通络生骨胶囊治疗股骨头坏死的Ⅲ期临床试验

Stage III Clinical Trial of Tongluoshenggu Capsule on Necrosis of Femoral Head

目的:评价通络生骨胶囊治疗股骨头坏死的疗效及安全性。方法:采用随机双盲、双模拟、阳性药对照的多中心研究方法,共治疗股骨头坏死患者428例,其中治疗组320例,对照组108例。结果:通络生骨胶囊对股骨头坏死的临床症状体征总有效率为79．06％;对照组健骨生丸则为71．30％,两组比较无显著差异。X线片改变,通络生骨胶囊组71．23％有死骨吸收,其中43．84％为明显吸收,而对照组55．45％有死骨吸收,其中32．67％为明显吸收;通络生骨胶囊组67.12％有新骨形成,其中31．85％为明显成骨,而对照组51．49％有新骨形成,其中25．74％为明显成骨。两组差异有显著性意义(P<0．05)。两组药物的不良事件发生率均很低。结论:通络生骨胶囊治疗股骨头坏死是有效和安全的。

Objective: To.evaluate the clinical effect and security of Tongluoshenggu capsule on necrosis of femoral head. Methods: The polycentric research approach was performed using the randomized double blind、double simulation and positive drug comparison. 428 cases of femoral head necrosis were treated in all (treated group-320 cases, control group-108 cases). Results: The general efficiency for the clinical symptom and physic sign of femoral head necrosis was 79.06% in Tongluoshenggu capsule treated group and 71.30% in Jiangusheng pill control group. There was no statistic significance in two group contrast. X-rays examination indicate: The proportion of necrotic bone absorption was 71.23% in treated group (43. 84% remarkable absorption) and 55.45% in control group(32.67% remarkable absorption); the proportion of new bone formation was 67.12% in treated group(31.85% remarkable formation) and 51.49% in control group(25.74% remarkable formation). There was all statistic significance in two above group contrast(P<0.05).The adverse event incidence of two group were all very low. Conclusion: Tongluoshenggu capsule on femoral head necrosis'treatment was effective and safe.