Department of Orthopaedics, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China.
Sci Rep. 2018 Jan 23;8(1):1450. doi: 10.1038/s41598-018-19884-z.
This study aimed to determine whether bisphosphonates exert an effect on preventing femoral head collapse after osteonecrosis of the femoral head (ONFH) in an animal model and in clinical trials. A systematic literature search was performed for studies published up to January 2017. Twenty-three articles (16 animal studies, seven clinical trials) were included in the meta-analysis. We found that the bisphosphonate group obtained significant improvement in epiphyseal quotients (MD = 15.32; 95% CI, 9.25-21.39) and provided better performance on bone volume (SMD = 1.57; 95% CI, 0.94-2.20), trabecular number (SMD = 1.30; 95% CI, 0.80-1.79), trabecular thickness (SMD = 0.77; 95% CI, 0.10-1.43) and trabecular separation (SMD = -1.44; 95% CI, -1.70 to -0.58) in the animal model. However, the bisphosphonate group did not achieve better results in pain score, Harris score, the occurrence rate of femoral head collapse, or total hip arthroplasty in the clinical trials. In conclusion, despite bisphosphonates significantly improving bone remodeling outcomes in animal models, no significant efficacy was observed in the treatment of ONFH in the clinical studies. Further studies are required to solve the discordant outcomes between the animal and clinical studies.
本研究旨在确定双膦酸盐类药物在动物模型和临床试验中是否对预防股骨头坏死(ONFH)后股骨头塌陷有作用。对截至 2017 年 1 月发表的研究进行了系统的文献检索。共有 23 篇文章(16 篇动物研究,7 篇临床试验)纳入荟萃分析。我们发现,双膦酸盐组在骺板比率(MD=15.32;95%CI:9.25-21.39)方面有显著改善,并且在骨量(SMD=1.57;95%CI:0.94-2.20)、骨小梁数量(SMD=1.30;95%CI:0.80-1.79)、骨小梁厚度(SMD=0.77;95%CI:0.10-1.43)和骨小梁分离(SMD=-1.44;95%CI:-1.70 至-0.58)方面表现更好。然而,在临床试验中,双膦酸盐组在疼痛评分、Harris 评分、股骨头塌陷发生率或全髋关节置换方面并未取得更好的结果。总之,尽管双膦酸盐类药物在动物模型中显著改善了骨重建结果,但在治疗 ONFH 的临床研究中并未观察到显著的疗效。需要进一步的研究来解决动物和临床研究之间的结果差异。