Discussion

Many studies and meeting reports have suggested that the use of some antibiotics in food animals can compromise the treatment of some infectious diseases in humans. Although the studies and reports are timely and important, it is difficult to assess the relative value of the conclusions in relationship to the overall situation concerning antibiotic resistant foodborne bacteria because the data used in the analyses are often of disparate origin. The studies have attempted to establish a cause and effect relationship between the use ('consumption') of antibiotics in food animals and treatment failures in human disease on the basis of [1] antibiotic usage data; [2] in vitro determinations of antibiotic susceptibility of animal and human isolates, [3] results obtained from controlled animal experiments or [4] epidemiological data. Each approach has sought to associate bacterial antibiotic resistance data with it's own immediate focus area of investigation. However, a true assessment of the degree of contribution to human antibiotic resistance problems from animal use can only be facilitated by comprehensively organizing these different approaches into a concerted, coordinated effort. Concurrently, the implementation of a multinational programme aimed at monitoring antibiotic usage in food animals and resistance in specific bacteria associated with those animals should be instituted. In parallel with this endeavour is the implementation of new prudent use guidelines for antibiotic use by veterinarians. Through the use of science-based approaches like these, the development and spread of antibiotic resistant bacteria associated with food animals could be minimized and contained.     

天津市2005年《药品不良反应/事件报告表》统计分析

目的 通过对2005年天津市涉药单位上报的915份报表进行统计分析，了解药品不良反应发生和分布情况，为今后更好地开展药品不良反应监测工作提供科学准确依据。方法 利用Excel电子表格和手工筛选，对结果进行分析、评价。结果和结论 药品不良反应的上报数量还不多，报表质量有待提高；发生不良反应的药物以抗微生物药物最多见。     

Department of pharmacy-initiated program for streamlining empirical antibiotic therapy

The outcome of a department of pharmacy-initiated "streamlining" study designed to promote cost-conscious modifications of empirically selected antibiotic therapy is described. Two hundred forty-one evaluable adult patients started on restricted-use antibiotics at this university-affiliated community private teaching hospital were enrolled in a 9-week prospective streamlining study. Patients were alternately assigned to a Control (i.e., no pharmacist-initiated streamlining recommendations offered based on culture and susceptibility reports) or a Pharmacist Intervention group (i.e., pharmacist offers recommendations to streamline therapy). A statistically significant greater number of patients had their empiric antibiotic treatment courses modified to more appropriate antibiotic choices after receipt of culture and susceptibility reports among private prescribers in the Pharmacist Intervention group (83%) than in the Control group (38%) (p = .006). Additionally, pharmacists were overall successful in gaining prescriber acceptance for 64% of recommended changes of empiric antibiotic treatment courses before the receipt of culture and susceptibility reports (e.g., dose and/or frequency changes). There was no program effect observed with respect to improved physician response to microbiologic data that would allow streamlining empirical antibiotic choices in the Housestaff (i.e., medical or surgical residents), or infectious disease consultant prescriber groups. Projected overall annual cost savings that would be achieved as a result of continued efforts by pharmacists directed at streamlining empirical "restricted" antibiotic regimens is approximately +40,000.     

Computer-assisted concurrent antibiotic review in a community hospital

A computer-assisted program that monitors the appropriateness of antibiotic prescribing by matching microbiology reports and patient drug profiles is described. An antibiotic review committee in conjunction with the quality assurance department developed the computer-assisted antibiotic review program. An antibiotic order sheet was incorporated into the physicians' order form. Automatic stop dates were assigned according to the reason the antibiotic was ordered, e.g., surgical prophylaxis or documented infection. Numerous reports are generated from the data gathered from the physicians' order form. A drug/microbiology report is used to match patients' antibiotic drug profiles with their microbiology culture and sensitivity results. This report identifies all patients who have been receiving antibiotics for 72 hours or longer with sensitivities on file and mismatched sensitivity results. All mismatches that are considered important are investigated. Any actions taken are reported to the antibiotic review committee for peer review. The computer-assisted program has helped this hospital screen large populations of inpatients receiving antibiotics. The concurrent review of the drug/microbiology report has made it possible to detect within 24 hours, patients who are receiving antibiotics inappropriately. A computer can be used to perform daily concurrent antibiotic use review as a by-product of order entry by both the pharmacy and laboratory.     

Refractory hypoglycemia from ciprofloxacin and glyburide interaction

Patients taking multiple medications may suffer from unpredictable and complex drug-drug interactions resulting in significant morbidity and mortality. There are few reports in the literature of hypoglycemia with concurrent administration of an oral hyperglycemic agent and a fluoroquinolone antibiotic. We present a case of a diabetic patient taking glyburide who was prescribed ciprofloxacin and developed prolonged hypoglycemia, which persisted for over 24 hours. The mechanisms by which these agents interact to produce prolonged hypoglycemia are complex and probably multifactorial. Patients stabilized on glyburide who are started on a fluoroquinolone should have their glucose levels monitored closely.     

