Chinese Journal of Tissue Engineering Research ›› 2014, Vol. 18 ›› Issue (21): 3438-3444.doi: 10.3969/j.issn.2095-4344.2014.21.027
Liu Wei-hong1, Liu Tao2, Yi Li1, Fu Li-na3
Online:
2014-05-21
Published:
2014-05-21
Contact:
Liu Wei-hong, Department of Rehabilitation, Tianjin Fourth Centre Hospital, Tianjin 300143, China
About author:
Liu Wei-hong, M.D., Attending physician, Department of Rehabilitation, Tianjin Fourth Centre Hospital, Tianjin 300143, China
CLC Number:
Liu Wei-hong, Liu Tao, Yi Li, Fu Li-na. Ankle-foot orthosis improves walking ability of hemiplegic patients: a Meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2014, 18(21): 3438-3444.
2.1 文献检索结果 初检出文献344篇,剔除重复检出文献250篇,逐层筛选后,最终纳入9个随机对照试验,共456例患者。纳入研究的基本特征见表1,文献筛选流程及结果见图1。 2.2 纳入研究的方法学质量评价 依据Cochrane协作网推荐的偏倚风险评估方法,对纳入研究进行偏倚风险评估。共纳入9个随机对照试验,质量均不高,所有文献均对患者的基线情况进行了报道,均在文中提及了“随机”。其中1个随机对照试验交代了具体的随机方法,8个研究随机分组方案不清楚;1个文献提及单盲,所有文献均未对分配隐藏方案进行描述;其中1项试验没有描述基线资料的可比性。9个随机对照试验数据报告均完整,纳入研究的方法学质量评价见图2。"
2.3 Meta分析结果 2.3.1 Fugl-Meyer量表下肢部分评分情况评价 5项研究报道了踝足矫形器对偏瘫患者Fugl-Meyer量表下肢部分评分的影响。其中1项研究报道了踝足矫形器连续治疗4周,每天配戴时间大于4 h的结果[12],亚组分析结果显示两组差异有显著性意义[加权均数差WMD=9.90,95%可信区间(4.87,14.93)];1项研究报道了踝足矫形器连续治疗6周,每天佩戴时间大于2 h的结果[11],亚组分析结果显示两组差异有显著性意义[加权均数差WMD=1.81,95%可信区间(0.46,3.16)];1项研究报道了连续治疗8周,每天配戴时间大于2h的结果[6],亚组分析结果显示两组差异有显著性意义[加权均数差WMD=9.50,95%可信区间(6.20,12.80)];另有2项研究报道了连续治疗3个月的结果,每天佩戴时间大于2 h的结果[5,9],亚组分析结果显示两组差异有显著性意义[加权均数差WMD=4.74,95%可信区间(2.48,6.99)](图3)。"
2.3.2 日常生活能力评分情况评价 3项研究采用Barthel指数对偏瘫患者日常生活能力进行了评定[6,8,13],3项研究均为踝足矫形器连续治疗8周,每天配戴时间大于2 h,Meta分析结果显示两组差异有显著性意义[WMD=24.44,95%可信区间(21.04,27.84)] (图4)。另有5项研究采用改良Barthel指数对偏瘫患者日常生活能力进行了评定,其中1项研究报道了踝足矫形器连续治疗4周[7],每天配戴的具体时间未描述,亚组分析结果显示两组差异有显著性意义[加权均数差WMD=23.20,95%可信区间(17.34,29.06)];1项研究报道了踝足矫形器连续治疗2个月,每天配戴时间大于4 h的结果[10],亚组分析结果显示两组差异有显著性意义[加权均数差WMD=32.70,95%可信区间(24.64,40.76)];2项研究报道了踝足矫形器连续治疗3个月的结果[5,9],2项研究存在较大的异质性[P=0.03,I2=78%],分析其异质性的原因,王宏图等[5]的研究纳入的患者Brunnstrom分级均小于3级,而李冬梅等[9]的研究纳入的患者均可独立行走,2项研究基线存在一定差异,故采用描述性分析。王宏图等的研究提示,经连续治疗3个月,每天配戴时间2-10 h,两组改良Barthel指数比较差异有显著性意义(P < 0.05)。李冬梅等的研究提示,经连续治疗3个月,每天配戴时间大于4 h,两组改良Barthel指数比较差异有显著性意义(P < 0.05)(图5)。"
