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一项评估结核病治疗药物监测系统的随机对照试验。

A randomised controlled trial to evaluate a medication monitoring system for TB treatment.

机构信息

Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Peru.

Instituto Nacional de Salud, Lima, Peru.

出版信息

Int J Tuberc Lung Dis. 2022 Jan 1;26(1):44-49. doi: 10.5588/ijtld.21.0373.

Abstract

Adherence to TB treatment and therefore treatment success could be improved using digital adherence technology. To evaluate the effectiveness of a medication event reminder monitor system (MERM) on treatment success and treatment adherence in patients with drug-susceptible pulmonary TB in Perú. This was an experimental, randomised, open-label, controlled study conducted among patients in the second phase of TB treatment. The intervention group received their medications through MERM with the support of a treatment monitor, whereas the control group used the usual strategy. Participants were followed until they completed the 54 doses of the second phase of treatment. The study included 53 patients in each group; four in the intervention group withdrew from the study. Treatment success was significantly more frequent in the MERM group (RR 1.15, 95% CI 1.02-1.30; = 0.0322). There was no significant difference in the adherence outcomes; however, the percentage of patients who missed at least one dose and patients with more than 10% of total doses missed were lower in the intervention group. The use of MERM in the second phase of treatment showed a significant improvement in the treatment success rate in patients with drug-susceptible pulmonary TB.

摘要

采用数字化服药提醒技术可提高结核病治疗的依从性,进而提高治疗成功率。本研究旨在评估秘鲁耐多药肺结核患者应用药物事件提醒监测系统(MERM)对治疗成功率和治疗依从性的影响。该研究为实验性、随机、开放标签、对照研究,纳入处于结核病治疗第二阶段的患者。干预组患者采用 MERM 服药并接受治疗监测员的支持,对照组采用常规策略。两组患者均随访至完成第二阶段的 54 剂治疗。每组纳入 53 例患者,干预组中有 4 例患者退出研究。MERM 组的治疗成功率显著更高(RR 1.15,95%CI 1.02-1.30;P=0.0322)。两组患者的服药依从性结局无显著差异,但干预组至少漏服一剂的患者比例和总剂量漏服 10%以上的患者比例更低。MERM 用于结核病治疗第二阶段可显著提高耐多药肺结核患者的治疗成功率。

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