西沙必利用药者心血管系统不良事件发生率的Meta分析
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摘要
目的系统评价西沙必利用药者心血管系统不良事件的发生情况。方法根据检索策略,系统检索CNKI、维普、万方和SinoMed数据库,纳入1994～2018年公开发表的有关西沙必利引起心血管系统不良事件的文章。由两位研究者独立筛选文献、提取数据和质量评价,使用随机效应模型进行心血管不良事件发生率的Meta分析,并按照研究人群、用药方式、用药剂量与疗程进行亚组分析。结果最终纳入53篇文献,包括57项研究。在38项小样本研究中进行Meta分析,计算心血管不良事件总体发生率为5.61%(95%CI:3.49%,8.10%),其中心慌/心悸、QT间期延长和心律失常的合并发生率分别为4.10%(95%CI:2.84%,5.54%)、10.98%(95%CI:5.13%,18.34%)和0.40%(95%CI:0.00%,1.44%)。另外,研究检索到3项基于数据库开展的专门针对西沙必利与心律失常发生风险的大样本研究,报告的心律失常发生率范围在0.91～1.28/1 000人年。亚组分析结果显示,儿童用药者发生QT间期延长的风险可能较高。汇总个案报告结果,多为QT间期延长、尖端扭转型室性心动过速等严重事件报告,有3例合并其他疾病的患者死亡。结论西沙必利可引起心血管系统不良事件,对于某些特殊人群可导致包括死亡在内的严重后果,应重视用药安全,严格遵循适应证、禁忌和注意事项用药。
Objective To systematically evaluate the incidence of cardiac adverse events of cisapride. Methods CNKI, VIP,WanFang and SinoMed databases were searched for eligible studies reporting the cardiac adverse events of cisapride from1994 to 2018, using the chemical names or trade names of cisapride as keywords. Two researchers independently screened literature according to the inclusion and exclusion criteria, extracted data and assessed the quality of included studies. Random-effects Meta-analysis was conducted to pool the incidence of cardiac adverse events, and subgroup analysis was performed based on the population, mode and dosage of medicine. Results A total of 53 articles were included, involving 57 researches. In 38 studies with small sample size, the results of Meta-analysis showed that the overall incidence of cardiac adverse events was 5.61%(95% CI: 3.49%, 8.10 %). The adverse event reported most was palpitation, followed by QT prolongation and arrhythmia, with the pooled incidence of 4.10%(95% CI: 2.84%,5.54%), 10.98%(95% CI: 5.13%, 18.34%) and 0.40%(95% CI: 0.00%, 1.44%), respectively. Three database studies with large sample size, which focused on cisapride and the risk of arrhythmia, reported the incidence of arrhythmia ranging between 0.91 and 1.28/1 000 person-years. The subgroup analysis suggested that children had higher risks of QT prolongation. 16 case reports included 17 adverse events, most of which were severe adverse drug events, such as QT prolongation and torsade de pointes. Three cases with comorbidity died, which suggested the cardiac risk of cisapride may increase for some special patients. Conclusion Cisapride was associated with potential cardiac toxicity. Prescribers should strictly follow the indications and contraindications to ensure clinical medication safety.
Objective To systematically evaluate the incidence of cardiac adverse events of cisapride. Methods CNKI, VIP,WanFang and SinoMed databases were searched for eligible studies reporting the cardiac adverse events of cisapride from1994 to 2018, using the chemical names or trade names of cisapride as keywords. Two researchers independently screened literature according to the inclusion and exclusion criteria, extracted data and assessed the quality of included studies. Random-effects Meta-analysis was conducted to pool the incidence of cardiac adverse events, and subgroup analysis was performed based on the population, mode and dosage of medicine. Results A total of 53 articles were included, involving 57 researches. In 38 studies with small sample size, the results of Meta-analysis showed that the overall incidence of cardiac adverse events was 5.61%(95% CI: 3.49%, 8.10 %). The adverse event reported most was palpitation, followed by QT prolongation and arrhythmia, with the pooled incidence of 4.10%(95% CI: 2.84%,5.54%), 10.98%(95% CI: 5.13%, 18.34%) and 0.40%(95% CI: 0.00%, 1.44%), respectively. Three database studies with large sample size, which focused on cisapride and the risk of arrhythmia, reported the incidence of arrhythmia ranging between 0.91 and 1.28/1 000 person-years. The subgroup analysis suggested that children had higher risks of QT prolongation. 16 case reports included 17 adverse events, most of which were severe adverse drug events, such as QT prolongation and torsade de pointes. Three cases with comorbidity died, which suggested the cardiac risk of cisapride may increase for some special patients. Conclusion Cisapride was associated with potential cardiac toxicity. Prescribers should strictly follow the indications and contraindications to ensure clinical medication safety.