2.3.3 限时步行功能检查法 2项研究采用限时步行功能检查法即10 m最大步行速度及6 min步行试验对步行速度进行了测定[6,8],2项研究报道了踝足矫形器连续治疗8周,配戴时间大于2 h的结果,Meta分析结果显示在提高10 m最大步行速度方面,两组差异有显著性意义[加权均数差WMD=-1.10,95%可信区间(-1.38,-0.82)](图6);2项研究报道了6 min步行试验结果[6,8],2项研究间存在较大的异质性[P=0.15,I2=97%],分析其异质性的原因,可能是2项研究分组不同,李哲等[6]的研究设计分组为动态踝足矫形器组、普通组及康复组,沈良册等[8]研究设计分组为改良型踝足矫形器组、普通组及康复组。故采用描述性分析,李哲等的研究结果表明,经连续治疗8周,每天配戴时间大于2 h,动态踝足矫形器组在6 min步行距离方面与其他两组相比较差异有显著性意义(P < 0.01)。沈良册等的研究结果表明,经连续治疗8周,每天配戴3 h,改良型踝足矫形器组在6 min步行距离方面与其他两组相比较,差异有显著性意义(P < 0.01或0.05)。 2.3.4 Berg平衡量表平衡功能评价 2项研究采用Berg平衡量表对偏瘫患者平衡功能进行了测定[5,9],2项研究间存在较大的异质性[P=0.05,I2=73%],分析其异质性的原因,王宏图[5]的研究纳入的患者Brunnstrom分级均小于 3级,而李冬梅等[9]的研究纳入的患者均可独立行走,2项研究基线存在一定差异,故采用描述性分析。王宏图等的研究提示,经连续治疗3个月,每天配戴时间2-10 h,踝足矫形器组平衡功能与对照组相比较差异有显著性意义(P < 0.05)。李冬梅等的研究提示,经连续治疗3个月,每天配戴时间大于4 h,踝足矫形器平衡功能与对照组相比较差异有显著性意义(P < 0.05)。 2.3.5 其他结局指标 由于纳入研究数量有限及各研究评价方法差异较大,故仅作描述性分析如下:李冬梅等[9]的研究结果显示,采用踝足矫形器配合药物及康复治疗组对步速及左右步幅差的改善与均优于单纯药物配合康复治疗组(P < 0.05)。李迎光等[11]的研究结果显示,早期使用动态踝足矫形器组Fugl-Meyer量表平衡功能评分优于单纯康复治疗组(P < 0.05)。并且与对照组相比较,踝足矫形器治疗组能明显改善偏瘫患者的步行功能分级(P < 0.05)。王静等[10]的研究结果显示,与单纯药物配合康复治疗相比较,早期使用踝足矫形器配合药物及康复治疗能明显改善偏瘫患者的Brunnstrom运动功能,降低踝关节畸形发生率(P < 0.05)。覃佩红等[13]的研究结果显示,与常规康复治疗相比,改良式踝足矫形器能明显提高偏瘫患者步行功能分级(P < 0.01)。王宏图[5]的研究结果显示,早期使用轻型高温热塑踝足矫形器配合药物及康复连续治疗3个月或单纯药物配合康复治疗后:①采用英文原版RVGA量表进行步态分析,两组10 m自由步行速度、步频之间的差异有显著性意义(P < 0.05),患侧跨步长之间差异无显著性意义(P > 0.05),步态周期和患/健肢跨步长(空间不对称性)间的差异有显著性意义(P < 0.05),双支撑相时间、双支撑相在步态周期中的百分比、患/健肢单支撑相比(时间不对称性)和患肢支撑相/摆动相间差异不显著(P > 0.05)。②两组下肢肌张力(改良Ashworth评测)和运动功能(以Brunnstrom分级评测)之间的比较差异无显著性意义(P > 0.05)。③生活能力改善方面采用简化SF-36量表中文版,结果提示两组患者在躯体角色、机体疼痛、总的健康、社会功能4个领域差异无显著性意义(P > 0.05),而在躯体功能、活力、情绪角色、心理卫生4个领域及总分间的比较差异有显著性意义(P < 0.05)。但比较治疗前后SF-36量表各领域改善及总分改善时,则显示两组患者在躯体角色、机体疼痛、活力、心理卫生4个领域的改善差异无显著性意义(P > 0.05);而在躯体功能、总的健康、社会功能、情绪角色4个领域的改善和总分的改善,治疗组明显好于对照组(P < 0.05)。"
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