Product Evaluation and Registration Unit, National Medicines and Food Administration, Asmara, Eritrea
Hazhaz Zonal Referral Hospital, Asmara, Eritrea.
BMJ Open Respir Res. 2021 Nov;8(1). doi: 10.1136/bmjresp-2021-001064.
Multidrug-resistant tuberculosis (MDR-TB) drugs have never been associated with erythrocytosis. In Eritrea, however, several cases of incident erythrocytosis had been observed in the MDR-TB hospital. This study was aimed at exploring the association between MDR-TB drugs and secondary erythrocytosis, characterising the cases, and identifying other possible risk factors.
A retrospective cohort study was conducted in Merhano National Referral MDR-TB hospital. Data were extracted from physically available clinical cards and laboratory results collected longitudinally between 23 June 2011 and 17 January 2021. Initially, univariate descriptive statistics (frequency, mean (SD), median (IQR) and range) were used as appropriate. Then, χ or Fisher χ test, and bivariate and/or multivariate Cox proportional hazard model were used to identify the predictors of incident erythrocytosis. All statistical analyses were conducted using R, and a two-sided alpha 0.05 was used to determine the statistical significance.
A total of 257 patients' medical cards were screened, and 219 were eligible for further analysis. The median age of the patients was 38 years (range: 13-90 years) and 54.8% were males. During the follow-up time, 31 (14.2%) patients developed secondary erythrocytosis yielding an incidence rate of 7.8 cases per 1000 person-months. On average, the median time to onset of the event was found to be 5-months (range: 1-24 months). Males were more likely to develop the event than females (adjusted HR=7.13, 95% CI=1.66 to 30.53), and as body weight increases by 1 kg, the likelihood of developing secondary erythrocytosis was found to increase by 7% (adjusted HR=1.07, 95% CI=1.03 to 1.10). Moreover, all cases of secondary erythrocytosis were found to be possibly associated with the MDR-TB drugs.
The authors hypothesised that the incident erythrocytosis is possibly be associated with MDR-TB drugs, and further studies are required to substantiate this finding.
多药耐药结核病（MDR-TB）药物从未与红细胞增多症有关。然而，在厄立特里亚，MDR-TB 医院观察到几例偶发性红细胞增多症病例。本研究旨在探讨 MDR-TB 药物与继发性红细胞增多症之间的关系，描述病例特征，并确定其他可能的危险因素。
在 Merhano 国家转诊 MDR-TB 医院进行了一项回顾性队列研究。数据从 2011 年 6 月 23 日至 2021 年 1 月 17 日期间纵向收集的临床病历和实验室结果中提取。最初，使用适当的单变量描述性统计（频率、均值（SD）、中位数（IQR）和范围）。然后，使用 χ 或 Fisher χ 检验，以及单变量和/或多变量 Cox 比例风险模型，确定偶发性红细胞增多症的预测因素。所有统计分析均使用 R 进行，双尾 α 0.05 用于确定统计学意义。
共筛选了 257 名患者的病历，其中 219 名符合进一步分析的条件。患者的中位年龄为 38 岁（范围：13-90 岁），54.8%为男性。在随访期间，31 名（14.2%）患者发生继发性红细胞增多症，发病率为每 1000 人月 7.8 例。平均而言，该事件的中位发病时间为 5 个月（范围：1-24 个月）。男性比女性更容易发生该事件（调整后的 HR=7.13，95%CI=1.66 至 30.53），体重每增加 1 公斤，发生继发性红细胞增多症的可能性增加 7%（调整后的 HR=1.07，95%CI=1.03 至 1.10）。此外，所有继发性红细胞增多症病例均与 MDR-TB 药物有关。
作者假设偶发性红细胞增多症可能与 MDR-TB 药物有关，需要进一步研究来证实这一发现。
