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Journal of Health Science 2016年第5期4卷 262-276页

作者： Xiao Fang1 Vahakn Bedig Shahinian Kristin Marie Sheffield Alai Tan Daniel Chaim Jupiter Yong-Fang Kuo Department of Preventive Medicine and Community Health the University of Texas Medical Branch Galveston 77555 USA University of Michigan Internal Medicine-Nephrology Ann Arbor USA Global Patient Outcomes and Real World Evidence Eli Lilly Indianapolis 46285 USA Sealy Center on Aging the Ohio State University Columbus 43210 USA

Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China

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Chinese Medical Journal 2010年第22期123卷 3184-3192页

作者： GAO Yan NING Guang JIA Wei-ping ZHOU Zhi-guang XU Zhang-rong LIU Zhi-min LIU Chao MA Jian-hua LI Qiang CHENG Lu-lu WEN Chong-yuan ZHANG Shu-yu ZHANG Qi Durisala Desaiah Vladimir Skljarevski Department of Endocrinology Peking University First Hospital Beijing 100034 China Department of Endocrinology Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine Shanghai 200025 China Department of Endocrinology Shanghai Sixth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai 200233 China Department of Endocrinology Xiangya Second Hospital Central South University Changsha Hunan 410011 China Department of Endocrinology 306 Hospital of People's Liberation Army Beijing 100101 China Department of Endocrinology Chang Zheng Hospital Second Military Medical University Shanghai 200003 China Department of Endocrinology First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu 210029 China Department of Endocrinology Nanjing First Hospital Nanjing Medical University Nanjing Jiangsu 210006 China Department of Endocrinology Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang 150086 China Department of Endocrinology Union Hospital Huazhong University of Science and Technology Wuhan Hubei 430022 China Department of Endocrinology Renmin Hospital of Wuhan University Wuhan Hubei 430060 China lilly Research Laboratories Eli Lilly and Company Indianapolis IN USA 46285

Background Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain （DPNP） in the United States, European Union, and many other countries. This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain. Methods This double-blind, randomized, placebo-controlled, flexible-dose study treated adult patients with diabetic peripheral neuropathic pain and baseline Brief Pain Inventory （BPI） 24-hour average pain severity ratings ≥4 with duloxetine 60 mg to 120 mg once daily or placebo for 12 weeks. Dose adjustments of duloxetine or matching placebo were based upon investigator＇s judgment of clinical response. Change from baseline to endpoint in BPI average pain was the primary efficacy outcome. Secondary outcome measures included BPI-severity and -Interference, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, EuroQol： 5 Dimensions, Athens Insomnia Scale, and safety measures. Results Of 215 patients randomized, 88.4% and 82.1% of patients in placebo and duloxetine groups, respectively,completed the study. Mean change from baseline to endpoint in BPI average pain was not statistically different between the treatment groups （P=0.124）. Duloxetinetreated patients showed significantly greater pain reduction compared with those in placebo group at weeks 1,2, and 4 （P=0.004, P=0.009, and P=0.006, respectively） but not at weeks 8 （P=0.125） and 12 （P=0.107）. Duloxetine-treated patients experienced statistically significant improvement in Patient Global Impression of Improvement, Clinical Global Impression of Severity, area under the curve for pain relief, BPI-severity pain right now, and BPI-interference walking ability. Patients treated with duloxetine 120 mg once daily showed significantly greater pain reductio

关键词： clinical trial duloxetine diabetic peripheral neuropathic pain Chinese patients

An analysis of treatment preferences and sexual quality of life outcomes in female partners of Chinese men with erectile dysfunction

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Asian Journal of Andrology 2016年第5期18卷 773-779页

作者： Hong-Jun Li Wen-Jun Bai Yu-Tian Dai Wen-Ping Xu Chia-Ning Wang Han-Zhong Li Department of Urology Peking Union Medical College Hospital Beijing 100730 China Department of Urology Peking University People's Hospital Beijing 100044 China Department of Andrology Nanjing Drum Tower Hospital Jiangsu 210008 China Department of Medical Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai 200021 China

