左氧氟沙星口服制剂评价性抽验结果及3年结果的质量评价

目的 评价国产左氧氟沙星口服制剂的质量现状及存在问题.方法 按照国家评价性抽验计划总体要求,采用现行标准规定检验方法结合探索性研究进行药品检验,统计分析检验结果.结果 324批样品均按现行标准进行了检验,结果2批溶出度低于限值;探索性研究采用2010年版药典方法检测,9批溶出度低于限值;大部分企业的产品3年来质量稳定,个别企业的有关物质、含量测定和溶出度结果3年变化较大.结论 左氧氟沙星口服制剂总体质量状况良好.但是同品种标准不统一,建议对相同品种、相同规格、相似工艺的制剂统一并提高质量标准,尤其是有关物质和溶出度项目等.     

肝硬化腹水并发自发性细菌性腹膜炎临床疗效观察

目的：探讨乙型肝炎肝硬化并发自发性细菌性腹膜炎（SBP）的临床疗效。方法探究主体为234例肝硬化者,依照治疗药物的不同随机分两组。对照组使用的药物是左氧氟沙星,治疗组加用培菲康。结果两组SBP的治疗结果差距较大,观察组的腹水治疗以及肝功能改善明显较好。观察组患者的平均腹水消失时间为（4.33±0.34）d,而对照组是（10.32±0.58）d, t=96.371, P〈0.01,差异存在统计学意义。观察组治疗后的ALT为（352.35±10.45）U/L,而对照组则是（249.57±10.47）U/L, P〈0.01,差异存在统计学意义。其余肝功能指标TBIL （t=46.986, P〈0.01）以及Aib （t=29.107, P〈0.01）均存在较大的差异, P〈0.01,差异存在统计学意义。结论肝硬化合并SBP者加用培菲康能够帮助加快治愈,有较好的治疗效果。     

口捷爽复方泡腾片稳定性考察

目的考察口捷爽复方泡腾片的稳定性,并初步确定其有效期。方法观察并测定复方泡腾片在强光、高温及高湿度等环境下的性状、崩解时限、重量差异、发泡量、酸度、含量等指标的变化。结果加速试验与长期试验中各项考察指标均无明显变化,符合药品质量标准的相关规定。结论口捷爽复方泡腾片在加速试验和长期试验条件下稳定,可初步预测该制剂的有效期1年。     

复方玄驹胶囊联合左氧氟沙星和前列康片治疗Ⅲ型前列腺炎的临床研究

目的探讨复方玄驹胶囊联合左氧氟沙星和前列康片治疗Ⅲ型前列腺炎的临床疗效。方法选取2012年1月—2015年1月北京市通州区新华医院收治的Ⅲ型前列腺炎患者156例,随机分为对照组和治疗组,每组78例。对照组口服左氧氟沙星片5片/次,1次/d,口服前列康片3片/次,3次/d。治疗组在对照组基础上口服复方玄驹胶囊3粒/次,3次/d。两组均连续治疗6周。观察两组的临床疗效,同时比较两组NIH-CPSI评分和前列腺液检查的变化情况。结果治疗后,对照组和治疗组总有效率分别为51.28%、71.79%,两组比较差异具有统计学意义(P0.05)。治疗后两组NIH-CPSI总分、疼痛、排尿、生活质量得分均较治疗前显著降低,同组治疗前后差异有统计学意义(P0.05),且治疗组显著低于对照组,两组比较差异有统计学意义(P0.05)。治疗后,两组精液中白细胞介素-6(IL-6)、白细胞水平均显著降低,同组治疗前后差异有统计学意义(P0.05),且治疗组显著低于对照组,两组比较差异有统计学意义(P0.05)。结论复方玄驹胶囊联合左氧氟沙星和前列康片治疗Ⅲ型前列腺炎疗效显著,可显著降低NIH-CPSI评分,具有一定的临床推广应用价值。     

头孢克肟联合左氧氟沙星治疗老年肺炎的疗效观察

目的 观察头孢克肟胶囊联合盐酸左氧氟沙星注射液治疗老年肺炎的临床疗效。方法 选取2014年2月-2015年2月在上海市浦东医院呼吸内科就诊的老年肺炎患者106例,随机分为治疗组和对照组,每组各53例。对照组给予静脉滴注盐酸左氧氟沙星注射液,0.4 g/次,2次/d。治疗组患者在对照组治疗基础上口服头孢克肟胶囊,200 mg/次,2次/d。疗程均为14 d。比较两组治疗前后患者的临床疗效、症状改善情况、相关实验室检查。结果 治疗后,对照组和治疗组的总有效率分别为84.91%、96.23%,两组总有效率比较差异具有统计学意义(P < 0.05)。治疗后,治疗组患者临床体征如发热、咳嗽、肺部啰音消失时间均显著短于对照组,差异具有统计学意义(P < 0.05)。治疗后,治疗组患者X线胸片炎症吸收、痰培养的临床控制率、总有效率均显著优于对照组,差异具有统计学意义(P < 0.05)。治疗后,两组血清中C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)、白细胞介素-4(IL-4)及白细胞介素-8(IL-8)水平均显著下降(P < 0.05),并且治疗组血清中CRP、TNF-α、IL-4、IL-8水平下降幅度明显高于对照组(P < 0.05)。结论 头孢克肟胶囊联合盐酸左氧氟沙星注射液治疗老年肺炎可以提高临床疗效,改善症状,控制感染,促进炎症吸收,且安全性较高,具有一定的临床推广应用价值。     

Formulation of sustained release bioadhesive minitablets containing solid dispersion of levofloxacin for once daily ocular use

