2017年遂宁市中心医院围手术期预防性应用注射用矛头蝮蛇血凝酶的合理性分析

目的 调查2017年遂宁市中心医院围手术期预防性应用注射用矛头蝮蛇血凝酶的情况,分析其应用合理性,促进合理用药。方法 抽取遂宁市中心医院2017年1～12月围手术期使用注射用矛头蝮蛇血凝酶预防出血的手术病例3 203例,分析注射用矛头蝮蛇血凝酶的合理应用情况。结果 围手术期预防使用注射用矛头蝮蛇血凝酶的合理率为38.46%。3 203例病历中,存在选药不合理24例,用药时机不合理1 447例,术后用药疗程长227例,用法用量不合理464例,不合理联合用药151例,其他不合理用药19例。结论 遂宁市中心医院围手术期预防性应用注射用矛头蝮蛇血凝酶主要存在用药时机不合理、用法不合理、术后预防用药疗程长等不合理用药现象,应加强规范用药。     

某三甲医院2014～2016年辅助用药使用分析

摘 要 目的：分析某三甲医院辅助用药使用情况,为该类药品合理使用提供参考。方法: 分类统计该院2014～2016年辅助用药的销售金额、使用数量、销售金额排名前10位的辅助用药单品种用药频度（DDDs）、限定日费用(DDC)等数据。结果: 该院2014～2016年辅助用药销售金额逐年上升,构成比均在30%以上。从类别看辅助用药销售金额排名前3位的是中药注射剂、神经营养类、肠内肠外营养类。DDDs 位居前列的品种是单唾液酸神经四己酸神经节苷脂注射液、前列地尔注射液、注射用复合辅酶。结论: 该院辅助用药品种多,消耗金额大,用药频次多,医院应加强管理,促进辅助用药的合理使用。     

2014~2016年武汉地区31家医院质子泵抑制药的使用情况分析

摘 要 目的：分析2014~2016年武汉地区31家医院质子泵抑制药（PPIs）的使用情况,为临床上该类药物的合理应用提供参考依据。方法: 对2014~2016年武汉地区31家医院PPIs的使用品种、用药剂型、销售金额、用药频度（DDDs）、限定日费用（DDC）、药品销售金额排序（B）/DDDs排序（A）以及进口用药构成比等进行统计,分析PPIs的应用现状。结果:2014~2016年武汉地区31家医院PPIs的销售金额与DDDs呈逐年递增趋势。用药剂型以口服为主,但注射用药构成比仍然较高。3年中销售金额与DDDs增速最快的分别是口服泮托拉唑与注射用兰索拉唑;注射用奥美拉唑的销售金额与DDDs却呈现大幅下降的趋势。口服泮托拉唑的DDDs排序连续3年居第1位,且其B/A值远大于1。大多数PPIs的同步性较好且DDC逐年减少。除埃索美拉唑外,PPIs的用药均以国产为主。结论:2014~2016年武汉地区31家医院PPIs的使用基本趋于合理,但仍存在不合理用药的可能性,需进一步加强监控,促进临床合理用药。     

2015—2017年辽宁省肿瘤医院保肝药物的使用情况分析

目的 分析辽宁省肿瘤医院保肝药物的使用情况及用药趋势,为临床合理用药提供参考。方法 收集辽宁省肿瘤医院2015-2017年保肝药物的应用数据,对销售金额、用药频度（DDDs）、日均药费（DDC）及药品排序比（B/A）等进行统计和分析。结果 2015-2017年保肝药物的销售金额及DDDs呈逐年增长趋势,其中注射用复方二氯醋酸二异丙胺和脱氧核苷酸钠注射液连续3年居前2位。注射用复合辅酶、异甘草酸镁注射液和注射用门冬氨酸鸟氨酸的DDC居前3位。B/A接近于1的药品包括注射用复方二氯醋酸二异丙胺、脱氧核苷酸钠注射液、注射用硫普罗宁和丁二磺酸腺苷蛋氨酸片。结论 辽宁省肿瘤医院保肝药物的使用基本合理,但仍需加强监督管理,规范使用行为。     