The impact of erectile dysfunction is distressing to both males and their female partners, but less attention has been paid to identify female partners＇ preferred treatment and sexual quality of life outcomes. The present analysis explores female partners＇ treatment preference for erectile dysfunction in Chinese Men. This was a phase 4, randomized, open-label, multicenter, crossover study in Chinese men with erectile dysfunction who were na＇fve to phosphodiesterase type 5 inhibitor treatments. eligible patients were randomized to sequential 20-mg tadalafil/100-mg sildenafil or lO0-mg sildenafil/20-mg tadalafil for 8 weeks each. Of 418 patients, female partners of 64 patients agreed to enter the study; of 64 patients who entered the study with female partners, 63 were randomized, and 62 completed the study. Baseline demographics and disease characteristics were comparable between treatment groups. Significantly more couples preferred tadalafil compared with sildenafil overall （75.4% vs 24.6%; P〈 0.001）, and irrespective of erectile dysfunction severity at baseline （P 〈 0.005）. Significant improvements in sexual quality of life scores were reported at endpoint （Visit 8） in male patients and female partners in both tadalafil and sildenafil treatment groups （P 〈 0.001）. Significantly higher mean changes from baseline were observed for male patients in the tadalafil group compared with the sildenafil group for the erectile function （P = 0.013） and overall satisfaction （P = 0.019） International Index for Erectile Function domains and the spontaneity domain （P〈 0.001） of the Psychological and Interpersonal Relationship Scale. No major safety concerns were reported during the study. Though both treatments were effective, safe, and tolerable, more couples preferred tadalafil compared with sildenafil.

关键词： erectile dysfunction partners' preference sexual quality of life sildenafil tadalafil

强效高选择性PPAR-α激动剂对致动脉粥样硬化性血脂紊乱或高胆固醇血症患者的影响—两项随机对照试验

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美国医学会杂志（中文版） 2008年第2期27卷 76-86页

作者： Steven E. Nissen, MD Stephen J. Nicholls, MBBS, PhD Kathy Wolski, MPH Daniel C. Howey, MD Ellen McErlean, RN, MSN Ming-Dauh Wang, PhD elisa V. Gomez, MS John M. Russo, MD 靳文英(译) 顾佳(校) Department of Cardiovascular Medicine Cleveland Clinic Lemer School of Medicine Cleveland Ohio eli lilly and Company Indianapolis Ind Guilford Medical Associates and Moses Cone Health System Greensboro. NC 不详

背景：贝特类药物是一种较弱的过氧化体增殖物激活型受体仪（peroxisome proliferators-activated receptor-α，PPAR-α）激动剂。目前尚无有关效果更强、选择性更高的相关制剂的报道。目的：研究PPAR-α激动剂LY518674的安全性和疗效... 详细信息

背景：贝特类药物是一种较弱的过氧化体增殖物激活型受体仪（peroxisome proliferators-activated receptor-α，PPAR-α）激动剂。目前尚无有关效果更强、选择性更高的相关制剂的报道。目的：研究PPAR-α激动剂LY518674的安全性和疗效。设计、地点及参试者：开展两项多中心、随机、双盲、安慰剂对照研究，其中一项针对高甘油三酯及低HDL-C血症患者（致动脉粥样硬化陛血脂紊乱），另一项针对高LDL-C患者（即高胆固醇血症）。2005年8月至2006年8月，参与血脂紊乱研究的研究人员在美国医疗中心随机入选309例患者，参与高胆固醇血症研究的研究人员入选304例患者。干预：在血脂紊乱研究中，患者服用安慰剂、非诺贝特（200mg）或LY518674（10μg、25μg、50μg或100μg），共12周。在高胆固醇血症研究中，患者首先服用安慰剂或阿托伐他汀（10mg或40mg）4周，然后服用安慰剂或LY518674（10μg或50μg）12周。主要观测指标：血脂紊乱研究的观测指标为HDL-C和甘油三酯变化的百分比，高胆固醇血症研究的观测指标为LDL-C变化的百分比。结果：血脂紊乱研究显示，LY518674（25μg）和非诺贝特分别使HDL—C水平增加5．9mg／dL和5．5mg／dL（15．8％和14．4％）（与安慰剂相比P值均≤0．001，组间比较P：0．79）。更高剂量的LY518674对HDL．C水平的影响不大。LY518674可使甘油三酯水平降低97．3～114．5rag／dE（34．9％～41．7％），与非诺贝特效果相似。LY518674可使LDL—C水平呈剂量依赖性升高，100μg LY518674可使LDL—C升高20．4mg／dL（19．5％），而非诺贝特仅使LDL-C升高0．3mg／dL（2．3％）。非诺贝特和LY518674（50μg和100μg）均可增加血清肌酐值（与安慰剂相比P≤0．001），分别有38％和37．3％的患者肌酐值超出正常范围。非诺贝特还可增加磷酸肌酸激酶水平（与安慰剂相比P=0．004），LY518674则无此反应。高胆固醇血症研究显示，LY518674（10μg或50μg）可使LDL—C降低21．4～26．0mg／dL（13．2％～15．8％），使甘油三酯降低约37％，使HDL-C升高6．3～6．7mg／dL（12．5％～15．0％）。当与阿托伐他汀合用时，LY518674可使HDL．C变化-0．7～6．2mg／dL（-0．6％～11．9％），使甘油三酯显著降低，但对LDL—C无明显的进一步降低作用。结论：在血脂紊乱患者中，LY518674和非诺贝特可降低甘油三酯水平，升高HDL-C水平，但同时也增加血清肌酐水平。与非诺贝特不同，LY518674还可升高LDL-C水平。在高胆固醇血症患者中，LY518674可降低甘油三酯水平，升高HDL-C水平，但与阿托伐他汀合用时并不能进一步降低LDL—C水平。非诺贝特和LY518674的安全陛均需进一步观察。

