通络骨蚀丸对痰瘀阻滞型1-2期股骨头坏死患者的临床疗效

Clinical effects of Tongluo Gushi Pills on stageⅠand Ⅱ femoral head osteonecrosis patients due to Phlegm Stagnation and Blood Stasis

目的考察通络骨蚀丸对痰瘀阻滞型1-2期股骨头坏死患者的临床疗效。方法 160例(233髋)患者随机分为对照组和观察组,每组80例,对照组给予双氯芬酸钠和仙灵骨葆胶囊,观察组给予通络骨蚀丸,疗程1年。然后,检测临床症状评分(Harris、FPS-R、JOA、中医证候)、血黏度指标(全血高切、中切、低切黏度、血浆黏度)、血清骨代谢指标(BMP2、ALP、TGF-β1、BGP)、股骨头塌陷区域、总有效率、复发率、不良反应发生率变化。结果与对照组比较,观察组总有效率显著提高(P<0.05),复发率、不良反应发生率显著降低(P<0.05),临床症状评分、血黏度指标、血清骨代谢指标、股骨头塌陷区域显著改善(P<0.05)。结论通络骨蚀丸对痰瘀阻滞型1-2期股骨头坏死患者临床疗效良好,复发率、不良反应发生率较低。

AIM To investigate the clinical effects of Tongluo Gushi Pills on stageⅠandⅡfemoral head osteonecrosis patients due to Phlegm Stagnation and Blood Stasis. METHODS One hundred and sixty patients (233 hips) were randomly divided into control group for 1-year intervention of diclofenac sodium and Xianling Gubao Capsules, and observation group for 1-year intervention of Tongluo Gushi Pills, 80 cases in each group. Subsequently, the changes in clinical symptom scores (Harris, FPS-R, JOA, TCM syndromes), blood viscosity indices (whole blood high-shear, medium-shear, low-shear viscosities, plasma viscosity), serum bone metabolic markers (BMP2, ALP, TGF-β1, BGP), femoral head collapse area, total effective rate, recurrence rate, and occurrence rate of adverse reactions were detected. RESULTS Compared with the control group, the observation group demonstrated significantly increased total effective rate (P<0.05), markedly decreased recurrence rate and occurrence rate of adverse reactions (P<0.05), obviously improved clinical symptom scores, blood viscosity indices, serum bone metabolic markers, and femoral head collapse area (P<0.05). CONCLUSION For the stageⅠandⅡfemoral head osteonecrosis patients due to Phlegm Stagnation and Blood Stasis, Tongluo Gushi Pills exhibit good clinical efficacy with low recurrence rate and occurrence rate of adverse reactions.