2015—2017年六安市人民医院住院患者注射用辅助用药的使用情况分析

目的 了解六安市人民医院住院患者注射用辅助用药的使用情况并进行分析与评估,为患者临床合理用药提供参考。方法 选取六安市人民医院2015年1月—2017年12月住院患者注射用辅助用药的相关数据,并对销售金额、用药频度（DDDs）、日均费用（DDC）和排序比（B/A）等情况进行统计分析。结果 2015—2017年注射用辅助用药的销售金额和构成比均逐年下降。神经系统用药的销售金额稳居第1位,中成药（理血剂）的DDDs在2016、2017年均最高。丹红注射液、参芪扶正注射液、鸦胆子油乳注射液的销售金额呈大幅下降趋势,前列地尔注射液、生脉注射液、脑苷肌肽注射液的销售金额呈逐年上升趋势。吡拉西坦氯化钠注射液、注射用血栓通（冻干）和木糖醇注射液的DDDs始终排前5位。丹红注射液和参芪扶正注射液的B/A<1.0外,其余B/A值均>1.0,整体DDC适中。结论 六安市人民医院注射用辅助用药的使用大幅下降,管控成效显著,但仍需对性价比较差的辅助用药进行重点跟踪,进一步促进其合理使用。     

艾司奥美拉唑在肝胆外科围术期的合理应用分析

目的 了解东方肝胆外科医院（简称"我院"）注射用艾司奥美拉唑钠在肝胆外科围术期应用的合理性,为肝胆手术围术期合理用药提供参考。方法 用回顾性研究方法,通过查阅电子病历、医嘱和检验结果等途径,随机采集了2017年1月至9月300例使用注射用艾司奥美拉唑钠患者的相关信息。300例病例艾司奥美拉唑的使用频次为416次,从给药时间、用药疗程、用法用量、溶剂和应激性溃疡危险因素等方面进行分析。结果 给药时间的合理率是15.67%（47/300）,用药疗程的合理率是10.67%（32/300）,用法的合理率是75%（312/416）,用量的合理率是100%（416/416）,溶媒的合理率为100%（416/416）,具有应激性溃疡危险因素的患者占3.33%（10/300）。结论 我院肝胆外科围术期应用艾司奥美拉唑合理性有待提高,临床药师应加强临床用药教育以提高合理用药水平。     

2009~2015年浙江省11家医院肺癌患者表皮生长因子受体酪氨酸激酶抑制药使用调查

摘 要 目的：了解2009~2015年浙江省11家医院肺癌患者表皮生长因子受体酪氨酸激酶抑制药（EGFR-TKI）的利用现状,分析其用药合理性。 方法: 抽取2009~2015年浙江省11家医院每年40天的医嘱数据,对肺癌患者使用EGFR-TKI的用药金额、用药频度（DDDs）、限定日费用（DDC）以及药物利用指数（DUI）进行统计分析。 结果: 埃克替尼、厄洛替尼和吉非替尼是目前最主要的3种EGFR-TKI,其中埃克替尼2013年之后才开始使用。EGFR TKI的用药总金额总体呈上升趋势,2015年的销售总金额是2009年的4.67倍;厄洛替尼的DDDs总体呈降低趋势,吉非替尼和埃克替尼的DDDs逐年升高;DDC排序最高的是厄洛替尼,吉非替尼次之,埃克替尼最低;3种靶向药物的DUI值均在1左右。 结论:浙江省11家医院EGFR TKI的用量逐年升高,但使用相对合理。     

