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English to Chinese: Summary General field: Medical
Source text - English Background:
Schizophrenia is a chronic debilitating illness with a prevalence of approximately 1% in the
general population worldwide, affecting over 3 million individuals in the US. Of this total,
almost 2.9 million individuals are diagnosed and 92% receive drug therapy. The World
Health Organization’s Global Burden of Disease 2000 ranked schizophrenia as the fifth
leading cause of years lived with a disability. At the forefront of current treatment options
are atypical antipsychotic drugs (APDs). Compared with first generation agents such as
haloperidol, atypical APDs have comparable efficacy in treating positive symptoms of
schizophrenia (eg, delusions and hallucination), but lower risk for extrapyramidal motor
adverse events. However, even with the improvements in toleration and efficacy, the unmet
medical need in schizophrenia is still high. Schizophrenia patients stabilized on APDs have
been documented to exhibit ongoing cognitive impairment1 that is associated with continuing
functional impairment.
Study Rationale:
This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to
evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of
XXX oral CR formulation in Japanese male subjects over the dose range of 20 to
60 mg single doses and at 40 mg twice daily (BID) for 7 days (40 mg single dose on the last
day). Based on in vitro metabolism data, PF-03463275 is mainly metabolized by CYP2D6.
Since 20-35% of the Asian population including Japanese are known to be intermediate
metabolizers (IMs),3 genotyping of CYP2D6 will be conducted for enrollment in this study to
investigate the potential relationship between the exposure of PF-03463275 and CYP2D6
genotype. Subject selection will only include Japanese and Western (defined as non-Asian)
patients subjects with an EM (extensive metabolizer) or IM (intermediate metabolizer)
CYP2D6 genotype. Additionally, this study will compare the pharmacokinetics, safety and
tolerability of XXX between Japanese and Western male subjects.
Translation - Chinese 摘要
背景：
精神分裂症是一种慢性致人衰弱的疾病，世界范围内患病率约为1%，全美有超过300万人受此病影响。在这些患者中，近290万已确诊，其中92%正接受药物治疗。《世界卫生组织2000年全球疾病负担》将精神分裂症列为第五位致残原因。在当前治疗的前沿，非典型抗精神病药物（APDs）是我们的选择。同第一代药物相比（例如，氟哌啶醇），非典型APDs在精神分裂症阳性症状(例如，妄想和幻想)治疗方面的疗效相当，但对于椎体外系运动不良事件而言风险较低。然而，即便耐受性和安全性得到了改善，精神分裂症的医学需求在很大程度上仍未得到满足。已证实接受APDs治疗后稳定的精神分裂症患者仍可表现出进行中的与功能障碍相关的认知障碍。
研究基本原理：
这项Ⅰ期研究为首项在日本受试者中进行的临床研究。该研究的设计目的为评价日本男性受试者中XXX口服控释制剂的单剂量（20-60mg单剂量）和多剂量（40mg每日两次[BID]连续7日[最后一日单剂量口服40mg]）给药的药代动力学、安全性和耐受性。根据体外代谢数据，PF-0346327主要经CYP2D6代谢。由于已知20-35%的亚洲人群（包括日本人）属中间代谢型（IMs）3。对于该研究，在入选时将进行CYP2D6基因型测定，籍此对PF-03463275的暴露与CYP2D6基因型的潜在关系进行研究。入选受试者仅包括基因型为强代谢型（EM）和中间代谢型(IM)的日本和西方（定义为非亚洲）患者。此外，在该研究中还将对XXX在日本和西方男性受试者中的药代动力学、安全性和耐受性进行比较。
English to Chinese: PUSR General field: Medical
Source text - English No serious adverse events (SAE) and no death were reported in the present study.
A total of 13 adverse events (AE) were reported in 10 included participants, all were emergent adverse events (EAEs). None of the EAEs was considered as related to the study treatments according to the investigator’s opinion. All EAEs were of mild intensity and all were recovered at the end of the study.
The most frequently reported emergent adverse events were:
- Headache: 3 EAEs in 3 participants (2 following S 06611 1.2 g administration and 1 following S 12911 2 g administration),
- Oropharyngeal pain: 3 EAEs in 3 participants (2 following S 06611 1.2 g administration and 1 following S 12911 2 g administration),
- Nasopharyngitis: 3 EAEs in 3 participants (1 following S 06611 1.2 g administration and 2 following S 12911 2 g administration).
No participant withdrew due to adverse event.
Translation - Chinese 当前研究未报告严重不良事件 (SAE)和死亡。.
入选的10名受试者共报告13起不良事件(AE)，所有均为引发不良事件(EAE)。根据研究者意见，无 EAEs被认为同研究治疗相关。所有EAE均为轻度，在研究结束时恢复。.
最常报告的引发不良事件包括：
- 头痛：3名受试者报告3起EAE(2名在接受1.2g S 06611治疗后，1名在接受2g S 12911治疗后)。
- 口咽疼痛：3名参与者报告3起EAE（2名在接受1.2g S 06611 治疗后，1名在接受2g S 12911治疗后)，
- 鼻咽炎：3名参与者报告3起EAE (1名在接受1.2g S 06611 治疗后，2名在接受2g S 12911治疗后).
无参与者因不良事件退出。
A freelancer with rich experience in translation of life science documents (En-CHS)
Summary of Qualifications
More than 30 million words (over 10 years) of experience in translating
English/ Simplified Chinese medical documents including clinical trial
documents.
Master of Medicine degree
Native fluency in Simplified Chinese – spoken and written
Fluency in English – spoken and written
5-year experience as a clinical doctor
A CAT user
Excellent interpersonal skills, and ability to work in a team
environment.
Education and Professional Training
Changzheng Hospital,
the 2nd Military Medical University, Shanghai 2005
-2008
Master of Medicine
Fields: systemic fungal infection and dermatology
· National Center of
Nanotechnology and Science, CAS, Beijing 2007
Visiting Scholar
The 2nd Military
Medical University, Shanghai 1996-2001
Portfolio 