Abstract：OBJECTIVE To understand the current situation of off-indication drug use of folic acid in our hospital, to explore the rationality of the use of folic acid in combination with the latest guidelines, Meta-analysis and other data, to put forward suggestions for improvement and to provide reference for the rational use of folic acid in clinic. METHODSE Retrospective study method was used to select all outpatient prescriptions of folic acid in our hospital from January 2019 to October 2019. According to the “drug instructions”,relevant guidelines and consensus of experts,the data were processed and analyzed by Excel software. RESULTS A total of 12 087 patients were included, including 11 226 patients using 5 mg folic acid and 861 patients using 0.4 mg folic acid.The results showed that there were 18 departments using 5 mg folic acid. The diagnosis of folic acid was found in nervous system, immune system and kidney system. Sixteen departments, including obstetrics, family planning, gynecology and respiratory medicine, used 0.4 mg folic acid, which were mainly diagnosed as pregnancy examination, infertility, menopause, postoperative lung cancer and so on. CONCLUSION At present,there is a universal phenomenon of off-indication drug use of folic acid. In the current study, clinical pharmacists should strengthen the evaluation of rational use of folic acid in the aspects of over-indication.
陶依然, 于芝颖, 黄琳, 刘刚, 赵美, 封宇飞. 门诊患者口服叶酸片超适应证用药调查分析[J]. 中国药学杂志, 2020, 55(14): 1158-1162.
TAO Yi-ran, YU Zhi-ying, HUANG Lin, LIU Gang, ZHAO Mei, FENG Yu-fei. Investigation and Analysis of Off-indication Drug Use of Folic Acid in Outpatient. Chinese Pharmaceutical Journal, 2020, 55(14): 1158-1162.
LI F. Folic acid and birth defects[J]. Int J Pediatr(国际儿科学杂志), 2019, 46(9):640-630.
STEELE J W, KIM S E, FINNELL R H. One carbon metabolism and folate transporter genes: do they factor prominently in the genetic etiology of neural tube defects?[J]. Biochimie, 2020,173:27-32.
BORRELL L N. Commentary: health policies in the US: can they increase or decrease the gap between subgroups of the population? The case of folic acid[J]. Int J Epidemiol, 2008, 37(5):1067-1068.
YANG M, LAO H Y, ZENG Y T. Expert consensus on the management of drug use beyond drug instructions in medical institutions[J]. Chin J Mod Appl Pharm(中国现代应用药学), 2017,34(3):436-438.
CHENG A C, ROBINSON P M, HARVEY K. Off-label use of medicines: consensus recommendations for evaluating appropriateness[J]. Med J, 2007,186(8):379-380.
GUANGDONG PHARMACEUTICAL ASSOCIATION. Expert consensus on the protection of patients′ right of informed consent in the use of drugs beyond the instructions[J]. Pharm Today(今日药学), 2019,29(6):361-367.
AAGAARD L, KRISTENSEN K. Off-label and unlicensed prescribing in Europe: implications for patients′ informed consent and liability[J]. Int J Clin Pharm, 2018,40(3):509-512.
VOGELZANG NICHOLAS J, RUSTHOVEN JAMES J, SYMANOWSKI J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma[J]. J Clin Oncol, 2003, 21(14): 2636-2644.
SOLOMON D H, GLYNN R T J, KARLSON E W, et al. Adverse effects of low-dose methotrexate: a randomized trial[J]. Ann Intern Med, 2020,172(6):369-380.
RHEUMATOLOGY AND IMMUNOLOGPHYSICIANS COMMITTEE OF CMDA. Chinese expert-based consensus for methotrexate in rheumatic diseases[J]. Chin J Int Med(中华内科杂志), 2018, 57(10):719-722.
SHEA B,SWINDEN M V, GHOGOMU E T, et al. Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis[J]. J Rheumatol,2014, 41(6):1049-1060.
SHEA B,SWINDEN M V, GHOGOMU E T, et al. Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis[J]. Cochrane Database Syst Rev, 2013, 6(5): CD000951.
WISE J. Folic acid significantly reduces risk of first stroke, large Chinese study finds[J]. BMJ, 2015, 350: h1461.