关键词：高胆固醇血症随机对照试验 PPAR-α 血脂紊乱动脉粥样硬化性激动剂高选择性过氧化体增殖物激活型受体

中国城市医疗保险体制改革:论成本分担的公平性

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中国城市医疗保险体制改革:论成本分担的公平性

Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science

作者：刘国恩蔡仁华熊先军赵忠云美国北卡大学北京大学光华管理学院卫生部卫生经济研究所劳动与社会保障部 Health Outcomes Research Eli Lilly & CompanyUSA

利用1994-1996年的镇江改革试点调查,该研究首次提供了实证数据,用以量化中国城市医疗保险改革如何影响不同社会经济和健康人群间的个人自付支出的分配。研究主要结论显示,虽然自付支出及其相对变量在改革后对普遍人群都有所增加,但处... 详细信息

利用1994-1996年的镇江改革试点调查,该研究首次提供了实证数据,用以量化中国城市医疗保险改革如何影响不同社会经济和健康人群间的个人自付支出的分配。研究主要结论显示,虽然自付支出及其相对变量在改革后对普遍人群都有所增加,但处于低等社会经济和健康状况的弱势人群的相对受益更大,这在自付支出总量模型、自付支出占总成本和占总收入比例模型中都获得一致和显著的证据。该研究的结论是,中国以城市为基本单位的医疗保险改革模式在控制医疗成本和扩大保险人群的前提下,也能有效地提高个人成本分担的公平性。

关键词：个人自付成本分担城市职工保险医疗改革公平性

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Journal of Clinical and Translational Hepatology 2022年第2期10卷 374-382页

作者： Yasser Fouad Melissa Palmer Minjun Chen Arie Regev Rajarshi Banerjee Rob Myers Robert Riccio Richard Torstenson Ramy Younes Puneet SArora Henrik Landgren Morten A.Karsdal Martin Blake David A.Shapiro Hans-Juergen Gruss Muhammad Y.Sheikh Dina Attia Steven Bollipo Alastair D.Smith Bradley Freilich Robert G.Gish Detlef Schuppan Department of Gastroenterology Hepatologyand Endemic MedicineFaculty of MedicineMinia UniversityMiniaEgypt Gan-nex/Ascletis Pharma Co Ltd BeijingChina Liver Consulting LLC New YorkNYUSA Division of Bioinformatics and Biostatis-tics National Center for Toxicological ResearchUS Food and Drug AdministrationJeffersonARUSA eli lilly and Company IndianapolisINUSA Perspectum Diagnostics Ltd OxfordUK Gilead Sciences Inc Foster CityCAUSA Syneos Health LLC MorrisvilleNCUSA Allergan Marlow International BuckinghamshireUKAstraZenecaCambridgeUK Boehringer Ingel-heim International GmbHIngelheimGermany Genentech IncSouth San FranciscoCAUSA AbbVie MarlowBuck-inghamshireUK Nordic Bioscience A/S HerlevDenmark Resonance Health BurswoodWAAustralia Intercept Phar-maceuticals Inc San DiegoCAUSA Fresno Clinical Research Center FresnoCAUSA Gastroenterology and Hepatology Department Beni-Suef UniversityBeni SuefEgypt Department of Gastroenterology and Endoscopy John Hunter HospitalNewcastleNSWAustralia School of Medicine and Public Health University of NewcastleNewcastleNSWAustralia Kan-sas City Research Institute Kansas CityMOUSA Division of Gastroenterology and Hepatology Loma Linda UniversityLoma LindaCAUSA Institute of Translational Immunology and Research Center for Immune Therapy University Medical CenterMainzGermany Division of Gastroenterology Beth Israel Deaconess Medical CenterHarvard Medical SchoolBostonMAUSA

