健脾活骨(康骨)方治疗早期股骨头坏死的中远期临床疗效评价OA
Medium-and long-term clinical efficacy of Jianpi Huogu(Kanggu)Formula in treatment of early-stage femoral head necrosis
通过长期随访非随机对照试验评价健脾活骨(康骨)方治疗早期(ARCO Ⅰ～Ⅱ期)股骨头坏死的中远期疗效,为中医药早期防治、改善症状及延缓疾病进展提供依据.纳入 2003 年 1 月—2020 年 6 月接受健脾活骨(康骨)方(试验组,61 例)或健脾活骨(康骨)方联合中药灌注(对照组,168 例),且随访≥3 年的患者.收集基线与年度随访的临床及影像学资料,采用倾向性评分匹配配对 40 对(80 例).主要终点指标包括临床疗效(含髋关节疼痛强度评分、屈髋功能评分、行走距离评分、临床疗效总分)、北京中医药大学X线评估(BUCMXE,含股骨头形态评分、坏死病灶密度评分、骨关节炎评分、BUCMXE总分),比较 2 组治疗前与治疗后 3、5、10 年的疗效.临床疗效显示,与本组治疗前比较,治疗后 3、5、10 年的髋关节疼痛强度评分、屈髋功能评分、行走距离评分及临床疗效总分均显著下降(P<0.001).影像学评估显示,与本组治疗前比较,试验组股骨头形态评分治疗后 3(0.65±1.00,P<0.05)、5(0.70±1.02,P<0.001)、10 年(0.80±1.08,P<0.05)显著升高,骨关节炎评分治疗后 3(0.32±0.66,P<0.05)、5 年(0.32±0.67,P<0.05)显著升高,坏死病灶密度评分治疗后 3(1.18±0.50,P<0.05)、5 年(1.19±0.52,P<0.05)显著下降,BUCMXE总分治疗后 3(2.15±1.29,P<0.05)、5 年(2.22±1.32,P<0.05)显著升高;与对照组比较,试验组股骨头形态评分升高(P<0.05).结果表明,健脾活骨(康骨)方可显著改善ARCO Ⅰ-Ⅱ期股骨头坏死患者的临床症状(疼痛及关节功能),中远期影像学提示病情进展缓慢(评分未达Ⅰ级病理标准).对于ARCOⅠ期或病情较轻者,可考虑单独应用该方剂治疗.
A long-term follow-up non-randomized controlled study was conducted to evaluate the medium-and long-term efficacy of the Jianpi Huogu(Kanggu)Formula in treating early-stage(ARCO Ⅰ-Ⅱ stage)femoral head necrosis,thereby providing evidence for the early prevention and treatment of the disease with TCM,improvement of symptoms,and delay of disease progression.Patients who received Jianpi Huogu(Kanggu)Formula(experimental group,n=61)or formula combined with TCM infusion therapy(control group,n=168)between January 2003 and June 2020,with a follow-up of≥3 years,were included.Clinical and imaging data at baseline and annual follow-ups were collected,and 40 matched pairs(80 cases)were selected using propensity score matching.The primary endpoints were clinical efficacy(hip pain scores,hip flexion function scores,walking distance scores,and total scores of clinical efficacy)and the Beijing University of Chinese Medicine X-ray Evaluation(BUCMXE),including femoral head morphology scores,osteoarthritis scores,necrotic lesion density scores,and total scores of BUCMXE.The efficacy of the two groups was compared before treatment and at 3,5,and 10 years post-treatment.Clinical efficacy showed that,compared with pre-treatment,both groups had significantly reduced hip pain scores and improved hip flexion function scores,walking distance scores,and total scores of clinical efficacy at 3,5,and 10 years(P<0.001).Imaging evaluation showed that,compared with pre-treatment,femoral head morphology scores in experimental group increased at 3(0.65±1.00,P<0.05),5(0.70±1.02,P<0.001)and 10 years(0.80±1.08,P<0.05);osteoarthritis scores increased at 3(0.32±0.66,P<0.05)and 5 years(0.32±0.67,P<0.05);necrotic lesion density scores decreased at 3(1.18±0.50,P<0.05)and 5 years(1.19±0.52,P<0.05);total scores of BUCMXE increased at 3(2.15±1.29,P<0.05)and 5 years(2.22±1.32,P<0.05).Compared with control group,the femoral head morphology scores increased in experimental group(P<0.05).These results confirm that the Jianpi Huogu(Kanggu)Formula can significantly improve clinical symptoms(pain and joint function)in patients with ARCO Ⅰ-Ⅱ stage femoral head necrosis.Medium-and long-term imaging data suggest slow disease progression(scores not reaching grade Ⅰ pathological criteria).For patients with ARCO Ⅰ stage or mild disease,monotherapy with this formula may be considered.
吴卓耘;周宝强;陈卫衡;宓保宏;李泰贤;王骁汉;王雪惠;林嘉铭;何海军;张彦琼;林娜
北京中医药大学 第三附属医院,北京 100029中医骨伤治疗与运动康复智能化教育部工程研究中心,北京 100029北京中医药大学 骨伤科研究所,北京 100029中医骨伤治疗与运动康复智能化教育部工程研究中心,北京 100029北京中医药大学 第三附属医院,北京 100029中医骨伤治疗与运动康复智能化教育部工程研究中心,北京 100029北京中医药大学 骨伤科研究所,北京 100029北京中医药大学 第三附属医院,北京 100029中医骨伤治疗与运动康复智能化教育部工程研究中心,北京 100029北京中医药大学 骨伤科研究所,北京 100029北京中医药大学 第三附属医院,北京 100029
早期股骨头坏死痰瘀阻络证健脾活骨(康骨)方中远期疗效
early-stage femoral head necrosisphlegm and blood stasis obstructing collateral syndromeJianpi Huogu(Kanggu)Formulamedium-and long-term efficacy
《中国中药杂志》 2026 (2)
316-322,7
国家自然科学基金面上项目(82474548)国家自然科学基金重点项目(82030122)
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