05).结论:应用左氧氟沙星治疗老年人下呼吸道细菌感染,采用序贯疗法比采用单纯静脉滴注给药方法有更佳的成本-效果比,建议应用左氧氟沙星老年人下呼吸道细菌感染治疗时宜采用序贯疗法.     

莫西沙星治疗老年性下呼吸道感染的临床疗效

目的观察莫西沙星与左氧氟沙星治疗老年性下呼吸道感染的临床疗效和安全性。方法选择老年性下呼吸道感染患者74例,随机分为治疗组（38例）和对照组（36例）。治疗组使用莫西沙星400 mg,对照组使用左氧氟沙星500 mg,均为静脉滴注给药,每日1次,疗程7~10 d,观察疗效与不良反应。结果治疗组和对照组的临床有效率分别为92.11%和80.56%,细菌清除率分别为93.33%和82.76%,两组间比较差异均有统计学意义（P〈0.05）,两组间不良反应相似。结论莫西沙星注射液治疗老年性下呼吸道感染疗效佳且安全,优于左氧氟沙星注射液。     

帕珠沙星治疗急性泌尿系统感染的多中心随机对照临床研究

目的评价国产帕珠沙星注射液治疗急性泌尿系统感染的疗效和安全性。方法采用多中心、单盲、区组随机、平行对照试验设计，以左氧氟沙星注射液为对照药，帕珠沙星每次静滴300mg，左氧氟沙星每次静滴200mg，两药均每日用药2次，疗程7～10d。结果本研究共纳入117例，帕珠沙星组和左氧氟沙星组分别为58例和59例，其中帕珠沙星组1例因细菌培养为耐药大肠埃希菌生长而剔除，故两组进行全分析集（FAS）和符合方案分析集（PPS）分析的病例数均分别为57例和59例。疗程结束时帕珠沙星组与左氧氟沙星组的痊愈率和有效率分别为71．9％与67．8％和93．0％与83．1％，细菌清除率和阴转率均分别为97．6％与93．8％，两组比较差异无显著性。帕珠沙星组和左氧氟沙星组的不良反应发生率分别为12．1％和15．3％，差异无显著性，均主要表现为恶心、腹泻、局部刺激及血清转氨酶增高等。两组均未见严重不良事件发生。结论国产帕珠沙星注射液与左氧氟沙星注射液治疗泌尿系统中、重度急性细菌性感染均疗效确切，安全性较好。     

高剂量左氧氟沙星在ICU治疗医院获得性肺炎的疗效分析

目的 探讨高剂量左氧氟沙星在重症监护室医院获得性肺炎治疗中的临床疗效.方法 鄂州二医院重症监护室收治获得性肺炎患者110例,将其按照分组法随机分为,高剂量组和低剂量组,每组各55例,高剂量组患者静脉滴注左氧氟沙星注射液500 mg,低剂量组静脉滴注左氧氟沙星注射液400 mg.治疗结束后对疗效和不良反应进行分析.结果 高剂量组和低剂量组的有效率分别为90.11%和63.64%,两组比较差异有统计学意义(P<0.05);高剂量和低剂量组的显效时间分别为(3.1±1.3)d和 (4.3±2.0)d,两组的疗程分别为(7.1±2.6)d和(10.4±3.2)d,两组比较差异有统计学意义(P<0.05);两组的不良反应发生率比较差异无统计学意义(P>0.05).结论 高剂量左氧氟沙星在重症监护室治疗获得性肺炎治疗中疗效显著,安全性好,值得临床推广使用.     

