Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.
Medical Student, Aga Khan University, Karachi, Pakistan.
PLoS One. 2019 Jul 10;14(7):e0219324. doi: 10.1371/journal.pone.0219324. eCollection 2019.
Bacillus Calmette-Guérin (BCG) vaccine is given to newborns soon after birth. BCG vaccine overdose has been rarely reported. Here we report the outcome of newborns who accidently received high dose BCG at a tertiary care hospital, Karachi. We reviewed records of 26 newborns, who accidentally received intradermal high dose BCG, used for the treatment of urinary bladder cancers and 80 times higher dose than the BCG used for routine vaccination. The incident happened from 14-16th April, 2016 at Aga Khan University Hospital, Karachi. Analysis was carried out using SPSS. A total of 23/26(88.5%) newborns were followed for atleast 3 months and 11/26 (42.3%) were followed for atleast one year. 13/26 (50%) were male. All 26 patients were prescribed isoniazid and rifampicin for 3 months. 3/26 (11.5%) were lost to follow-up before completion of anti-tuberculous drugs (ATT). Lesions at the BCG site were observed in 16/26 (61.5%) infants, of which 15 (93.8%) had a papule, 3 (18.8%) developed a pustule, 3 (18.8%) had skin induration and 2 (12.5%) had skin erythema. Axillary lymphadenopathy was observed in 1/26 (3.8%) patient. Coagulation was deranged in 3/26 (11.5%) of babies. Intracranial bleeding was observed in 1/26 (3.8%) case. Localized skin lesions were the most common adverse events. None of them developed clinical tuberculosis. Chemoprophylaxis for inadvertent high dose BCG administration should be given for atleast 3 months. Furthermore, vigilant follow-up, transparency and disclosure are the vital steps in the management of any medical error.
卡介苗（BCG）疫苗于新生儿出生后不久接种。BCG 疫苗过量的情况很少见。在这里，我们报告了在卡拉奇的一家三级护理医院，意外接受高剂量 BCG 的新生儿的结果。我们回顾了 26 名意外接受膀胱癌治疗用皮下高剂量 BCG 的新生儿的记录，剂量是常规接种 BCG 疫苗的 80 倍。该事件发生于 2016 年 4 月 14 日至 16 日，地点在卡拉奇的 Aga Khan 大学医院。使用 SPSS 进行分析。共有 23/26（88.5%）名新生儿至少随访了 3 个月，11/26（42.3%）名新生儿至少随访了 1 年。13/26（50%）名新生儿为男性。所有 26 名患者均接受异烟肼和利福平治疗 3 个月。3/26（11.5%）名患者在完成抗结核药物（ATT）治疗前失访。26 名患者中，有 16/26（61.5%）名患者在 BCG 部位出现病变，其中 15 名（93.8%）为丘疹，3 名（18.8%）为脓疱，3 名（18.8%）为皮肤硬结，2 名（12.5%）为皮肤红斑。1 名（3.8%）患者出现腋窝淋巴结肿大。3/26（11.5%）名婴儿凝血功能异常。1 名（3.8%）患者出现颅内出血。局部皮肤病变是最常见的不良事件。他们均未出现临床结核病。意外给予高剂量 BCG 后应至少给予 3 个月的化学预防。此外，警惕随访、透明度和披露是管理任何医疗错误的关键步骤。
