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| 1 | 瑞舒伐他汀治疗中国高胆固醇血症患者疗效和安全性的随机双盲多中心对照研究显示文摘目的评价瑞舒伐他汀治疗中国高胆固醇血症患者的疗效和安全性。方法采用随机、双盲、多中心研究。患者经6周筛选后符合 LDL-C≥4.14 mmol/L(160 mg/dl),<6.50 mmol/L(250 mg/dl)、TG<4.52 mmol/L(400 mg/dl)者以2:1随机接受瑞舒伐他汀10 mg/d 或阿托伐他汀10mg/d 治疗。12周后瑞舒伐他汀组 LDL-C 未达到 ATPⅢ治疗目标者,予瑞舒伐他汀20 mg 延续治疗8周。结果 304例进入随机治疗阶段,瑞舒伐他汀10 mg/d 组201例,阿托伐他汀10 mg/d 组103例。意向治疗人群290例,符合方案人群263例。瑞舒伐他汀组治疗12周后血 LDL-C 显著下降,下降幅度为45.6%,显著大于阿托伐他汀组的39.0%(P<0.001)。瑞舒伐他汀组患者 LDL-C 达标率也较阿托伐他汀组(78.0%比72.7%)有增高趋势,且在高危人群中优势更为明显(56.5%比35.0%),但差异未达到统计学意义。瑞舒伐他汀降低 TG(-22.8%)以及升高 HDL-C(+6.6%)和ApoA-1(+12.5%)的幅度与阿托伐他汀组差别无统计学意义(分别为-16.6%,+4.3%和+9.8%)。29例患者接受20 mg/d 瑞舒伐他汀延续治疗,22例完成治疗患者中10例(45.5%)LDL-C达标。研究中未发现药物相关的严重不良反应事件。结论本组研究显示瑞舒伐他汀10 mg 降低LDL-C 的疗效优于同等剂量的阿托伐他汀,治疗3个月安全性与之类似。 | Rosuvastatin Registration Clinical Trial Group.Cardiovascular Institute and Fu Wai Hospital,Peking Union Medical College and Chinese Academy of Medical Science,Beijing 100037,China | 2007 | 中华心血管病杂志2007，35，3： | 117 |
| 2 | 尿激酶治疗急性心肌梗塞多中心临床试验1406例总结显示文摘为观察尿激酶天普洛欣(UKTP)经静脉溶栓治疗急性心肌梗塞(AMI)的临床有效性及安全性。收集协作组148家医院1994年11月至1996年4月经静脉UKTP溶栓治疗AMI患者1406例,观察临床疗效、副作用及病死率等。其中124例行90分钟冠状动脉造影评价梗塞血管开通情况。结果:梗塞血管临床再灌注率为73.5%,90分钟冠状动脉造影血管开通率为72.6%,5周总病死率为7.8%(109/1406),轻度出血10.2%(143/1406),中重度出血0.43%(6/1406),脑出血0.50%(7/1406)。老年(>65岁)甚至高龄(>75岁)患者溶栓及距发病超过6小时者,其用药仍然安全有效,UKTP合适的用药剂量可能为150万U左右。结果提示UKTP治疗AMI安全有效。 | The collaborative study group for national multicenter clinical trial of urokinase thrombolytic therapy (Correspondence: Hu Dayi, Xu Zhimin. Beijing Red Cross Chao Yao Hospital, Beijing 100020) | 1997 | 中华心血管病杂志1997，25，3： | 139 |
| 3 | 临床研究协调员(CRC)行业指南(试行)显示文摘随着中国药物临床研究事业的发展,临床研究协调员(CRC)作为新兴的行业,扮演着越来越重要的角色。目前国内尚无统一的行业管理标准与指南,严重影响了CRC行业的健康发展。基于此,中关村玖泰药物临床试验技术创新联盟/中国药物临床试验机构联盟起草制定了《临床研究协调员行业管理指南》,从CRC职业基本要求、培训、等级评估、工作要求、监督管理等方面规范了行业行为。 | Zhongguancun Jiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association,China | 2015 | 药物评价研究2015，38，3： | 42 |
| 4 | 卡托普利对前壁与下壁心肌梗塞作用差异的临床试验显示文摘报告中国转换酶抑制剂治疗急性心肌梗塞多中心随机双盲安慰剂对照临床试验的一部分,重点探讨卡托普利对前壁与下壁心肌梗塞作用的差异。选择急性心肌梗塞患者12631例,随机分配到卡托普利治疗组或安慰剂对照组,口服卡托普利或安慰剂12.5mg3次/d,治疗4周。结果提示:前壁梗塞(n=6057)治疗组4周病死率(9.2%)明显低于对照组(10.8%),减少死亡危险15%(P=0.04),但下壁梗塞(n=3990)病死率治疗组(7.2%)与对照组(6.7%)差异无显著性(P=0.54)。发病6h内入选前壁梗塞病死率治疗组(9.5%)显著低于对照组(13.2%)(P=0.004),但下壁无此差异。非心动过缓(心率≥60次/分)者总病死率治疗组(9.5%)明显低于对照组(11.5%;P=0.04),在前壁尤为显著(治疗组8.6%;对照组12.5%,P=0.001)。结果表明:卡托普利早期治疗前壁心肌梗塞是安全和有益的,但对下壁则无益。 | (Chinese CEI-AMI Clinical Trial Collaboration Group)(Correspondence: Department of Hypertension, Fu Wai Hospital, CAMS, 100037 Beijing, China) | 1995 | 中华心血管病杂志1995，23，3： | 19 |
| 5 | 甲异靛治疗慢性粒细胞白血病 Ⅲ 期临床观察显示文摘目的:进一步考察甲异靛的疗效及副作用。方法:1994年3月~1995年7月中华医学会组织全国甲异靛治疗慢性粒细胞白血病(CML)Ⅲ期临床试验协作组,包括36个省级以上医疗单位,有402例CML患者进入临床观察,可评价疗效的有374例。结果:单一用药,每日75~150mg,总有效率为90.1%,缓解率为81.3%。初治患者疗效优于复治患者,缩脾效果好。获最佳疗效的时间平均为73.3天。副作用主要为不同程度的骨、关节、肌肉的疼痛,消化道反应轻微,近期与长期观察无心、肝、肾功能的损害,所有患者均未发生骨髓抑制。结论:甲异靛是一种新型的治疗CML的药物。 | Cooperative Study Group of Phase Ⅲ Clinical Trial on Meisoindico,Tianjin 300020 | 1997 | 中华血液学杂志1997，18，2： | 16 |
