Rituximab (RTX) is a monoclonal antibody that targets CD20 and is recommended by the KDIGO guidelines as a first-line treatment for membranous nephropathy (MN). The RTX biosimilar (HLX01) was the first biosimilar licensed in China in 2019. However, its efficacy and safety for MN treatment remain unclear. This study aimed to evaluate the performance of the RTX biosimilar for MN in a real-world setting. In this study, the medical records of 201 MN inpatients treated with high-dose RTX biosimilar and followed up for one year from January 2020 to December 2022 at PUMCH were retrospectively collected. Efficacy was evaluated in accordance with the KDIGO guidelines. Adverse reactions recorded in medical records during or after infusion were collected. During the one-year follow-up period, the overall remission rate of high-dose RTX biosimilar treatment for MN was 75.12

BACKGROUND:This study aimed to evaluate the steady-state plasma concentration, efficacy, and safety of bictegravir (BIC) in Chinese people with HIV (PWH) receiving BIC-based therapy for at least 6 months. RESEARCH DESIGN AND METHODS:PWH on BIC-based regimens for at least 6 months were enrolled. Plasma BIC concentrations, viral loads, CD4+ T cell counts, weight, renal and hepatic function, and adverse reactions were assessed. RESULTS:A total of 192 subjects were included. Geometric mean Cmax was 8.00 μg/mL and Cτ was 3.34 μg/mL, higher than in African and Caucasian populations. For treatment-naïve PWH, viral load < 50 copies/mL increased from 81% at 6 months to 98% at 12 months. For treatment-experienced PWH, the proportion was 90% at baseline and 98% at both 6 and 12 months. Weight increased by 5% and 7% in treatment-naïve PWH at 6 and 12 months, respectively. Renal and hepatic function remained normal, and mild adverse reactions were reported in 14 subjects (11.4%). CONCLUSIONS:BIC's steady-state plasma concentrations in Chinese PWH were higher than those in other ethnic groups, with good efficacy and safety.

Background: To establish a method for determining the bictegravir (BIC) concentration in human plasma using high-performance liquid chromatography coupled with ultraviolet detection. Methods: The analysis was performed on a CLC-octadecylsilane column (150 × 6.0 mm, 5 μm) using a mixture of phosphate buffer and acetonitrile (62:38, v/v) as the mobile phase at the flow rate of 1.4 mL/min. The column temperature was maintained at 40°C. Using triamcinolone acetonide as the internal standard, 100 μL of plasma sample was extracted by methyl tert-butyl ether, followed by evaporating under nitrogen stream, redissolving with 100 μL mobile phase, and injection of 20–40 μL of supernatant into the chromatographic system. Ultraviolet detection was performed at 260 nm, and the total run time for each sample was 14 minutes. Results: The method exhibited good linearity within the range from 0.10 to 10.0 mcg/mL (r = 0.9995, n = 5). The intraday and interday relative standard deviations for low-, medium-, and high-concentration quality control samples (0.20, 4.00, 8.00 mcg/mL) and the lower limit of quantification (0.10 mcg/mL) were 1.31%–6.20% (n = 10) and 1.18%–2.87% (n = 5), respectively. The intraday and interday accuracies were 100.53%–102.32% and 97.96%–103.84%, respectively. The extraction recovery rates ranged from 80.00% to 88.09% (n = 3). The stability tests showed that the BIC concentration changed by <15%. Conclusions: This study successfully established a high-performance liquid chromatography coupled with ultraviolet detection method for determining plasma BIC concentrations. This method is simple, selective, sensitive, and accurate, making it suitable for clinical monitoring and pharmacokinetic studies of BIC.

