Wang Ching-Jen, Wang Feng-Sheng, Yang Kuender D, Huang Chung-Cheng, Lee Mel Shiuann-Sheng, Chan Yi-Sheng, Wang Jun-Wen, Ko Jih-Yang
Department of Orthopedic Surgery, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University School of Medicine, 123 Ta-Pei Road, Niao-Sung Hsiang, Kaohsiung, Taiwan.
Arch Orthop Trauma Surg. 2008 Sep;128(9):901-8. doi: 10.1007/s00402-007-0530-5. Epub 2007 Dec 1.
Extracorporeal shockwave therapy (ESWT) and alendronate are reported effective in early osteonecrosis of the femoral head (ONFH). We hypothesized that joint effects of ESWT and alendronate may produce superior results. This prospective study compared the results of ESWT and alendronate with that of ESWT without alendronate in early ONFH.
Forty-eight patients with 60 hips were randomly divided into tow groups. There were 25 patients with 30 hips in group A and 23 patients with 30 hips in group B. Both groups showed similar demographic characteristics. All patients were treated with 6,000 impulses of ESWT at 28 KV (equivalent to 0.62 mJ/mm(2)) to the affected hip as a single session. Patients in group B also received alendronate 70 mg per week for 1 year, whereas patients in group A did not. The evaluations included clinical assessment, radiograph and MR image of the affected hip. Both groups were compared statistically using paired t, Mann-Whitney and Chi square tests with statistical significance at P < 0.05. The primary end point is the need for total hip arthroplasty (THA). The secondary end point is the improvement in pain and function of the hip. The third end point is the progression or regression of the lesion on image study.
The overall clinical outcomes were improved in 83%, unchanged in 7% and worsened in 10% for group A; and improved in 77%, unchanged in 13% and worsened in 10% for group B. THA was performed in 10% of group A and 10% of group B (P = 1.000). Significant improvements in pain and function of the hip were noted in both groups (P < 0.001), however, the differences between the two groups were not significant (P = 0.400, 0.313). On MR images, the lesions showed progression in 10%, regression in 47% and unchanged in 43% in group A, and progression in 7%, regression in 53% and unchanged in 40% in group B (P = 0.830).
ESWT and alendronate produced comparable result as compared with ESWT without alendronate in early ONFH. It appears that ESWT is effective with or without the concurrent use of alendronate. The joint effects of alendronate over ESWT in early ONFH are not realized in short-term.
据报道，体外冲击波疗法（ESWT）和阿仑膦酸盐对早期股骨头坏死（ONFH）有效。我们推测ESWT和阿仑膦酸盐的联合作用可能会产生更好的效果。这项前瞻性研究比较了ESWT联合阿仑膦酸盐与单纯ESWT治疗早期ONFH的效果。
48例患者共60髋被随机分为两组。A组25例患者共30髋，B组23例患者共30髋。两组患者的人口统计学特征相似。所有患者均接受单次28千伏（相当于0.62毫焦/平方毫米）、6000次冲击的ESWT治疗患髋。B组患者还接受每周70毫克阿仑膦酸盐治疗，持续1年，而A组患者未接受。评估包括患髋的临床评估、X线片和磁共振成像。两组采用配对t检验、曼-惠特尼检验和卡方检验进行统计学比较，P<0.05具有统计学意义。主要终点是全髋关节置换术（THA）的需求。次要终点是髋部疼痛和功能的改善。第三个终点是影像学检查中病变的进展或消退。
A组总体临床结果改善的占83%，不变的占7%，恶化的占10%；B组改善的占77%，不变的占13%，恶化的占10%。A组和B组各有10%的患者接受了THA（P = 1.000）。两组髋部疼痛和功能均有显著改善（P<0.001），但两组之间的差异无统计学意义（P = 0.400，0.313）。在磁共振图像上，A组病变进展的占10%，消退的占47%，不变的占43%；B组进展的占7%，消退的占53%，不变的占40%（P = 0.830）。
在早期ONFH中，ESWT联合阿仑膦酸盐与单纯ESWT的效果相当。似乎无论是否同时使用阿仑膦酸盐，ESWT均有效。在早期ONFH中，阿仑膦酸盐相对于ESWT的联合作用在短期内未得到体现。