Metabolic(dysfunction)-associated fatty liver disease(MAFLD)affects a third of the population and is a leading cause of liver-related *** no effective treatments exist,novel approaches to drug development are ***,outdated terminology and definitions of the disease are hampering efforts to develop new drugs and *** international consensus panel has put forth an influential proposal for the disease to be renamed from nonalcoholic fatty liver disease(NAFLD)to MAFLD,includ-ing a proposal for how the disease should be *** allies with the many stakeholders in MAFLD care―including patients,patients’advocates,clinicians,researchers,nurse and allied health groups,regional societies,and others―we are aware of the negative consequences of the NAFLD term and *** share the sense of urgency for change and will act in new ways to achieve our *** there is much work to be done to overcome clinical inertia and reverse worrisome recent trends,the MAFLD initiative provides a firm foundation to build *** provides a roadmap for moving for-ward toward more efficient care and affordable,sustainable drug and device innovation in MAFLD *** hope it will bring promising new opportunities for a brighter future for MAFLD care and improve care and outcomes for patients of one of the globe’s largest and costliest public health *** this viewpoint,we have revisited this initiative through the perspectives of drug development and regulatory science.

关键词： NAFLD MAFLD NASH Fatty liver disease Liver Fibrosis

关于度洛西汀治疗妇女压力性尿失禁安全性的整合分析

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世界核心医学期刊文摘（妇产科学分册） 2006年第8期2卷 32-32页

作者： Hurley D.J. Turner C.L. Yalcin I. 朱磊 lilly Research Laboratories Eli Lilly and Company Lilly Corporate Center Indianapolis IN 46285 United States

Objective: The objective was to characterize the safety of duloxetine for treatment of stress urinary incontinence (SUI)- in women, using an integrated database generated from four published placebo-controlled clinical trials. Methods: The database included 1913 women randomized to duloxetine (N = 958) or placebo (N = 955), exa-mining adverse events (AEs), serious adverse events (SAEs), vital signs, electrocardiograms, and laboratory analytes. AEs occurring initially or worsening during the double-blind treatment period were considered treatment-emergent (TEAE). Differences between duloxetinetreated and placebo-treated groups were compared statistically. Results: Common TEAEs included: nausea (23.2% ), dry mouth (13.4% ), fatigue (12.7% ), insomnia (12.6% ), constipation (11.0% ), headache (9.7% ), dizziness (9.5% ), somnolence (6.8% ), and diarrhea (5.1% ). Most TEAEs that emerged early were mild to moderate, rarely worsened, and resolved quickly. Overall AE discontinuation rates were 20.5% for duloxetine and 3.9% for placebo (P < .001). Most discontinuations (83% ) occurred within the first month of treatment. SAEs were uncommon and did not differ between treatments. Statistically significant, but clinically unimportant mean increases in heart rate (2.4 bpm) and systolic and diastolic blood pressure (≤ 2 mmHg) occurred. No arrhythmogenic potential was observed and any rare, transient, asymptomatic increases in hepatocellular enzymes normalized. Conclusions: Duloxetine was safe and tolerable, although transient AEs were not uncommon.

