Ippolito G, Puro V
Centro di Riferimento AIDS-Servizio di Epidemiologia delle Malattie Infettive, Ospedale L. Spallanzani, Rome, Italy.
Am J Med. 1997 May 19;102(5B):58-62. doi: 10.1016/s0002-9343(97)00064-8.
To evaluate the toxicity of zidovudine (ZDV) prophylaxis in human immunodeficiency virus (HIV)-exposed healthcare workers (HCWs) in Italy, a national protocol for postexposure prophylaxis has been implemented and a national registry has been established. All Italian clinical centers licensed to dispense ZDV participate. As of December 1995, data from 674 individuals who received ZDV prophylaxis have been collected. In three cases ZDV was used in combination with either didanosine (DDI) or dideoxycytidine (DDC). In 556 cases (82%), the daily dose of ZDV was 1,000 mg/day; 21 HCWs (3%) were treated with 300-800 mg/day, and in 72 persons (11%) the dose was 1,200-3,000 mg/day. A total of 332 (49%) HCWs reported at least one adverse effect; 132 (20%) discontinued prophylaxis because of side effects (40% of those reporting side effects). Nausea was reported in 243 cases; other side effects included vomiting, gastric pain, diarrhea, asthenia, and headache. Most constitutional adverse effects were reported during the first week of prophylaxis. Grade 1 anemia (hemoglobin 9.5-11 g/dL) occurred in 10 cases (3%); in 2 cases, the neutrophil count decreased to <1,000 cells/mm3. A transient increase of serum alanine aminotransferase to three times the upper limit of normal was observed in 7 persons. All side effects were reversible after the prophylaxis was stopped. Among those reporting at least one side effect the mean duration of treatment was 22 days; for HCWs reporting hematologic or liver adverse effects the mean length of treatment was 34 days. A total of 351 HCWs (54.6%) ceased the treatment before the scheduled 1-month period. In the 132 persons who discontinued treatment because of side effects, the mean length of prophylaxis was 8 days. One HCW seroconverted after conjunctival exposure to blood. The short-term toxicity of ZDV prophylaxis is frequent, mild, dose related, and reversible. Further studies are needed to assess the risk of long-term sequelae of this treatment as well as of prophylaxis with combinations of antiretroviral drugs.
为评估齐多夫定（ZDV）预防用药对意大利接触人类免疫缺陷病毒（HIV）的医护人员（HCWs）的毒性，已实施一项全国性的暴露后预防方案，并建立了一个全国性登记处。所有获许可分发ZDV的意大利临床中心均参与其中。截至1995年12月，已收集到674名接受ZDV预防用药者的数据。有3例ZDV与去羟肌苷（DDI）或双脱氧胞苷（DDC）联合使用。在556例（82%）中，ZDV的每日剂量为1000毫克/天；21名医护人员（3%）接受300 - 800毫克/天的治疗，72人（11%）的剂量为1200 - 3000毫克/天。共有332名（49%）医护人员报告至少出现一种不良反应；132名（20%）因副作用停止预防用药（占报告有副作用者的40%）。243例报告有恶心症状；其他副作用包括呕吐、胃痛、腹泻、乏力和头痛。大多数全身性不良反应在预防用药的第一周出现。10例（3%）出现1级贫血（血红蛋白9.5 - 11克/分升）；2例中性粒细胞计数降至<1000个/立方毫米。7人血清丙氨酸转氨酶短暂升高至正常上限的3倍。预防用药停止后，所有副作用均可逆。在报告至少一种副作用的人中，平均治疗持续时间为22天；报告有血液学或肝脏不良反应的医护人员平均治疗时长为34天。共有351名医护人员（54.6%）在预定的1个月疗程前停止治疗。在因副作用而停止治疗的132人中，预防用药的平均时长为8天。1名医护人员在结膜接触血液后发生血清转化。ZDV预防用药的短期毒性常见、轻微、与剂量相关且可逆。需要进一步研究来评估这种治疗以及抗逆转录病毒药物联合预防用药的长期后遗症风险。
