抗艾滋病毒治疗的药物联用模式

抗艾滋病毒(HIV)治疗就是联用不同的抗HIV药物以达到抗病毒作用最大化。新型抗病毒药物的出现为抗HIV治疗提供了新的选择,且许多新的药物联用模式的有效性已被临床证实。目前,抗HIV治疗的药物联用模式主要是以双核苷类药物为基础,再联用非核苷类药物(依非韦仑)、蛋白酶抑制剂或整合酶抑制剂。美国2011年的抗病毒指南对抗HIV治疗的药物联用模式进行了更新,本文予于介绍以供国内临床医师参考。     

Therapeutic drug monitoring of antiretroviral drugs in HIV-infected patients

Introduction: Therapeutic drug monitoring (TDM) may be beneficial when applied to antiretroviral (ARV). Even though TDM can be a valuable strategy in HIV management, its role remains controversial.

Areas covered: This review provides a comprehensive update on important issues relating to TDM of ARV drugs in HIV-infected patients. Articles from PubMed with keywords relevant to each topic section were reviewed. Search strategies limited to articles published in English.

Expert commentary: There is evidence supporting the use of TDM in HIV treatment. However, some limitations need to be considered. The evidence supporting the use of routine TDM for all patients is limited, as it is not clear that this strategy offers any advantages over TDM for selected indications. Selected groups of patients including patients with physiological changes, patients with drug-drug interactions or toxicity, and the elderly could potentially benefit from TDM, as optimized dosing is challenging in these populations.     

对照培养基研制技术要求的介绍

目的为保证药品微生物检验用培养基的质量,规范对照培养基的研制工作,制定技术规范。方法详细介绍对照培养基研制要求及主要工作流程。结果与结论进一步加强和规范了对照培养基的管理工作。     

创新药药学研究的特点及技术考虑

创新药研发是一个探索性的研究过程,具有不同于仿制药的研发规律和研究特点,研究和审评应遵循其规律有序开展。参考FDA、欧盟发布的IND申请药学相关技术指南,结合笔者近年来的审评实践,对创新药药学研发的特点、阶段性的技术要求进行讨论,并介绍近期国内创新药审评的相关政策。     

Initial antiretroviral therapy in chronically-infected HIV-positive adults

Currently, there are 20 individual antiretroviral drugs and two co-formulation products that are approved by the FDA for the treatment of HIV-infected individuals. It is widely accepted that the selection of an appropriate first-line regimen is critical in assuring durable treatment response. This article reviews the factors that should be considered in the selection of an initial antiretroviral regimen and present the currently available evidence regarding the status of individual antiretroviral agents and treatment strategies relative to these factors.     

抗病毒药物的用药量及要求分析

目的分析笔者所在医院抗病毒药物的用药量及要求,以探讨抗病毒药物的合理使用。方法随机选取医院皮肤科、儿科、内科、传染科门诊及眼科5个科室2009年1月～2012年1月的处方2000张,对其中抗病毒药物进行用药量分析。结果通过计算各类药物使用频率及药物利用指数得出,抗病毒类药物中核苷类药物的使用量较大,排序靠前的拉米夫定、阿昔洛韦、更昔洛韦、泛昔洛韦等均为核苷类药物,药物用量基本控制在合理使用范围。结论笔者所在医院抗病毒药物的使用基本控制在合理使用范围,但仍出现用药量偏大现象,需要引起重视和加以改进。     

海南省药品上市许可持有人药物警戒体系现状分析及讨论

目的:分析海南省药品上市许可持有人药物警戒体系建设现状,为提高药物警戒工作效率提供参考.方法:采用回顾分析法及文献分析法,结合监测网络数据、文献研究、海南省上市许可持有人首次提交的2019年药物警戒年度报告等结果以及当前法律法规要求,对我省药物警戒体系建设现状进行分析.结果:76个上市许可持有人中,有3个尚未设置药物警...     

