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著者: Manuel Ramos-Casals, Athanasios G Tzioufas, John H Stone, Antoni Sisó, Xavier Bosch
雑誌名: JAMA. 2010 Jul 28;304(4):452-60. doi: 10.1001/jama.2010.1014.
Abstract/Text
CONTEXT: A variety of topical and systemic drugs are available to treat primary Sjögren syndrome, although no evidence-based therapeutic guidelines are currently available.
OBJECTIVE: To summarize evidence on primary Sjögren syndrome drug therapy from randomized controlled trials.
DATA SOURCES: We searched MEDLINE and EMBASE for articles on drug therapy for primary Sjögren syndrome published between January 1, 1986, and April 30, 2010.
STUDY SELECTION: Controlled trials of topical and systemic drugs including adult patients with primary Sjögren syndrome were selected as the primary information source.
RESULTS: The search strategy yielded 37 trials. A placebo-controlled trial found significant improvement in the Schirmer and corneal staining scores, blurred vision, and artificial tear use in patients treated with topical ocular 0.05% cyclosporine. Three placebo-controlled trials found that pilocarpine was associated with improvements in dry mouth (61%-70% vs 24%-31% in the placebo group) and dry eye (42%-53% vs 26%). Two placebo-controlled trials found that cevimeline was associated with improvement in dry mouth (66%-76% vs 35%-37% in the placebo group) and dry eye (39%-72% vs 24%-30%). Small trials (<20 patients) found no significant improvement in sicca outcomes for oral prednisone or hydroxychloroquine and limited benefits for immunosuppressive agents (azathioprine and cyclosporine). A large trial found limited benefits for oral interferon alfa-2a. Two placebo-controlled trials of infliximab and etanercept did not achieve the primary outcome (a composite visual analog scale measuring joint pain, fatigue, and dryness); neither did 2 small trials (<30 patients) testing rituximab, although significant results were observed in some secondary outcomes and improvement compared with baseline.
CONCLUSIONS: In primary Sjögren syndrome, evidence from controlled trials suggests benefits for pilocarpine and cevimeline for sicca features and topical cyclosporine for moderate or severe dry eye. Anti-tumor necrosis factor agents have not shown clinical efficacy, and larger controlled trials are needed to establish the efficacy of rituximab.
PMID 20664046 JAMA. 2010 Jul 28;304(4):452-60. doi: 10.1001/jama.2010.1014.
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