地杞壮骨胶囊治疗早中期股骨头坏死的临床研究  

Clinical Study on the Therapy of Diqi Zhuanggu Capsules for Osteonecrosis of the Femoral Head at Early and Middle Stages

作　　者：郭浩山 岳海振 郑大伟 刘桂杰 孙建 陈文祥 董吉哲 周占国 刘刚 关涛 GUO Haoshan;YUE Haizhen;ZHENG Dawei;LIU Guijie;SUN Jian;CHEN Wenxiang;DONG Jizhe;ZHOU Zhanguo;LIU Gang;GUAN Tao(Department of Orthopedics,Liaocheng Hospital of Traditional Chinese Medicine,Liaocheng 252000,Shandong China.)

机构地区：[1]山东省聊城市中医医院,山东聊城252000

出　　处：《中国中医骨伤科杂志》2020年第10期30-34,共5页Chinese Journal of Traditional Medical Traumatology & Orthopedics

基　　金：国家中医临床研究基地业务建设第二批科研专项课题(JDZX2015282);中国中医科学院科技创新团队建设项目(YS1304)。

摘　　要：目的:观察地杞壮骨胶囊治疗早中期股骨头坏死的疗效。方法:自2017年4月至2018年3月,将100例(156髋)ARCOⅠ,Ⅱ期股骨头坏死患者随机分为试验组与对照组。试验组共50例(76髋),其中男43例,女7例;年龄21~60岁,平均(46.22±8.68)岁;口服本院自制中成药制剂地杞壮骨胶囊治疗。对照组共50例(80髋),其中男37例,女13例;年龄22~60岁,平均(46.76±9.92)岁;口服通络生骨胶囊治疗。分别记录治疗前及治疗后访视时影像学转归、WOMAC及Harris评分,观察优良率,进行疗效比较。结果:共有86例患者按照计划获得完整随访。两组在开始治疗后第3,6,9个月时影像学转归差异无统计学意义(P>0.05)。末次随访时,两组均有约70%的患者影像学表现稳定,约20%的患者加重,约10%的患者好转。两组治疗后的WOMAC及Harris评分与治疗前相比,差异均有统计学意义(P<0.05),治疗后得分均优于治疗前。两组间不同访视期WOMAC与Harris评分差异无统计学意义(P>0.05)。参照Harris髋关节评分系统评分,末次随访时试验组优37髋,良16髋,可6髋,差10髋,优良率76.81%;对照组优28髋,良14髋,可12髋,差12髋,优良率63.64%。经Ridit分析,两组疗效比较差异无统计学意义(P>0.05)。结论:两种药物对早中期股骨头坏死的治疗均有效,且疗效相当。采用补气益肾活血法治疗早中期股骨头坏死能够取得令人满意的疗效。Objective:To observe the efficacy of the therapy of Diqi Zhuanggu capsules for osteonecrosis of the femoral head at early and middle stages.Methods:100 patients(156 hips) diagnosed as osteonecrosis of the femoral head at ARCO Ⅰ,Ⅱ stages were randomly divided into test group and control group from April 2017 to March 2018.In the test group,there were 43 male and 7 female aged from 21~60 years old with an average of(46.22±8.68) years treated with Diqi Zhuanggu capsules.In the control group,there were 37 male and 13 female aged from 22~60 years old with an average of(46.76±9.92) years treated with Tongluo Shenggu capsules.The imaging,WOMAC and Harris scores were recorded before and after the treatment,and the excellent and good rates were observed to be compared.Results:A total of 86 patients were followed up in all.There were no significant differences in imaging outcome between the two groups at 3 rd,6 th,and 9 th month after starting treatment(P>0.05).At the last follow-up,about 70% of the patients in both groups had stable imaging performance,about 20% of patients aggravated and about 10% of patients improved.After treatment,the WOMAC and Harris scores of the two groups were significantly different before treatment(P<0.05).The scores after treatment were better than those before treatment.There were no significant differences in WOMAC and Harris scores between the two groups at different visit periods(P>0.05).With reference to the Harris hip scoring system,at the last follow-up,the test group revealed excellent at 37 hips,good at 16 hips,fair at 6 hips,and poor at 10 hips,which showed the excellent and good rate with 76.81%;the control group showed excellent at 28 hips,good at 14 hips,fair at 12 hips and poor at 12 hips,with excellent and good rate of 63.64%.According to Ridit analysis,there was no significant difference in efficacy between the two groups(P>0.05).Conclusion:Both drugs are effective in the treatment of osteonecrosis of the femoral head in the early and middle stages,and have similar effects

关 键 词：股骨头坏死 补气 益肾 活血 

分 类 号：R681.8[医药卫生—骨科学]