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目的客观评价骨复生胶囊治疗早期儿童股骨头缺血性坏死(Legg Calve Perthes病,简称Perthes病)的临床疗效。方法采用随机单盲对照试验,将4 5例早期Perthes病患儿随机分为两组,对照组(2 3例) ,应用病变侧髋关节滑膜切除、股骨头减压及带缝匠肌髂骨瓣移植术,治疗组(2 2例)采用内服中药骨复生胶囊联合上述术式治疗,疗程均为6个月。结果近期疗效:治疗组和对照组临床总有效率分别为90 . 9%和78 .3% ,优良率分别为72 . 7%和6 0 . 9% ,两组比较差异无显著性。两组治疗前后疼痛视觉模拟法(VAS法)评分及临床症状、体征评分比较均明显下降,两组治疗后比较差异有显著性(P <0. 0 5 ,P <0 . 0 1)。远期疗效(随访1年～4年1个月) :治疗组和对照组总有效率和优良率比较差异有显著性(χ2 =8 .5976 ,P <0 . 0 5 )。结论骨复生胶囊对于缓解早期Perthes病患儿疼痛及促进病变髋关节功能改善有明显的促进作用,是一种治疗早期Perthes病安全、有效中药复方,值得进一步研究和开发。
Objective To objectively evaluate the clinical efficacy of Gufusheng capsule in the treatment of Legg Calve Perthes disease (Perthes disease) in early childhood. Methods A randomized single-blind controlled trial of 45 children with early Perthes disease was randomly divided into two groups, the control group (23 cases), the application of lesion hip synovectomy, femoral head decompression and sartorius with sartorius Bone flap transplantation, the treatment group (22 cases) with oral administration of traditional Chinese medicine Gu Fusheng capsules combined with the above-mentioned surgical treatment, treatment were 6 months. Results The short-term curative effect: The total clinical effective rates of the treatment group and the control group were 90.9% and 78.3% respectively, the excellent and good rates were 72.7% and 60.9% respectively. There was no significant difference between the two groups. Visual acuity before and after treatment in both groups (VAS method) score and clinical symptoms and signs were significantly lower scores, the difference between the two groups after treatment was significant (P <0. 05, P <0. Long-term efficacy (follow-up of 1 year to 4 years and 1 month): The total effective rate and excellent and good rate of the treatment group and the control group were significantly different (χ2 = 8 .5976, P <0.05). Conclusion Gufusheng capsule can significantly relieve the pain and promote the improvement of hip joint function in children with early Perthes disease. It is a safe and effective traditional Chinese medicine compound for treating early Perthes disease and deserves further research and development.