中国组织工程研究2017，Vol.21Issue(28)：4442-4447,6.DOI:10.3969/j.issn.2095-4344.2017.28.003
富血小板血浆治疗股骨干缺血萎缩型骨不连:前瞻性随机对照临床试验
Platelet-rich plasma combined with conventional surgery in the treatment of atrophic nonunion of femoral shaft fractures: study protocol for a prospective, randomized,controlled clinical trial
摘要
Abstract
BACKGROUND:Internal and external fixation combined with autologous bone graft for treating atrophic nonunion has a long treatment cycle,and moreover,it cannot achieve a 100％ cure rate.Platelet-rich plasma contains a variety of growth factors and a large number of white blood cells,and contributes to tissue healing.However,there is no clinical study on the effectiveness of platelet-rich plasma combined with conventional surgery in the treatment of atrophic nonunion.OBJECTIVE:To investigate the effectiveness of platelet-rich plasma in the treatment of atrophic nonunion of femoral shaft fractures.METHODS:We conducted a prospective,open-label,randomized,controlled clinical trial at the Affiliated Hospital of Qinghai University,China.Ninety-two patients with atrophic nonunion of femoral shaft fractures were equally and randomly divided into control group and experimental group.Patients in the control group received conventional surgery.Patients in the experimental group were injected with autologous platelet-rich plasma on the basis of conventional surgery.The primary outcome was fracture healing rate at postoperative 9 months.The secondary outcomes were visual analogue scale scores in resting state and during passive motion,healing time,treatment costs,and adverse reactions.The study protocol was approved by the Ethics Committee of Affiliated Hospital of Qinghai University of China (approval number:QHG0223A) on May 20,2014.Written informed consent was provided by each patient and their family members after they fully understood the treatment plan.RESULTS AND CONCLUSION:Our partial results demonstrated that visual analogue scale scores and complications were similar between the two groups at postoperative 1-3 days.The healing rate was significantly higher in the experimental group than in the control group.The healing time was significantly shorter in the experimental group than in the control group.This trial will provide objective data for the clinical use of platelet-rich plasma combined with conventional surgery for the treatment of atrophic nonunion.关键词
组织构建/骨组织工程/临床试验/缺血萎缩型骨不连/富血小板血浆/股骨干/有效性/骨折愈合/疼痛/随机对照临床试验分类
医药卫生引用本文复制引用
赵子春,李钊伟,闫红秀,唐保明,李春亮,张启福,任荣,李沛,贾生龙..富血小板血浆治疗股骨干缺血萎缩型骨不连:前瞻性随机对照临床试验[J].中国组织工程研究,2017,21(28):4442-4447,6.基金项目
2015年青海省卫生和计划生育委员会指导性项目 （）
the Guidance Project of Qinghai Provincial Health and Family Commission in 2015 （）
