Objective To evaluate the clinical efficacy and safety of pazufloxacin for the treatment of moderate and severe acute bacterial respiratory infections.Methods A multicenter randomized controlled trial was conducted to compare the efficacy and safety of pazufloxacin versus levofloxacin. Patients in the pazufloxacin group were treated with pazufloxacin (500 mg twice daily for 7 to 10 days), and patients in the levofloxacin group were treated with levofloxacin (300 mg twice daily for 7 to 10 days). Results A total of 134 patients were enrolled in the study, 68 cases in pazufloxacin group and 66 cases in levofloxacin group were assessable for clinical efficacy by full analysis set(FAS). At the end of the treatment, in FAS analysis the total cure rates and effective rates were 52.9% and 86.7% in pazufloxacin group, 57.6% and 87.9% in levofloxacin group, in PPS analysis the total cure rats and effective rates were 57.1% and 93.7% in pazufloxacin group respectively, 61.3% and 93.6% in levofloxacin group. The bacterial clearance rates were 92.5% and 94.3% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 16.2% of patients in the pazufloxacin group and in 16.7% of patients in the levofloxacin group. These reactions were mainly local stimulation, nausea and diarrhea. No serious adverse event was reported in either group. Conclusion Pazufloxacin is as effective and safe as levofloxacin for the treatment of moderate to severe acute respiratory infections.
【摘要】 目的 探讨左氧氟沙星联合阿奇霉素治疗老年难治性呼吸道感染的疗效及安全性。 方法 选择2005年2月-2010年9月收治的高龄难治性呼吸道细菌感染患者68例，随机分为治疗组和对照组。治疗组34例，给予左氧氟沙星联合阿奇霉素；对照组34例，给予左氧氟沙星，两组总疗程皆为15 d。观察两组患者的临床疗效、细菌清除率和不良反应。 结果 治疗组的总有效率为64.71%，对照组总有效率为32.35%，两组差异有统计学意义（Plt;0.05） 。治疗组细菌清除率为76.19%，对照组细菌清除率为36.36%，两组差异有统计学意义（Plt;0.05） 。治疗组和对照组的不良反应发生率分别为5.88%和8.82%，差异无统计学意义（Pgt;0.05）。结论 左氧氟沙星联合阿奇霉素治疗老年难治性呼吸道感染疗效高， 能有效清除细菌， 不良反应较少， 值得临床推广应用。【Abstract】 Objective To evaluate the efficacy and safety of levofloxacin combined with azithromycin on refractory respiratory infections in elder patients. Methods A total of 68 elder patients with refractory respiratory infections in our hospital from February 2005 to September 2010 were randomly divided into two groups: treatment group (n=34) and control group (n=34). The patients in treatment group were treated with levofloxacin combined with azithromycin; while the patients in the control group were treated with levofloxacin alone. The total treatment periods of both groups were 15 days. The therapeutic efficacy, eradication rate of pathogens and the rate of aelverse reactions were observed. Results The therapeutic effect rate was 64.71% in the treatment group and 32.35% in the control group, and the difference between the two groups was statistically significant (Plt;0.05). The eradication rate of pathogens was 76.19% in the treatment group and 36.36% in the control group, and the difference was significant (Plt;0.05). The rate of the adverse reaction was 5.88% in the treatment group and 8.82% in the control group, and there were no significant differences between the two groups (Pgt;0.05). Conclusion Levofloxacin combined with Azithromycin is effective on refractory respiratory tract infection in elder patients, which can effectively remove the bacteria with few adverse reaction.
Objective To evaluate the efficacy and safety of Levofloxacin combined with Cefoperazone/Sulbactam on the patients with ventilator-associated pneumonia ( VAP) . Methods The clinical effect of Levofloxacin combined with Cefoperazone/ Sulbactam on ventilator-associated pneumonia in 58 paitiens with VAP were retrospectively analyzed. Results 26 patients ( 44. 8% ) were cured, 18 patients( 31. 1% ) were marked improved, and 14 patients ( 24. 1% ) were ineffective. The total clinical efficacy rate was 75. 9% . 55 strains of bacteria were isolated, and Gram-negative bacilli were dominant pathogens( 78. 2% ) . The bacterial clearance rate was 78. 2% . The prevalence of adverse reaction was 5. 1% . Conclusion Levofloxacin combined with Cefoperazone/ Sulbactam is effective and safe for patients with VAP.