HUO Y, LI J, QIN X, et al. Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial[J]. JAMA, 2015, 313(13):1325-1335.
TIAN T, YANG K Q, CUI J G, et al. Folic acid supplementation for stroke prevention in patients with cardiovascular disease[J]. Am J Med Sci, 2017, 354(4):379-387.
COMMITTEE OF EXPERTS ON RATIONAL DRUG USE,NHFPC,HYPERTENSION PROFESSIONAL COMMITTEE OF CMDA. Guidelines for rational use of drugs for hypertension (the secend edition)[J]. Chin J Front Med Sci(中国医学前沿杂志),2017, 9(7):28-126.
TOLMUNEN T, HINTIKKA J, VOUTILAINEN S, et al. Association between depressive symptoms and serum concentrations of homocysteine in men: a population study[J]. Am J Clin Nutr, 2004, 80(6):1574-1578.
BENDER A, HAGAN KELSEY E, KINGSTON N. The association of folate and depression: a Meta-analysis[J]. J Psychiatr Res, 2017, 95: 9-18.
FAVA M, BORUS J S, ALPERT J E, et al. Folate, vitamin B12, and homocysteine in major depressive disorder[J]. Am J Psychiatr, 1997, 154(3):426-428.
PAPAKOSTAS G I, PETERSEN T, MISCHOULON D, et al. Serum folate, vitamin B12, and homocysteine in major depressive disorder, part 1: predictors of clinical response in fluoxetine-resistant depression[J]. J Clin Psychiatr, 2004, 65: 1090-1095.
PAPAKOSTAS G I, PETERSEN T, LEBOWITZ B D, et al. The relationship between serum folate, vitamin B12, and homocysteine levels in major depressive disorder and the timing of improvement with fluoxetine[J]. Int J Neuropsychopharmacol, 2005, 8(4): 523-528.
PAPAKOSTAS GEORGE I, PETERSEN T, MISCHOULON D, et al. Serum folate, vitamin B12, and homocysteine in major depressive disorder, part 2: predictors of relapse during the continuation phase of pharmacotherapy[J]. J Clin Psychiatr, 2004, 65(8):1096-1098.
MØLLEHAVE L T, SKAABY T, SIMONSEN K S, et al. Association studies of genetic scores of serum vitamin B12 and folate levels with symptoms of depression and anxiety in two danish population studies[J]. Eur J Clin Nutr, 2017, 71(9):1054-1060.
SAMODELOV S L, GAI Z, KULLAK-UBLICK G A, et al. Renal reabsorption of folates: pharmacological and toxicological snapshots[J]. Nutrients, 2019,11(10):2353.
STOVER P J, BERRY R J, FIELD M S. Time to think about nutrient needs in chronic disease[J]. JAMA Intern Med, 2016, 176(10):1451-1452.
YE Z C, ZHANG Q Z, LI Y, et al. High prevalence of hyperhomocysteinemia and its association with target organ damage in Chinese patients with chronic kidney disease[J]. Nutrients, 2016,8(10):645.
XU X, QIN X H, LI Y B, et al. Efficacy of folic acid therapy on the progression of chronic kidney disease: the renal substudy of the China stroke primary prevention trial[J]. JAMA Intern Med, 2016, 176(10):1443-1450.
YANG H,JUANG S Y, LIAO K F, et al. Comparing the effect of folic acid and pentoxifylline on delaying dalysis initiation in patients with advanced chronic kidney disease [J]. Nutrients, 2019,11(9):2192.
GUO Z X,ZHAO X S. Research progress in pathogenesis and correlation between homocysteine and coronary heart disease[J]. Med Recapit(医学综述), 2019, 25(22):4477-4482.
YU B J, CHEN G, GAO Z H. Effect of folic acid combined with methotrexate on prevention of cardiovascular complications in patients with rheumatoid arthritis[J]. Chin J Med(中国医刊), 2010, 45(12):48-49.
WYATT CHRISTINA M,SPENCE J D. Folic acid supplementation and chronic kidney disease progression[J]. Kidney Int, 2016, 90(6):1144-1145.
BRAVO-SOTO GONZALO A,MADRID T. Is folic acid supplementation useful for chronic kidney disease?[J]. Medwave, 2016, 16(suppl 5): e6591.