| 6 | Dual antiplatelet therapy may increase the risk of non-intracranial haemorrhage in patients with minor strokes: a subgroup analysis of the CHANCE trial显示文摘Aim:The aim of this study was to explore the difference between haemorrhagic events among those patients on either aspirin or aspirin plus clopidogrel who were enrolled in the Clopidogrel in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events(CHANCE)trial.Methods:This was an ad hoc analysis of the CHANCE trial;data on all patients with any haemorrhagic event were reviewed and analysed.Cox proportional hazards regression was used to determine factors association with any bleeding.Results:In the CHANCE trial,there were a total of 101(2%)haemorrhagic events reported from 50 different hospitals.The clopidogrel–aspirin group had 60(2.3%)cases and the aspirin group had 41(1.6%,p=0.09).Moderate or severe haemorrhagic events occurred in 7 patients(0.3%)in the clopidogrel–aspirin group and in 8(0.3%)in the aspirin group(p=0.73).Of 36(0.7%)cases of intracranial haemorrhages,20(0.4%)were in the clopidogrel–aspirin group and 16(0.3%)in the aspirin group.Each group had 8(0.3%)cases of symptomatic haemorrhagic strokes.Other common haemorrhagic events included 24(0.5%)cases of skin bruises,13(0.3%)gastrointestinal haemorrhages,9(0.2%)gum haemorrhages and 8(0.2%)intraocular haemorrhages.Conclusions:There was no overall significant difference in haemorrhagic events(p=0.29),especially in the rate of intracranial haemorrhages between the 2 treatment groups.However,patients enrolled with minor strokes had an increased risk of haemorrhagic events regardless of treatment group,not seen in patients with high-risk transient ischaemic attacks.Being elderly,of male gender and with a history of aspirin or proton pump inhibitor usage were associated with increased risk of haemorrhage.Patients with higher body mass index had lower risk of haemorrhagic events. | David Wang Li Gui Yi Dong Hao Li Shujuan Li Huaguang Zheng Anxin Wang Xia Meng Li-Ping Liu Yi-Long Wang Guangyao Wang Jing Jing Zixiao Li Xing-Quan Zhao Yong-Jun Wang on behalf of the investigators for the CHANCE trial | 2016 | Stroke & Vascular Neurology2016，1，2： | 8 |
| 7 | Association of fluid balance trajectories with clinical outcomes in patients with septic shock:A prospective multicenter cohort study显示文摘Background:Septic shock has a high incidence and mortality rate in Intensive Care Units(ICUs).Earlier intravenous fluid resuscitation can significantly improve outcomes in septic patients but easily leads to fluid overload(FO),which is associated with poor clinical outcomes.A single point value of fluid cannot provide enough fluid information.The aim of this study was to investigate the impact of fluid balance(FB)latent trajectories on clinical outcomes in septic patients.Methods:Patients were diagnosed with septic shock during the first 48 h,and sequential fluid data for the first 3 days of ICU admission were included.A group-based trajectory model(GBTM)which is designed to identify groups of individuals following similar developmental trajectories was used to identify latent