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超速效赖脯胰岛素相比赖脯胰岛素能更好控制成人2型糖尿病患者的餐后血糖波动:一项前瞻性、随机化、双盲、3期研究

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Science Bulletin 2022年第17期67卷 1785-1791页

作者：周健陈思程杰朱建坤楼颖包玉倩贾伟平 Department of Endocrinology and Metabolism Shanghai Jiao Tong University School of Medicine Affiliated Sixth People’s HospitalShanghai Diabetes InstituteShanghai Clinical Center for DiabetesShanghai Key Laboratory of Diabetes MellitusShanghai 200233China lilly suzhou pharmaceutical co.ltd. Shanghai 200041China

超速效赖脯胰岛素(URLi)是一种新型的赖脯胰岛素制剂,旨在更好地改善餐后血糖控制.这是一项多国、多中心(中国、墨西哥和阿根廷3个国家的41个研究中心)、随机化、双盲、3期研究,旨在评估URLi相比赖脯胰岛素(优泌乐■[HL])在成人2型糖尿... 详细信息

超速效赖脯胰岛素(URLi)是一种新型的赖脯胰岛素制剂,旨在更好地改善餐后血糖控制.这是一项多国、多中心(中国、墨西哥和阿根廷3个国家的41个研究中心)、随机化、双盲、3期研究,旨在评估URLi相比赖脯胰岛素(优泌乐■[HL])在成人2型糖尿病患者中的有效性和安全性.患者随机接受26周的URLi(395名患者)或HL(200名患者)联合甘精胰岛素或德谷胰岛素治疗.主要研究终点为第26周HbAc相比基线变化的治疗间差异.第26周1和2 h餐后血糖波动(用餐开始后1 h和2 h测得的血糖分别减去空腹血糖)的治疗间差异为多重性调整终点.URLi和HL分别使HbA_(1c)较基线降低0.56%和0.63%,组间治疗差异无统计学意义.与HL相比较,URLi在控制第26周1 h和2h餐后血糖波动优效于HL,两组不良事件发生率相当.该研究表明在成人2型糖尿病患者中,基础-餐时给药方案中的URLi在控制HbA_(1c)方面非劣效于HL,而在控制餐后血糖波动方面显著优效于HL.

关键词：餐后血糖赖脯胰岛素随机化不良事件发生率给药方案甘精胰岛素空腹血糖 URL

A randomized clinical trial investigating treatment choice in Chinese men receiving sildenafil citrate and tadalafil for treating erectile dysfunction

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Asian Journal of Andrology 2017年第4期19卷 500-504页

作者： Wen-Jun Bai Hong-Jun Li Jian-Jun Jin Wen-Ping Xu Sorsaburu Sebastian Xiao-Feng Wang Department of Urology Peking University People's Hospital Beijing 100044 China Department of Urology Peking Union Medical College Hospital Beijing 100730 China Department of Medical Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai 200021 China Eli lilly and company Indianapolis Indiana 46285 USA

Sildenafil and tadalafil are efficacious and well tolerated in Chinese men with erectile dysfunction （ED）. Recent study results indicate that men with ED in China who were naive to phosphodiesterase inhibitor type 5 （PDE5） therapy prefer tadalafil 20-mg （on-demand） versus sildenafil 100-mg （on-demand）. Differences in psychosocial outcomes may help to explain treatment preference in favor of tadalafih This open-label, randomized, crossover study compared psychosocial outcomes and drug attribute choices between tadalafil and sildenafil in Chinese men with ED na＇（ve to PDE5 inhibitor therapy. Eligible patients were randomized to sequential 20-mg tadalafU/lOO-mg sildenafil （n = 190） or 100-mg sildenafil/20-mg tadalafil （n = 193） for 8 weeks each and were asked which treatment they preferred to take for the 8-week extension phase. Psychosocial outcomes were assessed using the Psychological and Interpersonal Relationship Scale （PAIRS）, Drug Attributes Questionnaire （DRAQ）, and Sexual Life Quality Questionnaire （SLQQ）. When taking tadalafil versus sildenafil, men had a higher mean endpoint score on the PAIRS Spontaneity Domain （tadalafil = 2.86 vs sildenafil = 2.72; P 〈 0.001）, and a lower mean endpoint score on the Time concerns Domain （tadalafil = 2.41 vs sildenafil = 2.55; P 〈 0.001）. A numerical increase in the Sexual Self-confidence Domain was observed when taking tadalafil versus sildenafil （tadalafil -- 2.76 vs sildenafil = 2.72; P= 0.102）. The most frequently chosen drug attributes explaining treatment preference were able to get an erection long after having drug, and ability to get an erection every time. SLQQ results were comparable between treatment groups. These psychosocial outcomes may explain why more Chinese men preferred tadalafil versus sildenafil for the treatment of ED in this clinical trial.

