论文部分内容阅读
目的:对比研究阿莫西林和阿莫西林-克拉维酸钾的不良反应,为临床安全用药提供参考。方法:收集解放军药品不良反应监测中心数据库2000年3月至2010年3月阿莫西林和阿莫西林-克拉维酸钾的不良反应报告,并进行回顾性分析。报告的病例分为阿莫西林组和阿莫西林-克拉维酸钾组,比较2组药物的不良反应在临床表现、转归、严重性、对原患疾病影响及发生时间等方面的差异。结果:共收集到576份阿莫西林和阿莫西林-克拉维酸钾不良反应报告。其中438份阿莫西林不良反应报告涉及814例次不良反应1,38份阿莫西林-克拉维酸钾不良反应报告涉及233例次不良反应。阿莫西林组男性220例,女性218例,平均年龄(36.4±19.0)岁;阿莫西林-克拉维酸钾组男性62例,女性76例,平均年龄(40.4±20.9)岁。阿莫西林组和阿莫西林-克拉维酸钾组患者出现皮肤及附件、胃肠、循环和中枢神经系统损害的构成比分别为77.4%(n=630)和55.8%(130)、5.3%(43)和19.7%(46)1、.3%(11)和4.3%(10)、1.3%(11)和4.3%(10);2组非严重和严重ADR病例的构成比分别为92.5%(405例)和97.8%(135例)7、.5%(33例)和2.2%(3例);对原患疾病影响明显和不明显患者的构成比分别为9.1%(40例)和1.4%(2例)9、0.9%(398例)和98.6%(136例);2组之间上述各项指标比较差异均有统计学意义(均P<0.05)。2组患者不良反应中位发生时间分别为3和1 d。结论:临床应用阿莫西林-克拉维酸钾治疗感染性疾病与阿莫西林相比似较为安全。
OBJECTIVE: To compare the adverse reactions of amoxicillin and amoxicillin-clavulanate potassium and provide a reference for clinical safety. Methods: The adverse reaction reports of amoxicillin and amoxicillin-clavulanate potassium from March 2000 to March 2010 in People’s Liberation Army Drug Adverse Reaction Monitoring Center were collected and analyzed retrospectively. The reported cases were divided into amoxicillin group and amoxicillin-clavulanate group. The adverse reactions of the two groups were compared in terms of clinical manifestations, prognosis, severity, impact on the original disease and time of onset. Results: A total of 576 amoxicillin and amoxicillin-clavulanate potassium adverse reactions were collected. Among them, 438 reports of adverse reactions of amoxicillin involved 814 adverse reactions and 1,38 reports of adverse reactions of amoxicillin-clavulanate involved 233 adverse reactions. There were 220 males and 218 females with an average age of (36.4 ± 19.0) years in the amoxicillin group, 62 males and 76 females in the amoxicillin-clavulanate group, with an average age of (40.4 ± 20.9) years. The constituent ratios of skin, appendages, gastrointestinal, circulatory and central nervous system lesions in amoxicillin and amoxicillin-clavulanate groups were 77.4% (n = 630) and 55.8% (130), respectively, with 5.3% (43) and 19.7% (46), 1.3% (11) and 4.3% (10), 1.3% (11) and 4.3% (10) respectively. The two groups of non-severe and severe ADR were 92.5 (405 cases), 97.8% (135 cases), 7.5% (33 cases) and 2.2% (3 cases). The proportions of patients with obvious or insignificant disease were 9.1% (40 cases) , 0.9% (398 cases) and 98.6% (136 cases) in 1.4% (2 cases) and 0.9% (2 cases). There was significant difference in the above indexes between the two groups (all P <0.05). The median time to adverse reactions in the two groups was 3 and 1 d, respectively. Conclusion: The clinical application of amoxicillin-clavulanate in the treatment of infectious diseases is more safe than amoxicillin.