Optimized duration of antituberculosis treatment for managing female genital tuberculosis: real-world experience from a high prevalence region in Eastern China

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT. Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9–12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 15–35 years) and group B (aged ≥ 36 years). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis ( P < 0.05), severer performance of genital lesions and pelvic adhensions ( P < 0.05), more signs of active pulmonary tuberculosis ( P < 0.01), and less performance of only TBP ( P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B ( P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate ( P < 0.01) and similar incidence of side effects ( P > 0.05) in group A, similar complete response rate ( P > 0.05) and increased incidence of overall single side effects ( P < 0.05) in group B at 9-mo duration. Conclusions Younger females with FGTB had a greater risk of systemic infection of TB compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for improving the side effects and poor compliance in the duration of treatment.