莫西沙星序贯治疗社区获得性肺炎住院患者疗效观察

目的 评价莫西沙星序贯治疗社区获得性肺炎(CAP)住院患者的疗效和安全性.方法 北京大学深圳医院2009年1月-2010年12月收治的186例CAP住院患者随机分为2组,莫西沙星序贯组(序贯组)和莫西沙星静脉滴注组(对照组),序贯组(86例)在治疗当天开始给予莫西沙星注射液400 mg/d静脉滴注,每日1次,3～5d后改为口服莫西沙星片剂400 mg/d,总疗程7～14 d;对照组(88例)给予莫西沙星注射液400 mg/d静脉滴注,每日1次,总疗程7～14 d.结果 经剔除部分患者后,两组均无严重不良反应,两组安全性比较差异无统计意义,临床疗效:序贯组有效率87.2%,对照组有效率89.8%.细菌学疗效比较:治疗后序贯组细菌清除率为92.1%,对照组细菌清除率为95.7%,两组差异无统计学意义(P>0.05).结论 莫西沙星对住院CAP患者疗效可靠,安全性好.序贯治疗组与全程静脉滴注相仿,对于可以口服的患者可以替代全程静脉滴注作为住院CAP患者的治疗方案.     

头孢西丁与左氧氟沙星治疗成人非重症CAP的成本-效果评价

目的评价头孢西丁与左氧氟沙星治疗成人非重症社区获得性肺炎(CAP)的成本-效果。方法回顾性选择2014年6月至2015年12月进行治疗的126例成人非重症CAP患者,将其随机分为头孢西丁组和左氧氟沙星组,每组63例。头孢西丁组患者静脉滴注头孢西丁钠,2.0 g/次,3次/d,8 d为1个疗程;左氧氟沙星组患者静脉滴注甲磺酸左氧氟沙星注射液,200 ml/次,1次/d,8 d为1个疗程。比较两组患者1个疗程后的临床治疗效果、显效时间、治疗成本、不良反应的发生情况,且进行成本-效果评价。结果左氧氟沙星组患者的总有效率为87.30%,显著高于头孢西丁组(63.49%,P<0.05);头孢西丁组患者的显效时间为(5.61±2.95)d,左氧氟沙星组为(3.65±2.66)d,两组比较差异有统计学意义(P<0.05);两组不良反应比较差异未见统计学意义(P>0.05)。头孢西丁组成本为8 513.20元,成本-效果为134.09,增量成本效果比为-59.85;左氧氟沙星组成本为7 080.52元,成本-效果为81.11,增量成本效果比为0。结论左氧氟沙星治疗成人非重症CAP的经济性更好。     

甲磺酸帕珠沙星注射液治疗急性细菌性感染39例

目的：评价国产甲磺酸帕珠沙星注射液治疗中、重度急性细菌感染的临床疗效与安全性。方法：采用随机对照试验设计,以左氧氟沙星为阳性对照药,甲磺酸帕珠沙星500mg,左氧氟沙星300mg,均为每12小时静脉滴注一次,每日两次,疗程为7～10天。结果：本研究共纳入39例,其中甲磺酸帕珠沙星组20例,左氧氟沙星19例。疗程结束时两组的痊愈率分别为70.00%和68.42%,有效率分别为85.00%和78.95%,细菌清除率分别为91.67%和100%。以上结果两组组间比较差异均无统计学差异。两组的不良反应发生率分别为4/20和1/19,主要表现为局部刺激及转氨酶升高等。结论：国产甲磺酸帕珠沙星注射液治疗中重度细菌感染疗效确切,安全性好。     

左氧氟沙星600mg静脉注射治疗下呼吸道细菌性感染的疗效和安全性研究

目的 评价左氧氟沙星注射液600 mg治疗下呼吸道感染的临床疗效与安全性.方法 采用多中心、前瞻性、开放性试验.入组病例996例,因各种原因剔出后可评价病例847例,左氧氟沙星注射液600 mg,每日1次静脉滴注,治疗下呼吸道感染患者,疗程为7~14 d.记录观察期间出现的任何不良反应,评估治疗结束时的临床疗效、细菌学疗效及安全性. 结果左氧氟沙星600 mg静脉滴注治疗社区获得性肺炎、慢性支气管炎急性加重、支气管扩张并发感染的有效率分别为92.3%(477/517)、89.8%(203/226)、90.4%(94/104),总有效率为91.4%(774/847),总细菌清除率为83.9%.试验期间不良反应总发生率为6.2%(52/847),其中消化系统不良反应发生率为3.54%(30/847),中枢神经系统为1.7%(14/847),注射部位刺激为0.6%(5/847),皮肤反应为0.4%(3/847).结论 左氧氟沙星注射液600 mg静脉滴注治疗下呼吸道感染具有良好的疗效和安全性.     

