关节功能障碍指数评价透明质酸钠治疗大骨节病的远期效果

Long-term therapeutic effect of hyaluronic acid on adults with Kashin-Beck disease assessed by joint dysfunction index

目的 评价透明质酸钠治疗成人大骨节病的远期效果及用关节功能障碍指数评价的适用性.方法 依据《大骨节病治疗效果判断标准》中的关节功能障碍指数综合评分及患者对治疗的总体评价,采用整群随机分组、以淀粉片为对照的临床试验.99例大骨节病患者来自陕西省永寿县,分为治疗组（50例）和对照组（49例）.治疗组膝关节腔内每周注射1支透明质酸钠（2.5 ml）,连续注射4次;对照组口服淀粉片3个月,每次2粒,3次/d.治疗开始后随访48月,评价透明质酸钠治疗大骨节病的可行性.结果 治疗组膝关节功能障碍改善率在治疗后1周和1、2、3、6、48月分别为80.0％ （40/50）、83.0％ （39/47）、86.4％ （38/44）、85.7％（36/42）、80.0％（36/45）、47.1％（16/34）,显著高于对照组[25.0％（12/48）、28.3％（13/46）、33.3％（16/48）、25.0％ （10/40）、30.0％ （12/40）、21.4％（6/28）],二者比较差异有统计学意义（x2值分别为29.744、28.236、17.762、30.665、21.537、4.406,P均＜0.05）.在治疗前,关节功能障碍指数评分分数：治疗组为7.59±1.82,对照组为6.89±1.97（t=1.837,P＞0.05）;治疗后1个月随访分数分别为3.44±1.71、5.55±2.34（t=4.972,P＜0.01）;治疗后6个月随访分数分别为3.46±2.78、6.10±1.83（t=5.102,P＜0.01）;治疗后48个月随访分数分别为5.13±2.88、6.81±3.07（t=2.219,P＜0.05）.治疗组患者满意度（85.1％,40/47）显著高于对照组（60.9％,28/46;Z=-4.012,P＜ 0.01）.治疗组总体评价透明质酸钠治疗后的Kappa值为0.526,一致性强度为中度（P＜0.01）.结论 膝关节腔内注射透明质酸钠治疗大骨节病效果显著且疗效持久,用关节功能障碍指数评价治疗的远期效果具有较好的适用性.

Objective To evaluate the long-term therapeutic effect of hyaluronic acid on adults with Kashia-Beck disease and the applicability of the joint dysfunction index.Methods A cluster-randomized,starch tablets-controlled trial was carried out depending on the joint dysfunction index of assessment for therapeutic efficacy on Kashin-Beck disease and self-assessment by patients of the ＂Treatment Effect of Kaschin Beck Disease in Criterion＂A total of 99 adults with Kashia-Beck disease were randomly divided into two groups：treatment group including 50 patients were intra-articular injected hyaluronic acid in knee weekly for 4 weeks,and the control group including 49 patients were treated with oral starch tablets for 3 months,2 tablets each time,3 times a day.We carried out 48 months follow-up and assessed the applicability of Kashia-Beck disease with treatment of hyaluronic acid.Results The improvement rates of joint dysfunction index were 80.0% （40/50）,83.0% （39/47）,86.4% （38/44）,85.7%（36/42）,80.0%（36/45）,and 47.1%（16/34） for 1 week and 1,2,3,6,48 months in treatment group,respectively,which were significantly higher than those of corresponding control group 25.0% （12/48）,28.3% （13/46）,33.3% （16/48）,25.0% （10/40）,30.0% （12/40）,and 21.4% （6/28）,and the differences were statistically significant between corresponding groups （x2=29.744,28.236,17.762,30.665,21.537,4.406; all P 〈 0.05）.Before treatment,the treatment group and control group in the joint dysfunction index scores were 7.59 ± 1.82 and 6.89 ± 1.97（t =1.837,P 〉 0.05）,respectively.After treatment,1 month follow up of the treatment group and control group in the joint dysfunction index scores were 3.44 ± 1.71 and 5.55 ± 2.34（t =4.972,P 〈 0.01）,respectively; 6 months follow up were 3.46 ± 2.78 and 6.10 ± 1.83（t =5.102,P 〈 0.01）,respectively; 48 months follow up were 5.13 ± 2.88 and 6.81 ± 3.07（t =2.219,P 〈 0.05）,respectively.The satisfaction of 85.1% （40/47） in treatment group was significantly higher than that of 60.9%（28/46） in control group （Z =-4.012,P 〈 0.01）.Kappa value between joint dysfunction index and the overall evaluation of the treatment group after treatment was 0.526,which belong to moderate intensity of consistent degree （P 〈 0.01）.Conclusion The therapeutic effect of intra-articular injection of hyaluronic acid on adults with Kashia-Beck disease is significant and lasting,and the joint dysfunction index has better applicability to evaluate the long-term therapeutic effect.