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中华儿科杂志 1991年第4期29卷 223-224页

作者：虞爱华韩铁铮杨生王景林罗仕芬杨令国李德荣中国人民解放军第302医院武汉市医药工业研究所

氟哌酸属新喹诺酮类药物,目前已广泛应用于临床,抗感染效果好。但动物实验发现该药对正在生长发育的幼畜有一定毒性,主要是对负重关节和中枢神经系统的损害。为此1985～1989年我科以氟哌酸治疗小儿腹泻433例过程中,对该药的安全性进行... 详细信息

氟哌酸属新喹诺酮类药物,目前已广泛应用于临床,抗感染效果好。但动物实验发现该药对正在生长发育的幼畜有一定毒性,主要是对负重关节和中枢神经系统的损害。为此1985～1989年我科以氟哌酸治疗小儿腹泻433例过程中,对该药的安全性进行了观察。

关键词：腹泻/药物疗法抗感染药/投药和剂量萘啶酸/副作用萘啶酸/类似物和衍生物

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Effect of a three month course of ciprofloxacin on the outcome of reactive arthritis

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ANNALS OF THE RHEUMATIC DISEASES 2000年第7期59卷 565-570页

作者： Yli-Kerttula, T Luukkainen, R Yli-Kerttula, U Möttönen, T Hakola, M Korpela, M Sanila, M Parviainen, J Uksila, J Vainionpää, R Toivanen, A Univ Turku Dept Med FIN-20520 Turku Finland Univ Turku Dept Med Microbiol FIN-20520 Turku Finland Univ Turku Dept Virol FIN-20520 Turku Finland Satalinna Hosp Harjavalta Finland Tampere Univ Hosp Dept Med Rheumatol Sect Tampere Finland Jyvaskyla Cent Hosp Jvyaskyla Finland

Background-Treatment of reactive arthritis (ReA) with antibiotics has so far remained controversial. Eradication of the causative microbe appears logical, but short term antibiotic treatment has no beneficial effect on the outcome of ReA. Objective-To evaluate the effect of a three month course of ciprofloxacin on ReA. Methods-In a randomised, double blind, placebo controlled trial, between December 1992 and February 1996, 71 patients with acute ReA triggered by a gastrointestinal or a urogenital infection were randomly assigned to receive ciprofloxacin 500 mg or placebo twice daily for three months. Patients were assessed at study entry, at 6 weeks, 3 months, 6 months, and 12 months. Sixty two patients were valid for the efficacy analysis. The primary outcome measures were erythrocyte sedimentation rate, number of swollen joints, patients self assessment, and complete recovery. Results-Adverse events were mostly mild and occurred in both treatment groups. There were no statistically significant differences in any of the primary or secondary efficacy variables between the study groups at baseline or during the 12 month follow up. All primary outcome measures indicated that the condition of the patients improved during the study. Conclusion-Both groups tended to recover. Ciprofloxacin, given as a three month course, had no advantage over placebo treatment.

关键词：抗感染药/投药和剂量抗感染药/副作用关节炎反应性/药物疗法环丙沙星/投药和剂量环丙沙星/副作用双盲法治疗结果成年人女(雌)性人类男(雄)性

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Implementing a program for switching from i.v. to oral antimicrobial therapy

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AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY 2001年第12期58卷 1146-1149页

作者： Wong-Beringer, A Nguyen, KH Razeghi, J Western Univ Hlth Sci Coll Pharm Pomona CA 91766 USA Huntington Mem Hosp Dept Pharm Serv Pasadena CA USA

Management Case Studies describe approaches to real-life management problems in health systems. Each installment is a brief description of a problem and how it was dealt with. The cases are intended to help readers deal with similar experiences in their own work sires. Problem solving, nor hypothesis testing, is emphasized. Successful resolution of the management issue is nora criterion for publication-important lessons can be lessons from failures, too.

关键词：投药口服算法抗感染药/投药和剂量抗感染药/经济学医务工作者的态度社区药房服务注射静脉内氧氟沙星/投药和剂量氧氟沙星/经济学人类

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Short-course moxifloxacin therapy for treatment of acute bacterial exacerbations of chronic bronchitis

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RESPIRATORY MEDICINE 2000年第1期94卷 18-27页

作者： Chodosh, S DeAbate, CA Haverstock, D Aneiro, L Church, D VA Outpatient Clin Boston MA 02114 USA Med Res Ctr New Orleans LA USA Bayer Corp Div Pharmaceut West Haven CT USA