含左氧氟沙星三联疗法根除幽门螺杆菌的临床观察

目的:进一步探讨左氧氟沙星在根除幽门螺杆菌治疗中的有效性和安全性。方法:治疗组给予枸橼酸铋雷尼替丁400mg、左氧氟沙星200mg、阿莫西林1000mg,每天2次,疗程10d;对照组给予枸橼酸铋雷尼替丁400mg、克拉霉素0.5g、阿莫西林1000mg,每天2次,疗程10d。停药4周后复查C14呼气试验。结果:治疗组根除55例,根除率91.67%;对照组根除52例,根除率86.67%;两组比较无统计学差异(P>0.05)。两组患者不良反应轻微,于停药后均消失,总体安全性好。结论:以枸橼酸铋雷尼替丁为基础的含左氧氟沙星三联方案根除幽门螺杆菌10d疗法根除率达91.67%,且不良反应轻微,同时10d疗程费用比对照组低廉,容易被患者接受,值得临床推广。     

含左氧氟沙星序贯疗法根除幽门螺杆菌的疗效和安全性

[目的]评价含左氧氟沙星序贯疗法根除幽门螺杆菌(Hp)的疗效和安全性.[方法]将145例Hp感染患者随机分为治疗组76例和对照组69例.治疗组在前7 d应用兰索拉唑30 mg、阿莫西林1 000 mg,每日早晚两次口服,在接下来的7 d中,应用兰索拉唑30 mg、左氧氟沙星500 mg、替硝唑500 mg,每日早晚两次...     

A randomized controlled clinical trial of levofloxacin 750 mg versus 500 mg intravenous infusion in the treatment of community-acquired pneumonia

The objective of this study was to compare the efficacy and safety of levofloxacin 750 mg for 5 days versus 500 mg for 7–14 days intravenous (IV) in the treatment of community-acquired pneumonia (CAP). This clinical trial was the first of its kind conducted in Chinese people and also in Asian population. A total of 241 were enrolled and randomized to 750 mg group (n = 121) or 500 mg (n = 120) group from 10 study centers. The median treatment duration was 5.0 days in 750 mg and 9.0 days in 500 mg group. The median total dose was 3750 mg in 750 mg and 4500 mg in 500 mg group. The bacterial eradication rate was 100% in both groups. The overall efficacy rate in 750 mg group was 86.2% (94/109), and 84.7% (94/111), in 500 mg group of full analysis set visit 4, 95% confidence interval of 1.6% (−7.8–10.9%); the statistical results showed that 750 mg group was non-inferior to 500 mg group. The most common clinical adverse drug reactions were injection site adverse reactions in both 750 mg group and 500 mg group; the other common adverse drug reactions were insomnia, nausea, skin rash, etc. The most common drug-related laboratory abnormalities were neutrophil percentage decreased, decreased white blood cell count, alanine aminotransferase, and aspartate aminotransferase elevation in both 750 mg group and 500 mg group. Most of adverse drug reactions were mild in severity and well-tolerated. In summary, the regimen of levofloxacin 750 mg IV for 5 days was at least as effective and well tolerated as 500 mg IV for 7–14 days for the treatment of CAP.     

