Pharmacokinetics of ofloxacin enantiomers after intravenous administration for antibiotic prophylaxis in biliary surgery

The pharmacokinetics of S-(-)- and R-(+)-ofloxacin, enantiomers of the fluoroquinolone ofloxacin, were characterized after prophylactic administration in 15 patients undergoing elective biliary surgery. A single dose of ofloxacin 400 mg given intravenously as an infusion was administered 1 hour before surgery. Plasma levels of S-(-)- and R-(+)-ofloxacin showed very small differences between both enantiomers, although the ratio of S-(-)- to R-(+)-enantiomer concentration in plasma showed significant differences (p < 0.05) at 4 and 12 hours. Adequate S-(-)-ofloxacin (levofloxacin, the active enantiomer) plasma levels (> or = minimum inhibitory concentration [MIC90] for Escherichia coli) were found throughout the procedure. For pharmacokinetic parameters, the authors found small but statistically significant differences (p < 0.05) in the area under the concentration-time curve, AUC0-infinity (22.30 +/- 2.72 mg h/L for S-(-)-ofloxacin vs. 20.50 +/- 2.06 mg h/L for R-(+)-ofloxacin), and in the clearance (0.15 +/- 0.04 L/h/Kg for S-(-)-ofloxacin vs. 0.16 +/- 0.04 L/h/Kg for R-(+)-ofloxacin). To test the penetration of ofloxacin enantiomers into tissues, the authors measured levels in subcutaneous cell tissue and gall-bladder cell tissue. They did not observe statistical differences between the two isomers, which means that distribution is not an estereoselective process. Enantiomer levels in these two tissues decreased rapidly, but the highest concentrations were reached during the 4 first hours (i.e., when the surgical procedure was being performed). In conclusion, with the prophylactic treatment used, levofloxacin plasma and tissue levels are high enough to prevent surgical infections.     

Pharmacokinetics and tissue distribution of intravenous ofloxacin for antibiotic prophylaxis in biliary surgery

The plasma levels and tissue penetration of ofloxacin were studied after prophylactic administration in 17 patients undergoing elective biliary surgery. A single dose of ofloxacin 400mg given intravenously as an infusion was administered 1 hour before surgery. Adequate drug plasma levels [>/= minimum inhibitory concentration (MIC(90)) for Escherichia coli] were found throughout the procedure. Mean peak (1 hour) and last-determined (36 hours) ofloxacin serum levels were 7.97 +/- 3.79 mg/L and 0.19 +/- 0.13 mg/L, respectively. The elimination half-life (t((1/2)lambda)) was 8.86 +/- 3.07 hours, and the clearance and steady-state volume of distribution were 0.17 +/- 0.05 L/h.kg and 112.90 +/- 37.09L, respectively. The area under the plasma concentration-time curve from zero to infinity (AUC(0-infinity)) was 41.60 +/- 12.51 mg/L.h. In bile, ofloxacin levels were higher than in plasma and showed great variability. Adequate ofloxacin levels in subcutaneous cell tissue and gallbladder wall tissue were observed during the surgical procedure. Patients were observed daily throughout their hospital stay. This included examination of the surgical wound and recording of body temperature. No cases of anaerobic infection were noted in the study patients. Other constants such as hospitalisation stay and time of recuperation were normal for this type of surgery.     

Appropriateness of surgical antibiotic prophylaxis for breast surgery procedures

Background Guidelines for the appropriate use of antibiotic prophylaxis are provided in the Therapeutic Guidelines: Antibiotics (eTG) in Australia. Inappropriate use of antibiotics is problematic. Objective To examine adherence with therapeutic guidelines (eTG) in breast surgery and trends in non-adherence dependent on the type of breast surgery performed. Setting Major Western Australian teaching hospital. Method A retrospective cross-sectional study reviewed a random sample of 150 from 1049 eligible medical records of patients who underwent a breast surgical procedure in 2013 or 2014. Main outcome measure Adherence to the eTG. Results Antibiotic prophylaxis was prescribed for 139 (92.7%) operations. Adherence to the eTG occurred in 20 (13.3%) operations, whilst 11 (7.3%) did not adhere to any element of the eTG. Appropriate timing was the main factor not adhered to. Postoperative antibiotics were prescribed following 35 (23.3%) operations, with 32 (91.4%) administered beyond 24 h. Length of stay was significantly different (p = 0.0036) between surgical groups. There was a tendency for risk of an infection to be decreased with adherence (odds ratio: 0.23; 95% CI: 0.05, 1.07; p = 0.06). Conclusion Adherence to the eTG was low (13.3%), despite a decreased risk of SSI when guidelines were followed.     

Clinical equivalence of IV paracetamol compared to IV dipyrone for postoperative analgesia after surgery for breast cancer

ABSTRACT

Objective: To assess clinical efficacy of IV paracetamol 1?g and IV dipyrone 1?g on a 24.h dosing schedule in this randomised, double-blinded study of 40 ASA I–III (American Society of Anesthesiologists classification of physical status) patients undergoing surgery for breast cancer.