subgroups of individuals following a similar progression of FB.The primary outcomes were hospital mortality,organ dysfunction,major adverse kidney events(MAKE)and severe respiratory adverse events(SRAE).We used multivariable Cox or logistic regression analysis to assess the association between FB trajectories and clinical outcomes.Results:Nine hundred eighty-six patients met the inclusion criteria and were assigned to GBTM analysis,and three latent FB trajectories were detected.64(6.5%),841(85.3%),and 81(8.2%)patients were identified to have decreased,low,and high FB,respectively.Compared with low FB,high FB was associated with increased hospital mortality[hazard ratio(HR)=1.63,95%CI 1.22–2.17],organ dysfunction[odds ratio(OR)=2.18,95%CI 1.22–3.42],MAKE(OR=1.80,95%CI 1.04–2.63)and SRAE(OR=2.33,95%CI 1.46–3.71),and decreasing FB was significantly associated with decreased MAKE(OR=0.46,95%CI 0.29–0.79)after adjustment for potential covariates.Conclusion:Latent subgroups of septic patients followed a similar FB progression.These latent fluid trajectories were associated with clinical outcomes.The decreasing FB trajectory was associated with a decreased risk of hospital mortality and MAKE. | Mei-Ping Wang Li Jiang Bo Zhu Bin Du Wen Li Yan He Xiu-Ming Xi China Critical Care Sepsis Trial(CCCST)workgroup | 2021 | Military Medical Research2021，8，3： | 4 |
| 8 | The prevalence and risk factors associated with esophageal varices in subjects with hepatitis C and advanced fibrosis <ce:link locator='fx1'/>显示文摘 | Arun J. Sanyal Robert J. Fontana Adrian M. Di Bisceglie James E. Everhart Michael C. Doherty Gregory T. Everson John A. Donovan Peter F. Malet Savant Mehta Muhammad Y. Sheikh Andrea E. Reid Marc G. Ghany David R. Gretch the HALT-C Trial Group | 2006 | Gastrointestinal Endoscopy2006，，6： | 2 |
| 9 | Pandemic influenza 2009: Impact of vaccination coverage on critical illness in children, a Canada and France observational study显示文摘AIM To study the impact of vaccination critical illness due to H1N1pdm09, we compared the incidence and severity of H1N1pdm09 infection in Canada and France.METHODS We studied two national cohorts that included children with documented H1N1pdm09 infection, admitted to a pediatric intensive care unit(PICU) in Canada and in France between October 1, 2009 and January 31, 2010.RESULTS Vaccination coverage prior to admission to PICUs was higher in Canada than in France(21% vs 2% of children respectively, P < 0.001), and in both countries, vaccination coverage prior to admission of these critically ill patients was substantially lower than in the general pediatric population(P < 0.001). In Canada, 160 children(incidence = 2.6/100000 children) were hospitalized in PICU compared to 125 children(incidence = 1.1/100000) in France(P < 0.001). Mortality rates were similar in Canada and France(4.4% vs 6.5%, P = 0.45, respectively), median invasive mechanical ventilation duration and mean PICU length of stay were shorter in Canada(4 d vs 6 d, P = 0.02 and 5.7 d vs 8.2 d, P = 0.03, respectively). H1N1pdm09 