用计算机进行体内药物不良相互作用分析

联合用药是临床普遍现象,作为护理部门,对药物在体外的相互作用十分重视,药物配伍禁忌表可见于每个治疗室,但对药物在体内的相互作用,特别是不良相互作用不甚了解。由于新药的不断出现,体内药物不良相互作用导致严重后果的报道也不断增加,提示我们,为进一步提高护理质量,体内不良相互作用值得重视。但是,要求护士全面掌握体内药物不良相互作用是不现实的,我们尝试运用ＣＯＤＲＵＧ软件在计算机上进行联合用药分析,快捷准确,发现查询的结果对护理人员有意识地观察病情和不良反应十分有益。现将结果报道如下。１材料与方法１．１材料对某院两…     

抗感染药物合理应用计算机查询分析系统

目的：为医师提供对抗感染药物的合理应用以计算机查询分析。方法：参阅近20年来国内医药期刊及有关书籍，建立“抗感染药物合理应用计算饥查询分析系统”，收集国内市场准入的所有抗感染药物及与抗感染药物有相互作用的药物，采用关系数据库系统FOXPRO编程，模块化设计。主要功能有编程管理、资料录入、资料修改、信息查询和系统维护等。结果：该系统具有功能多、易掌握、准确快捷、操作灵活的特点，有良好的开放性和安全性。结论：该系统便于临床药师不断增加新内容及用药查询，有较高的实用价值。     

护士药学知识掌握情况调查与分析

目的提高护士综合素质,提升护理服务水平。方法采用问卷调查法,对医院232名护士的药学知识掌握情况进行调查。结果护士的药学知识问卷总分为（60．42±9．020）分,药物名称项目得分最高为（7．47±1．289）分,药理作用项目得分最低为（3．69±2．040）分;学历越高的护士药学知识问卷得分越高（P〈0．001）;职称越高的护士药学知识问卷得分越高（P〈0．001）。结论大部分护士对药学知识掌握不全面,需要进行药学知识的培训。     

某院药物临床试验妊娠事件管理计划的设计质量调查

摘要：目的:以试验方案和知情同意书（ICF）为切入点,分析某三甲医院药物临床试验妊娠事件管理计划的设计现状,促进妊娠事件管理的规范化设计。方法:调查某院2011～2019年承接的Ⅱ～Ⅳ期药物临床试验项目文件,遴选提示妊娠毒性项目;以试验方案和ICF中妊娠事件管理要素为切入点,建立妊娠事件管理计划的设计质量评分标准（百分制）,对照分析各项目总得分及各要素得分率,评估各要素缺失程度。并比较国际和国内多中心项目的得分以及年度项目得分情况。结果:提示妊娠毒性项目27项,中位得分58.5（52.0, 67.5）。27个项目的试验方案中位得分率66.30%[赋值46分,中位得分30.5 （24, 32）],严重缺陷1项“提示妊娠毒性风险”中位得分率0%,相对缺陷1项“妊娠检测方式”中位得分率50%,相对完整4项。ICF中位得分率为51.85%[赋值54分,中位得分28 （24, 34）],严重缺陷2项,“妊娠风险告知”和“伴侣告知”中位得分率为0%;相对缺陷3项,“妊娠不许试验”57.14%,“避孕措施”50%,“意外妊娠处理”50%;完整1项。严重缺陷和相对缺陷项均提示目前设计的薄弱环节。国际多中心项目妊娠事件设计质量优于国内多中心[中位得分62.5 （58.5, 68.5）vs. 53 （43.5, 61）,P<0.05],其中ICF设计质量存在显著差异,国际项目得分优势主要在“避孕时间”和“避孕措施”。结论:试验方案和ICF中完善而周全的妊娠事件管理计划是项目安全性评价质量的重要保证。通过对妊娠事件管理计划的各步骤细节进行探讨,提出妊娠事件管理计划的规范化设计。     

随机对照试验Meta分析的质量评价

目的了解国内随机对照试验Meta分析的质量,找出问题所在,提高研究质量.资料与方法以检索到的6个国内随机对照试验的Meta分析报告为研究样本,以Sacks等提出的Meta分析质量评价方法为基础,对评分细则稍加调整,作为评价标准.评价标准包含6个方面的23个项目.根据每个项目是否被涉及和规范程度,酌情计予4、2或0分.每个研究的23个项目的总分除以满分(92分),得到一个质量百分数.结果6项研究的平均得分为(40 94±20.92),最高得分为71.74,最低为17.39,这些研究的得分差距非常大.对在此次质量评价中考虑的6个方面的所有23个项目,只有一项Meta分析强调了6个方面的至少1个项目;2项Meta分析强调了5个方面的至少1个项目;一项Meta分析强调了4个方面的至少1个项目;1项Meta分析强调了3个方面的至少1个项目;Meta分析只强调了2个方面的至少1个项目.对所有23个项目,只有4～17个项目被强调.结论急需对Meta分析方法的应用加以规范,既推广,又防止"滥用".     