A multicenter, randomized, double-blind, retrospective comparison of 5- and 10-day regimens of levofloxacin in a subgroup of patients aged > or =65 years with community-acquired pneumonia

OBJECTIVE: This subgroup analysis sought to determine the efficacy and tolerability of a 5-day regimen of levofloxacin 750 mg/d compared with a 10-day regimen of levofloxacin 500 mg/d in the treatment of community-acquired pneumonia (CAP) in elderly patients (aged > or =65 years). METHODS: This subgroup analysis was based on the outcomes in patients aged > or =65 years from a randomized, double-blind, controlled trial conducted at 70 US centers. Patients in Pneumonia Severity Index (PSI) class I/II and III/IV were randomized to receive levofloxacin 750 mg/d for 5 days or levofloxacin 500 mg/d for 10 days. Study investigators assessed clinical and microbiologic outcomes 7 to 14 days after administration of the last dose of medication and collected adverse events for 30 days after the last dose. RESULTS: This analysis included 177 elderly patients, 80 receiving levofloxacin 750 mg/d for 5 days and 97 receiving levofloxacin 500 mg/d for 10 days. Although most demographic and baseline clinical characteristics were comparable between the 2 groups, the group that received levofloxacin 500 mg/d was older than the group that received levofloxacin 750 mg/d (median age, 76.0 vs 72.5 years, respectively; P = 0.029) and had a higher mean PSI score (90.7 vs 83.1; P = 0.017). Despite the halved duration of therapy, unadjusted clinical success rates were comparable between the 2 groups (89.0% and 91.9% in the 750- and 500-mg arms, respectively; 95% CI, -7.1 to 12.7). Microbiologic eradication rates were 90.3% (28/31) in the 750-mg arm and 87.5% (14/16) in the 500-mg arm (P = NS). Multivariate analysis adjusting for baseline PSI score indicated that treatment assignment was not statistically associated with clinical success (adjusted odds ratio for clinical success with 500-mg dose, 1.92; 95% CI, 0.62 to 5.99). The incidence of treatment-emergent adverse events did not differ between the 2 study treatments. The most common adverse events in both groups were insomnia, constipation, and headache. CONCLUSIONS: This subgroup analysis found that levofloxacin 750 mg/d for 5 days was well tolerated in the treatment of CAP in elderly patients. Undajusted and adjusted rates of clinical success were statistically similar between levofloxacin 750 mg/d for 5 days and levofloxacin 500 mg/d for 10 days.     

A multicenter,open-label,randomized comparison of levofloxacin and azithromycin plus ceftriaxone in hospitalized adults with moderate to severe community-acquired pneumonia

BACKGROUND: Changing etiologic patterns and the growing problem of antimicrobial resistance, particularly an increase in macrolide-resistant pneumococcal bacteremia, are causing physicians to adopt new approaches to the treatment of community-acquired pneumonia (CAP). OBJECTIVE: The relative efficacy and tolerability of levofloxacin monotherapy and azithromycin and ceftriaxone combination therapy were assessed in hospitalized adults with moderate to severe CAP. METHODS: This Phase IV, multicenter, open-label, randomized trial compared 2 treatment regimens: (1) levofloxacin 500 mg PO or IV q24h, and (2) azithromycin 500 mg IV q24h for > or = 2 days plus ceftriaxone 1 g IV q24h for 2 days, followed by an optional transition to azithromycin 500 mg PO q24h at the investigator's discretion. The total duration of therapy was to be a minimum of 10 days in both treatment groups. Ceftriaxone was included in the initial azithromycin regimen to ensure coverage against pneumococcal bacteremia. RESULTS: Of 236 patients in the intent-to-treat population, completion or withdrawal information was available for 110 patients in the levofloxacin group and 114 in the azithromycin group. Baseline demographic and disease characteristics were comparable between groups. At the end of treatment, the clinical success rate (cured + improved) in clinically evaluable patients was 94.1% in the levofloxacin group and 92.3% in the azithromycin group. The respective posttherapy microbiologic eradication rates were 89.5% and 92.3%. Levofloxacin was as well tolerated as azithromycin, with an incidence of drug-related adverse events (AEs) for all body systems of 5.3% and 9.3%, respectively. None of the drug-related AEs were considered serious [corrected]. CONCLUSIONS: In this study in hospitalized patients with moderate to severe CAP, levofloxacin monotherapy was at least as effective as a combination regimen of azithromycin and ceftriaxone in providing coverage against the current causative pathogens in CAP. In addition, levofloxacin was as well tolerated as the combination of azithromycin and ceftriaxone.     

