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.
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 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.
【摘要】 目的 探讨肝炎后肝硬化自发性细菌性腹膜炎（spontaneous bacterial peritonitis，SBP）的诊疗情况及头孢哌酮舒巴坦联合左旋氧氟沙星对SBP的治疗效果。 方法 对2004年1月-2009年12月收治的54例肝炎后肝硬化SBP患者，应用头孢哌酮舒巴坦联合左旋氧氟沙星给与治疗，并观察分析治疗效果。 结果 肝炎后肝硬化SBP的临床表现以发热，腹痛为主，具有典型腹膜刺激征的不足半数。外周血白细胞升高者不多见，腹腔积液中白细胞计数、PMN计数和细菌培养是自发性细菌性腹膜炎的重要诊断指标。 结论 肝炎后肝硬化合并SBP的临床表现不典型。致病菌以G-杆菌为主。在早期诊断、综合治疗的基础上，头孢哌酮舒巴坦联合左旋氧氟沙星对自发性细菌性腹膜炎的治疗效果显著。【Abstract】 Objective To evaluate the diagnosis and treatment of post-hepatitis cirrhosis complicated with spontaneous bacterial peritonitis (SBP) cases and the efficacy of cefoperazone and sulbactam combined with levofloxacin in the treatment of cirrhotic patients with SBP. Methods From January 2004 to December 2009, the clinical data from 54 cases of SBP after cirrhosis were analyzed. The patients underwent the treatment of cefoperazone sulbactam combined with levofloxacin. The therapeutic effect was observed. Results The main clinical manifestations were fever and abdominal pain, and about half of the patients had the typical peritoneal irritation. Only a few patients had elevated peripheral white blood cells (WBC). The WBC count, abdominal effusion polymorphonuclearcyte count and bacteria cultivation were the indexes of diagnosis of SBP. Conclusion The clinical features of post-hepatitis cirrhosis complicated with SBP are not typical. The main pathogenic bacteria is G- bacilli. In the early diagnosis and treatment, cefoperazone sulbactam combined with levofloxacin is effective.
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.
This research was aimed to find the skin irritation and burns treatment effect of wound dressing with microspheres containing levofloxacin. We used reference GB/T16886.10-2005 to evaluate the dressing skin irritation. We prepared rabbit models divided into three groups. The control group was rapped with Vaseline gauze bandage, while the positive control group was rapped with the wounds of nano-silver paste bandage. The experimental sample group was rapped with wound dressing with microspheres containing levofloxacin. We measured the wound without healing area and the hydroxyproline content at the ends of 3 d, 6 d, 9 d, 14 d, 21 d, 28 d. and meanwhile performed histopathological examination. The experimental results showed that the dressing primary irritation index was 0. The nonhealing wound area of theexperimental sample group and positive control group at the ends of 6 d, 9 d, 14 d, 21 d were less than that of the control group (P<0.05). The nonhealing wound area of the experimental sample group at the ends of 9 d and 14 d was significantly lower than that of the positive control group (P<0.05). The hydroxyproline content of the experimental sample group at the ends of 6 d, 9 d and 14 d was significantly higher than that of the positive control group and blank control group (P<0.05). The pathology observed of the experimental sample group at 21 d were the earliest appendages. The wound dressing with microspheres containing levofloxacin has minimal skin irritation, effectively promote wound healing of burn.
【摘要】 目的 系统评价司帕沙星对比氧氟沙星治疗耐多药肺结核的有效性和安全性。 方法 计算机检索Cochrane图书馆临床对照试验资料库（2010年第2期）和PubMed（1978年-2010年10月）、EMBASE（1974年-2010年10月）、中国学术期刊网络出版总库（1978年-2010年10月）、维普（1989年-2010年10月）、中国生物医学文献数据库（1978年-2010年10月）；手工检索其他相关杂志。检索语种为中文和英文。纳入司帕沙星对比氧氟沙星治疗耐多药肺结核的随机对照试验。按Cochrane系统评价的方法评价纳入研究质量，用RevMan 5.0软件对数据进行Meta分析。 结果 共纳入8篇研究，Meta分析结果显示司帕沙星组与氧氟沙星组相比，痰菌转阴率、病灶显著吸收率、空洞闭合率均高于对照组，差异具有统计学意义（Plt;0.05）。 结论 现有的证据表明，司帕沙星与其他抗结核药物联用治疗难治、耐多药肺结核的疗效优于氧氟沙星的联用方案，但由于纳入的文献数量有限，质量参差不齐，存在潜在的发表偏倚。【Abstract】 Objective To assess the clinical efficacy and safety of sparfloxacin versus ofloxacin in treatment of multi-drug resistant pulmonary tuberculosis (MDR-TB). Methods Literatures were retrieved from PubMed (1978-October, 2010), EMBASE (1974-October 2010), Cochrane library (2nd volume, 2010), China Academic Journal Network Publishing Database (1978-October, 2010), VIP (1989-October, 2010) and CBM (1978 to October, 2010) by computer, and searched some other relevant journals manually. Chinese and English were both used in the search. Randomized controlled trials (RCTs) on sparfloxacin versus ofloxacin in treating pulmonary tuberculosis were included in this study. Meta-analysis was conducted by RevMan 5.0 software. Results The meta-analysis of 8 included RCTs showed that the sputum negative conversion rate, focus absorption rate, cavity closure rate in the sparfloxacin group were significantly higher than the ofloxacin group (P＜0.05). Conclusions The analysis indicates that combined treatment with sparfloxacin has a better effect in treating MDR-TB than with ofloxacin. However, the reliability of this review may be affected by the number and quality of studies included. Large-scale randomized controlled trials of high quality are needed to confirm the conclusions above.
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.