药品简介翻译-英译中

Raymond 2018年12月4日 16:11
翻译习作

★ INTRODUCTION
For the most accurate and current information regarding the efficacy and safety of R092670 (paliperidone palmitate), refer to the latest version of the Investigator's Brochure for R092670 (paliperidone palmitate; Edition 9, February 25, 2009).
★简介
有关R092670(帕利哌酮棕榈酸酯)的药效和安全性的最准确及最新信息,请参考最新版R092670研究手册(帕利哌酮棕榈酸酯;2009年2月25日,第9版)。

Paliperidone palmitate is the prodrug ester of paliperidone, an oral atypical antipsychotic with dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT] type 2A [5HT2A]) receptor antagonism characteristic of second-generation antipsychotics. Paliperidone palmitate is formulated as a long-acting intramuscular (i.m.) injection for administration by a healthcare professional at once-monthly dosing intervals. The once-daily oral formulation of paliperidone, paliperidone ER (INVEGA®), was approved by the U.S. FDA in December 2006 for the treatment of schizophrenia, and subsequently, in April 2007, for the stabilization treatment of schizophrenia. Although INVEGA® was first approved in 2006, clinicians have had extensive experience with the parent molecule of paliperidone, risperidone (RISPERDAL®), since 1994. RISPERDAL® is approved for the treatment of schizophrenia in adults and adolescents, the treatment of bipolar mania in adults (as monotherapy or in combination with lithium or valproate) and in children and adolescents (as monotherapy), and for irritability associated with autistic disorder in children and adolescents.
帕利哌酮棕榈酸酯是帕利哌酮的酯类药物前体,是一种具有多巴胺D2型和五羟色胺2A受体拮抗特性的第二代口服非典型类抗精神病药物。帕利哌酮棕榈酸酯为长效肌肉注射剂型,由专业医护人员管理每月给药一次。每日一次的帕利哌酮口服制剂,即帕利哌酮缓释片 (药品名INVEGA®),于2006年12月被美国FDA批准用于精神分裂症的治疗,随后在2007年4月被批准用于精神分裂症稳定期的治疗。尽管INVEGA®在2006年才获批,但自1994年起,临床医生便开始广泛使用帕利哌酮的母体分子药物,即利培酮(药品名RISPERDAL®)。利培酮获批用于治疗成人和青少年精神分裂症,成人双向型躁狂(采用单一治疗或与锂剂/丙戊酸盐联合治疗),也可用于治疗儿童及青少年双向狂躁(采用单一治疗),还可用于治疗儿童及青少年自闭性障碍相关的易怒症状。

However, while the efficacy and safety of oral atypical antipsychotics is well-documented, it is increasingly recognized that long-term data is required to support clinical decision-making when considering a change from short-acting oral to long-acting injectable antipsychotics. This lack of data represents a gap in understanding the relative value of the use of antipsychotic LAT for treating schizophrenia. To fill this knowledge gap and meet the medical needs related to adherence and functional preservation in schizophrenia, clinical examinations switching from oral antipsychotic medications into LAT are warranted. The current development of paliperidone palmitate, an atypical antipsychotic LAT, offers an important opportunity to conduct such a direct clinical examination.
然而,尽管非典型抗精神病口服药的疗效和安全性等相关数据充分,但人们日益认识到,在考虑从短效口服药换作长效注射型抗精神病药时,需要长期数据来支持这一临床决策。由于缺乏相关数据,在使用长效治疗方案(LAT)抗精神病药治疗精神分裂症时,专业人员对其相对价值的理解也有所差距。为了填补这一空白,满足治疗精神分裂症时患者依从性和功能维护的医疗需求,必须完成从口服抗精神病药到LAT对应临床检验的调整。帕利哌酮棕榈酸酯,一种非典型抗精神病LAT,其目前的发展为开展此类直接临床检验提供了契机。

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