引文
[1] Quigley E M. Cisapride:what can we learn from the rise and fall of a prokinetic?[J]. J Dig Dis, 2011, 12(3):147-156.
[2] Olsson S, Edwards I R. Tachycardia during cisapride treatment[J].BMJ, 1992, 305(6856):748-749.
[3] Barbey J T, Lazzara R, Zipes D P. Spontaneous adverse event reports of serious ventricular arrhythmias, QT prolongation, syncope, and sudden death in patients treated with cisapride[J]. J Cardiovasc Pharmacol Ther, 2002, 7(2):65-76.
[4] Smalley W, Shatin D, Wysowski D K, et al. Contraindicated use of cisapride:impact of food and drug administration regulatory action[J]. JAMA, 2000, 284(23):3036-3039.
[5] The European Agency for the Evaluation of Medicinal Products(EMEA/CPMP). Committee for proprietary medicinal products(CPMP)opinion following an article 31 referral cisapride[EB/OL].(2002-10-07)[2018-06-01]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Cisapride/human_referral_000160.jsp&mid=WC0b01ac05805c516f.
[6] Health Canada. Archived-Prepulsid(Cisapride)[EB/OL].(2000-05-30)[2018-06-01].http://healthycanadians.gc.ca/recall-alert-rappelavis/hc-sc/2000/14309a-eng.php?_ga=2.123543107.999978895.1523262834-1731413748.1523262834#affected-touches.
[7] Therapeutic Goods Administration(TGA). Restriction of indications for cisapride[EB/OL].(2002-12)[2018-06-01]. https://www.tga.gov.au/sites/default/files/aadrb-0012.pdf.
[8] The Cochrane Collaboration. Cochrane handbook for systematic reviews of interventions version 5.1.0[EB/OL].(updated 2011-03)[2018-06-01]. http://handbook-5-1.cochrane.org/.
[9] Ottawa Hospital Research Institute. The Newcastle-Ottawa Scale(NOS)for assessing the quality of nonrandomised studies in meta-analyses[EB/OL].(2015-07-05)[2018-06-01]. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp.
[10] National Institute for Health and Care Excellence(NICE). Appendix4 quality of case series form[EB/OL].(2015-07-08)[2018-06-01].https://www.nice.org.uk/guidance/index.
[11] Gagnier J J, Kienle G, Altman D G, et al. The CARE guidelines:consensus-based clinical case reporting guideline development[J].BMJ Case Rep, 2013, 2013:bcr2013201554.
[12] Enger C, Cali C, Walker A M. Serious ventricular arrhythmias among users of cisapride and other QT-prolonging agents in the United States[J]. Pharmacoepidemiol Drug Saf, 2002, 11(6):477-486.
[13] Walker A M, Szneke P, Weatherby L B, et al. The risk of serious cardiac arrhythmias among cisapride users in the United Kingdom and Canada[J]. Am J Med, 1999, 107(4):356-362.
[14] Hennessy S, Leonard C E, Newcomb C, et al. Cisapride and ventricular arrhythmia[J]. Br J Clin Pharmacol, 2008, 66(3):375-385.
[15] Maclennan S, Augood C, Cash-Gibson L, et al. Cisapride treatment for gastro-oesophageal reflux in children[J]. Cochrane Database Syst Rev, 2010,(4):CD002300.
[16] Bohets H, Lavrijsen K, Hendrickx J, et al. Identification of the cytochrome P450 enzymes involved in the metabolism of cisapride:in vitro studies of potential co-medication interactions[J]. Br J Pharmacol, 2000, 129(8):1655-1667.
[17] Khongphatthanayothin A, Lane J, Thomas D, et al. Effects of cisapride on QT interval in children[J]. J Pediatr, 1998, 133(1):51-56.
