Abstract:

Objective: To establish a multidimensional clinical comprehensive evaluation system for anti-tuberculosis drugs encompassing safety, effectiveness, economy, innovation, suitability, and accessibility, thereby providing a reference for rational drug use, new drug selection, and drug formulary optimization in healthcare institutions. Methods: Based on the indicator framework in the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Second Edition), the Delphi method was employed to screen and revise indicators, and to establish an evaluation framework tailored to anti-tuberculosis drugs. The analytic hierarchy process (AHP) was used to assign the weight of each indicator, forming a complete and quantifiable comprehensive evaluation system. An empirical evaluation was conducted on 6 drugs using for the treatment of multidrug-resistant tuberculosis (MDR-TB), including levofloxacin tablets, moxifloxacin hydrochloride tablets, linezolid tablets, clofazimine soft capsules, bedaquiline fumarate tablets and cycloserine capsules. Results: After two rounds of Delphi consultation with 15 experts, a comprehensive clinical evaluation system for anti-tuberculosis drugs was finally established, covering 6 dimensions (effectiveness, safety, economy, suitability, innovation and accessibility), the system comprised 6 first-level indicators, 20 second-level indicators and 35 third-level indicators. The questionnaire response rate reached 100.0%, the authority coefficient was 0.824 and the Kendall’s W for the final indicator system was 0.266 (P<0.001), indicating a high level of consensus among experts. By integrating the AHP judgment matrices from the 15 experts and passing the consistency test (CR<0.1), reliable indicator weights were obtained. The empirical evaluation results showed that the scores of levofloxacin tablets, moxifloxacin hydrochloride tablets, linezolid tablets, clofazimine soft capsules, bedaquiline fumarate tablets, and cycloserine capsules were 81.17, 67.17, 65.57, 62.77, 60.92, and 57.69, respectively, which were consistent with clinical practice. Conclusion: The anti-tuberculosis drug clinical comprehensive evaluation system constructed in this study aligns highly with the objectives and requirements of drug clinical comprehensive evaluation and demonstrates good scientific validity and practicality. It not only serves as a valuable reference for rational drug use, new drug selection, and drug formulary optimization in medical institutions but also provides a scientific foundation for regional health policy development.

Key words: Tuberculosis, Delphi technique, Drug evaluation, Systems integration, Analytic hierarchy process