Construction and clinical application of an innovative pharmacist-led service model for therapeutic drug monitoring in tuberculosis treatment: a pragmatic randomized controlled trial

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BACKGROUND: Therapeutic drug monitoring (TDM) is a well-established strategy for optimizing tuberculosis (TB) management. However, the conventional "physician-nurse-technician" TDM model often results in suboptimal drug concentrations, potentially leading to poor treatment outcomes. This study aimed to develop an innovative pharmaceutical service model for TDM of isoniazid (INH) and rifampicin (RFP) in drug-susceptible TB patients, and to assess its clinical effectiveness and safety through a pragmatic randomized controlled trial (PRCT). METHODS: A total of 489 TB patients undergoing first-line anti-TB treatment were enrolled and randomly assigned to a pharmacist-led multidisciplinary group or a control group. The intervention group received a pharmacist-led multidisciplinary model, which included TDM of INH and RFP, along with pharmaceutical care. In contrast, the control group received routine TDM-based treatment. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted to compare the safety and efficacy of the interventions. RESULTS: In the ITT analysis (n = 489), the pharmacist-led multidisciplinary model significantly increased the plasma concentrations of INH (χ²=5.016, P = 0.025) and RFP (χ²=38.410, P < 0.001), improved 1-month microbiological (adjusted OR = 1.855, 95%CI: 1.294-2.659) and culture conversion (aOR = 1.865, 95% CI: 1.237-2.811; n = 373), and enhanced 2-month cavity closure (aOR = 2.636, 95% CI: 1.435-4.844; n = 172). The intervention also reduced hospitalization duration by 4.1 days (95% CI: -7.134 to -1.102) and neutropenia risk (aOR = 0.611, 95% CI: 0.393-0.950). Per-protocol analyses confirmed consistent treatment effects (all point estimates within ± 10% of ITT results). CONCLUSION: This study develops an innovative pharmaceutical service model for drug-susceptible TB patients. The model achieves higher plasma concentrations of INH and RFP, improves treatment efficacy, and reduces the incidence of neutropenia. These findings highlight the clinical significance and potential application value of this model in optimizing TB management. TRIAL REGISTRATION: Registration number: ChiCTR2300074328. Registration Platform: Chinese Clinical Trial Registry ( https://www.chictr.org.cn/ ). MR-61-24-012842 (registration time: 2023-08-03).

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