基本信息

更新日期:
版本:
最新版
大小:
31.93 MB
类型:
医疗
平台:
Windows
评分:
1
发布日期:
2018-04-30
价格:
免费
开发者:

应用更新

Data update: 1361 patients from 3 publications added Data providers list update

应用截图

【图】TherapySelector(截图 0)【图】TherapySelector(截图 1)【图】TherapySelector(截图 2)

应用简介

Why use HCV Therapy Selector?
HCV Therapy Selector is an uniquely handy and complete source of information for the physician and his patient with hepatitis C to select the best fitting treatment.
Guideline recommendations indicate which therapies according to experts are eligible for a particular patient profile.
HCV Therapy Selector provides patient profile specific information about the likelihood of cure of hepatitis C infection for all published treatment regimens of FDA and EMA approved drugs, and treatment-specific information about side effects, costs and reimbursement. The cure rates are based on data from phase 2, phase 3 and prospective real-life clinical studies.

HCV Therapy Selector is developed by the completely independent TherapySelector organisation (previously LiverDoc), in collaboration with Erasmus Medical Center Rotterdam, the Netherlands Association for the Study of the Liver (NASL), and ExpertDoc.
TherapySelector and ExpertDoc make clinical decision support products to bring unbiased academic knowledge to the busy physician and informed choice to the patient.
Funding of HCV Therapy Selector has come from TherapySelector’s own resources without contributions of the pharmaceutical industry.

How is HCV Therapy Selector constructed?
HCV Therapy Selector connects patient profiles, published treatment combinations and clinical study results.

Patient profiles for chronic HCV infection are based on characteristics crucial for treatment decision making: HCV genotype 1-6, stage of cirrhosis (no/Child A/Child B-C), previous treatment (no/(peg)interferon/sofosbuvir/NS5A+NS3), thereby creating 72 patient profiles. Special comorbidity like HIV co-infection, HBV co-infection, liver transplant, renal failure increases the number of patient profiles further.

Published treatment combinations concern all published treatment combinations based on drugs approved by the FDA and European Medicines Agency.

Study results (cure of infection: HCV RNA not detectable 12-24 weeks after stopping antiviral therapy=SVR) were obtained from published preregistration clinical trials as well as prospective real-life postregistration studies with at least 8 patients with a specific treatment regimen.
From each publication, data (total number of patients treated and SVR evaluable, and number of patients with SVR) were extracted per patient profile. Regularly supplementary data had to be obtained from the first author or study sponsor. After an internal and external check the data were entered into a certified SQL database.

The cure rate (% SVR) was calculated by a computer program, which aggregated the data from various studies for each patient profile – treatment regimen combination, and then divided the number of persons with a cure x 100 by the number of evaluable persons.
Quality of evidence was graded according to a simple system: ‘high’ (at least 80 patients, data from two or more studies), ‘moderate’ (at least 40 patients or 80 patient data from one study) and ‘low’ (less than 40 patients).

Adverse effects are shown if such effects are clinically relevant by its severity or by a higher frequency than in placebo-controlled trials.

Costs and reimbursement information are derived from robust sources like www.hepatitisc.uw.edu (USA), www.base-donnees-publique.medicaments.gouv.fr (FR), www.g-ba.de (DE), www.agenziafarmaco.gov.it, and www.medicijnkosten.nl (NL).

中文翻译

为什么使用HCV治疗选择剂?
HCV治疗选择是一个独特的方便和完整的信息来源的医生和他的病人与丙型肝炎选择最佳的治疗。
指南建议表明,根据专家的哪种疗法适合特定的患者情况。
HCV治疗选择提供关于FDA和EMA批准的药物的所有已发表的治疗方案治愈丙型肝炎感染的可能性的患者档案的具体信息,以及关于副作用,费用和报销的治疗特异性信息。治愈率基于2期、3期和前瞻性的临床研究数据。

HCV治疗选择是由完全独立的治疗选择组织 (以前的LiverDoc),与鹿特丹Erasmus医疗中心,荷兰肝脏研究协会 (NASL) 和ExpertDoc合作开发。
TherapySelector和ExpertDoc使临床决策支持产品为繁忙的医生和知情选择的患者带来无偏见的学术知识。
HCV治疗选择器的资金来自TherapySelector自己的资源,而没有制药行业的贡献。

HCV治疗选择器是如何构建的?
HCV治疗选择连接患者概况,发表的治疗组合和临床研究结果。

慢性HCV感染的患者概况基于对治疗决策至关重要的特征: HCV基因型1-6,肝硬化阶段 (无/儿童A/儿童B-C),既往治疗 (无/(peg) 干扰素/sofosbuvir/NS5A + NS3),从而创建72例患者概况。特殊的合并症,如HIV合并感染,HBV合并感染,肝移植,肾功能衰竭进一步增加患者档案的数量。

已发表的治疗组合涉及所有基于FDA和欧洲药品管理局批准的药物的治疗组合。

研究结果 (感染治愈: 停止抗病毒治疗后12-24周HCV RNA不检测 = SVR) 从已发表的注册前临床试验以及前瞻性的现实生活后注册研究中获得,至少8例患者具有特定治疗方案。
从每个出版物中,每个患者概况提取数据 (治疗和SVR可评估的患者总数,以及SVR患者的数量)。定期补充数据必须从第一作者或研究申办者那里获得。经过内部和外部检查,数据被输入到认证的SQL数据库中。

通过计算机程序计算治愈率 (% SVR),该计算机程序将来自针对每个患者概况-治疗方案组合的各种研究的数据汇总,然后将具有治愈的人数 × 100除以可评估的人数。
证据质量根据一个简单的系统进行分级: “高” (至少80例患者,来自两个或更多研究的数据),“中等” (至少40例患者或80例数据来自一项研究) 和 “低” (少于40例患者)。

如果这种效应与安慰剂对照试验的严重程度或频率高于安慰剂对照试验,则显示出不良反应。

成本和报销信息来自强大的来源,如www.heepatistisc.uw.edu (美国),base-donnees-publique.medicaments.gouv.fr (FR),g-ba.de (DE),www.agenziafarmaco.gov.it,和www.medicijnkosten.nl (nl)。

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