消肿止痛合剂预防全髋关节置换术后异位骨化的临床研究

Clinical study on the prevention of heterotopic ossification after total hip arthroplasty by Xiaozhong Zhitong(消肿止痛) mixture

目的:探讨消肿止痛合剂预防全髋关节置换术后异位骨化形成的临床效果。方法:对2006年7月至2009年10月采用全髋关节置换术治疗的154例患者进行随机分组,其中空白组50例(A组)、消炎痛组55例(B组)和消肿止痛合剂组49例(C组)。154例患者中原发性骨性关节炎9例,继发于髋臼发育不良的骨性关节炎34例,继发于股骨头缺血坏死的骨性关节炎98例,类风湿性关节炎2例,股骨颈骨折5例,其他6例。手术采用改良Gibson入路,术后除常规治疗外A组患者不干预治疗;B组从术后第1天开始口服消炎痛,每次50mg,每天2次,应用4周;C组口服消肿止痛合剂,每次50ml,每天2次,应用4周。术后18个月为研究终点,对患者进行X线检查(包括双髋正位、闭孔斜位、髂骨斜位片),观察有无异位骨化形成(骨化程度采用Brooker分级法评定);同时采用Harris评分对髋关节功能进行评估,包括自我评价(PAHSS)80分和查评评价(IAHSS)20分。结果:154例患者均获随访,平均21.2个月。异位骨化发生情况:A组27例(54%),其中BrookerⅠ级8例,Ⅱ级9例,Ⅲ级8例,Ⅳ级2例;B组12例(21.82%),BrookerⅠ级10例,Ⅱ级2例;C组11例(22.45%),BrookerⅠ级9例,Ⅱ级2例。3组异位骨化发生情况经秩和检验,差异有统计学意义(P<0.05),而B组与C组比较差异无统计学意义(P>0.05)。3组患者术前Harris、PAHSS及IAHSS评分数据经单因素方差分析,差异无统计学意义(P>0.05);术后18个月Harris、PAHSS及IAHSS评分数据经单因素方差分析,差异有统计学意义(P<0.01)。对各组患者术前与术后18个月Harris、PAHSS及IAHSS评分进行t检验,差异均有统计学意义(P<0.01)。术后18个月Harris、PAHSS及IAHSS评分数据应用LSD-t法,A组与B,C组比较差异均有统计学意义(P<0.01),B组与C组比较差异无统计学意义(P>0.05)。胃肠反应A组5例,B组35例,C组4例。结论:消肿止痛合剂对全髋关节置换术后异位骨化形成的预防效果与消炎痛相似,但其不良反应明显减少,患者易于接受。

Objective：To explore the therapeutic effects of Xiaozhong Zhitong（消肿止痛） mixture preventing heterotopic ossification（HO） after total hip arthroplasty.Methods：From July 2006 to October 2009,154 patients underwent total hip replacement surgery were randomly divided into sham group（group A,50 cases）,indomethacin group（group B,55 cases）and Xiaozhong Zhitong（消肿止痛） mixture group（group C,49 cases）.Among 154 patients,9 cases were primary osteoarthris,34 cases osteoarthritis secondary to acetabular dysplasia,98 cases osteoarthritis secondary to avascular necrosis of the femoral head,2 cases rheumatoid arthritis,5 cases femoral neck fracture,6 cases other diseases.Modified Gibson approach was used during the operation.After operation,group A was no preventing treatment,group B was treated by indomethacin 50 mg every time,twice a day;group C was treated by Xiaozhong Zhitong（消肿止痛） mixture 50 ml every time,twice a day for 4 weeks.Eighteen months after operation was study termination point and X-ray（including the double hip anteroposterior,obturator oblique and iliac oblique film） was used to observe whether heterotopic ossification was formed（Brooker classification was used to evaluate ossification degree）;Harris scoring was used to evaluate the function of hip joint,including PAHSS 80 scores and IAHSS 20 scores.Results：All the patients were followed up,with the average of duration of 21.2 months.The condition of heterotopic ossification：for group A,there were 27 cases with heterotopic ossification（54%）,and Brooker I in 8 cases,Ⅱin 9 cases,Ⅲin 8 cases and Ⅳin 2 cases;for group B,there were 12 cases heterotopic ossification（21.82%）,and Brooker Ⅰ in 10 cases,Ⅱin 2 cases;for group C,there were 11 cases heterotopic ossification（22.45%）,and Brooker I in 9 cases,Ⅱin 2 cases.There was significant difference among three group in heterotopic ossification by rank test（P〈0.05）,but no difference between group B and C（P〉0.05）;there were no significant difference among three groups before treatment in Harris,PAHSS and IAHSS by analysis of variance（one-way ANOVA）（P〈0.05）,and has significant difference at 18 months after treatment（P〈0.01）.There were significant difference in Harris,PAHSS and IAHSS before and after treatment at 18 months（P〈0.01）.LSD-t was used to analyzed the scoring of Harris,PAHSS and IAHSS,there was significant difference among group A and group B and group C（P〈0.05）,but no difference between group B and C（P〈0.01）.There were gastrointestinal reaction in 5 of group A,35 in group B and 4 in group C.Conclusion：The effect of Xiaozhong Zhitong（消肿止痛） mixture on the prevention of heterotopic ossification after total hip arthroplasty is similar to indomethacin,but Xiaozhong Zhitong（消肿止痛） mixture has the advantages of less side effects and easily acceptance by patients.