Chronic bronchitis is common among adults and infectious exacerbations contribute considerably to morbidity and mortality. We aimed to compare the safety and efficacy of moxifloxacin to clarithromycin for the treatment of patients with acute bacterial exacerbations of chronic bronchitis (ABECB) using a prospective, randomized, double-blind, parallel group trial. Between November 21, 1996 and April 7, 1998, 936 patients with acute exacerbations of chronic bronchitis (AECB) were enrolled at 56 centers across the United States of which 491 (52%) had ABECB (i.e. pretherapy pathogen). Patients were randomized to either oral moxifloxacin 400 mg administer once daily, for either 5 or 10 days, or clarithromycin 500 mg bid for 10 days. For the purpose of study blinding, the patients taking moxifloxacin received placebo to maintain uniform dosing. The main outcome measures were bacteriological response at the end of therapy (post-therapy days 0-6) and follow-up (7-17 days post-therapy) visits, as well as overall clinical response, clinical response at the end of therapy and clinical response at follow-up. Two patient populations were analyzed: emcocy-valid (i.e., those with a pretherapy pathogen) and intent-to-treat (i.e., all subjects that took drug). In 420 efficacy valid patients with a pretherapy organism, overall clinical resolution was 89% for 5 days moxifloxacin vs. 91% for 10 day moxifloxacin vs. 91% for 10 day clarithromycin. Bacteriological eradication rates at the end of therapy were 94% and 95% for 5-day moxifloxacin and 10-day moxifloxacin, respectively, and 91% for the clarithromycin group. Eradication rates at follow-up were 89% and 91% for 5-day moxifloxacin and 10-day monifloxacin respectively, and 85% for the clarithromycin group. Among 926 intent-to-treat patients (312 5-day moxifloxacin. 302 10-day moxifloxacin and 312 clarithromycin), drug-related events were reported for 26%, 30% and 35%, respectively. Moxifloxacin 400 mg once daily, as a 5 or 10 day reg

关键词：急性病投药口服抗感染药/投药和剂量抗感染药/副作用氮杂化合物细菌感染/并发症细菌感染/药物疗法支气管炎/药物疗法支气管炎/微生物学慢性病双盲法荧光喹诺酮类喹啉类治疗结果女(雌)性人类男(雄)性中年人

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Cost-minimisation analysis of sequential treatment with ofloxacin or ciprofloxacin in hospitalised patients

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PHARMACOECONOMICS 1997年第4期11卷 359-366页

作者： Salewski, E Bassaris, HP Calangu, S Kitzes, R Kosmidis, J Raz, R Kompan, L 1.Hoechst AG Medical Department K 607 D-65926 Frankfurt am Main Germany 2.Department of Internal Medicine University of Patras Medical School Patras Greece 3.Istanbul Faculty of Medicine Department of Clinical Microbiology and Infectious Diseases Istanbul Turkey 4.Carmel Medical Center Clinical Pharmacology and Infectious Diseases Unit Haifa Israel 5.First Department of Medicine General Hospital of Athens Athens Greece 6.Central Emek Hospital Infectious Diseases Unit Afula Israel 7.Institute of Anaesthesiology University Medical Center Ljubljana Ljubljana Slovenia

This study evaluated the cost of sequential treatment with once-daily ofloxacin or twice-daily ciprofloxacin in 474 hospitalised patients in different countries. The patients were treated intravenously for at least 3 days, then orally for 7 to 10 days or for 3 days beyond the disappearance of infection-related symptoms. The overall clinical cure rate (86.8% with ofloxacin and 89.6% with ciprofloxacin) and the overall bacteriological response rate (89.9 and 89.0%, respectively) were similar, and a cost-minimisation analysis was conducted. The acquisition costs for ofloxacin and ciprofloxacin in Greece, Israel, Slovenia and Turkey were used and converted to Deutschmarks (DM), and the costs of administration were analysed for each hospital. The different cost categories for oral and intravenous (IV) treatment (e.g. antimicrobial acquisition, drug monitoring, drug delivery costs) were used to identify any differences. The total costs per patient varied between the countries involved, but were higher for ciprofloxacin (ofloxacin: DM239 to DM724;ciprofloxacin: DM540 to DM976). In a sensitivity analysis using identical daily acquisition costs for the 2 fluoroquinolones, the total cost of treatment was higher for ciprofloxacin, as a result of the lower cost of administration of ofloxacin in the once-daily regimen. Continuing IV therapy would be approximately 50% more expensive than switching to oral administration;however, whenever possible, both drugs can be switched from IV to oral treatment.

