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重组人骨形态发生蛋白-2多次钻孔治疗韩国非创伤性股骨头坏死患者:一项至少两年随访的前瞻性随机试验研究

Multiple Drilling with Recombinant Human Bone Morphogenetic Protein-2 in Korean Patients with Non-Traumatic Osteonecrosis of the Femoral Head: A Prospective Randomized Pilot Study with a Minimum Two-Year Follow-Up.

作者信息

Park Jun Young, Cho Byung Woo, Kwon Hyuck Min, Lee Woo-Suk, Park Kwan Kyu

机构信息

Department of Orthopedic Surgery, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin 16995, Korea.

Department of Orthopedic Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.

出版信息

J Clin Med. 2022 Sep 20;11(19):5499. doi: 10.3390/jcm11195499.

DOI:10.3390/jcm11195499
PMID:36233365
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9573457/
Abstract

We sought to determine whether multiple drilling (MD) combined with the injection of recombinant human bone morphogenetic protein-2 (rhBMP-2) and β-tricalcium phosphate (β-TCP) could improve survival of the femoral head in pre-collapse lesions of non-traumatic osteonecrosis of the femoral head (ONFH) as compared with MD alone. We conducted a single-site, off-label, comparative and prospective cohort study between November 2017 and May 2019. We enrolled 25 hips (25 patients) with non-traumatic ONFH (Ficat-Arlet stage 2A or less). We performed a survival analysis, and the primary outcome was the occurrence of femoral head collapse on follow-up radiograph. Our cohort consisted of 11 men and 9 women of age 52.5 ± 8.8 years and a body mass index of 24.3 ± 3.0 kg/m. The femoral heads were preserved in 9 hips (45.0%) and collapsed in 11 hips (55.0%) at the final follow-up; mean survival to collapse was 6.9 (range 2.8-13.5) months. There were no significant differences in the survival of the femoral head between the MD alone group and the MD with rhBMP-2 and β-TCP group (five hips survived, 50% vs. four hips survived, 40%, respectively; = 0.83). MD combined with the injection of rhBMP-2 and β-TCP did not improve femoral head survival compared to MD alone in the pre-collapse non-traumatic ONFH lesion.

摘要

我们试图确定,与单纯多次钻孔(MD)相比,多次钻孔联合注射重组人骨形态发生蛋白-2(rhBMP-2)和β-磷酸三钙(β-TCP)能否提高非创伤性股骨头坏死(ONFH)塌陷前病变股骨头的存活率。我们在2017年11月至2019年5月期间进行了一项单中心、超说明书用药、对比性前瞻性队列研究。我们纳入了25例非创伤性ONFH(Ficat-Arlet 2A期或更低分期)患者的25个髋关节。我们进行了生存分析,主要结局是随访X线片上股骨头塌陷的发生情况。我们的队列包括11名男性和9名女性,年龄为52.5±8.8岁,体重指数为24.3±3.0kg/m²。在末次随访时,9个髋关节(45.0%)的股骨头得以保留,11个髋关节(55.0%)的股骨头发生塌陷;至塌陷的平均存活时间为6.9个月(范围2.8 - 13.5个月)。单纯MD组和MD联合rhBMP-2及β-TCP组之间股骨头存活率无显著差异(分别为5个髋关节存活,50% vs. 4个髋关节存活,40%;P = 0.83)。在塌陷前的非创伤性ONFH病变中,与单纯MD相比,MD联合注射rhBMP-2和β-TCP并未提高股骨头存活率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eea1/9573457/188a444a810a/jcm-11-05499-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eea1/9573457/21778e700254/jcm-11-05499-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eea1/9573457/6117c50c4745/jcm-11-05499-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eea1/9573457/e336196b40dd/jcm-11-05499-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eea1/9573457/188a444a810a/jcm-11-05499-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eea1/9573457/21778e700254/jcm-11-05499-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eea1/9573457/6117c50c4745/jcm-11-05499-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eea1/9573457/e336196b40dd/jcm-11-05499-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eea1/9573457/188a444a810a/jcm-11-05499-g004.jpg

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