Tang Haiwei, Ling Tingxian, Zhao Enze, You Mingke, Chen Xi, Chen Gang, Zhou Kai, Zhou Zongke
Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Front Pharmacol. 2025 Jan 7;15:1501590. doi: 10.3389/fphar.2024.1501590. eCollection 2024.
The debate continues on whether combining core decompression (CD) with regenerative therapy provides a more effective treatment for early femoral head necrosis than CD alone. This systematic review and meta-analysis endeavored to assess its efficacy.
We systematically searched PubMed, Web of Science, and Cochrane Library through July 2024 for RCTs and cohort studies evaluating the impact of core decompression (CD) with regenerative therapy versus CD alone in early-stage osteonecrosis (ARCO I, II or IIIa or Ficat I or II) of the femoral head (ONFH). Bias was evaluated using the Cochrane ROB 2.0 for RCTs and the Newcastle-Ottawa Scale (NOS) for cohort studies. The primary outcome was disease progression, measured by the incidence of staging advancement and total hip arthroplasty (THA) conversion. Clinical outcomes, including VAS, HHS, WOMAC, and Lequesne index, were secondary measures. Subgroup analyses were performed for variables such as age, BMI, follow-up period, and dosage in the bone marrow aspirate concentrate (BMAC) group, with results depicted in forest plots.
This study represented a total of seven RCTs (mean follow-up time 36.57 months) and eight cohort trials (mean follow-up time 74.18 months) involving 954 hips. CD, when combined with agents, exhibited considerably enhanced efficacy over CD alone (risk ratio (RR) = 0.55 (95% CI 0.39-0.77), < 0.001, = 54%) and 0.59 (95% CI 0.43-0.81), = 0.001, = 51%), respectively). However, a significant difference was exclusive to the CD combined with BMAC group in terms of stage progression outcomes (stage progression, RR = 0.47 (95% CI 0.28-0.78), = 0.004, = 67%); THA conversions, RR = 0.41 (95% CI 0.32-0.52), < 0.001, = 43%). Secondary outcomes (VAS, HHS, WOMAC score and Lequesne index) showed improved results when CD was combined with other regenerative agents, such as bone mesenchymal stem cells (BMSCs) and bone morphogenetic proteins (BMPs), etc. In the reported data, the regenerative group demonstrated significantly higher rates of subjective improvement in pain and functional outcomes compared to those in the CD group (71.74% (66/92) vs. 56.38% (53/94). Subgroup analysis revealed superior outcomes in the low-dose (less than 20 mL) BMAC group and patients aged under 40 years old in stage progression rate and THA conversion rate.
CD, when combined with regenerative therapy, can diminish hip pain and enhance functionality, but its ability to slow disease progression remains uncertain. BMAC presents a more substantiated efficacy evidence than other agents, with low-doses of BMAC in patients under 40 years potentially slowing ONFH progression. Nonetheless, the high heterogeneity and relatively short follow-up time of these studies make it difficult to draw accurate conclusions, which necessitates verification through future trials comparing CD versus CD combined with regenerative therapy, with a focus on extended follow-up periods.
identifier CRD42023467873.
关于核心减压（CD）联合再生疗法是否比单纯CD能更有效地治疗早期股骨头坏死的争论仍在继续。本系统评价和荟萃分析旨在评估其疗效。
我们通过2024年7月对PubMed、Web of Science和Cochrane图书馆进行系统检索，以查找评估核心减压（CD）联合再生疗法与单纯CD对股骨头缺血性坏死（ONFH）早期阶段（ARCO I、II或IIIa或Ficat I或II）影响的随机对照试验（RCT）和队列研究。使用Cochrane ROB 2.0评估RCT的偏倚，使用纽卡斯尔-渥太华量表（NOS）评估队列研究的偏倚。主要结局是疾病进展，通过分期进展和全髋关节置换术（THA）转换的发生率来衡量。临床结局，包括视觉模拟评分（VAS）、髋关节 Harris 评分（HHS）、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）和 Lequesne 指数，为次要指标。对骨髓抽吸浓缩物（BMAC）组中的年龄、体重指数（BMI）、随访期和剂量等变量进行亚组分析，结果以森林图表示。
本研究共纳入7项RCT（平均随访时间36.57个月）和8项队列试验（平均随访时间74.18个月），涉及954个髋关节。CD联合药物治疗时，与单纯CD相比疗效显著提高（风险比（RR）分别为0.55（95%可信区间0.39 - 0.77），P < 0.001，绝对风险降低54%）和0.59（95%可信区间0.43 - 0.81），P = 0.001，绝对风险降低51%）。然而，在分期进展结局方面，仅CD联合BMAC组有显著差异（分期进展，RR = 0.47（95%可信区间0.28 - 0.78），P = 0.004，绝对风险降低67%）；THA转换，RR = 0.41（95%可信区间0.32 - 0.52），P < 0.001，绝对风险降低43%）。次要结局（VAS、HHS、WOMAC评分和Lequesne指数）显示，当CD与其他再生剂如骨间充质干细胞（BMSCs）和骨形态发生蛋白（BMPs）等联合使用时，结果有所改善。在报告的数据中，再生组在疼痛和功能结局的主观改善率方面显著高于CD组（71.74%（66/92）对56.38%（53/94））。亚组分析显示，低剂量（小于20 mL）BMAC组和40岁以下患者在分期进展率和THA转换率方面有更好的结局。
CD联合再生疗法可减轻髋关节疼痛并增强功能，但其减缓疾病进展的能力仍不确定。BMAC比其他药物有更确凿的疗效证据，40岁以下患者使用低剂量BMAC可能减缓ONFH进展。然而，这些研究的高异质性和相对较短的随访时间使得难以得出准确结论，这需要通过未来比较CD与CD联合再生疗法的试验进行验证，重点是延长随访期。
标识符CRD42023467873