Dolutegravir (DTG) has been the first-line drug in many human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) guidelines for the treatment of naïve and experienced HIV-infected individuals, which calls for cost-effective and convenient methods for quantitative detection of DTG in human plasma for pharmacokinetic studies and patient adherence evaluation. Here, an HPLC-ultraviolet method in combination with liquid-liquid extraction with isocratic elution was developed for the first time. The analysis was performed on a CLC-ODS column (6 mm internal diameter × 15 cm, 5 μm) using a mixture of acetonitrile and phosphate buffer (40:60, v/v) as the mobile phase at the flow rate of 1 mL/min. Using triamcinolone as the internal standard, 100 μL of plasma sample was extracted by methyl tert-butyl ether, followed by evaporating under nitrogen stream, re-dissolving with 100 μL mobile phase, and injection of 20-40 μL of supernatant into the chromatographic system. The linearity of DTG was good in the range of 0.05-10 μg/mL (r = 0.9995), and the inter- and intra-day variabilities were 0.4%-4.3% (n = 10) and 1.2%-6.2% (n = 10) for the lower limit of quantification, low-, medium-, and high-concentration quality control samples (0.05, 0.1, 0.8, and 8 μg/mL), respectively, while the methodological and extraction recoveries were 98.0%-103.0% (n = 20) and 65.2%-75.7% (n = 3), respectively. This method was successfully applied to analyze DTG plasma concentration in 84 Chinese patients with HIV.

目的:探索建立北京协和医院互联网药学服务模式,助力公立医院高质量发展,以期为"互联网+药学"发展提供参考.方法:查阅国内外文献、开展调查研究,结合医院实践经验,归纳总结北京协和医院互联网药学服务管理制度、操作规程、服务内容和质控体系.结果:初步搭建北京协和医院互联网药学服务模式,服务内容包括互联网药学咨询、互联网处方审核、互联网用药指导、药品配送到家和互联网药学门诊.截至2022年11月30日,已完成互联网用药咨询5515例,互联网处方审核152113例,互联网电子用药指导单覆盖药品959种,药品配送33583人次,配送区域覆盖全国31个省市自治区.已取得较好的社会和经济效益.结论:互联网药学服务可以更好地满足患者的医疗需求,实现以患者为中心的药学服务转型,体现创新服务模式的理念.

目的 通过分析多替拉韦(DTG)的临床试验数据,为优化基于DTG的抗反转录病毒疗法(ART)提供参考.方法 检索国内外有关DTG的文献,对DTG的药效学特性、药动学特性、安全性以及基于DTG的不同ART方案的疗效进行分析总结.结果 DTG具有强大的活性、良好的耐受性以及较高的耐药屏障.多项临床试验表明,基于DTG的二联法具有不劣于三联法的疗效和安全性.结论 DTG已成为目前ART中的核心药物,基于DTG的二联ART应用前景可观.

lonapegsomatropin-tcgd(商品名:SkytrofaTM)是美国FDA批准的第1款用于儿童生长激素缺乏症治疗的长效制剂,可在1周内持续释放生长激素,每周仅需注射1次.与传统的每日注射生长激素疗法相比,lonapegsomatropin-tcpd可通过降低给药频次提升患者依从性,从而改善治疗效果.临床研究证实,与生长激素相比,每周1次的lonapegsomatropin-tcpd在第52周显示出更高的年化身高增长速率.本文就lonapegsomatropin-tcgd的作用机制、药动学、临床疗效、安全性、药物相互作用等方面进行述评.

目的 借助北京协和医院"互联网+医疗"平台,探索提供互联网用药指导的工作模式.方法 通过问卷调研分析患者对用药指导的真实需求,成立互联网用药指导项目组,确定电子化用药指导依据,编写用药指导内容定期更新,最终嵌入APP使用.结果 北京协和医院互联网诊疗平台已成功上线电子化用药指导、开药提醒和线上咨询功能,截止到2022年10月31日已为142 295名患者提供互联网用药指导服务.结论 搭建"电子化用药指导+线上药师咨询"相结合的多元化远程药学服务模式,基本能满足患者共性和个体化需求,提升药学服务质量,保障合理用药.