浙江省11家医院2009~2014年肺癌合并糖尿病患者口服降糖药使用调查

摘 要 目的：分析浙江地区11家医院肺癌合并糖尿病患者口服降糖药的使用情况,为肺癌合并糖尿病患者此类药物的临床合理应用提供依据。方法：选取浙江地区11家医院肺癌合并糖尿病患者口服降糖药2009~2014年每年40d的医嘱数据,分析口服降糖药的用药金额、用药频度（DDDs）、限定日费用（DDC）和药物利用指数（DUI）等指标。结果：用药金额占前三位药物的分别是阿卡波糖、格列齐特和瑞格列奈;DDDs排前四位是阿卡波糖、二甲双胍、瑞格列奈和格列美脲;DDC排前四位是罗格列酮、西格列汀、格列齐特和阿卡波糖;12种口服降糖药的DUI值介于0.27~2.94。结论：浙江地区11家医院肺癌合并糖尿病患者口服降糖药的使用存在不合理现象,临床用药时应进一步掌握合理用药指征。     

2016-2017年郑州市妇幼保健院剖宫产术围手术期预防用抗菌药物合理性分析

目的 分析2016年1月-2017年12月郑州市妇幼保健院剖宫产术围手术期抗菌药物预防用药的使用情况,为进一步规范抗菌药物合理应用提供参考。方法 对2016年1月-2017年12月郑州市妇幼保健院剖宫产术围手术期预防用抗菌药物的使用情况进行回顾性调查,评价其合理性。结果 2 379例患者预防用抗菌药物共涉及10个品种,头孢呋辛、甲硝唑和头孢唑啉的使用频次居前3位。99.5%的手术术前0.5~1.0 h给药。用药维持时间以24、48 h为主,构成比分别为48.6%、50.4%。联合用药主要表现为头孢呋辛+甲硝唑,构成比为96.1%。不合理用药表现形式主要有用药维持时间长（44.1%）、品种选择不当（24.2%）、用药指征把握不严（18.3%）等。结论 郑州市妇幼保健院剖宫产术围手术期预防用抗菌药物使用基本合理,但仍存在不合理用药现象,应加强监督管理。     

2010~2015 年某三甲医院质子泵抑制药使用分析

摘 要 目的：了解并分析某三甲医院质子泵抑制药（PPIs）的使用情况,以促进该院PPIs的合理应用。方法: 从该院计算机信息管理系统中调取2010~2015年门诊及住院患者所有PPIs的销售记录,并对其销售金额、用药频度（DDDs）、限定日费用（DDC）、年消耗量等指标进行分析。结果: 2010~2015年该院PPIs销售金额和DDDs呈上升趋势,销售金额的年均复合增长率为13.84%。6年PPIs注射剂的销售金额及DDDs各占82.2%和29.6%;PPIs口服剂的销售金额及DDDs各占17.8%和70.3%;销售总金额位于前三位的是注射用泮托拉唑钠、注射用兰索美拉唑钠和注射用埃索美拉唑钠。结论:该院PPPs中注射用泮托拉唑钠、注射用兰索拉唑用量相对较大,不排除存在注射剂过度使用的情况。     

Risk assessment of botanicals and botanical preparations intended for use in food and food supplements: emerging issues

At present there is a growing interest for use of botanicals and botanical ingredients in medicines, for teas or in foods and in food supplements. In addition, a number of plant-derived food items form an integral part of regular human diets. Currently, there is an increasing awareness among safety experts and regulators of risks associated with the use of botanicals and botanical ingredients in food including food supplements. It is becoming clear that "natural" does not equal "safe" and that, in modern society, adverse health effects can occur as a result of (mis)use. With the growing awareness of these issues efforts to ensure safety of botanicals and botanical ingredients are also increasing. Several guidance documents on safety assessment of botanicals and botanical preparations to be used as ingredients in food and food supplements have been published, although, at present, relevant legislative frameworks and guidances for risk assessment are not established yet. Furthermore, when defining possible guidance documents for risk assessment of botanicals, several issues emerge that need to be developed beyond the present state-of-the-art. The present paper describes some of the issues to be considered and developed to a further extent to improve risk assessment of botanicals and botanical preparations, illustrated by examples based on some allylalkoxybenzenes. It is concluded that, for an improved and more accurate future risk assessment of botanicals, it is necessary to further develop and validate: (i) the use of the margin of exposure (MOE) concept for compounds that are both genotoxic and carcinogenic; (ii) new ways to quantify and incorporate matrix effects into risk assessment strategies; (iii) the use of analytical chemistry approaches, enabling complete chemical characterisation of complex mixtures. Defining new approaches in risk assessment would be in line with the inspiring attitude of the late Professor Robert Kroes, who, for example by supporting the threshold of toxicological concern (TTC) concept, was a pioneer for development and implementation of new paradigms in the field of risk assessment and food safety.     

