摘要(西班牙): :背景:目前有多种局部和全身用药可治疗原发性干燥综合征,但尚缺乏循证医学基础上的治疗指南。
目的 从随机对照试验中总结原发干燥综合征治疗的证据。 资料
来源 我们通过搜索MEDLINE 和EMBASE,检索发表于1986年1月1日到2010年4月30日有关原发干燥综合征治疗的文章。
研究选择:选择局部和全身药物治疗成人原发干燥综合征的对照试验作为主要的资料来源。
结果:应用搜索策略,筛选出37个临床试验。一个安慰剂对照试验发现,局部应用0.05%环孢素眼液的患者在Schirmer和角膜染色得分、视觉模糊和人工泪液应用上有明显改善。三个安慰剂对照试验发现,匹罗卡品对缓解口干(与安慰剂相比,为61%-70%对24%-31%)和眼干明显 (与安慰剂相比,为42%-53%对26%)。2个安慰剂对照试验发现,西维美林可明显改善口干(66%-76%对35%-37% ) 和眼干(39%-72%对 24%-30%)。小规模临床试验(<20 个患者)发现,口服强的松或羟氯喹不能明显改善口眼干燥,而免疫抑制剂(硫唑嘌呤和环孢素)对口眼干的作用也有限。大规模临床试验发现,口服2a-干扰素作用有限。两个安慰剂对照试验发现,英夫利昔和依那西普对干燥、疲劳和关节疼痛的联合vas评分无效。2个小规模临床试验发现(<30例),利妥昔也无效,但在某些次要终点较基线有改善。
结论 对于原发干燥综合征,对照试验提示匹罗卡品和西维美林对干燥有效,而中重度眼干者局部用环孢素有效。抗TNF制剂无疗效,而利妥昔单抗的疗效需大规模的临床试验来证实。
附原文:Abstract CONTEXT: A variety of topical and systemic drugs are available to treat primary Sj?gren syndrome, although no evidence-based therapeutic guidelines are currently available. OBJECTIVE: To summarize evidence on primary Sj?gren syndrome drug therapy from randomized controlled trials. DATA SOURCES: We searched MEDLINE and EMBASE for articles on drug therapy for primary Sj?gren syndrome published between January 1, 1986, and April 30, 2010. STUDY SELECTION: Controlled trials of topical and systemic drugs including adult patients with primary Sj?gren 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 sj?gren 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.
引自:Ramos-Casals M, Tzioufas AG, Stone JH, Sisó A, Bosch X. Treatment of primary Sj?gren syndrome: a systematic review. JAMA. 2010 Jul 28;304(4):452-60.