Comment on: withdrawal of growth-promoting antibiotics in Europe and its effects in relation to human health

In response to a review titled 'Withdrawal of growth-promoting antibiotics in Europe and its effects in relation to human health', published in this Journal by Ian Phillips, we hereby comment on the review. Phillips makes use of data from the Danish Integrated Antimicrobial Resistance Monitoring and Research Programme (DANMAP) reports and studies on Campylobacter and enterococci. Unfortunately, we find these data frequently misinterpreted by Phillips, leading to false conclusions such as inferences that the ban of antibiotic growth promoters should cause an increased prevalence of resistant enterococci and Campylobacter.     

肺炎克雷伯碳青霉烯酶的研究进展

肺炎克雷伯碳青霉烯酶型β-内酰胺酶（KPC）是近年来发现的肠杆菌科细菌对碳青霉烯酶抗生素耐药的主要机制,可水解除头霉素以外的所有β-内酰胺类抗生素。然而由于实验室检测KPC的及时性与准确性仍不能达到临床要求,这必将给一线的抗感染治疗和管理院内感染带来困难,因此,临床医师和实验室更应该重视,相互加强联系与沟通。     

A multidisciplinary approach to enhance documentation of antibiotic serum sampling

A procedure to improve interdepartmental communication and documentation of antibiotic serum sampling data for pharmacokinetic evaluation will be presented. A prospective audit by the Pharmacokinetic Service revealed that approximately 40% of all antibiotic serum levels were improperly drawn resulting in unsuitable specimens and erroneous serum concentrations or lacked sufficient data for pharmacokinetic analysis. A lack of communication and documentation between phlebotomy and nursing personnel was found to be the most significant source of potential error in serum sampling. Once the protocol for serum sampling was revised, less than 5% of antibiotic serum levels were found to be unsuitable for evaluation and interpretation. A continuous audit for procedural compliance identifies any source of potential sampling error and provides a means to improve the overall quality of a Pharmacokinetic Service.     

How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers

It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated in this article, the reporting of ADRs via e-mail would cause real problems for the drug safety units. Finally, they consider that telephone call centres should be restricted to a specific communication problem such as crisis management or Dear Dr letters.     

71例药物不良反应报告分析

目的对肝病医院的药物不良反应（ADR）进行分析，促进临床安全合理地使用药物。方法收集本院肝病医院中2008年ADR报告71例，按照患者性别、年龄分布、药品种类及品种、给药途径、ADR临床表现等进行统计分析。结果71例ADR报告中，抗感染药物所致ADR居首位；所致ADR的药物大多为静脉注射；涉及系统以皮肤及其附件最为常见，经过相应的治疗均好转或治愈。结论重视ADR的监测工作和提高ADR的报告水平，以减少ADR发生。     

Pamamycin: a new antibiotic and stimulator of aerial mycelia formation

Pamamycin is a new antibiotic isolated from Streptomyces alboniger ATCC 12461. The antibiotic is active in vitro against Gram-positive bacteria, Neurospora, and Mycobacteria. The compound also acts as a streptomycete differentiation effector. It stimulates aerial mycelia formation in the producing organism. The new antibiotic of elemental composition C36H63NO7 is completely different from puromycin, also produced by this strain. The present communication deals with the isolation, properties, and preliminary characterization of pamamycin.     

Linezolid for the treatment of adults with bone and joint infections

We reviewed the available evidence regarding the effectiveness and safety of linezolid administration for the treatment of patients with orthopaedic infections due to multidrug-resistant Gram-positive cocci. Although the reports published to date include promising results for the use of linezolid for bone and joint infections, controlled studies will be needed to reach safe conclusions. Attention should be paid to adverse effects that may be related to linezolid administration, especially bone marrow suppression with prolonged administration of the antibiotic. In addition, early identification of linezolid-induced peripheral neuropathy is necessary because this may be an irreversible event.     

我院2011—2012年注射剂不良反应分析

目的总结我院近年的注射药品不良反应（Adverse Drug Reaction，ADR）的规律和特点，减少注射剂不良反应对患者的危害，确保临床用药安全、有效。方法对我院2011至2012年度因临床使用注射剂出现ADR的275例患者，对性别、年龄、给药途径、药物种类、可疑药品及临床表现等方面进行回顾性统计分析。结果275例报告中，青壮年、中老年分别为54．18％和36．00％；主要为静滴方式占91．27％；主要为抗生素占47．64％，其次为中药制剂占21．45％，而抗生素中头孢菌类占52．67％，喹诺酮类占19．85％。结论我院注射剂ADR的发生与患者性别差异无统计学意义，年龄分布较广；给药途径以静滴为首要；药品以抗菌药物及中药制剂为主。临床应合理使用抗菌药物和中药注射剂，减少ADR的发生。     

