1. |
唐立, 康德英, 喻佳洁, 等. 实效性随机对照试验: 真实世界研究的重要设计. 中国循证医学杂志, 2017, 17(9): 999-1004.
|
2. |
孙鑫, 谭婧, 唐立, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-130.
|
3. |
王雯, 刘艳梅, 谭婧, 等. 回顾性数据库研究的概念、策划与研究数据库构建. 中国循证医学杂志, 2018, 18(2): 230-237.
|
4. |
谭婧, 程亮亮, 王雯, 等. 患者登记研究的策划与患者登记数据库构建: 基于观察性设计的真实世界研究. 中国循证医学杂志, 2017, 17(12): 1365-1372.
|
5. |
U.S. Food and Drug Administration. FDA's Sentinel Initiative 2016. Available at: https://www.fda.gov/Safety/ FDAsSentinelInitiative/default.htm.
|
6. |
Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res, 2016, 16: 299.
|
7. |
Ko CY, Hall BL, Hart AJ, et al. The American college of surgeons national surgical quality improvement program: achieving better and safer surgery. Jt Comm J Qual Patient Saf, 2015, 41(5): 199-204.
|
8. |
Garrison LP, Jr., Neumann PJ, Erickson P, et al. Using real-world data for coverage and payment decisions: the ISPOR real-world data task force report. Value Health, 2007, 10(5): 326-335.
|
9. |
Zhao Y, Pinnow E, Major JM. A systematic assessment of key design and performance characteristics of drug exposure registries requested by the U.S. Food and Drug Administration. Pharmacoepidemiol Drug Saf, 2018, 27(3): 299-306.
|
10. |
Brand M, Muller A, Alsop J, et al. Results from a 9-year Intensive Safety Surveillance Scheme (IS (3)) in miglustat (Zavesca ((R)))-treated patients. Pharmacoepidemiol Drug Saf, 2015, 24(3): 329-333.
|
11. |
Shin SM, Kim CS, Karkada N, et al. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix). Hum Vaccin Immunother, 2016, 12(10): 2590-2594.
|
12. |
Kyriacou DN, Lewis RJ. Confounding by Indication in Clinical Research. JAMA, 2016, 316(17): 1818-1819.
|
13. |
Cortese S, Panei P, Arcieri R, et al. Safety of methylphenidate and atomoxetine in children with attention-deficit/hyperactivity disorder (ADHD): data from the Italian National ADHD Registry. CNS Drugs, 2015, 29(10): 865-877.
|
14. |
Eapen ZJ, Lauer MS, Temple RJ. The imperative of overcoming barriers to the conduct of large, simple trials. JAMA, 2014,311(14): 1397-1398.
|
15. |
Wechsler ME, Yawn BP, Fuhlbrigge AL, et al. Anticholinergic vs long-acting beta-agonist in combination with inhaled corticosteroids in black adults with asthma: the BELT randomized clinical trial. JAMA, 2015, 314(16): 1720-1730.
|
16. |
Li L, Shen J, Bala MM, et al. Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies. BMJ, 2014, 348: g2366.
|
17. |
Li L, Li S, Deng K, et al. Dipeptidyl peptidase-4 inhibitors and risk of heart failure in type 2 diabetes: systematic review and meta-analysis of randomised and observational studies. BMJ, 2016, 352: i610.
|
18. |
Liu J, Li L, Deng K, et al. Incretin based treatments and mortality in patients with type 2 diabetes: systematic review and meta-analysis. BMJ, 2017, 357: j2499.
|
19. |
Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336(7650): 924-926.
|
20. |
Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. J Clin Epidemiol, 2013, 66(7): 719-725.
|
21. |
Andrews JC, Schunemann HJ, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength. J Clin Epidemiol, 2013, 66(7): 726-735.
|
22. |
Siemieniuk RA, Foroutan F, Mirza R, et al. Antiretroviral therapy for pregnant women living with HIV or hepatitis B: a systematic review and meta-analysis. BMJ Open, 2017, 7(9): e019022.
|
23. |
Siemieniuk RAC, Lytvyn L, Mah MJ, et al. Antiretroviral therapy in pregnant women living with HIV: a clinical practice guideline. BMJ, 2017, 358: j3961.
|
24. |
U.S. Food and Drug Administration. Exenatide (marketed as BYETTA): Acute Pancreatitis. Available at: http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm119034.htm#exenatide.
|
25. |
Cox E, Martin BC, Van Staa T, et al. Good research practices for comparative effectiveness research: Approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: The international society for pharmacoeconomics and outcomes research good research practices for retrospective database analysis task force report -Part II. Value Health, 2009, 12(8):1053-1061.
|
26. |
Lenzer J. Consumer group calls for antidiabetes drug to be withdrawn. BMJ, 2012, 344: e3259.
|
27. |
Cohen D. Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? BMJ, 2013, 346: f3680.
|
28. |
Kmietowicz Z. Potential harms of type 2 diabetes drugs have been ignored, finds BMJ investigation. BMJ, 2013,346: f3782.
|
29. |
Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med, 2013, 369(14): 1317-1326.
|
30. |
Yanoff L. Saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus (SAVOR). Available at: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm444144.pdf.
|
31. |
Zannad F, Cannon CP, Cushman WC, et al. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet, 2015, 385(9982): 2067-2076.
|
32. |
Green JB, Bethel MA, Armstrong PW, et al. Effect of sitagliptin on cardiovascular outcomes in Type 2 diabetes. N Engl J Med, 2015, 373(3): 232-242.
|
33. |
Li L, Li S, Liu J, et al. Glucagon-like peptide-1 receptor agonists and heart failure in type 2 diabetes: systematic review and meta-analysis of randomized and observational studies. BMC Cardiovasc Disord, 2016, 16(1): 91.
|
34. |
Sutton AJ, Cooper NJ, Lambert PC, et al. Meta-analysis of rare and adverse event data. Expert Rev Pharmacoecon Outcomes Res, 2002, 2(4): 367-379.
|
35. |
Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med, 2007, 356(24): 2457-2471.
|
36. |
Grieff M, Bushinsky DA. Diuretics and disorders of calcium homeostasis. Semin Nephrol, 2011, 31(6): 535-541.
|
37. |
Tsvetov G, Hirsch D, Shimon I, et al. Thiazide treatment in primary hyperparathyroidism-a new indication for an old medication? J Clin Endocrinol Metab, 2017, 102(4): 1270-1276.
|
38. |
Berger ML, Dreyer N, Anderson F, et al. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value in Health, 2012, 15(2): 217-230.
|
39. |
Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: recommendations from the joint ISPOR-ISPE special task force on real-world evidence in health care decision making. Value Health, 2017, 20(8): 1003-1008.
|