目的 探索如何科学地设计电子化用药指导方案,以弥补互联网诊疗过程中"窗口用药交代"环节的缺失,促进患者安全合理用药.方法 设计"用药指导的需求及意向"调查问卷,通过问卷星发放,收集不同群体对用药指导获取途径和形式的需求,以及医疗机构用药指导的开展情况,并采用SPSS软件进行统计分析.结果 公众更易接受传统的用药指导模式,且多数希望同时获得多种个性化的指导,但公众对药师的需求没有完全得到满足,且普遍对药师的职业认知度偏低.结论 远程指导不能完全替代传统的患者教育,药师应该在加强传统模式的药学服务的基础上,借助信息化技术,发展多元化的电子化用药指导,以适应不同人群在不同场景下的需求.

Abstract Background Generic medicines substitution is an important means to control rapid growth of pharmaceutical expenditures for the healthcare system in China. Acceptance and utilization of generic medicines is highly influenced by healthcare providers’ perceptions. This study aimed to compare the knowledge, awareness and perceptions of generic medicines between physicians and pharmacists in China. Methods We used an online, cross-sectional survey across China. The questionnaire explored four sections: demographic characteristics, assessment of the participants’ knowledge and awareness of generic medicines, perceptions of generic medicines and generic substitution practices. Chi-square or Mann–Whitney-U tests were applied to compare differences between physicians and pharmacists. P-values < 0.05 were considered significant. Results A total of 1644 physicians and 4187 pharmacists participated. Most physicians (82.8%, n = 1362) and pharmacists (89.8%, n = 3760) correctly identified the definition of generic medicines. A similar percentage of physicians and pharmacists agreed that approved generic medicines are as effective (64.1% vs 68.2%) or safe (63.8% vs 69.1%) as brand-name medicines. Most physicians and pharmacists (67.6% vs 71.0%) supported the policy of generic substitution. In practice, 79.4% (n = 1305) of physicians reported that they had prescribed generic medicines. More than 78% of respondents reported an obvious increase in the number of generic medicines prescribed in their medical institutions. The majority of physicians and pharmacists identified lack of trust regarding efficacy and safety of generic medicines and the difficulty of changing patients’ preference as top challenges in generic substitution. Conclusions Both physicians and pharmacists surveyed had adequate knowledge of generic medicines, and hold positive attitude towards generics and generic substitution. Efficacy and safety are key factors related to prescribing or dispensing generic medicines. Various policies and regulations should be taken to encourage successful generic substitution.

Objective To design a safety management system for antitumor drugs, which can intercept or warn the overdose of medical orders from the prescription source, and ensure the safety of clinical application of antitumor drugs. Methods The threshold of interception and warning strategy of 88 kinds of antitumor drugs were developed, and the safety management system of antitumor drugs was established to intercept or warn the overdose orders. The interception and warning data from January 2021 to June 2021 in the safety management system of antitumor drugs were extracted and analyzed. Results A total of 665 medical orders were intercepted or warned by the safety management system of antitumor drugs, and the majority of the intercepted or warned drugs were oral tablets(74.29%). The intercepted orders were 642 (96.54%), and the warned orders were 23(3.46%). Among the intercepted medical orders, frequency error (64.22%) has the highest proportion, followed by route error (11.73%) and dose error (9.92%). A total of 564 medical orders were intercepted, involving 28 kinds of antitumor drugs. Methotrexate tablets ranked first in overdose quantity, with an average of seven times. Pemetrexed ranked first in overdose multiples, with an average overdose of 1000 times. 78 medical orders were intercepted for over pathway, involving 5 kinds of antitumor drugs. Conclusion The safety management system of antitumor drugs can eliminate the error of overdose in prescription and guarantee the safety of antitumor drugs.

远程药学服务是指药师通过信息技术远程为患者提供药学服务的过程.我国的远程药学服务起步较晚,发展较慢,故本文通过收集文献,探讨了国内外药师在远程模式下可提供的药学服务模式.结果表明,国外远程药学服务起步早,较为成熟,内容主要包括远程随访与干预、24 h线上处方和医嘱审核、24 h线上药物重整,以及指导偏远地区或社区医院合理用药等,服务人群涵盖心血管疾病、糖尿病、哮喘、艾滋病等患者.我国已有医院建立了"互联网+医联体"一体化药学服务体系,药师借助该体系可为患者提供远程随访与干预、药物咨询等药学服务.随着互联网诊疗的推广,国内药师可逐渐扩大服务范围,拓展远程会诊、远程科普推送等药学服务,实现全民共享高质量药学服务.

