Chinese Journal of Tissue Engineering Research ›› 2016, Vol. 20 ›› Issue (53): 8010-8021.doi: 10.3969/j.issn.2095-4344.2016.53.016
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Hu Bing-yan1, Ai Jin-wei2, 3, Chen Qiong3, Yao Zhong-jun1
Revised:
2016-10-31
Online:
2016-12-23
Published:
2016-12-23
Contact:
Yao Zhong-jun, M.D., Chief physician, Professor, Department of Hand, Foot, Microscopic Orthopedics, Taihe Hospital, Hubei University of Medicine, Shiyan 442000, Hubei Province, China
About author:
Hu Bing-yan, Master, Attending physician, Department of Hand, Foot, Microscopic Orthopedics, Taihe Hospital, Hubei University of Medicine, Shiyan 442000, Hubei Province, China
Supported by:
the General Program of Health and Family Planning of Western Medicine in Hubei Province from 2015 to 2016, No. WJ2015MB187; the Key Project of Teaching and Research of Hubei University of Medicine, No. 2015025
CLC Number:
Hu Bing-yan, Ai Jin-wei, Chen Qiong, Yao Zhong-jun . InterTan nail versus proximal femoral nail antirotation for femoral intertrochanteric fractures: a systematic review and meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(53): 8010-8021.
2.1 文献检索结果 各数据库初检出文献426篇,NoteExpress3.1软件排重后获文献216篇,经标题、摘要初筛获得可能纳入的文献45篇,再通过阅读全文复筛,最终纳入16个研究[26-41]。其中,随机对照试验8篇[26-33],非随机对照试验8篇[34-41];中文文献13篇[26-31,34-40], 英文文献3篇[32,33,41]。 2.2 纳入研究基本特征 纳入的16个临床对照试验涉及1 323例股骨转子间骨折患者。其中,InterTan钉组658例,PFNA组665例。各研究患者平均年龄均> 50岁,骨折分型方法包括改良Evans分型和AO分型。各研究均描述两组在患者年龄、性别、骨折分型、麻醉风险评估等方面差异无统计学意义(P > 0.05)。结局指标主要包括:治疗优良率、手术时间、术中出血量、下地活动时间(卧床时间)、骨折愈合时间、髋关节Harris评分、并发症率等。纳入研究基本特征见表1。 2.3 纳入研究方法质量学评价 纳入的8个随机临床对照试验方法学质量评价[26-33],见表2;8个非随机临床对照试验方法学质量评价[34-41],见表3,总体为中等质量研究。"
2.4 Meta分析结果 2.4.1 手术时间 15个研究报告了两组手术时间差 异[26-38,40-41],合计样本量1 236例,其中InterTan组617例,PFNA组619例。异质性检验显示研究间存在异质性(P < 0.01,I2=94.6%)。采用随机效应模型进行统计分析(图1),结果显示InterTan组手术时间长于PFNA组[MD=11.51,95%CI(6.41,16.62),P < 0.01]。按研究类型进行亚组分析,8个随机对照试验[26-33][MD=7.50,95%CI(0.10,14.62),P=0.04]和7个非随机对照试验 [MD=16.27,95%CI(9.09,23.45)[34-38,40-41],P < 0.01]合并结果均显示两治疗组在手术时间上有差异,亦说明InterTan手术时间长于PFNA组。 2.4.2 术中出血量 13个研究报告了两组术中出血量差异[26-31,34-38,40-41],合计样本量1 048例,其中InterTan组528例,PFNA组520例。异质性检验显示研究间存在异质性(P < 0.01,I2=98.2%),采用随机效应模型进行统计分析(图2),结果显示两组术中出血量比较差异无显著性意义[MD=6.06,95%CI(-20.91,33.02),P=0.66]。按研究类型进行亚组分析,6个随机对照试验[26-31] [MD=15.17,95%CI(-40.48,70.82),P=0.59]和7个非随机对照试验[34-38,40-41] [MD=1.95,95%CI(-19.49,23.39),P=0.86]合并结果均显示两治疗组在术中出血量上无明显差异。"