关键词： drug attributes erectile dysfunction phosphodiesterase type 5 inhibitor psychological assessment of sexual dysfunction

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

Association between painful physical symptoms and clinical outcomes in Chinese patients with major depressive disorder：a three-month observational study

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Chinese Medical Journal 2010年第15期123卷 2063-2069页

作者： LI Hui-chun ZHANG Ming-yuan WANG Gang ZHANG Hong-geng ZHANG Hong-yan LIU Ying LI Ming ZHANG cong-pei TANG Ji-sheng WU Wen-yuan Pritibha Singh Renee Elizabeth Granger Joel Raskin ANG Qiu-qing Department of Psychiatry Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang 310009China Shanghai Institute of Mental Health Shanghai 200030 China An Ding Hospital Beijing 100088 China Mental Health Center Hunan Provincial Hospital of Brain Diseases Changsha Hunan 410007 China Sixth Hospital of Beijing University Beijing 100083 China First Hospital of China Medical University Shenyang Liaoning 110001 China suzhou Guang Ji Hospital Suzhou Jiangsu 215008 China Harbin First Specity Hospital Harbin Heilongjang 150056 China Shandong Mental Health Center JinanShandong 250014 China Tongji Hospital Tongji University Shanghai 430030 China Intercontinental Information Sciences Eli Lilly Australia Pty LtdMacquarie Park 2113 Australia lilly Research Laboratories Eli Lilly Canada Toronto ON M1N 2E8 Canada Eli lilly Asia Inc.Shanghai Shanghai 200021 China

Background Painful physical symptoms （PPS） may present as a component of major depressive disorder （MDD）.Their effect in Chinese patients has not been investigated.This analysis reports the changes in disease severity,treatment patterns, quality of life and outcomes in a Chinese cohort according to the presence （PPS＋） or absence （PPS-）of painful physical symptoms.Methods A subgroup of Chinese patients from a large observational 3-month study of patients from Asian countries and regions of China were classified using the modified Somatic Symptom Inventory （SSI） as PPS＋（mean score≥2） or PPS（mean score 〈2）.Depression severity was assessed with the Clinical Global Impression of Severity （CGI-S） scale and 17-item Hamilton depression rating scale （HAMD17）.Pain severity was measured using a visual analogue scale （VAS）,while the EuroQoL （EQ-5D） assessed patient well-being.Antidepressants were compared with regard to their efficacy.Results Of the 299 Chinese patients enrolled in the study, 105 were classified as PPS＋（73/105, 70% women）.At baseline, PPS＋ patients reported greater pain severity （VAS, mean （SD）： 49.56 （26.49） vs.16.60 （20.99） for PPS-, P 〈0.01）, were more depressed （HAMD17, mean （SD）： 25.32 （5.47） vs.23.33 （5.24） for PPS-, P=0.002） and had poorer quality of life （EQ-5D Health State, mean （SD）： 38.48 （22.38） vs.49.57 （18.54） for PPS-, P 〈0.001）.PPS＋ patients showed less overall improvement in depressive symptom severity （HAMD17, change from baseline （95% CI）：-17.38（-18.65, -16.12） vs.-19.20 （-20.05,-18.35） for PPS-,P=-0.032; CGI-S, change from baseline （95% CI）： -2.85（-3.11, -2.58） vs.-3.20 （-3.38, -3.02） for PPS-, P=0.044）.conclusions PPS were less frequent than expected compared with previous studies of Asian populations.PPS＋were associated with greater MDD severity and less improvement than PPS- when antidepressants were given.

