骨复生胶囊治疗早期儿童股骨头缺血性坏死的临床观察

Clinical Observation on Effect of Gufusheng Capsule in Treating Early Stage Legg-Calve-Perthes Disease

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。

ObjectiveTo evaluate the clinical efficacy of Gufusheng capsule (GFSC) in treating early stage Legg-Calve-Perthes disease. MethodsAdopting randomized single controlled trial, 45 cases with Legg-Calve-Perthes disease in early stage were randomly divided into 2 groups, 23 patients in the control group were treated with arthrectomy hip synovial membrane excision of affected lateral, femoral head decompression and transplantation of muscle-bone flap from ileum, above treatment were also given to the 22 patients in the treated group but combined with orally taking of GFSC. The treatment course for both groups was 6 months. Results Short-term effect after 6 months' treatment showed that the total effective rate in the treated group and the control group was 90.9% and 78.3% respectively, and the excellent rate was 72.7% and 60.9% respectively. The pain visual analogue scoring, clinical symptom and syndrome scoring markedly decreased before and after treatment, showing significant difference between the two groups (P<0.05, P<0.01). Long-term effect after 1-year to 4-year follow-up showed that the total effective rate and excellent rate between the treated group and the control group was significantly different (χ 2 = 8.5976, P<0.05). ConclusionGFSC has marked effect in alleviating pain and ameliorating function of hip joint, being an effective compound recipe for treatment of early stage Legg-Calve-Perthes disease. Therefore, it is worthy of researching and developing furthermore.