长骨骨折未愈合患者电磁刺激治疗的效果评价

Electromagnetic stimulation in treating nonunion or delayed union of long bone fractures ： a meta analysis

目的通过检索和分析国内外相关文献，评价电磁刺激治疗长骨骨折延迟愈合以及不愈合的临床疗效及安全性。方法采用计算机检索1978年1月至2012年2月荷兰医学文摘（Embase）、Medline、Ovid和万方医学网等中英文数据库并结合手工检索，按照既定的纳入标准和排除标准查找有关电磁刺激治疗长骨骨折愈合延迟及不愈合的临床随机对照试验，对纳入的研究进行质量评价，使用RevMan5．1软件对数据进行meta分析。估计结局指标的相对危险度（RR）及95％可信区间（c1）。结果最终有4篇文献符合既定的纳入标准和排除标准，共4项随机对照试验，共121例患者，其中采用电磁刺激疗法治疗的患者58例作为治疗组，采用假刺激疗法治疗的患者63例作为对照组。研究结果提示2组患者最终愈合率[RR=1．96，95％CI（0．86，4．48）]、治疗12周后的愈合率[RR=2．26，95％CI（0．29，17．28）]、治疗24周后的未愈合率[RR=1．61，95％CI（0．74，3．54）]、疼痛视觉评分（VAS）等组间比较，差异均无统计学意义（P〉0．05）。结论电磁刺激可能是长骨骨折延迟愈合和不愈合患者的一种治疗措施，但目前在临床实际应用中尚缺乏足够的证据支持其确切的有效性和安全性；尚需进一步开展高质量、多中心、大样本的随机对照试验去验证。

Objective To collect and analyze the literature on electromagnetic field stimulation in the treatment of nonunion or delayed union of long bone fractures, and to evaluate its efficacy and safety. Methods Re- search on electromagnetic stimulation indexed by Medline, Embase and other databases including unpublished litera- ture was collected using pre-established inclusion and exclusion criteria. Comparative studies reporting on the out- comes of electromagnetic field stimulation for the treatment of long bone fractures were the focus. Data were extracted for outcomes including total union rate, nonunion rate, adverse events, and visual analogue scale （VAS） ratings of pain. The quality of each reference was assessed. Where feasible, meta-analyses were performed using RevMan 5.1 software. Results A total of 4 papers reporting 4 randomized controlled trials were found. They reported on 58 pa- tients treated with electromagnetic field stimulation and 63 in sham stimulation groups. There was no significant differ- ence in total union rate after treatment for 12 weeks, or in the nonunion rate after treatment for 24 weeks. VAS scale ratings were also not significantly different in the two groups. Conclusions Electromagnetic field stimulation may be an effective and safe therapy to treat nonunion or delayed union of long bone fractures, but there is not yet ade- quate evidence to determine its real efficiency and safety. Large, well designed and multi-centre randomized and con- trolled clinical trials are needed.