关键词： depressive disorder, major pain quality of life epidemiology public health China

中国有症状的精神分裂症患者由传统抗精神病药物换用奥氮平治疗的效果

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中国有症状的精神分裂症患者由传统抗精神病药物换用奥氮平治疗的...

首次接受5型磷酸二酯酶抑制剂治疗的中国男性勃起功能障碍患者中比较枸橼酸西地那非和他达拉非治疗的开放、多中心、随机交叉研究

中华医学会第十次全国精神医学学术会议

作者： William Montgomery 叶文育 Zbigniew Kadziola Tamas Treuer 柳丽薛海波吴胜虎 Haya Ascher-Svanum Eli lilly and company NSWAustralia lilly suzhou pharmaceutical co.ltd.Shanghai Branch

目的探讨传统抗精神病药物治疗后症状控制不佳的精神分裂症患者换用奥氮平的治疗结果。方法本研究为一项多国参与的前瞻性、非干预性观察性研究,在使用传统抗精神病药物治疗但因症状控制不佳而换用奥氮平治疗的精神分裂症患者中展开,为...

目的探讨传统抗精神病药物治疗后症状控制不佳的精神分裂症患者换用奥氮平的治疗结果。方法本研究为一项多国参与的前瞻性、非干预性观察性研究,在使用传统抗精神病药物治疗但因症状控制不佳而换用奥氮平治疗的精神分裂症患者中展开,为期12个月,对其中中国亚组(n=475)的数据进行事后分析。采用简明精神病量表(Brief Psychiatric Rating Scale,

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Asian Journal of Andrology 2015年第1期17卷 61-67,I0007,I0008页

作者： Wen-Jun Bai Hong-Jun Li Yu-Tian Dai Xue-You He Yi-Ran Huang Ji-Hong Liu Sebastian Sorsaburu Chen Ji Jian-Jun Jin Xiao-Feng Wang Department of Urology People's Hospital of Peking University Beijing China Department of Urology Peking Union Medical College Hospital Beijing China Department of Andrology Nanjing Drum Tower Hospital Jiangsu China Department of Urology Chinese PLA General Hospital Beijing China Department of Urology Shanghai Renji Hospital Shanghai China Department of Urology Tongji Hospital Tengji Medical College of Huazhong University of Science and Technology Wuhan China Department of Medical Eli Lilly and Company Indianapolis IN USA Department of Medical Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai China.

本研究旨在比较中国男性勃起功能障碍（ED）患者首次接受5型磷酸二酯酶（PDE5）抑制剂治疗时，西地那非和他达拉非治疗的选择偏爱、疗效和耐受性。本研究对中国男性ED患者偏爱20mg他达拉非或100mg西地那非进行了评估。4周基线评估后，38... 详细信息

本研究旨在比较中国男性勃起功能障碍（ED）患者首次接受5型磷酸二酯酶（PDE5）抑制剂治疗时，西地那非和他达拉非治疗的选择偏爱、疗效和耐受性。本研究对中国男性ED患者偏爱20mg他达拉非或100mg西地那非进行了评估。4周基线评估后，383例合格患者随机接受20mg他达拉非／100mg西地那非序贯治疗或相反顺序给药治疗8周，在之后的8周延长期间患者自主选择治疗方案。采用PDE5抑制剂治疗偏爱问卷（PITPQ）的问题1作为主要疗效指标，PITPQ问题2、国际勃起功能指数．勃起功能域（IIEF．EF）、SEP问题25U3，及药品属性问卷分析次要疗效指标。350例男性患者（91％）完成了随机治疗阶段。8周的延长期治疗中，242（69．1％）例患者偏爱20mg他达拉非以及108（30．9％）例患者偏爱100mg西地那非治疗（P〈O．001）。92（38％）例患者强烈偏爱他达拉非治疗以及37（34_3％）例患者强烈偏爱西地那非治疗。他达拉非和西地那非治疗组的SEP2、SEP3$1]IIEF．EF域评分均有所改善。偏爱他达拉非治疗的患者服药很长时间后可以发生勃起是偏爱他达拉非的主要原因。大于2％的不良反应只含头痛症状。西地那非和他达拉非治疗均有效且安全。在接受他达拉非和西地那非治疗后，更多首次接受PDE5抑制剂治疗的中国男性ED患者偏爱他达拉非治疗。