Levofloxacin in the treatment of community-acquired pneumonia

Levofloxacin is a fluoroquinolone that has a broad spectrum of activity against several causative bacterial pathogens of community-acquired pneumonia (CAP). The efficacy and tolerability of levofloxacin 500 mg once daily for 10 days in patients with CAP are well established. Furthermore, a high-dose (750 mg), short-course (5 days) of once-daily levofloxacin has been approved for use in the USA in the treatment of CAP, acute bacterial sinusitis, acute pyelonephritis and complicated urinary tract infections. Levofloxacin can be used as a monotherapy in patients with CAP, however, levofloxacin combination therapy with anti-pseudomonal β-lactam (or aminoglycoside) should be considered if Pseudomonas aeruginosa is the causative pathogen of the respiratory infection. The high-dose, short-course levofloxacin regimen maximizes its concentration-dependent antibacterial activity, decreases the potential for drug resistance and has better patient compliance. Oral levofloxacin is rapidly absorbed and is bioequivalent to the intravenous formulation and the patients can switch between these formulations, which results in more options with respect to the therapeutic regimens. Furthermore, levofloxacin is generally well tolerated, has good tissue penetration and adequate concentrations can be maintained at the site of infections.     

Clinical and bacteriological efficacy and safety of 5 and 7 day regimens of telithromycin once daily compared with a 10 day regimen of clarithromycin twice daily in patients with mild to moderate community-acquired pneumonia

OBJECTIVES: This study was conducted to investigate the potential equivalence in clinical efficacy and assess safety of a 5 or 7 day regimen of oral telithromycin (800 mg once daily) and a 10 day regimen of oral clarithromycin (500 mg twice daily) in treating community-acquired pneumonia (CAP). Bacteriological efficacy was also compared. METHODS: This was a multicentre, randomized, double-blind, active-controlled study. Patients with mild to moderate CAP received telithromycin 800 mg once a day for 5 (n=193) or 7 (n=195) days or clarithromycin 500 mg twice a day for 10 days (n=187). In these groups, 159, 161 and 146 patients, respectively, completed the study. RESULTS: At the post-therapy/test-of-cure evaluation, clinical cure rates (per-protocol clinical population) were 89.3% (5 days) and 88.8% (7 days) for telithromycin, and 91.8% for clarithromycin 10 days. Satisfactory bacteriological outcome rates (per-protocol bacteriological population) were 87.7% and 80.0% for 5 and 7 days of telithromycin, respectively, and 83.3% for 10 days of clarithromycin. Bacteriological eradication rates in the respective treatment groups were, for Streptococcus pneumoniae, 95.8% (23/24), 96.7% (29/30) and 88.5% (23/26); for Haemophilus influenzae, 88.0% (22/25), 84.0% (21/25) and 88.2% (15/17) and for Moraxella catarrhalis, 1/1, 4/5 and 3/4. Both telithromycin regimens demonstrated clinical efficacy against pneumococcal bacteraemia (19/19), atypical pathogens (9/9) and erythromycin-resistant S. pneumoniae isolates (5/5). Most treatment-emergent adverse events were mild to moderate in intensity with most commonly reported adverse events involving the gastrointestinal system. CONCLUSIONS: Telithromycin 800 mg administered once a day for 5 or 7 days was as effective and safe as clarithromycin 500 mg administered twice a day for 10 days in treating patients with CAP caused by common respiratory pathogens, including macrolide-resistant isolates, and pneumococcal bacteraemia.     