目的 通过文献计量学及可视化分析方法针对CYP2C19基因与氯吡格雷关系,研究其现状、热点及发展趋势.方法 以Web of Science数据库为数据源,使用VOSviewer 1.6.13绘制网络图谱,分析CYP2C19基因与氯吡格雷的研究趋势.结果 共检索出符合要求的文献202篇,发文量整体呈逐年上升趋势;研究方向集中在药理学、心血管系统学和血液学方面;发文量最多的杂志是Thrombosis Research;最多的作者是Hulot J S.结论 氯吡格雷的基因多态性研究从早期药物代谢逐步发展到真实世界不良临床结局.目前研究热点为基于血小板功能和基因检测的精准治疗,从多基因位点、病理生理学、药物相互作用等多因素评价疗效差异.

随着医疗人才“组团式”援藏工作的逐年深入开展,北京协和医院药剂科向西藏自治区人民医院药剂科派出了5批援藏专家,将协和经验与西藏实际相结合,不断思考和创新,积累并传递经验,在硬件完善、药事管理、临床药学建设、自动化设备引进、信息系统完善、人才培养、科研及患者服务方面取得了一定成效.通过总结药剂科5年来对口支援工作经验,分析对口支援工作中存在的问题,对药剂科援藏工作未来运行模式进行探讨并提出相关建议.

获得性免疫缺陷综合征(AIDS),即艾滋病的治疗是一个漫长的过程.3种及以上的抗逆转录病毒药物的联合使用显著提高病毒学疗效,但同时也增加AIDS患者发生潜在药物相互作用(DDI)的风险,尤其当患者合并机会性感染,用药更加复杂多样时风险增加.了解药物的代谢途径及转运方式可以更好地预判DDI的发生并相应调整治疗方案以减少对患者产生不良影响的风险.本文总结了AIDS治疗药物间的相互作用以及AIDS治疗药物与合并机会性感染和其他常见疾病治疗药物的DDI,为提升用药安全提供参考.

Effective antibiotic treatment of critically ill patients remains a significant challenge to intensivists world-wide with persisting high mortality and morbidity rates. Pathophysiological changes in critically ill patients lead to changes in the pharmacokinetics (PK)/pharmacodynamics (PD) of antibiotics. Optimizing the current antibiotic delivery regimen is an important strategy to cope with this problem. In this paper, we review the PD characteristics and the potential changes of PK of antibiotics in critically ill patients, and the application and research progress of PK/PD in the optimization of antibiotic treatment regimens for them.

艾滋病患者需要终生进行药物治疗.我国常用的抗人类免疫缺陷病毒(HIV)药物主要有依非韦伦、替诺福韦、奈韦拉平、拉米夫定、齐多夫定、洛匹那韦/利托那韦等.为了明确国产抗反转录病毒药物在中国人群的药代动力学/药效动力学(PK/PD)特性,进一步明确和优化治疗方案,开展中国成人HIV感染者服用抗反转录病毒药物的PK/PD系列研究,结果表明这些药物在中国HIV感染患者的PK参数和安全性与外国人群不尽相同,主要表现为峰浓度(Cmax)和药时曲线下面积(AUC)较高,表观清除率(CI/F)较低,肝毒性、皮疹、骨骼和肾脏毒性等不良反应发生率较高,其原因可能与体质量和不同种族人的药物遗传学差异有关,提示应根据中国人的PK/PD特点调整给药方案.综述5种常用抗反转录病毒药物的PK/PD,以期为优化中国HIV感染者的临床治疗提供参考.