关键词：勃起功能障碍患者偏爱 5型磷酸二酯酶抑制剂

Evaluation of the long-term safety and effectiveness of tadalafil once daily in Chinese men with erectile dysfunction： interim results of a multicenter, randomized, open-label trial

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Asian Journal of Andrology 2018年第6期20卷 587-592页

作者： Hui Jiang Lian-Ming Zhao Hao-Cheng Lin Su Yan Ji-Hong Liu Zhao-Hui Zhu Jin-Dan Luo Yu-Tian Dai Fu-Biao Li Ying Lou Zhi-Chao Zhang Department of Urology Peking University Third Hospital Beijing 100191 China Department of Urology Peking Union Medical College Hospital Beijing 100730 China Department of Urology Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan 430030 China Department of Urology Union Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan 430022 China Department of Urology The First Affiliated Hospital Zhejiang University Hangzhou 310003 China Department of Andrology Nanjing Drum Tower Hospital Nanjing 210008 China Department of Andrology The First Hospital of Jilin University Changchun 130021 China lilly suzhou pharmaceutical co Ltd Shanghai Branch Shanghai 200041 China Peking University First Hospital Institute of Urology Peking University Beijing 100034 China

Once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction （n = 635）. The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event （serious or nonserious）. The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function （IIEF-EF） domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg （least squares [LS] mean change： 6.3; 95% confidence interval [CI]： 5.4-7.1; P 〈 0.001） and 5.0-mg （LS mean change： 7.4; 95% CI： 6.8-7.9; P 〈 0.001） tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function （IIEF-EF 〉26） following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.

关键词： erectile dysfunction long-term safety once-daily dosing tadalafil

中国在神经科就诊的病因不明的慢性躯体疼痛患者中抑郁症发病率与严重程度

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中国在神经科就诊的病因不明的慢性躯体疼痛患者中抑郁症发病率与...

体重指数较高的中国2型糖尿病患者有较差的血糖控制和较高的并发症患病率

中华医学会第十次全国精神医学学术会议

作者：吴胜虎 Joel Raskin Susanna Holt Medical Department Lilly Suzhou Pharmaceutical Co.Ltd.Shanghai Branch Eli lilly Canada TorontoCanada Asia Pacific Medical communications Development Centre of ExcellenceEli Lilly Australia Pty LtdWest RydeNSWAustralia

目的一项在6个亚洲国家与地区的精神病疗养机构开展的研究显示,在因抑郁症(majordepressive disorder,MDD)急性发作而接受治疗的患者中,有51.8%同时伴有躯体疼痛症状(Dainful physical symptoms,PPS)。合并抑郁可增加慢性疼痛的发病率,...

目的一项在6个亚洲国家与地区的精神病疗养机构开展的研究显示,在因抑郁症(majordepressive disorder,MDD)急性发作而接受治疗的患者中,有51.8%同时伴有躯体疼痛症状(Dainful physical symptoms,PPS)。合并抑郁可增加慢性疼痛的发病率,并给疼痛的治疗及康复加大难度;而合并疼痛会使抑郁症的病程更为迁延,治疗效果也更差。该项非介入性观察研

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体重指数较高的中国2型糖尿病患者有较差的血糖控制和较高的并发...