目的:观察双合汤联合微创保髋术治疗围塌陷期酒精性股骨头坏死(Alcohol-induced Osteonecrosis of the Femoral Head，AOFH)的临床疗效。方法:84例AOFH患者随机分成对照组与观察组，每组各42例。对照组给予微创保髋术+仙灵骨葆，观察组给予微创保髋术+双合汤，疗程均为6个月。分别观察两组JOA评分、FPS-R评分、股骨头坏死(ONFH)指数;检测血脂[总胆固醇(TC)、甘油三酯(TG)、载脂蛋白A(ApoA)、载脂蛋白B(ApoB)]水平，凝血指标[凝血酶时间(TT)、凝血酶原时间(PT)、P选择素、血栓调节蛋白(TM)含量]，骨代谢指标[骨特异性碱性磷酸酶(BALP)、Ⅰ型前胶原氨基端前肽(PⅠNP)、转化生长因子-β1(TGF-β1)、骨保护素(OPG)]含量，生化标记物[癌胚抗原相关细胞黏附分子1(CEACAM1)、瘦素、神经肽(Nesfatin-1)]含量;比较两组中医证侯疗效、不良反应情况。结果:观察组总优良率为80。95％(34/42)，高于对照组的52。38％(22/42)(x2=5。093，P<0。05);观察组术后6月、12月时，JOA评分、FPS-R评分、ONFH坏死指数优于对照组(P<0。05);与本组治疗前比较，两组术后6月、12月时，TC、TG、ApoA、ApoB、P选择素、TM、PINP、瘦素、Nesfatin-1含量明显降低(P<0。05)，TT、PT时间、BALP活力、TGF-β1、OPG、CEACAM1含量明显升高(P<0。05);术后6月、12月时与对照组比较，观察组TC、TG、ApoA、ApoB、P选择素、TM、PINP、瘦素、Nesfa-tin-1含量明显降低(P<0。05)，TT、PT时间、BALP活力、TGF-β1、OPG、CEACAM1含量明显升高(P<0。05);两组治疗期间未见明显不良反应。结论:双合汤联合微创保髋术治疗围塌陷期AOFH临床疗效良好，可明显改善患者临床症状，降低血液黏度，改善骨代谢指标和生化标记物水平。
Clinical Efficacy of Shuanghe Decoction (双合汤) Combined with Minimally Invasive Hip-Preserving Surgery on Alcohol-Induced Osteonecrosis of the Femoral Head in Peri-Collapse Stage
Objective:To observe the clinical efficacy of Shuanghe Decoction (双合汤) combined with minimally invasive hip-preserving surgery in the treatment of alcohol-induced osteonecrosis of the femoral head (AOFH) in the peri-collapse stage.Methods:Eighty-four AOFH patients were randomly divided into a control group and an observation group,with 42 patients in each group.The control group received minimally in-vasive hip-preserving surgery combined with Xianling Guibao (仙灵骨葆),while the observation group received minimally invasive hip-pre-serving surgery combined with Shuanghe Decoction.The treatment course for both groups was six months.JOA scores,FPS-R scores,and Os-teonecrosis of the Femoral Head (ONFH) necrosis index for both groups were observed.Blood lipid levels[total cholesterol (TC),triglycer-ide (TG),apolipoprotein A (ApoA),and apolipoprotein B (ApoB)],coagulation indicators[thrombin time (TT),prothrombin time (PT),P-selectin,and thrombomodulin (TM)],bone metabolism indicators[bone-specific alkaline phosphatase (BALP),type Ⅰ procollagen N-ter-minal propeptide (PⅠNP),transforming growth factor-β1 (TGF-β1),and osteoprotegerin (OPG)],and biochemical markers[carcinoembry-onic antigen-related cell adhesion molecule 1 (CEACAM1),leptin,and nesfatin-1]were detected.Traditional Chinese medicine (TCM) syn-drome efficacy and adverse reaction rates were also compared between the two groups.Results:The total excellent rate in the observation group was 80.95％ (34/42),significantly higher than 52.38％ (22/42) in the control group (x2=5.093,P<0.05).Six months and 12 months after surgery,the JOA scores,FPS-R scores,and ONFH necrosis index were superior in the observation group to the control group (P<0.05).Six and twelve months after surgery,TC,TG,ApoA,ApoB,P-selectin,TM,PINP,leptin,and nesfatin-1 levels were reduced (P<0.05),while TT,PT,BALP,TGF-β1,OPG,and CEACAM1 levels were elevated compared with those before treatment (P<0.05).Six and twelve months after surgery,compared with the control group,the observation group showed significantly lower levels of TC,TG,ApoA,ApoB,P-selectin,TM,PINP,leptin,and nesfatin-1 (P<0.05),and significantly higher levels of TT,PT,BALP,TGF-β1,OPG,and CEACAM1 (P<0.05).No significant adverse reactions were observed in either group during the treatment period.Conclusion:Shuanghe Decoction com-bined with minimally invasive hip-preserving surgery shows good clinical efficacy in treating AOFH in the peri-collapse stage.This approach can significantly improve patient clinical symptoms,reduce blood viscosity,and enhance bone metabolism indicators and biochemical marker levels.
Shuanghe Decoction (双合汤)Hip-preserving surgeryAlcohol-induced osteonecrosis of the femoral headPeri-collapse stageClinical efficacy
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