柳氮磺吡啶治疗强直性脊柱炎有效性和安全性的Meta分析  

Meta-analysis of the effectiveness and safety of sulfasalazine in the treatment of ankylosing spondylitis

作　　者：臧加成[1] 马剑雄[2] 王涛[1] 田鹏[1] 韩超[1] 马信龙[1] 

机构地区：[1]天津市天津医院骨科,天津300211 [2]天津市骨科研究所,天津300050

出　　处：《哈尔滨医科大学学报》2017年第6期568-576,共9页Journal of Harbin Medical University

基　　金：国家自然科学基金资助项目(81401792);天津市天津医院科技基金项目(TJYY1504)

摘　　要：目的系统评价柳氮磺吡啶(SSZ)治疗强直性脊柱炎的有效性和安全性。方法收集关于SSZ和安慰剂治疗强直性脊柱炎的临床随机对照试验。计算机检索以下7个数据库(时间为1984年~2017年3月)MEDLINE、EMBASE、Cochrane CENTRAL(First Quarter 2017)、Science Direct、OVID、SpringerLink、中国生物医学文献数据库,手工检索相关杂志。制定纳入和排除标准,筛选出符合纳入标准的文献,评价纳入研究的方法学质量。利用Rev Man 5.1.1(下载于Cochrane Library)进行Meta分析。结果经过筛选,最终纳入13篇研究论著,共1 110例患者,其中SSZ组606例,安慰剂组504例。Meta分析结果显示:脊柱炎功能指数[MD=-0.18,95%CI(-0.23,-0.18),P<0.00001]、背部疼痛VAS评分[MD=-2.25,95%CI(-4.04,-0.26),P=0.01]、晨僵时间[MD=-0.28,95%CI(-0.35,-0.20),P<0.00001]、胸廓扩张度[MD=-0.18,95%CI(-0.32,-0.03),P=0.02]、ESR[MD=-3.28,95%CI(-4.60,-1.96),P<0.00001]等指标SSZ与安慰剂组之间差异具有统计学意义;SSZ组副作用发生率明显高于安慰剂组[MD=1.65,95%CI(1.18,2.3),P=0.003];而夜间痛发生率、脊柱功能物理试验、CRP等二者无明显差别。结论 SSZ治疗临床上早期、活动性、伴有外周关节炎并且急性炎性反应物水平较高的AS患者疗效显著且效能费用比较高。经过严格的实验室监测,可有效地预防和控制并发症。Objective To assess the effectiveness and safety of sulfasalazine in the treatment of ankylosing spondylitis （AS）. Methods Randomized trials of SSZ and placebo in treatment of AS were selected. A computer-based online search of Medline, EMBASE, Cochrane CENTRAL （ First Quarter 2017 ） , ScienceDireet, OVID, SpringerLink and The China Biological Medicine Database, and manual retrieval of several related journals were used. The included trials were screened out according to the criterion of inclusion and exclusion. The quality of included trials was evaluated. Data were extracted by two reviewers independently. RevMan 5.1.1 was used for data analysis. Results After screening, 13 studies were included. A total of 1 110 pa- tients, of which 606 were in group SSZ, and 504 in the placebo group. The results of meta- analysis showed that outstanding relativity and statistically significant difference were found in the following indexes： Spondylitis function index[ MD = - 0. 18, 95% CI（ - 0. 23, - 0. 18）, P〈0. O0001], VASofback pain[MD= -2.25, 95%CI（ -4.04, -0.26）, P=0.01], duration of morning stiffness [ MD = - 0. 28, 95% CI（ - 0. 35, - 0. 20）, P 〈 0. 00001 ], Chest expansion[MD =-0.18, 95%CI（ -0.32, -0.03）, P =0.02], and ESR[MD = -3.28, 95% CI（ -4.60, - 1.96）, P 〈0. 00001 ]. The incidence of side effect in SSZ was higher than placebo group[ MD = 1.65, 95% CI （ 1.18, 2.3 ）, P = 0. 003 ]. There was no sig- nificant difference in followings： night pain, physical examination of spine and CRP. Conclu- sion The efficacy of SSZ in the treatment of early, active, peripheral arthritis and high levels of acute inflammatory reaction is significant and the efficacy cost is higher in AS patients. Un- der the strict laboratory monitoring, complications can be effectively prevented and controlled.

关 键 词：强直性脊柱炎 柳氮磺吡啶 安慰剂 META分析 

分 类 号：R593.2[医药卫生—内科学]