This study aimed to increase ocular residence time of levofloxacin by formulation into zero-order sustained release mucoadhesive minitablets for once daily administration using a hydrophobic–hydrophilic polymeric matrix. Levofloxacin was first formulated into solid dispersion with different ratios of Eudragit^® RS then the resulting solid dispersion was mixed with different concentrations of Carbopol^® and other excipients to be finally compressed into minitablets. A 2⁴ full factorial design was employed to estimate the effects and interactions of two formulation factors, and to establish their relationships with selected responses in the developed minitablets. The studied factors were: drug to Eudragit^® RS ratio, and percent of Carbopol^® in the minitablets. Sixteen ocular minitablets formulations were prepared and evaluated for the cumulative percentages drug release at 6, 12, and 24?h, as well as mucoadhesion time, mucoadhesive strength, and swelling index as response variables. After optimizing the responses, the optimized formulation was found to be stable on sterilization using gamma-irradiation and storage at 40?°C/75% RH for six months. In vivo testing of the optimized formulation showed that the minitablets extended levofloxacin release up to 24?h without causing any ocular irritation. The optimized formulation exhibited superior microbiological activity compared to the commercial product.     

急性肾盂肾炎应用左氧氟沙星的临床干预效果分析

目的：观察急性肾盂肾炎应用左氧氟沙星的临床干预效果。方法将我院2010年4月~2013年11月确诊并收治的110例急性肾盂肾炎患者随机分为临床组和参照组各55例。临床组应用左氧氟沙星静脉滴注进而口服治疗,参照组应用氨苄青霉素静脉滴注治疗进而用磺胺甲恶唑口服治疗。比照两组症状体征消失时间、临床疗效及治疗时间。结果两组用药完成后,症状体征逐渐改善,临床组其症状体征消失速度均显著好于参照组,差异有统计学意义（P＜0.05）。临床组总有效率为98.18%,参照组为96.36%,两组比较差异无统计学意义（P＞0.05）。但临床组其平均治疗时长显著低于参照组,差异有统计学意义（P＜0.05）。临床组1例发生恶心、呕吐,1例头晕,1例皮肤瘙痒;参照组4例发生恶心、呕吐。两组相比不良反应率差异无统计学意义（P＞0.05）。结论急性肾盂肾炎应用左氧氟沙星疗效确切,迅速缓解症状体征、疗程短、安全性好。     

Efficacy of PPI,levofloxacin and amoxicillin in the eradication of Helicobacter pylori compared to conventional triple therapy at a Venezuelan hospital

Background and study aimsHelicobacter pylori is the main cause of gastritis, gastroduodenal ulcers and gastric cancer. In the past two decades, the recommended treatment for its eradication as a first-line regimen is the standard triple therapy consisting of a proton pump inhibitor (PPI), amoxicillin and clarithromycin or metronidazole. However, the effectiveness of this traditional regime, which initially was 90%, progressively declined in many parts of the world and is currently 57–73%. The aim of this study was to evaluate whether the eradication rate with triple therapy with levofloxacin is superior as first-line therapy to that with treatment using clarithromycin in the population that attended as outpatients at the Hospital of Lídice.Patients and methodsWe designed a prospective study, with two groups of patients presenting dyspeptic symptoms, from October 2010 to October 2011, who underwent upper gastrointestinal endoscopy and whose biopsies were positive for infection with H. pylori. At the end, 81 patients were included in the order of biopsy result arrival to fill the quota of each group. The first group with 42 patients underwent triple therapy with clarithromycin and the second group with 39 patients underwent therapy with levofloxacin, amoxicillin and a PPI. The patients’ age ranged between 23 and 76 years, the average being 49.5. The predominant sex was female, at 72.84%. Both treatments lasted for 10 days and the patients were clinically re-evaluated 15 days after their conclusion and programmed for a second endoscopy to verify H. pylori eradication.ResultsAmong the 42 patients in the control group, there were 14 eradication failures with 33.33% resistance to clarithromycin. Among the 39 patients in the experimental group, two eradication failures with 5.13% resistance to levofloxacin were observed. The χ² value was 6.96.ConclusionsTreatment with levofloxacin was more effective than conventional triple therapy. Triple therapy with levofloxacin can be implemented in populations where resistance to clarithromycin has been observed.     

家兔体内思密达对左氧氟沙星药动学的影响

目的:探讨口服思密达和左氧氟沙星后左氧氟沙星的药动学有无改变。方法:取家兔6只随机交叉(间隔1周)经口灌胃左氧氟沙星(A组)、左氧氟沙星+思密达(B组)、左氧氟沙星2h后+思密达(C组)。采用高效液相色谱法测定不同时间血样中左氧氟沙星浓度,计算并比较药动学参数。结果:A组与C组比较,Cmax、tmax、AUC、t1/2均无显著性差异(P>0.05);B组除tmax与其它组无差异外(P>0.05),t1/2延长,AUC、Cmax值降低(P<0.05)。结论:同时使用左氧氟沙星和思密达,可明显改变前者的药动学参数;使用左氧氟沙星2h后再用思密达,此用药方案较为合理。     

头孢硫脒联合左氧氟沙星治疗社区获得性肺炎的疗效分析

目的：评价头孢硫脒与左氧氟沙星联合用药治疗社区获得性肺炎（CAP）的疗效和安全性。方法：140例CAP患者随机分成两组，治疗组应用头孢硫脒2g静脉滴注，每目2次，左氧氟沙星200mg静脉滴注，每日2次，连续7～8d；对照组给予头孢曲松1g静脉滴注，每日2次，连续7～8d。结果：治疗组总有效率95．83％，明显高于对照组82．39％（P〈0．01）。结论：头孢硫脒与左氧氟沙星联合用药治疗CAP有良好的临床细菌学疗效和安全性。