Research design and methods: General anaesthesia using remifentanil and propofol was performed for surgery. The patients were randomly allocated to two groups, receiving infusions of paracetamol 1?g/100?mL (Para Group) or of dipyrone 1?g/100?mL (Dipy Group) 30?min before arrival in the recovery area and every 6?h up to 24?h postoperatively. All patients had unrestricted access to opioid rescue medication via an IV patient-controlled analgesia (PCA) device.

Main outcome measures: The primary variables for clinical equivalence were the differences between the mean values for pain scores at rest and pain scores on coughing over 30?h postoperatively. The equivalence margin was determined as ±10?mm on the visual analogue scale (VAS).

Results: Regarding pain scores at rest, the 90% CI of the mean differences between the treatment groups over 30?h postoperatively was found to be within the predefined equivalence margin [+7.5/–6.2], and the CI values for pain scores on coughing [+7.3/–9.0] were similar. The two groups did not differ in cumulative opioid rescue consumption (Dipy-Group 14.8 ± 17.7?mg vs. Para Group 12.1 ± 8.8?mg, p = 0.54) nor in piritramide loading dose (Dipy Group 0.95 ± 2.8?mg vs. Para Group 1.3 ± 2.8?mg, p = 0.545). Five patients in the Dipy Group experienced hypotension in contrast to none in the Para Group (?p = 0.047). There were no significant between-treatment differences for other adverse events, patient satisfaction scores (?p = 0.4) or quality of recovery scores (?p = 0.3).

Conclusion: IV paracetamol 1?g is clinically equivalent to IV dipyrone 1?g for postoperative analgesia after surgery for breast cancer.     

Treatment of lower respiratory infections in outpatients with ofloxacin compared with erythromycin.

To assess the safety and efficacy of a ten-day oral course of ofloxacin (400 mg 12 hourly) as compared with erythromycin (400 mg every 6 hours) for treatment of lower respiratory tract infections, fifty-two adult outpatients with pulmonary infiltrates (pneumonia) or with a cough and purulent sputum (bronchitis) were evaluated. Expectorated sputum specimens were Gram-stained and cultured, and antibody titres to Mycoplasma pneumoniae, Legionella pneumophilia, and in most cases Chlamydia pneumoniae were measured on acute and convalescent serum samples. Patients were evaluated clinically, microbiologically and radiographically three to five days after concluding therapy; the incidence of adverse reactions was monitored throughout the study period. The ofloxacin group (N = 25) was comprised of nineteen patients with pneumonia and six patients with bronchitis. The erythromycin group (N = 27) was comprised of thirteen patients with pneumonia and fourteen patients with bronchitis. All fifty-two patients were either clinically improved or cured after therapy. Microbiological cure was documented in all fourteen cases (27%) in which causative pathogens were identified. Clinical cure was achieved with ofloxacin in 68% of patients with pneumonia and in 83% of patients with bronchitis, while clinical cure with erythromycin was achieved in 46% of patients with pneumonia and 54% of patients with bronchitis. Adverse reactions (mostly mild gastrointestinal or central nervous system symptoms) were reported by eight patients receiving ofloxacin and four patients receiving erythromycin. While the types of adverse effects were similar, ofloxacin showed a trend toward a higher rate of cure than erythromycin. Ofloxacin is a promising new antibiotic for the treatment of acute lower respiratory infections.     

药师对1例转移性乳腺癌术后伴癌痛患者的药学监护

目的 通过参与1例癌症疼痛患者的药物治疗和药学监护过程,临床药师参与制订药物治疗方案,并提出合理化用药建议,同时对患者进行健康教育,以减少或避免药物不良反应的发生.方法 药师通过参与审方、发现问题,对不当处方及时干预,与医生沟通、更改用药方案,对患者进行健康教育等方式,参与患者的药学监护过程.结果 在药师的干预下,医生...     

乳腺癌早期行保乳手术治疗的体会

目的:总结早期乳腺癌行保留乳房根治术的治疗效果.方法:分析2005年1月～2009年12月我科开展的保乳手术的42例患者的近期治疗效果.结果:本组患者均行保留乳房的乳腺癌根治术,术后联合化疗、放疗、内分泌治疗均获得较满意的效果.结论:早期乳腺癌行保乳手术联合放、化疗可达到与传统根治手术相同的近期效果,并具有患者心理打击小、美容效果好的优点.     

护理干预用于乳腺癌手术患者的观察及体会

目的：探讨临床护理干预在乳腺癌改良根治术患者中的应用效果。方法：回顾性分析52例行乳腺癌手术患者的临床资料，所有患者都采用全程的临床护理干预措施。结果：所有患者住院10～19d，痊愈出院。结论：乳腺癌患者实施护理干预的关键是进入患者的角色中去理解和体察，做好术前、术中、术后的护理，做到有的放矢，才能获得治疗及护理的理想效果。     

乳腺癌保乳手术30例治疗体会

目的 探讨应用保乳手术治疗乳腺癌的临床效果.方法 选取本院普外科2004～2009年收治的30例乳腺癌保乳手术患者为研究对象,术后采取常规治疗,辅助放、化疗与内分泌治疗等.结果 患者均未出现复发与远处转移现象,随访3年生存率为100％.术后患者乳房美容效果综合满意率为96.7％.结论 应用保乳手术治疗早期乳腺癌临床较好,保留了患者的乳房外观,乳房外形改变较小,未见患者术后有出血、感染、皮下积液等并发症发生,值得临床推广应用.     