Objective To access the effectiveness and safety of levofloxacin in controlling multidrug resistant tuberculosis (MDR-TB). Methods The electronic searches in databases of PubMed, EMbase, The Cochrane Library, CNKI, CBM and VIP, handsearches and other searches were conducted from the date of their establishment to April 2011 for collecting randomized controlled trials (RCTs) on levofloxacin treating MDR-TB. Two researchers independently screened the literature according to the inclusive and exclusive criteria, extracted the data, assessed the quality of the included studies by adopting the Jadad scale, and performed Meta-analysis by using RevMan 5.0 software. Results A total of 31 RCTs involving 2836 cases were included. The results of meta-analysis showed: a) Compared with the placebo group, levofloxacin could increase the sputum negative conversion rate after 3-month taking and at the end of the treatment period; b) Compared with the ofloxacin group, levofloxacin could increase the sputum negative conversion rate after 3 months and at the end of the treatment period; c) levofloxacin replacing either ethambutol or streptomycin could increase the sputum negative conversion rate after 3 months and at the end of the treatment period; d) Compared with the levofloxacin group, gatifloxacin and moxifloxacin could increase the sputum negative conversion rate after 3 months and at the end of the treatment period; e) There was no significant difference in the adverse reaction rate between each of the medication regimens (P=0.19). Conclusion Levofloxacin is more effective for MDR-TB than ofloxacin, ethambutol and streptomycin, but it is inferior to gatifloxacin or moxifloxacin. Its adverse reaction rate is equivalent to other medicines’.
Objective To assess the effectiveness and safety of moxifloxacin versus levofloxacin for the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods Such databases as PubMed, EMbase, The Cochrane Library, CBM, CNKI and VIP were electronically searched, and the relevant conference proceedings were also hand-searched. The search time was up to July, 2011. Randomized controlled trials (RCTs) on moxifloxacin versus levofloxacin for AECOPD were included. Literature was screened according to inclusive and exclusive criteria, data were extracted, quality was assessed, and then meta-analysis was performed using RevMan 5.0. Results A total of 6 RCTs involving 482 patients with AECOPD were included. The results of meta-analysis showed that moxifloxacin group was significantly superior to levofloxacin group in the effective rate (OR=3.15, 95%CI 1.80 to 5.49, Plt;0.000 1). The bacterial clearance rate in moxifloxacin group was also higher than that in the levofloxacin group (OR=2.79, 95%CI 1.30 to 5.97, P=0.008). In addition, adverse effects of moxifloxacin group were less than levofloxacin (OR=0.48, 95%CI 0.24 to 0.98, P=0.04). Conclusion Based on current studies, moxifloxacin is superior to levofloxacin in improving effective rate and bacterial clearance rate, and in lowering side effects when treating AECOPD. Hence it is considerable to use moxifloxacin instead of levofloxacin in the treatment of AECOPD if necessary. Due to the limitation of both quantity and quality of included studies, this conclusion should be further confirmed with more high quality and large sample studies.
Objective To assess the effectiveness and safety of prulifloxacin in the treatment of urinary tract infection. Methods The double-blind, double dummy and randomized controlled method was adopted. One hundred and forty-four patients were randomized to the treatment group (prulifloxacin , 4 tablets, bid) and the control group (levofloxacin, 4 tablets, bid). The randomization code was produced by computer. The treatment duration for both groups was from 7 to 10 days. Results Data were analyzed on the basis of full analysis sets (FAS) and per-protocol (PP) analysis. The total improvement rates of the trial and control groups were 85.07% and 88.52% respectively by FAS analysis, and 90.48% and 91.53% respectively by PP analysis. There was no significant difference between the two groups in improvement rates (Pgt;0.05). Bacterial negative rates in the trial and control groups were 93.75% and 93.88% respectively by FAS analysis and 97.83% and 97.87% respectively by PP analysis. The results showed no statistical significance difference between the two groups in bacterial negative rates (Pgt;0.05). The adverse events in the prulifloxacin and levofloxacin groups were 2.80% and 5.60% respectively. Conclusion Prulifloxacin has the same clinical effectiveness as levofloxacin with a few toxic adverse effects in the treatment of urinary tract infection.
