Effectiveness of Two Tinidazole Regimens in Treatment of Bacterial Vaginosis  

Oleh:

Livengood, Charles H. ; Ferris, Daron G. ; Wiesenfeld, Harold C. ; Hillier, Sharon L ; Soper, David E. ; Nyirjesy, Paul ; Marrazzo, Jeanne ; Chatwani, Ashwin ; Fine, Paul ; Sobel, Jack D. ; Taylor, Stephanie N ; Wood, Lindsey ; Kanalas, John J.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Obstetrics and Gynecology vol. 110 no. 02 (Aug. 2007), page 302.

Ketersediaan

Perpustakaan FK Nomor Panggil: O01.K.2007.03 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

OBJECTIVE: To assess the effectiveness at 21–30 days after treatment of tinidazole administered orally at 1 g once daily for 5 days and 2 g once daily for 2 days, compared with placebo, in the treatment of bacterial vaginosis, using rigorous U.S. Food and Drug Administration (FDA)–recommended criteria to define cure. METHODS: A total of 235 women at 10 U.S. centers participated in this prospective, randomized, double-blinded, placebo-controlled trial. Presence or absence of all five following criteria was required to define diagnosis or cure of bacterial vaginosis: 1) clue cells were at least 20% of squamous cells in microscopic examination of vaginal fluid; 2) positive potassium hydroxide whiff test; 3) a homogeneous, thin, white-gray vaginal discharge; 4) vaginal pH greater than 4.5; and 5) Nugent score greater than or equal to 4 on Gram-stained vaginal fluid. Compliance, tolerability, and safety were assessed using patient diaries and interviews at 8–10 days and 21–30 days after treatment. Cochran-Mantel-Haenszel statistical analysis with Bonferroni adjustment was used to compare outcomes. RESULTS: Superior efficacy was demonstrated by tinidazole for the 1 g once daily for 5 days regimen (36.8% cured, P<.001, number needed to treat 3.2) and for the 2 g once daily for 2 days regimen (27.4% cured, P<.001, number needed to treat 4.5), when compared with placebo (5.1% cured) in the primary endpoint analysis. Using more traditional criteria for cure, efficacy was greater. Compliance with study therapy and tolerability were comparable in the three treatment groups. CONCLUSION: Both tinidazole regimens studied provided effective treatment for bacterial vaginosis.

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