2.4.3 卧床时间 6个研究报告了两治疗组术后患者卧床时间[28-29,31,33-35],合计样本量450例,其中IinterTan组209例,PFNA组241例。异质性检验显示研究间存在异质性(P < 0.01,I2=81.9%)。采用随机效应模型进行统计分析(图3),结果显示两组卧床时间比较差异无显著性意义[MD=-0.45,95%CI(-1.42,0.52),P=0.36]。按研究类型进行亚组分析,4个随机对照试验[28-29,31,33] [MD=-0.42,95%CI(-1.62,0.78),P=0.50]和2个非随机对照试验[34-35] [MD=-0.54,95%CI(-1.97,0.90),P=0.46]合并结果均显示两治疗组在卧床时间上无明显差异。 2.4.4 骨折愈合时间 11个研究报告了两治疗组患者骨折愈合时间[26-28,30-31,33,36-38,40-41],合计样本量869例,其中IinterTan组440例,PFNA组429例。异质性检验显示研究间无明显异质性(P=0.12,I2=39.8%)。采用固定效应模型进行统计分析(图4),结果显示两组骨折愈合时间比较差异无显著性意义[MD=-0.23,95%CI(-0.46,0),P=0.07]。按研究类型进行亚组分析,6个随机对照试验[26-28,30-31,33][MD=-0.17,95%CI (-0.55,0.22),P=0.25]和5个非随机对照试验[36-38, 40-41] [MD=-0.36,95%CI(-0.88,0.16),P=0.18]合并结果均显示两组在骨折愈合时间上无明显差异。 "
2.4.5 髋关节Harris评分 6个研究报告了两治疗组患者髋关节Harris评分[26,31-33,38,40],合计样本量434例,其中IinterTan组213例,PFNA组221例。异质性检验显示研究间无明显异质性(P=0.47,I2=0.0%)。采用固定效应模型进行统计分析(图5),结果显示InterTan组髋关节Harris评分高于PFNA组[MD=1.38,95%CI(0.25,2.51),P=0.02]。按研究类型进行亚组分析,4个随机对照试验[26,31-33] [MD=1.22,95%CI(-0.24,2.68),P=0.10]和2个非随机对照试验[38,40][MD=2.13,95%CI(-0.99,5.24), P=0.18]合并结果均显示两组髋关节Harris评分无明显差异。 2.4.6 治疗优良率 7个研究以髋关节Harris评分为评价标准[27,29-30,34-36,38],报告了两组治疗优良率,合计样本量564例,其中IinterTan组278例,PFNA组286例。异质性检验显示研究间无明显异质性(P=0.31,I2=31.3%)。采用固定效应模型进行统计分析(图6),结果显示两组治疗优良率比较差异无显著性意义[RR=0.97,95%CI(0.90,1.05),P=0.31]。按研究类型进行亚组分析,3个随机对照试验[27,29-30][RR=1.02,95%CI(0.93,1.11),P=0.53]和4个非随机对照试验[34-36,38][MD=0.92,95%CI(0.79,1.06),P=0.07]合并结果均显示两组治疗优良率无明显差异。"
2.4.7 术后并发症发生率 15个研究报告了两组术后并发症发生率[26-30,32-41],合计样本量1 245例,其中IinterTan组615例,PFNA组630例。异质性检验显示研究间无明显异质性(P=0.70,I2=0.0%)。采用固定效应模型进行统计分析(图7),结果显示PFNA组术后并发症发生率较高于IinterTan组[RR=0.57,95%CI(0.47,0.70),P < 0.01]。按研究类型进行亚组分析,7个随机对照试验[26-30,32-33][RR=0.60,95%CI(0.45,0.80),P < 0.01]和8个非随机对照试验[34-41][MD=0.54,95%CI(0.41,0.72),P < 0.01]合并结果均显示PFNA组术后并发症发生率高于InterTan组。 2.5 发表偏倚 对各结局指标分析绘制Begg’s漏斗图识别发表偏倚,各漏斗图基本对称,说明本研究存在发表偏倚可能性小。以治疗优良率和并发症发生率为例显示漏斗图,见图8,9。"
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