目的 探讨含左氧氟沙星的三联疗法作为一线方案对幽门螺杆菌感染治疗的有效性和安全性。 方法 选择2008年9月－2011年3月125例确诊为幽门螺杆菌感染的初治患者，随机分为雷贝拉唑、阿莫西林联合左氧氟沙星组（A组）和雷贝拉唑、阿莫西林联合克拉霉素组（B组），经治疗7 d后比较两组根除率和不良反应发生率。 结果 A、B组幽门螺杆菌符合方案分析根除率分别为91.8%、77.6%，意向性治疗根除率分别为88.9%、72.6%，A组根除率高于B组，差异有统计学意义（P＜0.05）。A、B组不良反应发生率分别为4.8%、3.2%（P＞0.05）。 结论 以左氧氟沙星、阿莫西林、雷贝拉唑为组合的三联疗法能显著提高幽门螺杆菌感染的初治成功率，不良反应少，安全有效。
ObjectiveTo evaluate the effectiveness and side-effects of levofloxacin-based triple therapy as rescue regimen for Helicobacter pylori, and to compare it with the quadruple therapy. MethodsScience Direct, PubMed, Medline, China National Knowledge Infrastructure (CNKI), Chinese Social Sciences Citation Index (CSSCI, developed by Chongqing VIP Company), and Wanfang Database were electronically searched from January 2000 to September 2013. Randomized controlled trials (RCT) were focused on the eradication rate and adverse effects of levofloxacin-based regimens and generally recommended quadruple therapy after failure to eradicate Helicobacter pylori for one or more times. Two reviewers independently screened studies according to exclusion and inclusion criteria, extracted data, and assessed the methodological quality. Then, meta-analysis was performed using RevMan 5.0 software. ResultsFourteen literatures involving 1 402 patients were included. Meta-analysis showed that the levofloxacin-based group was better than the quadruple therapy group [RR=1.16, 95%CI (1.04, 1.30), P=0.009]. In addition, the adverse effects of levofloxacin group was less than the quadruple therapy group[OR=0.44, 95%CI (0.24, 0.81), P=0.008]. ConclusionAfter the failure of eradication of Helicobacter pylori, levofloxacin-based rescue regimen is more effective and better tolerated than the generally recommended quadruple therapy.
ObjectiveTo evaluate the bone repair efficacy of the new nano-hydroxyapatite (n-HA)/polyurethane (PU) composite scaffold in the treatment of chronic osteomyelitis in tibia.MethodsA novel levofloxacin@mesoporous silica microspheres (Lev@MSNs)/n-HA/PU was successfully synthesized. Its surface structure was observed by scanning electron microscopy (SEM). Fifty adult female New Zealand rabbits were randomly selected, and osteomyelitis was induced in the right tibia of the rabbit by injecting bacterial suspension (Staphylococcus aureus; 3×107 CFU/mL), which of the method was described by Norden. A total of 45 animals with the evidence of osteomyelitis were randomly divided into 4 groups, and the right medullary cavity of each animal was exposed. Animals in the blank control group (group A, n=9) were treated with exhaustive debridement only. The remaining animals were first treated by exhaustive debridement, and received implantations of 5 mg Lev@PMMA (group B, n=12), 1 mg Lev@MSNs/n-HA/PU (group C, n=12), and 5 mg Lev@MSNs/n-HA/PU (group D, n=12), respectively. At 12 weeks postoperatively, the right tibia of rabbits were observed by X-ray film, and then gross observation, methylene blue/acid fuchsin staining, and SEM observation of implant-bone interface, as well as biomechanical test (measuring the maximal compression force) were performed.ResultsX-ray films showed that the infection were severer than those of preoperation in group A, while the control of inflammation and bone healing of rabbits in group D were obviously better than those at preoperation. The gross observation showed extensive bone destruction in group A, a significant gap between bone tissue and the material in groups B and C, and close combination between bone tissue and the material in group D. The histology of the resected specimens showed that there was no obvious new bone formation around the materials in groups B and C, and there was abundant new bone formation around the periphery and along the voids of the materials and active bone remodeling in group D. The SEM observation of the bone-implant interface demonstrated that no new bone formation was observed at the bone-implant interface in groups B and C. However, bony connections and blurred boundaries were observed between the material and host bone tissue in group D. The biomechanical test showed the maximal compression force of groups B and D were significantly higher than that of groups A and C (P<0.05), but there was no significant difference between groups B and D (P>0.05).ConclusionThe novel synthetic composite Lev@MSNs/n-HA/PU exhibit good antibacterial activities, osteoconductivity, and biomechanical properties, and show great potential in the treatment of chronic osteomyelitis of rabbits.