关键词：抗感染药/投药和剂量环丙沙星/投药和剂量卫生保健费用住院氧氟沙星/投药和剂量回顾性研究人类

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Pharmacokinetics and burn eschar penetration of intravenous ciprofloxacin in patients with major thermal injuries

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JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY 2000年第3期45卷 337-342页

作者： Varela, JE Cohn, SM Brown, M Ward, CG Namias, N Spalding, PB Univ Miami Sch Med Dept Surg Div Trauma Miami FL 33101 USA Univ Miami Sch Med Dept Surg Div Burns Miami FL 33101 USA Univ Miami Sch Med Dept Surg Div Surg Crit Care Miami FL 33101 USA

Adequate penetration of antibiotics into burn tissue and maintenance of effective serum levels are essential for the treatment of patients sustaining major thermal injuries. The pharmacokinetics and burn eschar penetration of intravenous ciprofloxacin were determined in 12 critically ill patients with burn injuries. Mean age for the 12 patients was 45 +/- 17 (range 25-82 years), total body surface area burned (TBSAB) = 38 +/- 15% and Acute Physiology and Chronic Health Evaluation (APACHE) II score = 8 +/- 6. Patients received recommended doses of ciprofloxacin, 400 mg q12h iv, for three doses beginning 72 h post-burn. Serum concentrations were measured at t = 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 4.0 and 12.0 h after the first and third doses. Burn eschar biopsies were obtained after the third ciprofloxacin dose. Three of these 12 patients (25%) manifested later signs of clinical sepsis (TBSAB = 61 +/- 6% and APACHE II score = 11 +/- 3) and underwent a second infusion of three doses of intravenous ciprofloxacin, blood sampling and eschar biopsy. Serum and eschar concentrations were determined by high performance liquid chromatography. Serum ciprofloxacin concentrations were comparable to those of normal volunteers (C-max = 4.0 +/- 1 mg/L and AUC = 11.4 +/- 2 mg.h/L) during the immediate post-burn period after dose 1 (C-max1 = 4.8 +/- 3 mg/L and AUC(0-12) = 12.5 +/- 7 mg.h/L) end dose 3 (C-max3 = 4.9 +/- 2 mg/L and AUC(24-36) = 17.5 +/- 11 mg.h/L). Mean burn eschar concentration during the 72 h post-burn was significantly lower than that found during clinical sepsis (18 +/- 17 compared with 41.3 +/- 54 mu g/g;P < 0.05 by t test). Similar serum concentrations were achieved in patients with clinical sepsis (C-max1 = 4.2 +/- 0.2 mg/L and AUC(0-12) = 15.0 +/- 3 mg.h/L;C-max3 = 5.0 +/- 1 mg/L and AUC(24-36) = 22.8 +/- 9 mg.h/L). A positive correlation between burn eschar concentrations and C-max (r = 0.71, r(2) = 0.51, P = 0.01) was found by linear regression analysis.

关键词：抗感染药/投药和剂量抗感染药/血液抗感染药/药代动力学曲线下面积细菌感染/药物疗法细菌感染/病因学细菌感染/微生物学烧伤/并发症烧伤/代谢烧伤/微生物学环丙沙星/投药和剂量环丙沙星/血液环丙沙星/药代动力学危重病人医疗注射静脉内成年人老年人老年人 80以上女(雌)性人类男(雄)性中年人

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Antibiotic dosing issues in lower respiratory tract infection: population-derived area under inhibitory curve is predictive of efficacy

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JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY 1999年第Sup1期43卷 55-63页

作者： Highet, VS Forrest, A Ballow, CH Schentag, JJ Millard Fillmore Hlth Syst Clin Pharmacokinet Lab Buffalo NY 14209 USA SUNY Buffalo Sch Pharm Buffalo NY USA

Several lower respiratory tract infection (LRTI) trials have documented a correlation between clinical response and area under the inhibitory curve (24 h AUC/MIC;AUIC). The AUIC values in these studies were based on measured MICs and measured serum concentrations. This study evaluates AUIC estimates made using population pharmacokinetic parameters, and MICs from an automated microbiological susceptibility testing system. A computer database review over 2 years yielded 81 patients at Millard Fillmore Hospital with a culture-documented Gramnegative LRTI who had been treated with piperacillin and an aminoglycoside, ceftazidime, ciprofloxacin or imipenem. Their AUIC values were estimated using renal function, drug dosages and MIC values. Outcome groups (clinical and microbiological cures and failures) were related to the AUIC values using Kruskal-Wallis ANOVA, linear regression and classification and regression tree (CART) analysis. A significant breakpoint for clinical cures was an AUIC value at least 72 SIT-1.24 h (inverse serum inhibitory titre integrated over time). All antibiotics performed significantly better above this value than below it. Clinical cure was well described by a Hill-type equation. Within the piperacillin/aminoglycoside regimen, most of the activity came from the piperacillin, which had a higher overall AUIC value than the aminoglycoside. AUIC estimations based upon MIC values derived from the automated susceptibility testing method differed from NCCLS breakpoint data and from tube dilution derived values in this hospital by as much as three tube dilutions. These automated methods probably overestimated the MIC values of extremely susceptible organisms. The lack of precise MIC estimates in automated clinical microbiology methods impairs the use of AUIC to prospectively optimize microbiological outcome. Even ignoring this limitation and using the values as they are reported, the results of this analysis suggest that AUIC targets between 72 and 275