我院药物临床试验实施质量回顾性分析

目的:评价我院药物临床试验的实施质量,探讨临床试验实施中的不足,并提出有针对性的改进措施。方法:根据2007-2013年我院药物临床试验项目的质控记录,对照项目实施质量评分标准,分析临床试验质量得分以及各要素的得分情况。并分别对实行和未实行临床研究协调员(CRC)制的A科室和B科室,以及国际多中心和同期国内多中心项目的实施质量进行比较。结果:我院药物临床试验质量得分逐年提高,2013年达90.4分,比2007年增加了1倍;但2013年有3个要素的得分率低于90%,分别为试验实施、试验药物管理和试验记录。A科室项目完成质量得分均高于B科室;2011-2013年A科室的优势要素(得分率差异>15%)显著优于B科室,主要为试验实施(98.8%vs.75.0%)、试验药物管理(100%vs.83.0%)、试验记录(89.9%vs.63.0%)和试验资料管理(100%vs.81.2%),均P<0.01。国际多中心项目实施质量得分高于国内(94.7分vs.83.0分),P<0.01。结论:我院临床试验的薄弱环节主要为试验实施、试验药物管理和试验记录。而CRC制的推广以及国际多中心临床试验的承接是解决以上薄弱环节、提高临床试验质量的有效措施。     

10家儿科医疗机构用药安全自我评估结果分析

目的初步了解国内10家儿科医疗机构用药安全管理现状。方法采用"ISMP医院用药安全自我评估量表优化版(161项)"(简称"量表"), 福棠儿童医学发展研究中心药学专业委员会的10家儿科医疗机构对本单位用药安全管理情况进行自我评估。"量表"包括10个关键要素、20个核心指标和161项测评项目。汇总参评机构用药安全自我评估结果, 对各关键要素、核心指标和测评项目的百分得分、实施比例等情况进行描述性分析。结果 10家参评医疗机构均在规定时间内完成"量表"的填写。汇总结果显示, 用药安全自我评估总体百分得分为74.72%;百分得分最高和最低的关键要素分别为要素Ⅲ(用药医嘱和其他药品信息的沟通, 83.89%)和要素Ⅹ(质量流程和风险管理, 67.84%), 完全实施比例最高和最低者分别为要素Ⅲ(66.67%)和要素Ⅸ(患者教育, 40.00%), 部分实施比例最高和最低者分别为要素Ⅸ(46.25%)和要素Ⅲ(26.67%), 未实施比例最高和最低者分别为要素Ⅹ(18.38%)和要素Ⅵ(药物治疗设备的采购、使用和监控维护, 6.25%)。20项核心指标中, 百分得分最高和最低者分别为指标10(保...     

对一款合理用药软件审核处方相互作用的效果评估

目的:评估北京协和医院使用的合理用药软件在处方审核中关于药物相互作用方面的符合率,为其他医疗机构选择合理用药软件提供参考。方法:随机抽取该院2016年10月3 d的门急诊处方共20 536份,利用合理用药软件药物相互作用审查功能对其进行回顾性分析,并用CCIS数据库网络版"相互作用"查询功能对合理用药软件评价的西药与西药间相互作用的结果进行复核。结果:共有1 578张处方出现3 845次药物相互作用,其中西药与西药间相互作用出现3 372次,西药与中药间相互作用出现473次。CCIS数据库复核显示西药与西药间有相互作用的1272次,与合理用药软件符合率仅37.72%。结论:此款软件是多部门共同论证后选择的比较结合临床工作实际的合理用药软件,但药物相互作用比对结果的符合率提示合理用药软件与实际情况还是存在差距。为了避免误报影响诊疗,最终使临床医生关闭软件运行而失去拦截作用,需要对软件中的专业条目进一步结合临床实际进行优化。     

利用PASS系统对我院住院医嘱调查分析

目的:了解住院患者的合理用药情况。方法:应用PASS软件进行相互作用分析,“医院患者信息查询系统”查询病历。结果:调查涉及814例患者29 156条住院医嘱,涉及药物526种,出现频率依次为水、电解质平衡调节类、抗感染药、维生素和矿物质、抗肿瘤药、消化系统用药等;当用药品种为1种~4种、5种~10种、>10种时,存在药物不良相互作用的比例分别为6.49%、25%、49.76%。结论:为防止发生药物相互作用,临床应注意合理用药,尽量减少用药品种,避免不合理用药。     

