通络骨蚀丸治疗早中期痰瘀阻滞型股骨头坏死的疗效观察

Therapeutic Study of Early-to-middle Stage Osteonecrosis Caused by Phlegm and Stasis Block Patients Treated with Tongluo Gushi Pills

目的:探讨通络骨蚀丸治疗早中期痰瘀阻滞型股骨头坏死的临床疗效。方法:将90例符合条件的患者随机分为对照组和观察组,各45例。对照组口服双氯芬酸钠和仙灵骨葆胶囊,观察组口服通络骨蚀丸,疗程均为12个月。观察两组患者治疗前后Harris、MPQ-SF、影像学指标和中医证候评分;检测血流变和血脂指标的变化;比较两组有效率、随访6个月复发率和不良反应发生率。结果:观察组总有效率97. 5%,高于对照组的88. 4%(P <0. 05);观察组复发率2. 5%,低于对照组的12. 8%(P <0. 05);与对照组治疗后比较,观察组Harris、MPQ-SF和影像学积分明显升高(P <0. 05),中医证候积分、血流变和血脂指标明显降低(P <0. 05);观察组不良反应发生率7. 3%,低于对照组的46. 5%(P <0. 05)。结论:通络骨蚀丸可明显改善早中期痰瘀阻滞型股骨头坏死的临床症状及血流变和血脂指标,且复发率和不良反应发生率低。

Objective: To explore the therapeutic effect of treating early-to-middle stage osteonecrosis of femoral head( ONFH) caused by phlegm and stasis block patients by Tongluo Gushi Pills. Methods: A total 90 cases eligible patients were randomly divided into the control group and the observation group. The control group was treated with Tongluo Gushi Pills;the diclofenac sodium sustained-release tablets and Tongluo Gushi Pills were adopted in the observation group,a course of 12 months. The Harris,the MPQ-SF and imaging indicators were applyied to estimate the efficacy of the two group before and after treatment. The blood flow index and blood lipid index were detection. We compared the effect and the incidence of adverse reactions in the two groups. Results: The efficiency of the observation group was better than that of the control group. To compare with the control group after treatment,the observation group’ s Harris,MPQ-SF and radiographic integral increased significantly( P < 0. 05) and the TCM syndrome integral,indexes and blood lipids index decreased significantly( P < 0. 05). Conclusion: Tongluo Gushi Pills for the ONFH caused by phlegm and stasis block patients has the significant effect,and the incidence of adverse reactions was lower. To treat the ONFH caused by phlegm and stasis block patients with Tongluo Gushi Pills is remarkable.