关键词：抗感染药/投药和剂量抗感染药/血液抗感染药/药代动力学曲线下面积头孢他啶/投药和剂量头孢他啶/血液头孢他啶/药代动力学头孢菌素类/投药和剂量头孢菌素类/血液头孢菌素类/药代动力学环丙沙星/投药和剂量环丙沙星/血液环丙沙星/药代动力学剂量效应关系药物用药计划表药物疗法联合/投药和剂量药物疗法联合/血液药物疗法联合/药代动力学亚胺培南/投药和剂量亚胺培南/血液亚胺培南/药代动力学微生物敏感性试验青霉素类/投药和剂量青霉素类/血液青霉素类/药代动力学哌拉西林/投药和剂量哌拉西林/血液哌拉西林/药代动力学试验预期值呼吸道感染/药物疗法呼吸道感染/代谢呼吸道感染/微生物学噻烯霉素类/投药和剂量噻烯霉素类/血液噻烯霉素类/药代动力学治疗结果老年人女(雌)性人类男(雄)性

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Comparison of in-vitro pharmacodynamics of once and twice daily ciprofloxacin

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JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY 1999年第5期44卷 661-667页

作者： Bowker, KE Wootton, M Rogers, CA Lewis, R Holt, HA MacGowan, AP Southmead Hlth Serv NHS Trust Bristol Ctr Antimicrobial Res & Evaluat Bristol BS10 5NB Avon England Univ Bristol Southmead Hosp Dept Med Microbiol Bristol BS10 5NB Avon England Univ W England Fac Sci Appl Bristol BS16 1QY Avon England

The pharmacodynamics of ciprofloxacin were explored in an in-vitro continuous bacterial culture model of infection, by simulating two oral dosing regimens;0.5 g 12-hourly (bd) and 1 g 24-hourly (od). Three strains of Escherichia coli(ciprofloxacin MICs 0.03, 0.5 and 2 mg/L);two strains of Pseudomonas aeruginosa (MICs 0.09 and 1.5 mg/L), two strains of Staphylococcus aureus (MICs 0.12 and 1 mg/L) and two strains of Streptococcus pneumoniae (MICs 0.5 and 2 mg/L) were used. Three pharmacodynamic parameters, T> MIC, C-max/MIC and AUC/MIC (T = time, C-max = peak serum concentration, AUC = area under the curve), were compared with area under the bacterial-kill curve (AUBKC) (after transformation of the AUBKC) using a simple E-max or sigmoidal E-max model. AUBKC was taken to be the main antibacterial effect measure. The models were compared by inspection of residuals and Akaike information criterion. E-max models adequately described the relationship between AUC/MIC and AUBKC and between C-max/MIC and AUBKC, but not between T> MIC and AUBKC. All three pharmacodynamic parameters are related to each other but multiple regression analysis indicated that AUC/MIC was the best individual predictor of AUBKC. Despite this, comparison of od and bd regimens indicates some advantage to od in terms of early antibacterial effect. Serum concentration-time curve shape has some importance in determining antibacterial effect. These data indicate that for ciprofloxacin AUC/MIC ratio is not the sole determinant of antibacterial effect.

关键词：抗感染药/投药和剂量抗感染药/药理学曲线下面积细菌/药物作用细菌感染/微生物学环丙沙星/投药和剂量环丙沙星/药理学大肠杆菌/药物作用大肠杆菌/生长和发育微生物敏感性试验模型生物学假单胞菌铜绿/药物作用假单胞菌铜绿/生长和发育葡萄球菌金黄色/药物作用葡萄球菌金黄色/生长和发育链球菌肺炎/药物作用链球菌肺炎/生长和发育人类

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A combination of ciprofloxacin and Rowachol does not prevent biliary stent occlusion

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GASTROINTESTINAL ENDOSCOPY 1999年第3期49卷 316-321页

作者： Luman, W Ghosh, S Palmer, KR Western Gen Hosp Gastrointestinal Unit Edinburgh EH4 2XU Midlothian Scotland

