股骨近端防旋髓内钉与动力髋螺钉治疗不稳定型粗隆间骨折的meta分析

Proximal femoral nails antirotation and dynamic hip screws for fixation of unstable intertrochanteric fractures of femur: A meta-analysis

目的:不稳定型粗隆间骨折手术治疗采用髓内固定还是髓外固定仍存在争议,本研究运用meta分析方法评价股骨近端防旋髓内钉(proximal femoral nail antirotation,PFNA)和动力髋螺钉(dynamic hip screw,DHS)用于不稳定型粗隆间骨折的疗效及安全性。方法:计算机检索PubMed、Embase、The Cochrane Central Register of Controlled Trials(CENTRAL)、Google Scholar、中国科技论文与引文数据库(CSTPCD)、中国期刊全文数据库(CNKI)等数据库,截止日期为2019年1月1日,由2位研究者独立按照纳入与排除标准筛选PFNA与DHS治疗不稳定型粗隆间骨折的随机对照研究,进行质量评价,以切口长度、手术时间、术中出血量、开始负重时间、骨折愈合时间、Harris功能评分等临床疗效指标和并发症等安全性指标为观察指标,提取相关数据,应用RevMan 5.3统计软件进行数据分析。结果:纳入随机对照试验9篇,共779例患者,其中PFNA固定383例、DHS固定396例。分析结果提示,与DHS固定相比,PFNA固定的手术切口长度小[均数差(mean difference, MD )=-7.43, 95% CI (-9.31,5.55), P <0.05]、手术时间短[ MD =-20.76, 95% CI (-29.57,-11.95), P <0.05]、术中出血量少[ MD =-216.34, 95% CI (-275.18 ,-157.49), P <0.05]、术后可更早开始负重[ MD =-12.34, 95% CI (-17.71,-6.97), P <0.05]、骨折愈合时间短[ MD =-5.00, 95% CI (-7.73,-2.26), P <0.05]、术后Harris功能评分高[ MD =12.22, 95% CI (3.88,20.55), P <0.05]、Harris评分优良率高[ OR =3.56, 95% CI (1.44,8.81), P <0.05]、并发症发生率低[ OR = 0.48, 95% CI (0.33,0.70), P <0.05]。按年龄亚组分析,组间差异均无统计学意义。二者在住院时间及发生内固定松动、术中和术后股骨干骨折以及内固定断裂、切出、移位、退钉等固定失效并发症方面的差异均无统计学意义( P >0.05)。结论:现有证据表明针对不稳定型粗隆间骨折,PFNA内固定临床疗效优于DHS内固定,但二者的安全性分析仍需更多高质量随机对照研究提供更可靠的证据。

Objective: To evaluate the efficacy and safety of proximal femoral nail antirotation (PFNA) and dynamic hip screw (DHS) for unstable intertrochanteric fractures using meta-analysis. Methods : The PubMed, Embase, Cocharane Central Register of Controlled Trials, Google Scholar, China Science and Technology Papers and Citation Database (CSTPCD) and China Journal Full-text Database (CNKI) were searched for published randomized controlled trials before January 1, 2019. Two researchers independently screened the literature in the light of the inclusion and exclusion criteria, evaluated the quality of the studies and extracted the data which were consisted of clinical efficacy indexes, such as incision length, operation time,intraoperative blood loss, weight-bearing time,fracture-healing time, Harris hip score and safety indicators like complications. Meta-analysis was performed with the Revman 5.3 software provided by Cochrane Community in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) standard. Results : Nine randomized controlled trials met the requirement with a total of 779 patients, of whom 383 were fixed with PFNA and 396 with DHS. Meta-analysis demonstrated that PFNA was associated with smaller surgical incision length [ MD =-7.43, 95% CI (-9.31,-5.55 ), P <0.05], shorter operation time [ MD =-22.76, 95% CI (-29.57,-11.95), P < 0.05 ], less intraoperative blood loss [ MD =-216.34, 95% CI (-275.18,-157.49), P <0.05], earlier weight bearing after surgery [ MD =-12.34, 95% CI (-17.71,-6.97), P <0.05], shorter fracture healing time [ MD =-5.00, 95% CI (-7.73,-2.26), P <0.05], higher postoperative Harris hip score [ MD =12.22, 95% CI (3.88, 20.55), P <0.05], higher rate of excellent Harris hip score [ OR =3.56, 95% CI (1.44, 8.81), P <0.05] and lower incidence rate of postoperative complications [ OR =0.48, 95% CI (0.33, 0.70), P <0.05], such as hip varus, wound infection, urinary tract infection, pulmonary infection, pressure sore, deep vein thrombosis, pulmonary embolism, heart failure and cerebral infraction when compared with DHS. No statistical difference was shown between the groups when it came to subgroup analysis by age. However, there was no significant difference ( P > 0.05 ) in the duration of hospitalization and the complications resulting in the occurrences of internal fixation loosening, such as femoral shaft fracture (during or post operation), internal fixation fracture, cut-out, displacement or retraction. Conclusion : Current published evidence supports the superiority of PFNA to DHS for unstable intertrochanteric fractures in terms of clinical efficacy. The conclusion was limited because of the relatively low quality of evidence with low strength of confidence. Large scale and high-quality randomized controlled trials are required to validate the safety of PFNA and DHS for unstable intertrochanteric fractures.