Abstract:

Objective: To analyze the effectiveness and safety of modified all-oral short course chemotherapy in the treatment of multidrug-resistant pulmonary tuberculosis (MDR-PTB). Methods: A prospective study was conducted in 22 MDR-PTB patients diagnosed in the Infectious Disease Hospital of Heilongjiang Province from April 2020 to April 2021 according to the inclusion criteria. The patients were treated with a modified short all-oral course chemotherapy regimen (6Lfx(Mfx)-Bdq-Lzd-Cfz-Cs/3Lfx(Mfx)-Lzd-Cfz-Cs). The changes of sputum smear, sputum culture, chest CT and adverse events were assessed during treatment. The main outcome indicators were culture negative conversion rate and treatment success rate and the secondary outcome indicator was the time of sputum culture negative conversion. Results: Of the 22 enrolled patients, 15 patients (68.2%) were male and the average age was (40±11) years old. All of the patients completed the 9-month therapy. The total success rate of treatment was 100.0% with no failure, lost to follow up or death at the end of treatment. During treatment, the cumulative sputum smear negative conversion rate, culture negative conversion rate, effective rate of chest lesions absorption and the improvement rate of cavities all increased gradually with the extension of treatment time. The effective rate of chest lesions absorption and the improvement rate of cavities both reached 100.0% (22/22 and 10/10, respectively) after 12-week treatment; the sputum smear negative conversion rate reached 100.0% (22/22) after 16-week treatment; the culture negative conversion rate reached 100.0% (22/22) after 20-week treatment. A total of 61 adverse events were reported in 21 patients (95.5%). However, no serious adverse event was observed and the treatment outcomes were not influenced. The most frequently reported adverse events were peripheral neuropathy (18 patients, 81.8%), gastrointestinal discomfort (15 patients, 68.2%) and QTc prolongation (14 patients, 63.6%). Conclusion: The modified short all-oral course chemotherapy regimen achieved a high treatment success rate with shortened treatment course and satisfactory safety, and it is worthy to be promoted in clinic.

Key words: Tuberculosis, multidrug resistance, Drug therapy, Clinical protocols, Feasibility studies, Treatment outcome