Griffin Xavier L, Smith Nick, Parsons Nick, Costa Matthew L
Warwick Orthopaedics, Warwick Medical School, University of Warwick, Coventry, UK.
Cochrane Database Syst Rev. 2012 Feb 15(2):CD008579. doi: 10.1002/14651858.CD008579.pub2.
The morbidity and socioeconomic costs of fractures are considerable. The length of time to healing is an important factor in determining a patient's recovery after a fracture. Ultrasound may have a therapeutic role in reducing the time to union after fracture.
To assess the effects of low intensity ultrasound (LIPUS), high intensity focused ultrasound (HIFUS) and extracorporeal shockwave therapies (ECSW) as part of the treatment of acute fractures in adults.
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2011), the Cochrane Central Register of Controlled Trials (in The Cochrane Library 2011, Issue 4), MEDLINE (1950 to November Week 3 2011), EMBASE (1980 to 2011 Week 49), trial registers and reference lists of articles.
Randomised controlled trials evaluating ultrasound treatment in the management of acute fractures in adults. Studies including participants over 18 years of age with acute fractures, reporting functional outcomes, time to union, non-union, secondary procedures such as for fixation or delayed or non-union, adverse effects, pain, costs or patient adherence were included.
Two authors independently extracted data from the included studies. Treatment effects were assessed using mean differences or risk ratios and, where there was substantial heterogeneity, pooled using a random-effects model. Results from 'worst case' analyses, which gave more conservative estimates of treatment effects for time to fracture union, are reported in preference to those from 'as reported' analyses.
Twelve studies, involving 622 participants with 648 fractures, were included. Eight studies were randomised placebo-controlled trials, two studies were randomised controlled trials without placebo controls, one study was a quasi-randomised placebo controlled trial and the remaining study was a quasi-randomised controlled trial without placebo control. Eleven trials tested LIPUS and one trial tested ECSW. Four trials included participants with conservatively treated upper limb complete fractures and six trials included participants with lower limb complete fractures; these were surgically fixed in four trials. The remaining two trials reported results for conservatively treated tibial stress fractures.Very limited data from two complete fracture studies showed no difference between ultrasound and placebo control in functional outcome. Pooled estimates from two studies found LIPUS did not significantly affect the time to return to training or duty in soldiers or midshipmen with stress fractures (mean difference -8.55 days, 95% CI -22.71 to 5.61).Based on a 'worst case' analysis, which adjusted for incomplete data, pooled results from eight heterogeneous studies showed no statistically significant reduction in time to union of complete fractures treated with LIPUS (standardised mean difference -0.47, 95% CI -1.14 to 0.20). This result could include a clinically important benefit or harm, and should be seen in the context of the highly significant statistical heterogeneity (I² = 90%). This heterogeneity was not explained by the a priori subgroup analyses (upper limb versus lower limb fracture, smoking status). An additional subgroup analysis comparing conservatively and operatively treated fractures raised the possibility that LIPUS may be effective in reducing healing time in conservatively managed fractures, but the test for subgroup differences did not confirm a significant difference between the subgroups.Pooled results from eight trials reporting proportion of delayed union or non-union showed no significant difference between LIPUS and control. Adverse effects directly associated with LIPUS and associated devices were found to be few and minor, and compliance with treatment was generally good. One study reporting on pain scores found no difference between groups at eight weeks.One quasi-randomised study (59 fractures) found no significant difference between ECSW and no-placebo control groups in non-union at 12 months (risk ratio 0.56, 95% CI 0.15 to 2.01). There was a clinically small but statistically significant difference in the visual analogue scores for pain in favour of ECSW at three month follow-up. The only reported complication was infection, with no significant difference between the two groups.
AUTHORS' CONCLUSIONS: While a potential benefit of ultrasound for the treatment of acute fractures in adults cannot be ruled out, the currently available evidence from a set of clinically heterogeneous trials is insufficient to support the routine use of this intervention in clinical practice. Future trials should record functional outcomes and follow-up all trial participants.
骨折的发病率和社会经济成本相当可观。愈合所需时间是决定骨折患者康复情况的一个重要因素。超声可能在缩短骨折后的愈合时间方面具有治疗作用。
评估低强度超声(LIPUS)、高强度聚焦超声(HIFUS)和体外冲击波疗法(ECSW)作为成人急性骨折治疗一部分的效果。
我们检索了Cochrane骨、关节和肌肉创伤小组专业注册库(2011年12月)、Cochrane对照试验中央注册库(《Cochrane图书馆》2011年第4期)、MEDLINE(1950年至2011年11月第3周)、EMBASE(1980年至2011年第49周)、试验注册库以及文章的参考文献列表。
评估超声治疗成人急性骨折的随机对照试验。纳入的研究包括18岁以上急性骨折患者,报告功能结局、愈合时间、不愈合、二次手术(如固定或延迟愈合或不愈合)、不良反应、疼痛、成本或患者依从性。
两位作者独立从纳入研究中提取数据。使用均值差或风险比评估治疗效果,若存在显著异质性,则采用随机效应模型进行汇总。优先报告“最差情况”分析的结果,该分析对骨折愈合时间的治疗效果给出了更保守的估计,而不是“按报告”分析的结果。
纳入了12项研究,涉及622名参与者和648处骨折。8项研究为随机安慰剂对照试验,2项研究为无安慰剂对照的随机对照试验,1项研究为准随机安慰剂对照试验,其余研究为准随机对照试验且无安慰剂对照。11项试验测试了LIPUS,1项试验测试了ECSW。4项试验纳入了保守治疗的上肢完全骨折患者,6项试验纳入了下肢完全骨折患者;其中4项试验进行了手术固定。其余两项试验报告了保守治疗的胫骨应力骨折的结果。两项完全骨折研究的非常有限的数据显示,超声与安慰剂对照在功能结局方面无差异。两项研究的汇总估计发现,LIPUS对应力骨折士兵或海军学员恢复训练或执勤的时间没有显著影响(均值差 -8.55天,95%置信区间 -22.71至5.61)。基于“最差情况”分析(对不完整数据进行了调整),八项异质性研究的汇总结果显示,LIPUS治疗的完全骨折愈合时间在统计学上没有显著缩短(标准化均值差 -0.47,95%置信区间 -1.14至0.20)。该结果可能包括临床上重要的益处或危害,应结合高度显著的统计学异质性(I² = 90%)来看待。这种异质性无法通过先验亚组分析(上肢与下肢骨折、吸烟状况)来解释。一项比较保守治疗和手术治疗骨折的额外亚组分析提出,LIPUS可能在缩短保守治疗骨折的愈合时间方面有效,但亚组差异检验未证实亚组之间存在显著差异。八项报告延迟愈合或不愈合比例的试验的汇总结果显示,LIPUS与对照组之间无显著差异。发现与LIPUS及相关设备直接相关的不良反应很少且轻微,治疗依从性总体良好。一项报告疼痛评分的研究发现,八周时两组之间无差异。一项准随机研究(59处骨折)发现,12个月时ECSW组与无安慰剂对照组在不愈合方面无显著差异(风险比0.56,95%置信区间0.15至2.01)。在三个月随访时,疼痛视觉模拟评分在临床上有小但统计学上显著的差异,有利于ECSW组。唯一报告的并发症是感染,两组之间无显著差异。
虽然不能排除超声治疗成人急性骨折的潜在益处,但目前一组临床异质性试验的现有证据不足以支持在临床实践中常规使用这种干预措施。未来的试验应记录功能结局并对所有试验参与者进行随访。