关键词: 非达霉素, 万古霉素, 艰难梭菌感染, 临床治愈率, 复发率

Abstract:

To compare the efficacy and safety of fidaxomicin and vancomycin for the treatment of patients with Clostridium difficile infection (CDI), randomized controlled trials (RCTs) of fidaxomicin versus vancomycin for the treatment of CDI published in Pubmed, Embase, Web of Science and the Cochrane library were searched. Two reviewers independently extracted the data. The primary outcome was the rates of clinical cure. The secondary endpoints were the rates of CDI recurrence in the 4 weeks period after the end of therapy and rates of global cure, adverse events. Meta-analysis was performed using the Mantle-Haenszel fixed effect method (FEM). Odds ratios (ORs) with 95% confidence intervals (95% CIs) were reported. The results indicated that two large randomized controlled trials were included in the meta-analysis. Clinical cure with fidaxomicin was similar to with vancomycin both in the modified intention to treat (OR = 1.17, 95% CI 0.82-1.66, P = 0.40) and in the per-protocol population (OR = 1.24, 95% CI 0.80-1.92, P = 0.34). There were no significant differences in the rates of clinical cure between fidaxomicin and vancomycin in the subgroups analyzed by age, patients’ status, and previous CDI, infection with B1 strain, severity baseline, and exposure to concomitant antibiotics. Recurrence of CDI was significantly less common among fidaxomicin-treated patients compared with vancomycin-treated patients both in the modified intention-to-treat population (OR = 0.47, 95% CI 0.34-0.65, P<0.00001) and in the per-protocol population (OR = 0.45, 95% CI 0.31-0.62, P<0.0001). Treatment with fidaxomicin compared with vancomycin was associated with significantly higher rates of global cure both in the modified intention-to-treat population (OR = 1.75, 95% CI 1.35–2.27, P<0.0001) and in the per-protocol population (OR = 1.86, 95% CI 1.40-2.47, P<0.0001). Our meta-analysis suggests that fidaxomicin is not superior to vancomycin in rates of clinical cure, while fidaxomicin significantly decreases the rates of CDI recurrence and significantly improves the rates of global cure compared with vancomycin. Thus, fidaxomicin is a promising candidate for treatment of the CDI, especially in decreasing the rates of CDI recurrence and improving the rates of global cure.

Key words: Fidaxomicin, Vancomycin, Clostridium difficile infection, Clinical cure, Recurrence