Communication in pharmacovigilance

Pharmacovigilance is a field where communication is paramount. Information, such as single case reports, is transferred from health professionals to National Regulatory Administrations and between administrations and industry. The cumulation of reports may be used for information purposes, and to assist in the identification of possible signals. These are then assessed by the analysis of individual and aggregate cases, the latter being exchanged between administrations for multinational analysis at the European level. Once a decision has been made on a possible alert, the decisions and the reasons thereof must be transmitted to administrations and to other correspondents, such as health professionals, the pharmaceutical industry and WHO. Within the CARE project of the DGXIII European Nervous System telematics research programme, the Pharmacovigilance Pilot, consisting of representatives of the French, Spanish, and UK pharmacovigilance systems, set out to identify and describe the messages corresponding to these communication needs, and the methods best suited to effective telematic transmission. The messages identified concern: the transmission of individual case reports, the transmission of cumulative and aggregate case reports, and of regulatory decisions. Each of these information messages have been structured for future inclusion into a network for electronic data interchange between administrations in pharmacovigilance. In time they should provide a common electronic vocabulary enabling all parties involved in pharmacovigilance to communicate telematically. Transmission options have been considered also. In view of the large number of existing and potential partners involved in the communication processes in pharmacovigilance, EDI (electronic data interchange) seems the most appropriate method to exchange these messages. Two of these, concerning the single case and the aggregate cases (rapid alerts) have been submitted to the Western European EDIFACT Board MD9 for integration into EDIFACT (as MEDADR and MEDPHV).     

Probable vancomycin-associated toxic epidermal necrolysis

A 52-year-old man with no previous drug allergies or skin disorders developed a widespread papulovesicular rash while receiving an antimicrobial regimen of piperacillin-tazobactam, tobramycin, and vancomycin. Skin biopsy suggested leukocytoclastic vasculitis, which responded well to antibiotic discontinuation and steroid therapy. Fifteen days later, during steroid tapering, an additional course of vancomycin was begun for suspected line infection. The subsequent maculopapular rash that developed was diagnosed as toxic epidermal necrolysis (TEN) based on a second skin biopsy and clinical presentation. This case is consistent with previous reports of vancomycin-associated TEN. Any patient who develops TEN while receiving vancomycin therapy should be evaluated for possible vancomycin-induced TEN.     

Comité de l'Antibiogramme de la Société Française de Microbiologie report 2003

Following the recommendations of the WHO Expert Committee for Biological Standardization (Technical reports No. 610, 1977), the French Society for Microbiology created an Antibiogram Committee (CA-SFM), with the aim of proposing the standards which define the clinical categories of antibiotic susceptibility (formerly therapeutic categories). The MIC and zone diameter interpretive standards, as well as the specific recommendations for certain species or certain antibiotic groups, are published in a yearly report.     

新抗菌素10676化学结构研究

本文对抗菌素10676进行了化学结构研究,结果表明:它是一个由2,6-二氨基-2,6-二脱氧-D-葡萄糖(2,6-diamino-2,6-dideoxy-D-glucose Ⅰ),2-脱氧链霉胺(2-deoxy-streptamine Ⅱ)连结构成新霉胺(neamine Ⅰ-O-Ⅱ)、再与D-木糖(D-xylose Ⅲ)和新霉糖胺B(neosamine B Ⅳ)通过甙键连结的四单元化合物,是一个新的氨基糖甙类抗菌素,初步认为连接方式如Ⅴ所示。     

我院2012～2013年抗菌药物不良反应报告回顾性分析

目的：分析抗菌药物不良反应（ADR）发生的特点及临床表现,为临床合理用药提供参考。方法：对我院2012-2013年上报的124例抗菌药物ADR报告进行回顾性分析。结果：男性ADR发生率51.61%略高于女性48.39%;静脉滴注118例（95.16%）是引起ADR的主要给药途径;ADR报告中,以头孢菌素类为最多73例（58.87%）,其次是氟喹诺酮类为22例（17.74%）;ADR临床表现主要为皮肤及其附件损伤为48例（38.71%）,消化系统为36例（29.03%）。结论：医院应加强ADR监测工作,提高医护人员对ADR报告制度的认知,促进抗菌药物的合理应用。     

我院173例药品不良反应报告分析

目的:了解我院药品不良反应(ADR)发生的特点及规律。方法:对我院2009-2011年上报的173例ADR报告进行回顾性分析。结果:173例ADR报告中,新的严重的ADR占30.64%;门/急诊上报的ADR占29.48%;注射剂是引发ADR的主要剂型,占总例数的78.61%;抗菌药物引发的ADR占30.64%;在临床表现方面,以皮肤及其附件损害最常见,占42.77%。结论:临床应加强抗菌药物使用管理,ADR发生率高的药品应重点监测,以保证药物使用的安全、有效,促进临床合理用药。