儿泻停颗粒治疗小儿急性腹泻（湿热泻）的临床综合评价

目的 对儿泻停颗粒治疗小儿急性腹泻（湿热泻）进行临床综合评价,判断其临床价值,为临床合理用药提供参考。方法 通过课题组专家讨论,围绕安全性、有效性、经济性、适宜性、可及性、创新性6个维度,选择《儿童中成药临床综合评价指标框架》中的评价指标,基于文献资料（公开/未公开）、证据性信息、临床调查问卷等,通过现存统计资料分析法、内容分析法、系统性文献综述法等收集证据,应用《儿童中成药临床综合评价工具》进行综合价值判断,对儿泻停颗粒开展评价。结果 （1）安全性维度：儿泻停颗粒的不良反应发生率较低,未发现严重不良反应,安全性良好且风险可控,证据充分,得分 24.47分。（2）有效性维度：Meta分析和前瞻性队列研究结果均提示,本品治疗小儿急性腹泻,具有显著疗效,在同类品种中成药疗效排序为第2位,得分31.94分;（3）经济性维度：本品日药品费用为3.1～24.6元,每增加1个单位有效率,仅需多花费0.40～3.14元,具有经济学优势,得分3.63分。（4）适宜性维度：本品药物信息和药品使用方面都具有较好的适宜性,得分 7.87 分。（5）可及性维度：本品在可负担性与可获得性方面均具有较好的可及性,得分6.34分。（6）创新性维度：本品在技术创新方面,优化了工艺、提高和修订质量标准;并获得多项国家专利,具有良好创新性,得分2.73分。（7）综合评价结果：儿泻停颗粒的综合价值指数为76.98。结论 儿泻停颗粒综合价值指数≥75,其治疗小儿急性腹泻（湿热泻）临床综合价值较好。     

Evaluation of personal digital assistant software for drug interactions.

PURPOSE: The accuracy, comprehensiveness, and ease of use of drug interaction software used with personal digital assistants (PDAs) were studied. METHODS: Each program was assessed for accuracy using 40 clinically important and 40 clinically unimportant drug interaction pairs. Accuracy was scored through the summation of software sensitivity, specificity, and positive and negative predictive values. The comprehensiveness of each program was determined by the number of components in the drug interaction monograph. Time needed to identify the management of five important drug interactions defined each program's ease of use. The aggregate scores for accuracy, comprehensiveness, and ease of use were calculated. RESULTS: Scoring 777 and 756 out of a possible 800 points, iFacts and Lexi-lnteract, respectively, provided the most competent, complete, use-friendly compendia for assessment of drug interactions. Mosby's Drug Consult and Mobile Micromedex ranked third and fourth, scoring 688 and 655 points, respectively, while ePocrates Rx v. 6.0 rated seventh, with a score of 559. All drug interaction resources suffer from limitations in the quality or relevance of evidence for the interaction, an absence of identifiable patient and medication risk factors, and a lack of standardization in assigning significance to the interaction. Consequently, clinicians must interpret the importance of the interaction based on all available evidence. Discussion of such evidence was available for only iFacts and Lexi-Interact. CONCLUSION: Both iFacts and Lexi-Interact excelled as PDA pharmacopoeia for assessing drug interactions. However, clinicians should understand the limitations of all current drug interaction resources and exercise vigilance in prevention and recognition of interactions relevant to their patients.     

Drug interaction microcomputer software evaluation: Therapeutic Software's Adverse Interactions.

Therapeutic Software's Adverse Interactions was evaluated using general and specific criteria. The installation process, ease of learning, and technical support were rated as excellent. The ease of use and documentation for use were rated as good. The program received an excellent rating for the quality of the clinical documentation and good ratings for the scope of coverage and overall clinical performance. The frequency of updates is fair. The program is an excellent value because of its comprehensiveness, sources of the data base, and relatively low cost. It may be one of the better buys for drug interaction softwares.     

非商用（Q）SAR软件在药物遗传毒性杂质评估中的应用

目前国内外法规均要求对药物遗传毒性杂质进行控制,当缺乏致突变、致癌性数据时,制药企业大多以商业软件对杂质进行评估,评估费用高昂。FDA推荐了非商用的评估软件,并接受其评估结果,本文对非商用评估软件进行介绍,并以实例对商用与非商用软件预测结果进行对比评价,结果表明所测非商用软件预测结果具有一定参考价值,其参考使用或可节省成本。     

The incidence of potential drug–drug interactions in elderly patients with arterial hypertension