Objective To investigate the clinical use of 17 antineoplastic drugs passing national medical insurance negotiation in one hospital before and after the implementation of national policies about promoting the inclusion of antineoplastic drugs in health insurance. To provide reference for the optimization and adjustment of hospital catalogue. Methods The prescription data of 17 antineoplastic drugs of outpatients and inpatients in our hospital from 2018 to 2019 were collected. The basic information of patients, the usage amount and cost, defined daily doses (DDDs), and defined daily cost (DDC) were analyzed. Results The 17 antineoplastic drugs were mainly used for thorax, hematologic malignancies and urinary tract tumors. The top three antineoplastic drugs in terms of cost were osimertinib, octreotide acetate microspheres and crizotinib, with good synchronization between cost and frequency of usage. The top three drugs in terms of DDC were vemurafenib, cetuximab and ibrutinib. The proportions of the cost of 17 antineoplastic drugs to that of all antineoplastic drugs and all formulary drugs in our hospital were 16.3% and 3.8%, respectively. Among them, the total cost of the six drugs which had already been included in the formulary of our hospital before the policy implementation increased by 78.2% in 2019 compared with that in 2018. After the implementation of national policies, the quantity and cost of osimertinib increased significantly, and the drugs with increased quantity but decreased cost were cetuximab, axitinib, and sunitinib in sequence. The quantity and cost of pegaspargase both decreased significantly. Conclusions The national health insurance negotiation policy promoted the use of 17 antineoplastic drugs in our hospital and improved the accessibility of these drugs to patients significantly. At the same time, the total cost of the involved drugs had a sharp rise. It is necessary to strengthen the monitoring and dynamic evaluation of the clinical application of related drugs, so as to promote rational drug use while meeting patients' need.

目的 分析门诊前列地尔注射液的超适应证使用情况,为加强合理用药管理提供依据.方法 回顾性分析某院2016年7月至2019年6月门诊前列地尔注射液全部处方数据,通过信息系统调取患者在院完整就诊信息,用Excel软件对药品使用的数量、患者一般情况、临床诊断等逐一进行分析,将临床诊断、病历资料等信息与药品说明书、国内权威指南、数据库包括的适应证等进行对比,参考Micromedex的Thomson分级系统对超适应证用药进行证据等级分级.结果 该院门诊前列地尔注射液处方中88.9％为超适应证用药,但大部分(81.5％)证据较为充足,证据等级为category B及以上,如阳痿等.尚有7.4％的超适应证用药证据不够充分,如头痛等.结论 该院门诊前列地尔注射液使用总体较为合理,但仍需进一步规范前列地尔注射液的超适应证用药,并建立全院重点监控药品长效点评和超适应证用药备案管理制度,以提高用药合理性.

Objective To evaluate pharmacists’ knowledge, perceptions and practices towards generic substitution in the 11 pilot locations in China. Design An online cross-sectional survey using questionnaires was conducted. A convenience sampling technique was implemented to recruit pharmacists. Setting and participants The study took place in medical institutions of 11 pilot locations that participated in the pilot national centralised procurement programme in 2019. Two thousand two hundred and ninety-one pharmacists including hospital pharmacists or community pharmacists based on health-systems or clinics participated in the study. Results Most of the participants had the good knowledge of requirements for evaluating the quality and efficacy of generic drugs (n=2118; 92.4%), and the definition of generic drugs (n=2078; 90.7%). In terms of perceptions, 67.3% of respondents were of the opinion that generic drugs are equally as effective as the brand-name drugs, and 69.0% of respondents were of the opinion that generic drugs are as safe as brand equivalents. A high percentage of participants supported the policy of generic substitution (n=1634; 71.4%). A significant positive correlation was demonstrated between total knowledge score and total perception score (ρ=0.267; p<0.001). Efficacy, safety and the direction of national policies and hospital regulations were the main factors affecting pharmacists’ willingness to dispense generic drugs. Conclusions The study identified gaps in respondents’ knowledge and perceptions of generic substitution. Pharmacists who are more knowledgeable in generic drugs tend to hold a more supportive attitude towards generic substitution. Although it appeared that pharmacists in China have largely accepted generic substitution, they still have concerns regarding the reliability and quality of generic drugs. The current issues need to be addressed for the realisation of the true value of generic drugs as part of the country’s healthcare cost-containment strategy as well as the implementation of generic substitution policy in China.