Department of Clinical Pharmacy, Faculty of Pharmacy, Universitas Airlangga, Surabaya, Indonesia.
Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia.
J Basic Clin Physiol Pharmacol. 2021 Jun 25;32(4):421-427. doi: 10.1515/jbcpp-2020-0415.
Indonesia is one of the top 20 countries with the highest prevalence of drug resistant tuberculosis (DR-TB) worldwide with a percentage of new cases of 2.4% and retreatment of 13%. Bedaquiline (BDQ) is one of the drugs that used in the individual long regimen treating DR-TB. BDQ is also combined with levofloxacin (LFX) and/or clofazimine (CFZ) that can cause QTc interval prolongation. The aim was to study the differences in the use of BDQ regimens to the lengthening of the QTc interval and to study risk factors (diabetes, hypokalemia, sex, BMI, and age) in BDQ regimen.
This study was an observational retrospective study with a total sampling method, which was conducted at Dr. Soetomo General Hospital Surabaya. Samples from this study were patients diagnosed with DR-TB at Dr. Soetomo General Hospital Surabaya in the period of January 2015-December 2019 who used BDQ regimen and met the inclusion criteria. The ECG data were analyzed from the mean of each group (BDQ regimen and risk factors), also analyzed using statistical analysis.
Data obtained from total sample in this study were 73 patients. The most widely used different regimens in this study were the combination of BDQ + LFX by 36 patients (49.3%), BDQ + LFX + CFZ by 16 patients (21.9%), BDQ by 11 patients (15.1%) and BDQ + CFZ 10 patients (13.7%). Out of 73 patients, 52 patients (71.2%) experienced lengthening of the QT interval and grade 1 of QTc interval prolongation occurred in most patients and also the onset was mostly one month after using BDQ regimen. The side effects of QTc interval prolongation from groups of combination and risk factors were no difference in each month (p>0.05).
This study can be concluded that there were no differences in the QTc prolongation between the groups of BDQ regimen (BDQ, BDQ + LFX, BDQ + CFZ and BDQ + LFX + CFZ) and the groups of risk factors.
印度尼西亚是全球耐药结核病（DR-TB）患病率最高的 20 个国家之一，新发病例比例为 2.4%，复治比例为 13%。贝达喹啉（BDQ）是治疗 DR-TB 的个体长程方案中使用的药物之一。BDQ 还与左氧氟沙星（LFX）和/或氯法齐明（CFZ）联合使用，可能导致 QTc 间期延长。目的是研究 BDQ 方案的使用差异对 QTc 间期的延长，并研究 BDQ 方案中的危险因素（糖尿病、低钾血症、性别、BMI 和年龄）。
这是一项观察性回顾性研究，采用总抽样法，在泗水苏加诺博士综合医院进行。本研究的样本为 2015 年 1 月至 2019 年 12 月在泗水苏加诺博士综合医院诊断为 DR-TB 并符合纳入标准的患者。从每个组（BDQ 方案和危险因素）的平均值分析心电图数据，并进行统计学分析。
本研究总样本量为 73 例。本研究中最广泛使用的不同方案是 36 例患者（49.3%）使用 BDQ+LFX 联合方案，16 例患者（21.9%）使用 BDQ+LFX+CFZ 联合方案，11 例患者（15.1%）使用 BDQ 方案，10 例患者（13.7%）使用 BDQ+CFZ 联合方案。在 73 例患者中，52 例（71.2%）出现 QT 间期延长，其中大部分患者出现 1 级 QTc 间期延长，且大多数患者在使用 BDQ 方案后 1 个月开始出现。BDQ 方案和危险因素组的 QTc 间期延长的副作用在每个月均无差异（p>0.05）。
本研究表明，BDQ 方案（BDQ、BDQ+LFX、BDQ+CFZ 和 BDQ+LFX+CFZ）组与危险因素组之间 QTc 延长无差异。
