针刀治疗强直性脊柱炎疗效和安全性系统评价

Effectiveness and Safety of Needle-knife for Ankylosing Spondylitis:A Systematic Review

目的 :评价针刀治疗强直性脊柱炎的有效性及安全性。方法 :采Cochrane系统评价方法,电子检索PUBMED、EMBASE、Cochrane图书馆临床对照试验资料库、CBM、CNKI、VIP、Wan fang Data。文献年限为1989年1月—2013年2月,检索汉语及英语文献。由两名评价员独立评价文献质量、提取资料并交叉核对,电话访问标称随机对照试验作者证实是否真正RCT,而后采用RevMan 5.2软件进行Meta分析。结果 :共5个针刀治疗强直性脊柱炎的临床随机对照试验符合纳入标准,总共304例患者。针刀+常规治疗VS常规治疗的总疗效效率的Meta分析:[MD=10.33,95%CI(4.31,24.78),P<0.000 01],远期疗效汇总[:MD=8.11,95%CI(1.61,40.77),P=0.01]。治疗组的不良反应与对照组无统计学意义[MD=0.52,95%CI(0.16,1.64),P=0.26]。结论 :目前有限的纳入研究初步显示针刀治疗强直性脊柱炎安全,在改善症状、提高整体功能等方面较对照组有效,但因本系统评价纳入研究的方法学质量较低,例数较少,且诊断标准、随访时间、结果测量指标和判效标准等均不一致,因此临床研究质量有待提高。

Objective ： To evaluate the efficacy and safety of needle-knife for ankylosing spondylitis and make out the current situation, validity of effect and applicability. Methods ： Pubmed, EMBASE, the Cochrane Library, CBM, CNKI, VIP and Wanfang data were retrieved to identify randomized controlled trials of needle-knife versus control for ankylosing spondylitis. The literatures were limited from 1989.1 to 2013.2 in both Chinese and English. Quality assessment and data extraction were conducted by two reviewers independently. Disagreement was resolved through discussion. Telephone survey was used with authors which adopted randomized controlled study in order to verify whether real RCT or not. All data was analyzed by using RevMan 5.2 so ware. Results ： 5 studies, total of 304 eases were enrolled.5 studies used response rate as primary outcome measures. Meta-analysis showed there was sufficient evidence that needle-knife was superb to the other therapies. Meta-analysis showed that the total-term effect MD= 10.33,95%CI （ 4.31, 24.78 ）, P〈0.00001, long-term effect MD=8.11,95%CI （ 1.61,40.77 ）, P=0.01, the adverse events in the treatment group between the two groups were similar without significant difference[ MD= 0.52,95%CI（ 0.16, 1.64 ）, P=0.26 ], Conclusion ： Needle-knife therapy is effective in the treatment of ankylosing spondylitis, but its superiority over control is not demonstrated due to the poor quality and small sample of the included trials. More large-scale, multi-center, well-designed, scientific method to standardize the quality of randomized controlled trials are needed .