期刊先容
《柳叶刀》（The Lancet ）出身于1823年，是一本综合性医学周刊。近200年来，《柳叶刀》一贯致力于用最好的科学推动更好的生活。
《柳叶刀》以其在全天下所拥有的高影响因子，甚至有一群主要的读者阶层来支持它。期刊登载有：原创性的研究文章、评论文章（\"大众小组谈论\"大众及\"大众评论\公众）、社论、书评、短篇研究文章、也有其它一些在刊内常登载的文章诸如：特刊、及案例宣布等。
《柳叶刀医学期刊》被视为一种\"大众核心的\公众医学综合期刊；其它同性子的刊物有新英格兰医学期刊、美国医学协会期刊、及英国医学期刊。
期刊名称：Lancet
SCI缩写：LANCET
创刊韶光：1823
出版周期：Weekly
国家：England
总引用：247292
2018年影响因子：59.10
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以下对柳叶刀7月6号揭橥的一篇论文：口服semaglutide与皮下利拉鲁肽和安慰剂治疗2型糖尿病（PIONEER 4）：一项随机，双盲，3a期试验论文进行学习。
1Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial (译名：口服semaglutide与皮下利拉鲁肽和安慰剂治疗2型糖尿病（PIONEER 4）：一项随机，双盲，3a期试验)
揭橥韶光：2019-07-06
原文作者：Pratley R, Amod A, Hoff ST, et al.
BACKGROUND:Glucagon-like peptide-1 (GLP-1) receptor agonists are effective treatments for type 2 diabetes, lowering glycated haemoglobin (HbA1c) and weight, but are currently only approved for use as subcutaneous injections. Oral semaglutide, a novel GLP-1 agonist, was compared with subcutaneous liraglutide and placebo in patients with type 2 diabetes.
背景：胰高血糖素样肽-1（GLP-1）受体激动剂是治疗2型糖尿病，降落糖化血红蛋白（HbA1c）和体重的有效方法，但目前仅被批准用作皮下注射。
将口服利马鲁肽（一种新型GLP-1激动剂）与皮下利拉鲁肽和安慰剂进行比较，用于2型糖尿病患者。
METHODS:In this randomised, double-blind, double-dummy, phase 3a trial, we recruited patients with type 2 diabetes from 100 sites in 12 countries. Eligible patients were aged 18 years or older, with HbA1cof 7·0-9·5% (53-80·3 mmol/mol), on a stable dose of metformin (≥1500 mg or maximum tolerated) with or without a sodium-glucose co-transporter-2 inhibitor. Participants were randomly assigned (2:2:1) with an interactive web-response system and stratified by background glucose-lowering medication and country of origin, to once-daily oral semaglutide (dose escalated to 14 mg), once-daily subcutaneous liraglutide (dose escalated to 1·8 mg), or placebo for 52 weeks. Two estimands were defined: treatment policy (regardless of study drug discontinuation or rescue medication) and trial product (assumed all participants were on study drug without rescue medication) in all participants who were randomly assigned. The treatment policy estimand was the primary estimand. The primary endpoint was change from baseline to week 26 in HbA1c(oral semaglutide superiority vs placebo and non-inferiority [margin: 0·4%] and superiority vs subcutaneous liraglutide) and the confirmatory secondary endpoint was change from baseline to week 26 in bodyweight (oral semaglutide superiority vs placebo and liraglutide). Safety was assessed in all participants who received at least one dose of study drug. This trial is registered on Clinicaltrials.gov, number NCT02863419, and the European Clinical Trials registry, number EudraCT 2015-005210-30.
方法：在这项随机，双盲，双仿照，3a期试验中，我们从12个国家的100个地点招募了2型糖尿病患者。
符合条件的患者年事为18岁或以上，患有HbA1c在有或没有钠 - 葡萄糖共转运蛋白-2抑制剂的稳定剂量的二甲双胍（≥1500mg或最大耐受）下，7·0-9·5％（53-80·3mmol / mol）。
参与者被随机分配（2：2：1），具有交互式网络反应系统，并按背景降糖药物和原产国分层，逐日一次口服司美鲁肽（剂量递增至14 mg），逐日一次皮下利拉鲁肽（剂量升高至1.8mg），或安慰剂52周。
确定了两项估计：治疗政策（不论研究药物停药或接济药物）和试验产品（假设所有参与者均为研究药物，无需急救药物），所有参与者均被随机分配。治疗政策的紧张缘故原由是紧张的成分。
1c（口服司美鲁肽优胜性VS安慰剂和非劣效性[余量：0·4％]和优胜性 VS皮下利拉鲁肽）和验证次要终点是从基线的变革至26周体重（口服司美鲁肽优胜性 VS安慰剂和利拉鲁肽）。在接管至少一剂研究药物的所有参与者中评估安全性。
该试验在Clinicaltrials.gov注册，编号为NCT02863419，欧洲临床试验注册编号为EudraCT 2015-005210-30。
