Kusmiati Tutik, Made Mertaniasih Ni, Nugroho Eko Putranto Johanes, Suprapti Budi, Luthfah Nadya, Soedarsono Soedarsono, Koesoemoprodjo Winariani, Prawita Sari Aryani
Doctoral Program of Medical Science, Faculty of Medicine, Universitas Airlangga, Indonesia.
Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, Indonesia.
J Clin Tuberc Other Mycobact Dis. 2022 Jun 6;28:100320. doi: 10.1016/j.jctube.2022.100320. eCollection 2022 Aug.
Drug-resistant tuberculosis (DR-TB) continues to be a global threat. Moxifloxacin is one of the components of the shorter treatment regimen which is suspected to increase the risk of QT prolongation, although it is also likely to be the most effective against DR-TB. A study to evaluate the correlation between the concentration of moxifloxacin and QTc interval in RR-TB patients who received shorter regimens is needed.
This was an observational study in 2 groups of RR-TB patients on shorter treatment regimens (intensive phase and continuation phase), contain moxifloxacin with body weight-adjusted dose. Blood samples were collected at 2 h after taking the 48th-hour dose and 1 h before taking the 72nd-hour dose.
Forty-five RR-TB patients were included in this study. At 2 h after taking the 48th-hour dose, the mean of QTc interval in intensive phase and continuation phase was 444.38 ms vs. 467.94 ms, p = 0.026, while mean of moxifloxacin concentration in intensive phase and continuation phase was 4.3 µg/mL vs. 4.61 µg/mL, p = 0.686). At 1 h before taking the 72nd-hour dose, both moxifloxacin concentration and QTc interval in intensive phase and continuation showed no significant difference with p-value of 0.610 and 0.325, respectively. At 2 h after taking the 48th-dose, moxifloxacin concentration did not correlate with QTc interval, both in intensive phase (p = 0.576) and in continuation phase (p = 0.691). At 1 h before taking the 72nd-hour dose, moxifloxacin concentration also did not correlate with QTc interval in intensive phase (p = 0.531) and continuation phase (p = 0.209).
Our study found that moxifloxacin concentration did not correlate with QTc interval, which indicates the safe use of moxifloxacin on QTc interval. In addition to close monitoring of QTc interval, the clinicians should also consider other variables which potentially increase risk for QTc prolongation in DR-TB patients who received shorter treatment regimens.
耐多药结核病（DR-TB）仍然是一个全球性威胁。莫西沙星是较短疗程治疗方案的组成部分之一，尽管它可能是治疗耐多药结核病最有效的药物，但怀疑其会增加QT间期延长的风险。需要开展一项研究来评估接受较短疗程治疗方案的耐多药结核病患者中莫西沙星浓度与QTc间期之间的相关性。
这是一项针对两组接受较短疗程治疗方案（强化期和继续期）的耐多药结核病患者的观察性研究，治疗方案中含有根据体重调整剂量的莫西沙星。在服用第48小时剂量药物后2小时和服用第72小时剂量药物前1小时采集血样。
本研究纳入了45例耐多药结核病患者。在服用第48小时剂量药物后2小时，强化期和继续期的QTc间期平均值分别为444.38毫秒和467.94毫秒，p = 0.026，而强化期和继续期的莫西沙星浓度平均值分别为4.3微克/毫升和4.61微克/毫升，p = 0.686）。在服用第72小时剂量药物前1小时，强化期和继续期的莫西沙星浓度和QTc间期均无显著差异，p值分别为0.610和0.325。在服用第48剂药物后2小时，强化期（p = 0.576）和继续期（p = 0.691）的莫西沙星浓度与QTc间期均无相关性。在服用第72小时剂量药物前1小时，强化期（p = 0.531）和继续期（p = 0.209）的莫西沙星浓度与QTc间期也无相关性。
我们的研究发现莫西沙星浓度与QTc间期无相关性，这表明莫西沙星在QTc间期方面的使用是安全的。除密切监测QTc间期外，临床医生还应考虑其他可能增加接受较短疗程治疗方案的耐多药结核病患者QTc间期延长风险的变量。