Exploring Botanicals in Indian System of Medicine—Regulatory Perspectives

Abstract

India has a rich heritage of traditional medicine constituting with its different components like Ayurveda, Siddha and Unani and traditional health care has been flourishing in this country for many centuries. Botanicals constitute of major part of these traditional medicines. With the emerging world wide interest, in adopting traditional practices, in the health care systems by exploiting their potential, the evaluation of the botanicals in these systems of medicine in India is utmost essential. Various regulations and control on use of botanicals has come up with their use in traditional medicine which will not only help to cure different ailments through indigenous resources but also will help in screening and evaluation of the natural resource in a better way to use them in traditional health care program.     

Approaches in fostering quality parameters for medicinal botanicals in the Indian context

India is among the important megabiodiversity centers of the world with nearly 45,000 known plant species. This diversity coupled with a rich heritage of traditional knowledge has made India a home to several important time-honored systems of health care such as Ayurveda, Siddha and Unani. Herbal medicines, however, are associated with a number of shortcomings including uniform efficacy and lack of appropriate quality control measures at various stages of product development. The review intends to outline the importance of fostering quality parameters towards standardization and manufacturing of botanicals for India to emerge as a leader in global market of herbal products. Literature survey was carried out on important parameters for processing and manufacturing of botanicals. The review highlights that there have been constant efforts for developing state of the art technologies in the field of herbal research. It also reflects that Government authorities have also taken a number of initiatives to formulate appropriate guidelines from standardization of raw materials to obtaining botanical products. However, in the Indian context, there exist certain lacunae in the current regulatory mechanisms which need to be strengthened and stringently implemented to ensure safety, purity and efficacy of herbal medicines. Towards this the approaches being developed globally can be adopted. Based on the literature reviewed, in our opinion, four areas viz., benefit sharing, investment by industry, standardization and national/international networking structure need immediate attention for strengthening Traditional Systems of Medicine in India.KEY WORDS: India, quality control, regulations, standardization, traditional medicine     

Herb-drug interactions: Focus on metabolic enzymes and transporters

As the uses of herbal medicines from traditional natural products are increased, the need for pharmacokinetic studies and relevant data are also increased for safe pharmacotherapy. The market entry for the traditional herbal medicine is easier compared with that for synthetic drugs because of a lower regulatory barrier. Thus, the exact mechanisms for the absorption, distribution, metabolism and excretion of active components in herbal medicines and the potential herb-drug interactions are not always fully understood. Recently, there has been an increasing interest in pharmacokinetic studies of herbal remedies and relevant data of commonly used herbal remedies are accumulating in this field. In this review, the effects of nine botanicals (ginkgo, green tea, grapes, licorice, saw palmetto, garlic milk thistle, ginseng and St. John’s wort) on metabolic enzymes and transporters affecting absorption and disposition of herbal products are summarized. The source of samples (extracts and individual components), the species (human and animal) and in vivo and in vitro systems were separately reviewed for a better understanding of herb-drug interactions.     

Rapid analysis of 56 pesticide residues in natural medicines by GC/MS with negative chemical ionization

Many methods for determining pesticide residues in food have been reported. Although natural medicines should be confirmed to be as safe as food, few methods for determining pesticide residues in natural medicines have been reported. In this study, 56 pesticides were detected in natural medicines with a simple, rapid sample preparation method. This study indicates that the proposed method is useful for analyzing pesticides in natural medicines.     