洛美沙星与氧氟沙星治疗细菌性感染临床研究

研究了国产洛美沙星与氧氟沙星随机对照治疗细菌性感染４４对（８８例）的临床疗效与不良反应。洛美沙星与氧氟沙星口服剂量为２００ｍｇ每日２次或４００ｍｇ每日１次，疗程７～１４ｄ。治疗结束后两药临床有效率分别为９３．２％（４１／４４）与９５．５％（４２／４４），治疗各种致病菌所致感染的临床疗效分别为９２．１％（３５／３８）与９４．４％（３４／２６），细菌清除率分别为９４．９％（３７／３９）与９２．１％（３５／３８）。其不良反应发生率分别为６．８％（３／４４）与４．５％（２／４４）。上述结果经统计学比较无显著性差异。说明洛美沙星是一个安全有效的抗菌药物。     

Randomized study of minocycline + gentamicin compared with metronidazole + gentamicin for prophylaxis or treatment of mixed infections in abdominal surgery

Seventy patients admitted for abdominal surgery requiring short-term perioperative prophylaxis were randomized to receive minocycline + gentamicin or metronidazole + gentamicin. Thirty patients were considered to be infected at the time of surgery and were treated with the same regimen. In the prophylactic cohort, one patient from each group developed postoperative fever. One patient receiving minocycline developed a wound infection. The overall infection rate was 2.6%. In the treatment cohort, it appeared that the patients receiving metronidazole had more severe underlying diseases than those receiving minocycline. Consequently, more postoperative non-infectious complications were observed in the former. Minocycline + gentamicin appeared at least as effective than metronidazole + gentamicin in preventing postoperative infectious complications associated with abdominal surgery or in treating intra-abdominal infections.     

Antimicrobial prophylaxis in surgery

Antimicrobial prophylaxis is widely performed in any surgical procedures to prevent postoperative infections. However, we have neither double-blind placebo-controlled studies nor sufficient surveillance of postoperative infections that are common in Europe and the United States, and therefore there is little convincing scientific basis accounting for the validity of this therapy. In addition, prophylactic agent is still uncovered by medical insurance despite the persistent arguments as to its necessity. To establish the guidelines in our own country, a greater deal of evidence needs to be accumulated. Strategies for antimicrobial prophylaxis should be determined based on the types of possible postoperative infections and the classifications of operations according to contamination levels in individual operative fields. This process may involve the precise selection of prophylactic agents for suspected contaminating bacterial species in each operative organ and their administration regimens suitable for the individual surgery. Upon selection of prophylactic agents for postoperative infections, various conditions should be considered: e.g., susceptibility, resistance, blood concentrations, urinary excretion, transition into body fluid and tissues, and adverse reactions. The first and second generations of cephem and cephamycin derivatives can be the first choice, but the use of various other antibacterial agents may be necessary for resistant bacterial strains such as methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). Cyclic therapy based on penicillins (including mixtures), cephems (including cephamycins) and phosphomycins also seems useful for such resistant strains. At present, there is only limited evidence supporting the importance of prophylactic agents. Controlled trials employing well-designed protocols that endure scientific criticism must be done with due consideration for medical economics.     

Sentinel node role in breast cancer surgery

Radical surgery of breast cancer includes lymphadenectomy of axilla as well as the dissection of the neoplastic tissue. However recently many works have raised doubts on the opportunity of performing routinary axillary dissection, which elevates morbidity risk, in absence of axillary metastases. However, unfortunately, information on axillary lymph node pathology, is not available with any other technique excluding complete dissection and istopathological examination. Sentinel node technique is a new methodology that consents evaluation of lymph node status in the operating theatre. It allows the surgeon to judge on the opportunity of carrying out the lymphadenectomy or not.     

本院乳腺和甲状腺清洁手术预防性应用抗菌药物的调查分析

目的探讨外科乳腺、甲状腺清洁手术中预防性应用抗菌药物的合理性。方法对本院2008-2010年的330例乳腺手术患者和179例甲状腺手术患者的用药情况进行调查、分析。结果乳腺清洁手术抗菌药物使用率为24.2%,其中预防用抗菌药物病例中有用药指征的占100%;预防用药术前0.5～2.0 h用药的占18.8%,术后24 h内停药的占18.8%。甲状腺清洁手术抗菌药物使用率为3.3%,其中预防用抗菌药物病例中有用药指征的占50%。药物选择以喹诺酮类药物使用率最高。结论本院乳腺手术、甲状腺手术围术期抗菌药物使用率控制较好,但用药品种选择、给药时机及术后停药时间等有待进一步规范管理。