Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Health Economics Unit, Faculty of Health Sciences, School of Public Health and Family Medicine, Cape Town, South Africa.
Health Qual Life Outcomes. 2019 May 31;17(1):94. doi: 10.1186/s12955-019-1155-4.
Adverse events (AEs) are common during treatment of drug-resistant tuberculosis (DR-TB). Little is known about the health-related quality of life (HRQoL) of patients receiving treatment for DR-TB or the effect of AEs on HRQoL.
We conducted a cross-sectional study among adult patients with laboratory-confirmed rifampicin resistant tuberculosis (TB) on DR-TB treatment at a public-sector outpatient DR-TB clinic in Johannesburg, South Africa between 02/2015-01/2018. Data on HRQoL using the Medical Outcomes Short Form-36 (SF-36) questionnaire and self-reported AEs were collected by trained interviewers through face-to-face interviews. We report averages for the eight major domains and mental (MCS) and physical health (PCS) component summary scores, stratified by whether AEs were reported in the last four weeks. For comparative purposes, we enrolled two other patient groups and included data on a separate group of healthy adults.
We enrolled 149 DR-TB patients (median age 36 years IQR 29-43, 55% male, 77.9% HIV-positive, 81% on ART, 61.8% on a standard long-course regimen and 44.3% on DR-TB treatment for less than 6 months). 58/149 (38.9%) patients reported a total of 122 AEs in the preceding 4 weeks, of these the most common were joint pain (n = 22), peripheral neuropathy (n = 16), hearing loss (n = 15), nausea and vomiting (n = 12) and dizziness or vertigo (n = 11). SF-36 domains and summary scores (MCS and PCS) were lower in those who reported an AE compared to those who did not, and both were lower than healthy adults. Compared to those who did not report an AE, patients who reported AEs were more likely to have a low MCS (aRR 2.24 95% CI 1.53-3.27) and PCS (aRR 1.52 95% CI 1.07-2.18) summary score. HRQoL was lower among those on DR-TB treatment for 6 months or less.
Results show that DR-TB had a substantial impact on patients' quality of life, but that AEs during the early months on treatment may be responsible for reducing HRQoL even further. Our findings highlight the negative effects of injectable agents on HRQoL. Patients require an integrative patient-centered approach to deal with DR-TB and HIV and the potential overlapping toxicities which may be worsened by concurrent treatment.
在治疗耐药结核病（DR-TB）期间，不良事件（AEs）很常见。对于接受 DR-TB 治疗的患者的健康相关生活质量（HRQoL）或不良事件对 HRQoL 的影响知之甚少。
我们在南非约翰内斯堡的一家公立部门门诊 DR-TB 诊所对实验室确认的利福平耐药结核病（TB）患者进行了一项横断面研究，这些患者正在接受 DR-TB 治疗。通过经过培训的访谈员通过面对面访谈收集使用医疗结局短期表单 36（SF-36）问卷和自我报告的不良事件的 HRQoL 数据。我们报告了最后四周报告不良事件的情况下，八个主要领域和心理健康（MCS）和身体健康（PCS）综合评分的平均值。出于比较目的，我们还招募了另外两组患者，并纳入了一组健康成年人的数据。
我们招募了 149 名 DR-TB 患者（中位年龄 36 岁 IQR 29-43，55%男性，77.9%HIV 阳性，81%接受 ART，61.8%接受标准长程方案，44.3%DR-TB 治疗时间少于 6 个月）。149 名患者中有 58 名（38.9%）报告了过去 4 周内共发生 122 起不良事件，其中最常见的是关节痛（n=22）、周围神经病（n=16）、听力损失（n=15）、恶心和呕吐（n=12）以及头晕或眩晕（n=11）。与未报告不良事件的患者相比，报告不良事件的患者的 SF-36 领域和综合评分（MCS 和 PCS）较低，且均低于健康成年人。与未报告不良事件的患者相比，报告不良事件的患者更有可能出现较低的 MCS（ARR 2.24 95%CI 1.53-3.27）和 PCS（ARR 1.52 95%CI 1.07-2.18）综合评分。接受 6 个月或更短时间 DR-TB 治疗的患者的 HRQoL 较低。
结果表明，DR-TB 对患者的生活质量有重大影响，但治疗早期发生的不良事件可能会进一步降低 HRQoL。我们的研究结果突出了注射剂对 HRQoL 的负面影响。需要一种综合的以患者为中心的方法来治疗 DR-TB 和 HIV，以及潜在的重叠毒性，这些毒性可能会因同时治疗而恶化。
