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Abstract

Vol.68 No.6 November 2020

Safety and effectiveness of metronidazole injection: A drug use-results survey

Masashi Katsuura1), Noriko Sugiyama2), Momoko Kaneko2), Takumi Koyama2) and Naomi Sugimoto1)

1)Post Marketing Study Strategy and Management, Pfizer R&D Japan G.K., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan
2)Biometrics and Data Management, Pfizer R&D Japan G.K.

Abstract

Metronidazole (MNZ) injection (ANAEMETRO Intravenous infusion 500 mg) was approved for the treatment of anaerobic infections, infectious enterocolitis, including pseudomembranous colitis, and amebic dysentery in July 2014. We conducted a drug use-results survey to evaluate the safety and effectiveness of MNZ injection used in routine medical practice in Japan. In an analysis of 107 patients, the percentages of male patients and patients ≥65 years of age were comparatively high, at 64.5% and 62.6%, respectively. The diagnoses included anaerobic infection in 74 patients, infectious enterocolitis in 23 patients, amebic dysentery in 7 patients, and anaerobic infection with infectious enterocolitis in 3 patients. Seven patients developed 10 adverse drug reactions (ADRs), representing an incidence rate of 6.54%. The common ADRs were nausea and liver disorder, occurring at an incidence rate of 1.87% each. One patient developed a serious liver disorder, which was a serious ADR. Two patients developed 2 unpredictable ADRs, namely, tongue discoloration and serious liver disorder. One patient developed an ADR involving the central nervous system. Overall, the clinical response to MNZ injection was classified as effective in 91 patients, ineffective in 4 patients, and indeterminate in 12 patients; the overall clinical response rate was 95.8%. When evaluated by the diagnosis, the clinical response rate was 93.8% in patients with anaerobic infection and 100.0% in those with infectious enterocolitis, amebic dysentery, and anaerobic infection with infectious enterocolitis. The microbiological response was rated as eradicated in 13 patients, presumed eradicated in 22 patients, and indeterminate in 72 patients; the rate of eradication was 100.0%. When evaluated by the causative microorganism, the clinical response rates were 100.0% for Bacteroides thetaiotaomicron and Fusobacterium spp. in patients with anaerobic infection, for Clostridioides (Clostridium) difficile in patients with infectious enterocolitis, for Entamoeba histolytica in patients with amebic dysentery, and for C. difficile in patients with anaerobic infection with infectious enterocolitis. The eradication rate was 100.0% for Fusobacterium spp. in patients with anaerobic infection. The eradication rate of C. difficile in patients with infectious enterocolitis was 85.7%. The eradication rate of E. histolytica in patients with amebic dysentery was 100%. In conclusion, MNZ injection is effective for the treatment of infections caused by anaerobic bacteria, infectious enterocolitis, and amebic dysentery. No specific concerns with respect to drug safety were identified.

Key word

metronidazole, postmarketing surveillance, effectiveness, safety

Received

June 4, 2020

Accepted

September 8, 2020

Jpn. J. Chemother. 68 (6): 632-645, 2020