大活络丸加减治疗股骨头坏死痰瘀阻络证的疗效及安全性

Clinical Efficacy and Safety of Da Huoluowan in Treatment of Osteonecrosis with Phlegm Stasis Syndrome

目的：探讨大活络丸加减治疗早中期股骨头坏死（ONFH）痰瘀阻络证的疗效及安全性。方法：将180例（317髋）患者随机分为中药组、西药组和中西药组,各60例。分别给予大活络丸加减,双氯芬酸钠,大活络丸加减联合双氯芬酸钠治疗,疗程均为6个月,随访6个月。观察各组患者治疗前后髋关节功能评分量表（harris hip joint function scale,Harris）,影像学指标量表和中医证候积分;检测血清白细胞介素-1β（interleukin-1β,IL-1β）,肿瘤坏死因子-α（tumor necrosis factor-α,TNF-α）,超氧化物歧化酶（superoxide dismutase,SOD）和C反应蛋白（C-reactive protein,CRP）的变化;比较各组有效率、随访6个月复发率和安全性指标。结果：研究期间中药组脱落3例,5髋;西药组脱落5例,8髋;中西药组脱落4例,7髋。中西药组总有效率高于中药组和西药组（P〈0.05）;中西药组Harris,影像学指标和中医证候积分,血清IL-1β,TNF-α,SOD和CRP含量改善优于中药组和西药组（P〈0.05）,中药组与西药组比较无明显差异。有效患者随访复发率比较中西药组〈中药组〈西药组（P〈0.05）。安全性比较西药组〈中西药组〈中药组（P〈0.05）。结论：大活络丸加减治疗ONFH痰瘀阻络证的疗效与双氯芬酸钠无明显差异,说明其具有有效性,且安全性评价优于双氯芬酸钠;大活络丸加减联合双氯芬酸钠治疗ONFH痰瘀阻络证具有协同增效的作用,且可降低双氯芬酸钠的不良反应。

Objective： To explore the clinical efficacy and safety of Da Huoluowan in treatment of earlyto-middle stage osteonecrosis of femoral head（ ONFH） with phlegm stasis syndrome. Method： A total of 180（ 317 hips） eligible patients were randomly divided into the traditional Chinese medicine（ TCM） group,western medicine group and TCM combined with western medicine group,60 cases in each group. The TCM group was treated with Da Huoluowan,western medicine group was treated with diclofenac sodium sustained-release tablets,and Da Huoluowan combined with diclofenac sodium sustained-release tablets was adopted in the TCM combined with western medicine group. The treatment course was 6 months,and the patients were followed up for 6 months.The harris hip joint function scale（ Harris）,imaging index scale and TCM syndrome scores were applied to estimate the efficacy in the three groups before and after treatment. The changes of serum interleukin-1β（ IL-1β）,tumor necrosis factor-α（ TNF-α）,superoxide dismutase（ SOD） and C-reactive protein（ CRP） were detected,and then the effective rate,recurrence in 6 months of follow-up and safety indexes were compared among groups.Result： The 3 cases（ 5 hips） withdrew from TCM group,5 cases（ 8 hips） withdrew from western medicine group,and 4 cases（ 7 hips） withdrew from the TCM combined with western medicine group. The total effective rate in TCM combined with western medicine group was higher than the TCM group and the western medicine group（ P 0. 05）. After treatment,the improvement in Harris scores,serum IL-1β,TNF-α,SOD and CRP levels in the TCM combined with western medicine group was significantly superior to that in TCM group and western medicine group（ P 〈0. 05）,but there was no significant difference between TCM group and western medicine group. The recurrence rate in follow-up of effective patients was as follows： western medicine group TCM group TCM combined with western medicine group（ P 〈0. 05）,and the safety was as follows： western medicine group TCM combined with western medicine group TCM group. Conclusion： There was no significant difference in clinical efficacy between Da Huoluowan and diclofenac sodium sustained-release tablets in treatment of ONFH with phlegm stasis syndrome,indicating the effectiveness of Da Huoluowan. In addition,it had a higher safety than diclofenac sodium sustained-release tablets. Da Huoluowan combined with diclofenac sodium sustained-release tablets showed synergistic Effect and could reduce the incidence of adverse reactions of diclofenac sodium sustained-release tablets.