Weber E, Jacubeit T, Auwärter A, Ding R, Gutzler F, Mörike K, Walter-Sack I
Medizinische Universitätsklinik, Abteilung Klinische Pharmakologie, Heidelberg.
Infection. 1987;15 Suppl 5:S241-7. doi: 10.1007/BF01643197.
This study concerns the incidence of side effects occurring in connection with the prescription of co-trimoxazole which, according to the observations of medical practitioners, were suspected of being drug related. It is based on reports from 260 doctors in the Nordbaden/Rheinlandpfalz area between 1981 and 1984, as well as on those from hospital doctors concerning 33,300 in-patients at the Department of Internal Medicine at the University Hospital of Heidelberg from 1980 to 1983. General practitioners' reports: Of 3,739 side effects reported over a three and a half year period, 180 were related to drugs containing co-trimoxazole. Side effects were 3.3 times as frequent with the "forte" dosage as compared to the 80 mg trimethoprim/400 mg sulfamethoxazole preparation. The most frequently cited unwanted reactions concerned the skin (n = 63, of which two were Quincke oedema and three were urticarious reactions) and the gastrointestinal tract (n = 52), as well as disturbance of well being (n = 30). Gastro-intestinal disturbances appeared to occur more frequently after a higher than after a lower dosage. Clinicians' reports: During the period of observation an average of 12.6% of all in-patients were treated with drugs containing co-trimoxazole. The total number of cases of side effects due to this drug amounted to 255. Serious reactions included: two anaphylactic reactions; two thrombocytopenias below 80,000/mm3; and two cases of Lyell's syndrome (one of which could not be confirmed beyond all doubt). Side effects occurred more often after i.v. than after oral application.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究关注与复方新诺明处方相关的副作用发生率,据医生观察,这些副作用疑似与药物有关。该研究基于1981年至1984年期间北巴登/莱茵兰普法尔茨地区260名医生的报告,以及1980年至1983年期间海德堡大学医院内科33300名住院患者的医院医生报告。全科医生报告:在三年半的时间里报告的3739例副作用中,180例与含复方新诺明的药物有关。“强力”剂型的副作用发生率是80毫克甲氧苄啶/400毫克磺胺甲恶唑制剂的3.3倍。最常提及的不良反应涉及皮肤(n = 63,其中2例为昆克水肿,3例为荨麻疹反应)、胃肠道(n = 52)以及健康状况紊乱(n = 30)。胃肠道紊乱似乎在高剂量后比低剂量后更频繁发生。临床医生报告:在观察期间,平均12.6%的住院患者接受了含复方新诺明的药物治疗。该药物导致的副作用病例总数为255例。严重反应包括:2例过敏反应;2例血小板减少症,血小板计数低于80,000/mm³;以及2例莱尔综合征(其中1例无法完全确诊)。静脉注射后副作用比口服后更常发生。(摘要截选至250字)