股密葆方治疗早中期非创伤性股骨头坏死肾虚血瘀证的临床研究

Aclinical study of oral application of Gumibao Fang(股密葆方)for treatment of early-and mid-stagenon-traumatic osteonecrosis of the femoral head with kidney-deficiency and blood-stasis syndrome

目的:观察股密葆方治疗早中期非创伤性股骨头坏死肾虚血瘀证的临床疗效。方法:2010年1月至2018年12月收治57例(61髋)非创伤性股骨头坏死肾虚血瘀证患者,男33例、女24例;年龄28~63岁,中位数41岁;国际骨微循环研究学会(association research circulation osseous,ARCO)分期Ⅰ期7髋、Ⅱ期41髋、ⅢA期13髋。均采用口服股密葆方治疗,每日1剂,水煎服,早晚各1次,3个月为1个疗程,共治疗4个疗程。采用Harris髋关节评分标准和欧洲五维健康量表(EuroQol-5 dimension,EQ-5D)进行疗效评价。治疗及随访期间复查双侧髋关节正位、蛙位X线片,记录观察时间及患髋ARCO分期,以ARCO分期超过ⅢA期为塌陷标准,作为观察终点进行生存分析。结果:所有患者均观察随访至治疗开始后2年以上(治疗开始后25~76个月,中位数43个月)。至观察结束时,共有13髋发生塌陷(进展至ⅢA期以上),其中Ⅱ期8髋(19.51%)、ⅢA期5髋(38.46%)。股骨头生存时间(64.51±3.61)个月,中位生存时间66个月。治疗开始后2年时,患者的Harris髋关节评分总分及其中的疼痛评分、关节功能评分、关节活动度评分均较治疗前提高[(73.58±10.02)分,(84.92±7.56)分,t=3.130,P=0.016;(32.25±6.17)分,(38.67±5.06)分,t=4.210,P=0.000;(34.42±5.85)分,(39.00±3.66)分,t=3.960,P=0.000;(3.25±0.53)分,(4.35±0.53)分,t=2.100,P=0.023],关节畸形评分与治疗前的差异无统计学意义[(3.67±1.13)分,(3.50±1.35)分,t=-1.460,P=0.230];EQ-5D指数也较治疗前提高(0.54±0.16,0.66±0.13,t=2.300,P=0.021)。结论:采用股密葆方治疗早中期非创伤性股骨头坏死肾虚血瘀证,可有效缓解髋关节疼痛、改善髋关节功能,提高患者生活质量,延缓股骨头塌陷。

Objective:To observe the clinical outcome of oral application of Gumibao Fang(股密葆方,GMBF)in treatment of early-and mid-stage non-traumatic osteonecrosis of the femoral head(NONFH)with syndrome of kidney-deficiency and blood-stasis.Methods:Fifty-seven kidney-deficiency-blood-stasis-type NONFH patients(61 hips)recruited from January 2010 to December 2018 were enrolled in the study,and they consisted of 33 males and 24 females and ranged in age from 28 to 63 years(Median=41 yrs).According to the staging standard issued by the association research circulation osseous(ARCO),the NONFH belonged to ARCO stage Ⅰin 7 hips,stage Ⅱ in 41 hips and stage ⅢA in 13 hips.All patients were treated with oral application of GMBF,one dose a day in the morning and evening respectively for consecutive 4 courses of treatment,3 months for each course.The clinical outcome was evaluated according to Harris hip score(HHS)and EuroQol-5 dimension(EQ-5D).The X-ray examination of bilateral hip in normotopia and froglike position were per-formed during the treatment and follow-up period.The observation timepoints and ARCO stage of the affected hips were recorded.The obser-vation was terminated when ARCO stage of the hips was beyond ARCO stage ⅢA,which was considered as the criterion of collapse,and the survival analysis was conducted.Results:All patients were followed up for 25-76 months(Median=43 months)after the start of treatment.By the end of follow-up,the collapse was found in 13 hips(stage ⅢA or above),among which 8 hips at stage Ⅱ(19.51%)and 5 hips at stage ⅢA(38.46%).The survival time of femur head was 64.51±3.61 months with a median of 66 months.The HHSs including total scores,pain scores,function scores and scores of range of motion were higher at 2 years after the start of treatment compared to pretreatment(73.58±10.02 vs 84.92±7.56 points,t=3.130,P=0.016;32.25±6.17 vs 38.67±5.06 points,t=4.210,P=0.000;34.42±5.85 vs 39.00±3.66 points,t=3.960,P=0.000;3.25±0.53 vs 4.35±0.53 points,t=2.100,P=0.023),while there was no statistical difference in joint deformity scores between the 2 timepoints(3.67±1.13 vs 3.50±1.35 points,t=-1.460,P=0.230).Furthermore,the EQ-5D index increased at 2 years after the start of treatment compared to pretreatment(0.54±0.16,0.66±0.13,t=2.300,P=0.021).Conclusion:Oral application of GMBF can effectively relieve the hip pain,improve hip function,delay femoral head collapse and improve patient's life quality in treatment of early-middle NONFH with kidney-deficiency and blood-stasis syndrome.