Background: Endoscopic insertion of biliary prostheses is now an established palliative treatment for frail and elderly patients with distal extrahepatic malignant biliary strictures who are unable to tolerate major surgery. The major limitation to long-term biliary stenting is tate stent occlusion caused by bacterial adherence followed by encrustation with amorphous bacterial products. We studied the effect on the duration of stent patency of combination therapy with ciprofloxacin and Rowachol, a choleretic agent, in a group of patients who underwent stent insertion for extrahepatic malignant biliary strictures. Methods: Patients with this diagnosis were randomized to either active treatment with ciprofloxacin (500 mg twice daily) and Rowachol (2 tablets 3 times daily) or no drug treatment (control group). They were followed up prospectively and the end points of the study were stent occlusion and patient survival. Results: Forty-eight patients who had successful stent placement were recruited;8 patients were excluded from the final analysis because of death in less than 1 month (5 patients) or stent replacement within a month because of persistent jaundice (3 patients). Twenty patients were randomized to the active and control groups. One patient in the active group withdrew because of nausea. The 2 groups were comparable with regard to age, gender, causes of extrahepatic malignant biliary strictures, and levels of serum alkaline phosphatase and bilirubin. There were significant reductions in mean serum bilirubin and alkaline phosphatase concentrations I month after stent placement. At the time of analysis, 12 patients were still alive (7 patients from the control group). Median survival was 23 weeks in both the active treatment group and the control group. There were 3 episodes (45%) of stent occlusions in the active treatment group and In episodes (50%) in the control group. The median time to stent occlusion was 23 (range 7 to 68) weeks for the active treatment

关键词：碱性磷酸酶/血液抗感染药/投药和剂量胆管肿瘤/并发症胆红素/血液利胆药和促胆汁分泌药/投药和剂量胆汁淤积/死亡率胆汁淤积/预防和控制环丙沙星/投药和剂量复方合剂药物疗法联合设备失效随访研究虚弱老人单萜类前瞻性研究支架存活率萜类/投药和剂量老年人女(雌)性人类男(雄)性

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Which antimicrobial impregnated central venous catheter should we use? Modeling the costs and outcomes of antimicrobial catheter use

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AMERICAN JOURNAL OF INFECTION CONTROL 2003年第1期31卷 1-8页

作者： Marciante, KD Veenstra, DL Lipsky, BA Saint, S Univ Washington Dept Pharm Pharmaceut Outcomes Res & Policy Program Seattle WA 98195 USA Vet Adm Puget Sound Hlth Care Syst Seattle WA USA Univ Michigan Ann Arbor Vet Adm Med Ctr Ann Arbor MI 48109 USA Univ Michigan Dept Internal Med Ann Arbor MI 48109 USA Univ Michigan Patient Safety Enhancement Program Ann Arbor MI 48109 USA

Background: Catheter-related bloodstream infections are costly and associated with substantial morbidity and mortality. Trials suggest that central venous catheters impregnated with minocycline/rifampin, although more expensive, are clinically superior to chlorhexidine/silver sulfadiazine impregnated catheters. It remains unclear whether minocycline/rifampin catheters are cost-effective for all high-risk patients or only those requiring longer-term catheterization. Methods: We developed a series of decision models with patient-level clinical trial data to determine whether minocycline/rifampin catheters are cost-effective for patients requiring various durations of catheterization. We calculated incremental cost-effectiveness ratios for patients catheterized for durations ranging from 1 to 25 days. Results: The data were too sparse to estimate cost-effectiveness for patients catheterized less than 8 days. The probability that minocycline/rifampin catheters were cost-effective compared with chlorhexidine/silver sulfadiazine catheters in patients catheterized for 8 days was 91%. The probability that the minocycline/rifampin catheters in patients catheterized 13 days or longer resulted in cost savings was more than 95%. Conclusions: Our analysis suggests that central venous catheters coated with minocycline/rifampin are cost-effective for patients catheterized for at least 1 week and lead to overall cost savings when patients are catheterized for 2 weeks or longer. Policies for the use of antimicrobial catheters in high-risk patients should reflect patients' expected duration of catheterization.

关键词：抗感染药/投药和剂量抗感染药/经济学菌血症/预防和控制导管插入术中心静脉/经济学导管插入术中心静脉/方法导管留置/经济学导管留置/微生物学氯己定/投药和剂量氯己定/经济学费用效益分析决策支持技术药物释放系统米诺环素/投药和剂量米诺环素/经济学质量校正寿命利福平/投药和剂量利福平/经济学敏感性与特异性磺胺嘧啶银/投药和剂量磺胺嘧啶银/经济学时间因素美国人类中年人

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