新形势下非处方药的营销渠道分析

在国家全面深化医疗体制改革的进程中,医药行业发展既迎来了历史的发展机遇,也面临着新的压力与挑战。新医改的出台必将导致药品行业的转型与变革。紧密结合新医改,分析了非处方药的市场现状及其现有营销渠道存在的问题,并对未来非处方药的营销渠道优化提供了建议。     

药品标准中替代对照品研究技术要求探讨

近年来,以标准物质为对照而建立的各种色谱技术在中药和天然药物分析方面有广泛的应用,但是对照物质的缺乏严重妨碍了中药及天然药物质量控制工作的顺利开展。研究并寻找适当的替代品是解决以上问题的有效途径之一。为了统一并规范药品标准中替代对照品的研究,本文对对照品替代法的应用情况及相关技术要求进行了探讨,以供开展此项研究工作参考。     

美国非处方药的上市路径和监管研究

本文对美国非处方药进行研究,发现非处方药具有安全窗宽、无需执业医师指导用药等特点,这些特点决定了非处方药在上市路径、申报资料递交、审评及监管、标签等方面与处方药存在差异。此外,还对美国2020年3月27日实施的非处方药改革进行研究,以期为我国非处方药的申报、审评和监管提供参考。     

HIV entry inhibitors： a new generation of antiretroviral drugs

AIDS is presently treatable, and patients can have a good prognosis due to the success of highly active antiretroviral therapy (HAART), but it is still not curable or preventable. High toxicity of HAART, and the emergence of drug resistance add to the imperative to continue research into new strategies and interventions. Considerable progress in the understanding of HIV attachment and entry into host cells has suggested new possibilities for rationally designing agents that interfere with this process. The approval and introduction of the fusion inhibitor enfuvirtide (Fuzeon) for clinical use signals a new era in AIDS therapeutics. Here we review the crucial steps the virus uses to achieve cell entry, which merit attention as potential targets, and the compounds at pre-clinical and clinical development stages, reported to effectively inhibit cell entry.     

Potential benefits of cyproheptadine in HIV-positive patients under treatment with antiretroviral drugs including efavirenz

Introduction: More than 50% of HIV-positive patients experience neuropsychiatric adverse reactions following efavirenz therapy. Discontinuation of efavirenz due to its neuropsychiatric side effects has been reported in 2 – 13% of patients. Dizziness, headache, nightmares, abnormal dreams, mild cognitive difficulty, sleep disturbance (somnolence and insomnia), impaired concentration, depression, hallucination, delusion, paranoia, anxiety, agitation, aggressive behavior, mania, emotional labiality, catatonia, melancholia, psychosis, and fatigue are the most reported efavirenz adverse reactions.

Areas covered: In this review, potential benefits of cyproheptadine in prevention and management of HIV/antiretroviral-associated neuropsychiatric complications are evaluated. The available evidence was collected by searching Scopus, PubMed, Medline, Cochrane central register of controlled trials, and Cochrane database systematic reviews.

Expert opinion: Cyproheptadine is a cheap and safe drug that does not have significant interactions with antiretroviral drugs. Cyproheptadine's common side effects including increasing appetite and weight gain can be useful in HIV-positive individuals with their decreased appetite and weight loss. There is limited evidence regarding the effectiveness of cyproheptadine in neuropsychiatric disorders. It is essential to evaluate cyproheptadine efficacy in the prevention and management of neuropsychiatric complications of HIV/antiretroviral infection in well-designed studies in the future.     

基于药品储存要求探讨口服单剂量药品拆零规范化管理

目的 通过对云南省昆明市延安医院口服药品储存条件及影响因素的分析,为单剂量药品拆零规范化管理提供参考,保证药品质量及用药安全。方法 依据笔者所在医院317种口服西药说明书中贮藏项下规定及拆零药品储存现状,分析药品储存的规范性。结果 317种药品储存40.69%对温度有要求,51.42%对光线有要求,86.75%对封闭性有要求,全自动单剂量摆药拆零药品158种。结论 笔者所在医院药品拆零工作存在不规范现象,建议进一步健全药品拆零工作规范,保障药品质量及患者用药安全。     

