Larson AM, Polson J, Fontana RJ, et al.; Acute Liver Failure Study Group (2005). Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology, 42(6):1364-1372. doi.org/10.1002/hep.20948;国家药监局关于修订对乙酰氨基酚常释及缓释制剂说明书的公告(2020年第15号)及附件1《对乙酰氨基酚常释制剂处方药说明书修订要求》、附件2《对乙酰氨基酚常释制剂非处方药说明书修订要求》、附件3《对乙酰氨基酚缓释制剂说明书修订要求》(湖南省药品监督管理局转载). mpa.hunan.gov.cn/mpa/xxgk/tzgg/wjtz/202003/t202003…;21 CFR 201.326(a)(1)(iii)(A) Liver warning. ecfr.gov/current/title-21/chapter-I/subcha…;Smilkstein MJ, Knapp GL, Kulig KW, Rumack BH (1988). Efficacy of oral N-acetylcysteine in the treatment of acetaminophen overdose: analysis of the national multicenter study (1976 to 1985). New England Journal of Medicine, 319(24):1557-1562. doi.org/10.1056/NEJM198812153192401;MedlinePlus. Acetaminophen (In case of emergency/overdose). medlineplus.gov/druginfo/meds/a681004.html
备注
对乙酰氨基酚也叫扑热息痛。复方感冒药的通用名里带「氨酚」两个字的,比如氨酚伪麻、氨咖黄敏,就含这个成分。拿不准就把几盒药都拿给药店的药师看。定 B 是因为美国那组数字是病例登记,没有对照组,算不出看了成分表能少出多少事。收益定「大」是按后果定的:急性肝衰竭里有近三成直接死亡。解毒药越早越好的数字来自没有随机分组的多中心观察,只和过去的病例比过。
Belay ED, Bresee JS, Holman RC, Khan AS, Shahriari A, Schonberger LB (1999). Reye's syndrome in the United States from 1981 through 1997. New England Journal of Medicine, 340(18):1377-1382. doi.org/10.1056/NEJM199905063401801;关于加强尼美舒利口服制剂使用管理的通知(国食药监安〔2011〕209号). nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20110515145…;国家药监局关于修订安乃近相关品种说明书的公告(2020年第34号)及附件1至3. nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/ypgg…;U.S. Food and Drug Administration. Questions and Answers – Important change in concentration for over-the-counter (OTC) liquid acetaminophen marketed for infants. fda.gov/drugs/drug-safety-and-availabilit…;Falagas ME, Vouloumanou EK, Plessa E, Peppas G, Rafailidis PI (2010). Inaccuracies in dosing drugs with teaspoons and tablespoons. International Journal of Clinical Practice, 64(9):1185-1189. doi.org/10.1111/j.1742-1241.2010.02402.x;Yin HS, Dreyer BP, Ugboaja DC, et al. (2014). Unit of measurement used and parent medication dosing errors. Pediatrics, 134(2):e354-e361. doi.org/10.1542/peds.2014-0395
Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, et al. (2013). Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet, 382(9894):769-779. doi.org/10.1016/S0140-6736(13)60900-9;21 CFR 201.326(a)(2)(iii)(A) Stomach bleeding warning. ecfr.gov/current/title-21/chapter-I/subcha…
U.S. Food and Drug Administration (2020-10-15). FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. Drug Safety Communication. fda.gov/drugs/drug-safety-and-availabilit…
备注
FDA 提醒,很多治感冒、流感、失眠的非处方药里也含这类成分,要看成分表。美国非处方药标签原来只警告怀孕最后 3 个月,这次把界线提前到了 20 周左右。小剂量阿司匹林防子痫前期,见第 27 节第 5 条(小剂量阿司匹林)。定 B 是因为数字来自不良事件报告,有多少人吃了药却没出事不知道。收益定「中」是判断:结局严重,但发生得少。
国家药监局 2022 年第 68 号公告把奥美拉唑肠溶片从处方药转成非处方药,同时发布说明书范本。范本写的适应症是「胃酸过多引起的烧心和反酸症状的短期缓解」。注意事项写明:使用不得超过 7 天,症状没缓解要咨询医师或药师。两个月以内不得再次服用,症状反复要立即就医。吞咽困难或疼痛、呕血、便血或黑便时请勿使用,这些可能是严重情况的征兆。出现明显消瘦、反复呕吐、吞咽困难、呕血或黑便这类报警症状时,要先排除恶性肿瘤。原因是治疗可能掩盖症状、延误诊断。55 岁以上出现新的症状或症状有变化,要咨询医生。在吃氯吡格雷的人要避免同时吃奥美拉唑。原因看美国氯吡格雷(Plavix)说明书。奥美拉唑会抑制体内转化氯吡格雷的酶(CYP2C19)。说明书写着「omeprazole was shown to reduce significantly the antiplatelet activity of Plavix when given concomitantly or 12 hours apart」。两药同时吃或隔 12 小时吃,氯吡格雷防血栓的作用都明显变弱。这份说明书写的用途是急性冠脉综合征、近期心梗、近期中风和外周动脉病。
一篇 Cochrane 系统综述汇总了 6 项随机试验、1147 人。感冒吃抗生素和吃安慰剂比,没好或症状持续的比例没有明显差别(RR 0.83,95% CI 0.60–1.14,差别不显著)。不良反应的风险是安慰剂组的 1.8 倍(95% CI 1.01–3.21)。其中成人 2.62 倍(1.32–5.18),儿童没有增加(0.91,0.51–1.63)。流脓鼻涕不到 10 天的急性脓性鼻炎,吃抗生素也没有明确好处(RR 0.73,0.47–1.13)。不良反应却多了(RR 1.46,1.10–1.94,高约 46%)。作者结论是:这两种情况都不推荐常规用抗生素。
原始出处
Kenealy T, Arroll B (2025). Antibiotics for the common cold and acute purulent rhinitis. Cochrane Database of Systematic Reviews, 11:CD000247. doi.org/10.1002/14651858.CD000247.pub4
World Health Organization (2005). The treatment of diarrhoea: a manual for physicians and other senior health workers, 4th revision. iris.who.int/handle/10665/43209(中文版《腹泻治疗:医生和高年资卫生工作者使用手册》第 2.6 节,同一页面下载);Hahn S, Kim S, Garner P (2002). Reduced osmolarity oral rehydration solution for treating dehydration caused by acute diarrhoea in children. Cochrane Database of Systematic Reviews, (1):CD002847. doi.org/10.1002/14651858.CD002847
Headache Classification Committee of the International Headache Society (2018). The International Classification of Headache Disorders, 3rd edition. Cephalalgia, 38(1):1-211. doi.org/10.1177/0333102417738202;ICHD-3 在线版 8.2 Medication-overuse headache(含 8.2.3、8.2.5). ichd-3.org/8-headache-attributed-to-a-substa…
备注
药名里带「咖」字的止痛片,一般加了咖啡因,按复方算 10 天。一个月里头痛的天数越来越多,就去神经内科看,别只靠加药。定 B 是因为分类标准给的是诊断门槛,不是对照试验。收益定「中」是判断:它换回的是少头痛的日子,不涉及死亡。