甲硝唑不良反应的国内外文献分析

Analysis on domestic and foreign case report on the adverse drug reaction of metronidazole

目的分析国内外甲硝唑引起的不良反应并分析其一般规律,为临床合理安全用药提供依据。方法以"甲硝唑"为关键词检索2002年1月-2012年12月CNKI与CALIS系统中有关不良反应的个案报道,对用药原因、给药剂量、不良反应发生时间、临床表现等进行回顾性分析。结果 75例患者中国内以静脉滴注给药居多占55.0%,国外口服给药占80.0%;联合用药34例占45.3%,单独用药41例占54.7%;选择甲硝唑治疗的原因主要包括牙周疾病占22.7%、预防感染占22.7%、生殖系统占14.7%及胃肠道感染占12.0%等;甲硝唑的主要不良反应为全身性损害占29.3%、皮肤及附件损害占22.3%、神经系统损害占13.3%等,出现不良反应的日剂量集中在≥0.5g占84.0%,不良反应发生时间集中在给药后3d内占76.0%。结论甲硝唑常规剂量口服较安全但临床仍应重视其不良反应的危害性,尽量避免长期与大剂量使用。

OBJECTIVE To analyze the adverse drug reaction （ADR） and the general law of metronidazole from domestic and foreign case report so as to provide reference for the clinical rational use of drugs. METHODS The retrospective analysis was made on pathogeny, dosage, adverse reaction onset time and clinical manifestations by collecting the case reports using ＂metronidazole＂ as a key word to research from CNKI and CALIS database （Jan 2002-Jan 2012）. RESULTS In the total 75 cases, domestic cases mostly used intravenous infusion, which accoun- ted for 55.0%, and foreign cases mostly used oral administration, which accounted for 80.0%. There were 34 cases with combined use of drugs, accounting for 45.3%, as well as 41 cases of single medication, accounting for 54.7%. The etiology on using metronidazole mainly included periodontal disease （22.7%）, infection prevention （22.7 % ）, reproductive system infection （14.7 %） and alimentary infection（12.0 %）. The main adverse reaction of metronidazole included systematic disorders （29.3 %）, skin and accessory disorders （22.3 %） and nervous sys- tem disorders（13.3%）. The daily dose causing adverse reaction was equal or greater than 0.5 g, accounting for 84%. The adverse reaction happened usually 3 days after the administration, accounting for 76%. CONCLUSION Metronidazole is safe for oral conventional dosage, but the clinical doctors should pay more attention to the dangers of ADRs, and avoid long-term and high-dosage of metronizadole.