vaccination prior to PICU admission was associated with a decreased risk of requiring invasive mechanical ventilation(OR = 0.30, 95%CI: 0.11-0.83, P = 0.02).CONCLUSION The critical illness due to H1N1pdm09 had a higher incidence in Canada than in France. Critically ill children were less likely to have received vaccination prior to hospitalization in comparison to general population and children vaccinated had lower risk of ventilation. | Olivier Fléchelles Olivier Brissaud Robert Fowler Thierry Ducruet Philippe Jouvet the Pediatric Canadian Critical Care Trials Group H1N1 Collaborative and Groupe Francophone de Réanimation et Urgences Pédiatriques | 2016 | World Journal of Clinical Pediatrics2016，5，4： | 2 |
| 10 | Randomised trial of plasma exchange,intravenous immunoglobulin,and combined treatments in Guillain-Barre syndrome显示文摘 | Plasma Exchange/Sandoglobulin Guillain-Barr syndrome trial group | 1997 | Lancet1997，349，9047： | 1 |
| 11 | The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus显示文摘 | The Diabetes Control and Complications Trial Research Group | 1993 | N Eng J Med1993，329，： | 1 |
| 12 | Preliminary report: effect of encainide and flecainide on mortality in randomized trial of arrhythmia suppression after myocardial infarction显示文摘 | | 1998 | N Engl J Med1998，321，： | 1 |
| 13 | Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis显示文摘 | North American Symptomtic Carotid Endarterectomy Trial collaborators | 1991 | N Engl J Med1991，325，7： | 1 |
| 14 | The effect of intensive diabetes therapy on the development and progression of neuropathy 显示文摘 | The Diabetes Control and Complications Trial Research Group | 1995 | Ann Intern Med1995，122，8： | 1 |
| 15 | The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus显示文摘 | The Diabetes Control and Complications Trial Research Group | 1993 | N Engl J Med1993，329，： | 1 |
| 16 | Effect ofrosiglitazone on the frequency of diabetes in patients with impaired glucosetolerance or impaired fasting glucose:a randomised controlled trial显示文摘 | DREAM(Diabetes REduction Assessment with ramipril and rosiglitazoneMedication)Trial Investigators Gerstein HC Yusuf S | 2006 | Lancet2006，368，9541： | 1 |
| 17 | The effect of intensive treatment of diabetes on the development and progression of long-time complication in insulin-dependent diabetes 显示文摘 | Diabetes control and complication trial research(DCCT) | 1993 | N Engl Med1993，329，14： | 1 |
| 18 | Rationale and design of The National Emphysema Treatment Trial Group(NETr) :A prospective randomized trial of lung reduction surgery 显示文摘 | The National Emphysema Treatment Trial Group | 1999 | J Thorac Cardiovase Surg1999，118，3： | 1 |
| 19 | Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke显示文摘 | EAFT(European Atrial Fibrillation Trial)Study Group | 1993 | Lancet1993，342，： | 1 |
| 20 | Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy显示文摘 | The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group | 2000 | N Engl J Med2000，342，6： | 1 |
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