NEJM, May17 2017
Multicenter, open label, RCT
P=AP+ACS, N=2037, I=IFR, C=FFR,
O=death+nonfatal MI+revascularization<1yr
IFR was No-inferior to FFR. Low CP during procedure
2. Cancer-Associated Mutations in Endometriosis w/o Cancer
子宮内膜症のdeeply infiltrating lesionsの1/4でsomatic cancer driver mutationsが認められた。
3. Use of the NHLBI Data Repository
Clinical trial dataのdata sharing需要が高まっているが進んでいない。
NHLBI repositoryにおけるdata sharingの実例を提示。
Data sharingについての正しい理解を。
（重要性・発展性の理解・疑義は少・所有期間）
Lancet，May 10 2017
1.HIV and the criminalisation of drug use among people who inject drugs: a systematic review
法規制がどれだけ薬物注射に伴うHIV感染予防や治療に結びついたかに関するｼｽﾃﾏﾃｨｯｸﾚﾋﾞｭｰ
→効果ありとの結論
2. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH) P4，non-inferiority, RCT
P=infliximab user(Crohn, UC, RA等)，I=Switch to CT-P13,
C=continue, O=worsening<52w
Infliximab(TNF inhibitors)→より安価なCT-P13切替は有効かつ安全
3. Epitope-specific immunotherapy targeting CD4-positive T cells in coeliac disease
Nexvax2→gluten-specific CD4-positive Tの作用を止める
P1 trial, 患者対象, placebo controlled RCT
→Go
JAMA May 15 2017
1.Effect of Bevacizumab vs Aflibercept on Visual Acuity Among Patients With Macular Edema Due to Central Retinal Vein Occlusion
VEGF阻害薬：Bevacizumab(適応外でよくつかわれる？) vs Aflibercept(FDA承認)
網膜静脈閉塞による黄班浮腫に対する有効性比較RCT→非劣性だった
2. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non–Small Cell Lung Cancer
Selumetinib＝mitogen-activated protein kinase kinase (MEK) inhibitor
KRAS mutant NSCLC：most common genomically defined subset
RCT: P=KRAS-Mutant Advanced Non–Small Cell Lung Cancer（1st line Tx無効例）, I=Selumetinib ＋ Docetaxel C=Docetaxel Alone, O= investigator assessed progression-free survival.
効果は認められなかった
3. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event.
生物製剤・精神科薬・accelerated approval, near–regulatory deadline approvalには注意