FINDINGS:Between Aug 10, 2016, and Feb 7, 2017, 950 patients were screened, of whom 711 were eligible and randomly assigned to oral semaglutide (n=285), subcutaneous liraglutide (n=284), or placebo (n=142). 341 (48%) of 711 participants were female and the mean age was 56 years (SD 10). All participants were given at least one dose of study drug, and 277 (97%) participants in the oral semaglutide group, 274 (96%) in the liraglutide group, and 134 (94%) in the placebo group completed the 52-week trial period. Mean change from baseline in HbA1cat week 26 was -1·2% (SE 0·1) with oral semaglutide, -1·1% (SE 0·1) with subcutaneous liraglutide, and -0·2% (SE 0·1) with placebo. Oral semaglutide was non-inferior to subcutaneous liraglutide in decreasing HbA1c(estimated treatment difference [ETD] -0·1%, 95% CI -0·3 to 0·0; p<0·0001) and superior to placebo (ETD -1·1%, -1·2 to -0·9; p<0·0001) by use of the treatment policy estimand. By use of the trial product estimand, oral semaglutide had significantly greater decreases in HbA1cthan both subcutaneous liraglutide (ETD -0·2%, 95% CI -0·3 to -0·1; p=0·0056) and placebo (ETD -1·2%, -1·4 to -1·0; p<0·0001) at week 26. Oral semaglutide resulted in superior weight loss (-4·4 kg [SE 0·2]) compared with liraglutide (-3·1 kg [SE 0·2]; ETD -1·2 kg, 95% CI -1·9 to -0·6; p=0·0003) and placebo (-0·5 kg [SE 0·3]; ETD -3·8 kg, -4·7 to -3·0; p<0·0001) at week 26 (treatment policy). By use of the trial product estimand, weight loss at week 26 was significantly greater with oral semaglutide than with subcutaneous liraglutide (-1·5 kg, 95% CI -2·2 to -0·9; p<0·0001) and placebo (ETD -4·0 kg, -4·8 to -3·2; p<0·0001). Adverse events were more frequent with oral semaglutide (n=229 [80%]) and subcutaneous liraglutide (n=211 [74%]) than with placebo (n=95 [67%]).
结果：2016年8月10日至2017年2月7日期间，筛选了950名患者，个中711名符合条件，随机分配至口服司美鲁肽（n=285），皮下利拉鲁肽（n=284）或安慰剂（n=142）。
711名参与者中有341名（48％）为女性，均匀年事为56岁（标准差10）。所有参与者至少服用一剂研究药物，口服司美鲁肽组277例（97％），利拉鲁肽组274例（96％），安慰剂组134例（94％）完成52周试用期。
HbA1c与基线的均匀变革在第26周，口服司美鲁肽为-1·2％（SE 0·1），皮下利拉鲁肽为-1·1％（SE0·1），安慰剂为-0·2％（SE 0·1）。口服利马鲁肽在降落HbA1c方面不逊于皮下利拉鲁肽 （估计治疗差异[ETD] -0·1％，95％CI -0.3~0.0; p <0.0001）且优于安慰剂（ETD） -1·1％，-1·2至-0·9; p <0.0001）利用治疗政策目标。
通过利用试验产品，口服semaglutide的HbA1c显著降落 皮下利拉鲁肽（ETD -0·2％，95％CI -0·3至-0·1; p=0,0056）和安慰剂（ETD-1％，-1·4~-1·0）第26周时，口服semaglutide导致体重减轻（-4·4 kg [SE 0·2]），而利拉鲁肽（-3·1 kg [SE 0·2]; ETD -1） ·2 kg，95％CI -1·9至-0·6; p = 0·0003）和安慰剂（-0.5 kg [SE 0·3]; ETD -3·8 kg，-4·7 to在第26周（治疗方针）-3·0; p <0·0001）。
通过利用试验产品，第26周时口服利马鲁肽的体重减轻明显大于皮下利拉鲁肽（-1.5 kg，95％CI -2·2至-0.9;p<0.0001）和安慰剂（ETD -4·0 kg，-4·8至-3·2; p <0.0001）。
INTERPRETATION:Oral semaglutide was non-inferior to subcutaneous liraglutide and superior to placebo in decreasing HbA1c, and superior in decreasing bodyweight compared with both liraglutide and placebo at week 26. Safety and tolerability of oral semaglutide were similar to subcutaneous liraglutide. Use of oral semaglutide could potentially lead to earlier initiation of GLP-1 receptor agonist therapy in the diabetes treatment continuum of care.
阐明：在第26周时，口服利拉鲁肽在降落HbA1c方面优于皮下利拉鲁肽，优于安慰剂，在降落体重方面优于利拉鲁肽和安慰剂。口服利马鲁肽的安全性和耐受性与皮下利拉鲁肽相似。
口服semaglutide的利用可能导致在糖尿病治疗连续照顾护士中更早开始GLP-1受体激动剂治疗。
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3Expanding traditional tendon-based techniques with nerve transfers for the restoration of upper limb function in tetraplegia: a prospective case series(译名：扩大传统的肌腱技能与神经转移规复四肢瘫痪的上肢功能：一个前瞻性病例系列)
4Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial (译名：Risankizumab与中度至重度斑块状银屑病（IMMvent）患者中的阿达木单抗比较：一项随机，双盲，主动 - 比较对照掌握的3期试验)
5The public health control of scabies: priorities for research and action (译名：疥疮的公共卫生掌握：研究和行动的优先事变)
6Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study (译名：对付新诊断的多发性骨髓瘤（CASSIOPEIA），在自体干细胞移植之前和之后利用或不该用daratumumab的硼替佐米，沙利度胺和地塞米松：一项随机，开放标记的3期研究)
7Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial (译名：中风后机器人赞助演习（RATULS）：一项多中央随机对照试验)
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