甲磺酸帕珠沙星注射液治疗急性呼吸道感染的多中心随机对照试验

目的评价国产甲磺酸帕珠沙星注射液治疗急性呼吸道细菌感染的有效性与安全性。方法试验采用多中心、随机、阳性药物平行对照、非盲法试验设计,共纳入134例受试者,随机分为试验组68例和对照组66例,试验组与对照组分别接受甲磺酸帕珠沙星500mg与左氧氟沙星300mg,每12h静脉滴注1次,每日两次治疗,疗程均为7~10天,病情重者可延长至14天。结果试验组与对照组的急性呼吸道感染的临床痊愈率分别为52.9%、57.6%(FAS分析集)和57.1%、61.3%(PPS分析集);临床有效率分别为86.8%、87.9%(FAS分析集)和93.7%、93.6%(PPS分析集),两组比较差异无统计学意义,表明两药疗效相当。两组的细菌阴转率分别为92.5%和94.3%,两组差异无统计学意义(P>0.05)。安全性评价结果显示,两组临床不良反应发生率分别为16.2%和16.7%,均以局部刺激及消化道反应为主,但大多轻微,无需特殊处理。结论甲磺酸帕珠沙星注射液治疗急性呼吸道细菌感染疗效确切,不良反应少,安全性较好,适合敏感菌所致的中重度呼吸道细菌感染及不能口服给药的患者使用。     

Doxycycline vs. levofloxacin in the treatment of community‐acquired pneumonia

Background: Community‐acquired pneumonia (CAP) affects 5–10 million adults annually in the United States with approximately 1·1 million hospitalizations. Current guidelines recommend fluoroquinolones as monotherapy for treatment of CAP in general medical wards and doxycycline monotherapy for outpatient therapy only. Fluoroquinolones are expensive and development of bacterial resistance to them has become a concern. Therefore, we studied whether doxycycline is as efficacious as levofloxacin in treatment of CAP in general medical wards. Methods: In this prospective double‐blinded trial, non‐pregnant adults with clinical and radiological evidence of pneumonia requiring hospitalization were enrolled. Patients who were septic, hypoxic requiring intubations, nursing home residents, diagnosed with severe hepatic or renal dysfunction, recently hospitalized or immunocompromised were excluded from the study. Subjects were randomly assigned to either i.v. levofloxacin 500 mg daily or doxycycline 100 mg twice daily. After discharge, patients were followed for 2 months. Results: There were 30 patients in the levofloxacin group and 35 patients in the doxycycline group. Groups were comparable in both clinical and laboratory profiles. Additionally, efficacy of treatment was not significantly different between the two groups (P = 0·844). Length of stay was 5·7 ± 2·05 days in the levofloxacin group and 4·0 ± 1·82 days in the doxycycline group (P < 0·0012). Failure rate was similar in both groups (P = 0·893). Total antibiotic cost was $122·07 ± 15·84 for levofloxacin and $64·98 ± 24·4 for doxycycline (P < 0·0001). Conclusions: Our study supports doxycycline as an effective and economical alternative therapy for levofloxacin in the empirical treatment of CAP in general medical wards.     

经纤维支气管镜介入治疗重症肺炎34例临床分析

目的:探讨经纤维支气管镜介入病灶灌注对重症肺炎的治疗效果及其安全性。方法:将2010年1月至2013年6月我院收治的重症肺炎患者68例随机分为对照组和实验组各34例,对照组应用克倍宁1.0静滴,q12h,共5天,实验组在对照组治疗的基础上应用纤维支气管镜插入病灶肺段支气管,灌注左氧氟沙星400mg,qd,共5天。比较两组的临床疗效、细菌学清除率及不良反应。结果:实验组临床有效率为94.1%,细菌清除率为88.0%,均明显高于对照组的76.5%和69.6%(P均0.05);实验组的不良反应发生率8.8%和对照组5.9%(P0.05)无明显差异。结论:经纤维支气管镜介入感染病灶支气管内灌注药物对重症肺炎的疗效优于常规治疗,且无明显不良反应,建议推广应用。