Objective To assess the incidence and type of potential, clinically significant drug–drug interactions in elderly outpatients with arterial hypertension. Setting Three community pharmacies in Croatia. Method Eligible patients were aged 65 or older, treated for arterial hypertension and received 2 or more drugs. Potential interactions were identified by Lexi-Interact software. The software categorized each potential interaction according to clinical significance in five groups: (A) No known interaction; (B) Specified agents may interact, but there is little to no evidence of clinical concern; (C) Specified agents may interact in a clinically significant manner. Monitoring therapy is suggested; (D) The two medications may interact in a clinically significant manner. Modification of therapy is suggested; (X) Contraindicated combination. Interactions of level C, D and X were considered clinically significant. Main outcome measure The incidence and type of potential drug–drug interactions. Results There were 265 patients included in the study. Potential, clinically significant drug interactions were identified in 240 (90.6%) patients, out of which 97.9% had interactions with clinical significance C, 20.4% D, and 0.8% X. The median number of drug interactions per patient was 4. We identified 215 drug combinations with the potential to cause clinically significant interaction, out of which 83.3% had clinical significance C, 16.3% clinical significance D, and 0.4% clinical significance X. Conclusion Drug–drug interactions are common in elderly hypertensive patients. Computer-based screening could help pharmacists and physicians to recognize potential, clinically significant interactions.     

左甲状腺素钠的药物相互作用及机制初探

目的：对左甲状腺素钠的药物相互作用及机制作一综述，供临床用药时参考。方法：查阅国内外献，从影响左甲状腺素浓度的药物和左甲状腺素钠对其他药物的影响两个方面探讨了左甲状腺素与其他药物之间的相互作用及可能机制。结果：通过分折，对左甲状腺素与其有相互作用的其他药物合用时，提出了具体的用药建议。结论：左甲状腺素钠的药物相互作用值得关注，以减少可避免的不良后果。     

Evaluation of three brands of drug interaction software for use in intensive care units

Objective To evaluate drug interaction software programs and determine their accuracy in identifying drug-drug interactions that may occur in intensive care units. Setting The study was developed in Brazil. Method Drug interaction software programs were identified through a bibliographic search in PUBMED and in LILACS (database related to the health sciences published in Latin American and Caribbean countries). The programs’ sensitivity, specificity, and positive and negative predictive values were determined to assess their accuracy in detecting drug–drug interactions. The accuracy of the software programs identified was determined using 100 clinically important interactions and 100 clinically unimportant ones. Stockley’s Drug Interactions 8th edition was employed as the gold standard in the identification of drug-drug interaction. Main outcome Sensitivity, specificity, positive and negative predictive values. Results The programs studied were: Drug Interaction Checker (DIC), Drug-Reax (DR), and Lexi-Interact (LI). DR displayed the highest sensitivity (0.88) and DIC showed the lowest (0.69). A close similarity was observed among the programs regarding specificity (0.88–0.92) and positive predictive values (0.88–0.89). The DIC had the lowest negative predictive value (0.75) and DR the highest (0.91). Conclusion The DR and LI programs displayed appropriate sensitivity and specificity for identifying drug–drug interactions of interest in intensive care units. Drug interaction software programs help pharmacists and health care teams in the prevention and recognition of drug–drug interactions and optimize safety and quality of care delivered in intensive care units.     

Evaluation of drug information databases for personal digital assistants.

PURPOSE: Core and supplemental drug information databases available for use with personal digital assistants (PDAs) were evaluated. METHODS: Ten core (or standalone) databases, six drug interaction analyzers, and three dietary supplement databases used with the Palm and Pocket PC operating systems were selected for study. The databases were rated for scope (the absence or presence of an answer to a drug information question), completeness (the comprehensiveness of an answer), and ease of use (the number of hypertext links needed to reach the desired answer). A total of 14 weighted categories, consisting of 146 and 30 drug questions for the core and supplemental databases, respectively, were used to determine the overall scores. RESULTS: The best overall performers were, in order of total scores, Lexi-Drugs Platinum, Tarascon Pocket Pharmacopoeia, ePocrates Rx Pro, and Clinical Pharmacology OnHand. The databases with the lowest composite scores were Triple i Prescribing Guide and A2Z Drugs. CONCLUSION: Drug information databases for PDAs varied in scope, completeness, and ease of use. The results may help clinicians find the most appropriate product for their practice setting.     

Evaluation of drug interaction microcomputer software: Dambro's Drug Interactions

Dambro's Drug Interactions was evaluated using general and specific criteria. The installation process, ease of learning and use were rated excellent. The user documentation and quality of the technical support were good. The scope of coverage, clinical documentation, frequency of updates, and overall clinical performance were fair. The primary advantages of the program are the quick searching and detection of drug interactions, and the attempt to provide useful interaction data, i.e., significance and reference. The disadvantages are the lack of current drug interaction information, outdated references, lack of evaluative drug interaction information, and the inability to save or print patient profiles. The program is not a good value for the pharmacist but has limited use as a quick screening tool.