武汉生物医药产业重点技术需求分析与建议

摘 要 目的：为武汉生物医药产业发展提供技术服务平台建设等建议。方法: 通过文献检索、实地考察、问卷调查、专家咨询等方法,了解并分析武汉生物医药产业存在的问题及重点技术需求。结果与结论:提出了当前武汉生物医药产业重点技术需求和促进医药产业健康发展的建议。     

放射性药物化学前体的药学研究技术要求探讨

放射性药物一般由放射性核素和非放射性成分2个部分组成,两者结合后可将其递送至体内特定部位,并利用前者的辐射属性发挥诊断和治疗作用.本文中放射性药物化学前体是指通过化学合成制备的非放射性物质(以下简称化学前体),用于制备放射性药物药盒和PET放射性药物等.目前中国无化学前体的概念,尚无包括化学前体在内的放射性药物药学研究...     

Does choice of antiretroviral drugs matter for inflammation?

Introduction: The massive implementation of combination antiretroviral therapy (cART) has forever changed the landscape of HIV infection. This unprecedented success has turned HIV infection into a manageable chronic disease. The increased survival of people living with HIV is, however, shadowed by a high burden of aging-related comorbidities. The pathogenic basis underlying this excess of co-morbid conditions is most likely a persistent inflammatory and immune activation state, despite an optimal control of HIV replication, which in turn has largely been attributed to bacterial or bacterial products translocation from the gut.

Area covered: This review is focused on the relationship between cART and the chronic inflammatory and immune activation status in otherwise virologically well-controlled people living with HIV (PLWH). Particular focus will be placed on the differences, if any, between distinct cART modalities, with emphasis on less-drug cART regimens, and especially on dual therapies.

Expert opinion: Research to address the increased inflammatory and immune activation status of cART-treated, HIV-infected patients, should focus on adjuvant means of therapy, rather than on the cART regime itself. With current antiretrovirals, no difference between dual and triple regimens has been demonstrated, provided that virological and immunological outcomes be non-inferior.     

抗肿瘤新药临床试验和上市的非临床安全性评价要点

非临床安全性评价可贯穿在新药进入临床试验和上市申请的全部过程.新修订的人用药品注册技术要求国际协调会(ICH)指导原则M3(2)对新药进行临床试验和上市申请的非临床安全性评价提出了总体考虑.M3技术指导原则明确指出:对于危及生命或严重疾病(如进展性的癌症)且缺少有效的治疗手段时,抗肿瘤新药的毒理学和临床试验评价,应遵循具体问题具体分析的原则,以促进和完善药物研究和开发.为此本文围绕新M3技术指导原则,探讨我国抗肿瘤新药非临床安全性研发中的技术研究和评价考虑要点.     

Assessing teratogenicity of antiretroviral drugs: monitoring and analysis plan of the Antiretroviral Pregnancy Registry

This paper describes the Antiretroviral Pregnancy Registry's (APR) monitoring and analysis plan. APR is overseen by a committee of experts in obstetrics, pediatrics, teratology, infectious diseases, epidemiology and biostatistics from academia, government and the pharmaceutical industry. APR uses a prospective exposure-registration cohort design. Clinicians voluntarily register pregnant women with prenatal exposures to any antiretroviral therapy and provide fetal/neonatal outcomes. A birth defect is any birth outcome > or = 20 weeks gestation with a structural or chromosomal abnormality as determined by a geneticist. The prevalence is calculated by dividing the number of defects by the total number of live births and is compared to the prevalence in the CDC's population-based surveillance system. Additionally, first trimester exposures, in which organogenesis occurs, are compared with second/third trimester exposures. Statistical inference is based on exact methods for binomial proportions. Overall, a cohort of 200 exposed newborns is required to detect a doubling of risk, with 80% power and a Type I error rate of 5%. APR uses the Rule of Three: immediate review occurs once three specific defects are reported for a specific exposure. The likelihood of finding three specific defects in a cohort of < or = 600 by chance alone is less than 5% for all but the most common defects. To enhance the assurance of prompt, responsible, and appropriate action in the event of a potential signal, APR employs the strategy of 'threshold'. The threshold for action is determined by the extent of certainty about the cases, driven by statistical considerations and tempered by the specifics of the cases.