[18] Hill S L, Evangelista J K, Pizzi A M, et al. Proarrhythmia associated with cisapride in children[J]. Pediatrics, 1998, 101(6):1053-1056.
[19] Piquette R K. Torsade de pointes induced by cisapride/clarithromycin interaction[J]. Ann Pharmacother, 1999, 33(1):22-26.
[2] Olsson S, Edwards I R. Tachycardia during cisapride treatment[J].BMJ, 1992, 305(6856):748-749.
[3] Barbey J T, Lazzara R, Zipes D P. Spontaneous adverse event reports of serious ventricular arrhythmias, QT prolongation, syncope, and sudden death in patients treated with cisapride[J]. J Cardiovasc Pharmacol Ther, 2002, 7(2):65-76.
[4] Smalley W, Shatin D, Wysowski D K, et al. Contraindicated use of cisapride:impact of food and drug administration regulatory action[J]. JAMA, 2000, 284(23):3036-3039.
[5] The European Agency for the Evaluation of Medicinal Products(EMEA/CPMP). Committee for proprietary medicinal products(CPMP)opinion following an article 31 referral cisapride[EB/OL].(2002-10-07)[2018-06-01]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Cisapride/human_referral_000160.jsp&mid=WC0b01ac05805c516f.
[6] Health Canada. Archived-Prepulsid(Cisapride)[EB/OL].(2000-05-30)[2018-06-01].http://healthycanadians.gc.ca/recall-alert-rappelavis/hc-sc/2000/14309a-eng.php?_ga=2.123543107.999978895.1523262834-1731413748.1523262834#affected-touches.
[7] Therapeutic Goods Administration(TGA). Restriction of indications for cisapride[EB/OL].(2002-12)[2018-06-01]. https://www.tga.gov.au/sites/default/files/aadrb-0012.pdf.
[8] The Cochrane Collaboration. Cochrane handbook for systematic reviews of interventions version 5.1.0[EB/OL].(updated 2011-03)[2018-06-01]. http://handbook-5-1.cochrane.org/.
[9] Ottawa Hospital Research Institute. The Newcastle-Ottawa Scale(NOS)for assessing the quality of nonrandomised studies in meta-analyses[EB/OL].(2015-07-05)[2018-06-01]. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp.
[10] National Institute for Health and Care Excellence(NICE). Appendix4 quality of case series form[EB/OL].(2015-07-08)[2018-06-01].https://www.nice.org.uk/guidance/index.
[11] Gagnier J J, Kienle G, Altman D G, et al. The CARE guidelines:consensus-based clinical case reporting guideline development[J].BMJ Case Rep, 2013, 2013:bcr2013201554.
[12] Enger C, Cali C, Walker A M. Serious ventricular arrhythmias among users of cisapride and other QT-prolonging agents in the United States[J]. Pharmacoepidemiol Drug Saf, 2002, 11(6):477-486.
[13] Walker A M, Szneke P, Weatherby L B, et al. The risk of serious cardiac arrhythmias among cisapride users in the United Kingdom and Canada[J]. Am J Med, 1999, 107(4):356-362.
[14] Hennessy S, Leonard C E, Newcomb C, et al. Cisapride and ventricular arrhythmia[J]. Br J Clin Pharmacol, 2008, 66(3):375-385.
[15] Maclennan S, Augood C, Cash-Gibson L, et al. Cisapride treatment for gastro-oesophageal reflux in children[J]. Cochrane Database Syst Rev, 2010,(4):CD002300.
[16] Bohets H, Lavrijsen K, Hendrickx J, et al. Identification of the cytochrome P450 enzymes involved in the metabolism of cisapride:in vitro studies of potential co-medication interactions[J]. Br J Pharmacol, 2000, 129(8):1655-1667.
[17] Khongphatthanayothin A, Lane J, Thomas D, et al. Effects of cisapride on QT interval in children[J]. J Pediatr, 1998, 133(1):51-56.
[18] Hill S L, Evangelista J K, Pizzi A M, et al. Proarrhythmia associated with cisapride in children[J]. Pediatrics, 1998, 101(6):1053-1056.
[19] Piquette R K. Torsade de pointes induced by cisapride/clarithromycin interaction[J]. Ann Pharmacother, 1999, 33(1):22-26.