关键词：度洛西汀压力性尿失禁生命体征安慰剂双盲试验舒张期血压实验室分析心率失常统计学分析无

Predictability of polygenic risk score for progression to dementia and its interaction with APOEε4 in mild cognitive impairment

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Translational Neurodegeneration 2021年第3期10卷 412-420页

作者： Jung‑Min Pyun Young Ho Park Keon‑Joo Lee SangYun Kim Andrew J.Saykin Kwangsik Nho Department of Neurology Uijeongbu Eulji Medical CenterEulji UniversityUijeongbuRepublic of Korea Department of Neurology Seoul National University Bundang Hospital and Seoul National University College of Medi‑cineSeongnamRepublic of Korea Department of Radiology and Imaging Sciences and the Indiana Alzheimer Disease CenterIndiana University School of MedicineIndianapolisINUSA Department of Medical and Molecular Genetics Indiana University School of MedicineIndianapolisINUSA Center for Computational Biology and Bioinformatics Indiana University School of MedicineIndianapolisINUSA.

Background:The combinatorial efect of multiple genetic factors calculated as a polygenic risk score(PRS)has been studied to predict disease progression to Alzheimer’s disease(AD)from mild cognitive impairment(MCI).Previous studies have investigated the performance of PRS in the prediction of disease progression to AD by including and excluding single nucleotide polymorphisms within the region surrounding the APOE *** studies may have missed the APOE genotype-specifc predictability of PRS for disease progression to ***:We analyzed 732 MCI from the Alzheimer’s Disease Neuroimaging Initiative cohort,including those who progressed to AD within 5 years post-baseline(n=270)and remained stable as MCI(n=462).The predictability of PRS including and excluding the APOE region(PRS_(+APOE) and PRS_(−APOE))on the conversion to AD and its interaction with the APOEε4 carrier status were assessed using Cox regression ***:PRS_(+APOE)(hazard ratio[HR]1.468,95%CI 1.335-1.615)and PRS_(−APOE)(HR 1.293,95%CI 1.157-1.445)were both associated with a signifcantly increased risk of MCI progression to *** interaction between PRS_(+APOE) and APOEε4 carrier status was signifcant with a P-value of *** association of PRSs with the progression risk was stronger in APOEε4 non-carriers(PRS_(+APOE):HR 1.710,95%CI 1.244-2.351;PRS_(−APOE):HR 1.429,95%CI 1.182-1.728)than in APOEε4 carriers(PRS_(+APOE):HR 1.167,95%CI 1.005-1.355;PRS_(−APOE):HR 1.172,95%CI 1.020-1.346).Conclusions:PRS could predict the conversion of MCI to dementia with a stronger association in APOEε4 noncarriers than APOEε4 *** indicates PRS as a potential genetic predictor particularly for MCI with no APOEε4 alleles.

关键词： Polygenic risk score Mild cognitive impairment Alzheimer’s disease Disease progression APOEε4

直接血管成形术早期与围手术期应用阿昔单抗:6项相关研究的汇总分析

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世界核心医学期刊文摘(心脏病学分册) 2006年第4期 36-36页

作者： Gdicke J. Flather M. Noc M. 柴大军 eli lilly and Company Critical Care Europe PO Box 580 1214 Vernier/GE Switzerland Dr.

Background: The 2004 ACC/AHA guidelines on ST-elevation myocardial infarction state that it is reasonable to start treatment with abciximab as early as possible before primary percutaneous coronary intervention(PCI). We investigated the potential benefit of early use of abciximab by pooling data from all the available studies. Methods: Six prospective studies were identified that had allocated 260 patients to receive early abciximab(either prehospital or soon after the pat ient arrived in hospital)and 342 to receive late abciximab(at the time of PCI). Results: TIMI flow grade 2 or 3 was present in 42%of the early group compared w ith 29%in the late group(P=.001). After PCI, 59%of patients in the early group showed ST-resolution ≥70%, compared with 41%in the late group(P=.003). The composite clinical outcomes death, new myocardial infarction, or repeat target v essel revascularization at 30 days occurred in 7.3%of the early group compared with 9.7%in the late group(odds ratio 0.73, 95%CI 0.41-1.32)and death alone o ccurred in 2.7%versus 4.7%, respectively(odds ratio 0.56, 95%CI 0.23-1.39). Conclusions: Early administration of abciximab improves epicardial patency(TIMI flow)before PCI and results in better myocardial tissue perfusion(ST-resolution )after the procedure. The promising effects on clinical outcomes need to be test ed in larger studies.

关键词：阿昔单抗患者 ST 临床终点 PCI