Making the most of Papua New Guinea’s biodiversity: Establishment of an integrated set of programs that link botanical survey with pharmacological assessment in “the land of the unexpected”

An integrated and coordinated set of programs has been established to meet International Cooperative Biodiversity Group (ICBG) goals in Papua New Guinea (PNG). Here we give an overview of the PNG ICBG and focus on the key elements and major steps taken to establish a program necessary for the pharmacological assessment of botanicals and traditional medicines in PNG and, by extrapolation, in other developing countries.     

Simultaneous analysis of 10 pyrethroid pesticides in natural medicines by GC/MS with negative chemical ionization

Many methods for the determination of pesticides residues in food have been reported. Although natural medicines should be confirmed as safe as food, only a few methods for the determination of pesticide residues in natural medicines have been reported. In this study, 10 pyrethroid pesticides were detected in natural medicines by GC/MS with negative chemical ionization (NCI). GC/MS with NCI can detect halogenated pesticides selectively, and thus is suitable for the detection of pyrethroid pesticides. This study indicates that GC/MS with NCI is useful for analyzing pyrethroid pesticides in natural medicines.     

Simultaneous analysis of 17 organochlorine pesticides in natural medicines by GC/MS with negative chemical ionization

Many methods for the determination of pesticide residues in food have been reported. Although natural medicines should be confirmed to be as safe as food, few methods for the determination of pesticide residues in natural medicines have been reported. In this study, 17 organochlorine pesticides were detected in natural medicines using GC/MS with negative chemical ionization (NCI). GC/MS with NCI can detect halogenated pesticides selectively and thus is suitable for the detection of organochlorine pesticides. This study indicates that GC/MS with NCI is useful for analyzing organochlorine pesticides in natural medicines.     

Difference and alteration in pharmacokinetic and metabolic characteristics of low-solubility natural medicines

Drug metabolism plays vital roles in the absorption and pharmacological activity of poorly soluble natural medicines. It is important to choose suitable delivery systems to increase the bioavailability and bioactivity of natural medicines with low solubility by regulating their metabolism and pharmacokinetics. This review investigates recent developments about the metabolic and pharmacokinetic behavior of poorly soluble natural medicines and their delivery systems. Delivery systems, dosage, administration route and drug–drug interactions alter the metabolic pathway, and bioavailability of low-solubility natural medicines to different degrees. Influencing factors such as formulation, dosage, and administration route are discussed. The metabolic reactions, metabolic enzymes, metabolites and pharmacokinetic behaviors of low-solubility natural medicines, and their delivery systems are systematically reviewed. There are various metabolic situations in the case of low-solubility natural medicines. CYP3A4 and CYP2C are the most common metabolic enzymes, and hydroxylation is the most common metabolic reaction of low solubility natural medicines. The stereo isomeric configuration can have a large influence on metabolism. This review will be useful for physicians and pharmacists to guide more accurate treatment with low-solubility natural medicines by increasing drug efficacies and protecting patients from toxic side effects.     

Research highlights from the Purdue-UAB Botanicals Research Center for Age Related Diseases

The Purdue-UAB Botanicals Research Center for Age Related Disease uses multidisciplinary and innovative technologies to investigate the bioavailability of bioactive polyphenolic constituents from botanicals and their relationship to human health. Many age-related diseases are associated with oxidative stress and tissue damage. One of the research goals of the Purdue-UAB Center is to investigate the bioavailability of bioactive natural compounds from a complex botanical mixture to the organ affected by the disease, determine the uptake and metabolism of these compounds, and relate these data to a protective mechanism. Equally important is to screen commercially available botanicals for their safety and efficacy. The central aims of the Center include the investigation of botanicals and their relationship to bone antiresorptive capacity, cognitive function, vascular effects, and cancer prevention.