真实世界恒古骨伤愈合剂治疗膝骨关节炎缓解期患者用药特征及临床疗效分析

Analysis on Medication Characteristics and Clinical Efficacy of Osteoking in Treatment of Knee Osteoarthritis in Remission Stage in Real-world Research

目的探究真实世界恒古骨伤愈合剂治疗膝骨关节炎缓解期患者的用药特征和临床疗效,为恒古骨伤愈合剂的临床合理用药提供依据。方法基于“恒古骨伤愈合剂治疗膝骨关节炎病例注册登记系统”资料,采用SPSS25.0、SPSS Modeler 18.0软件Apriori算法及TCMIP2.0数据库对应用过恒古骨伤愈合剂的膝骨关节炎缓解期病例数据进行分析。结果使用恒古骨伤愈合剂治疗膝骨关节炎缓解期患者共526例,女性357例(67.87%),男性169例(32.13%),平均年龄(64.32±12.87)岁,平均体质量指数(23.18±3.18)kg/m^(2),平均疗程(16.32±9.72)d;Kellgren-Lawrence影像分级(K-L分级)以Ⅱ级(50.38%)、Ⅲ级(26.05%)为主,疼痛视觉模拟评分法(VAS)评分中位数为6分,以6分(39.92%)、5分(28.71%)为主,VAS评分与K-L分级不存在显著相关性(P>0.05)。通过聚类分析可以将缓解期证型归纳为气滞血瘀证、寒湿痹阻证、肝肾亏虚证。526例患者中单用组353例(67.11%),多于联用组的173例(32.89%);单用组平均疗程(15.48±6.96)d,少于联用组的(16.68±10.80)d,差异有统计学意义(P<0.05),单用组K-L分级Ⅱ级以上患者占77.05%,低于联用组的89.60%(P<0.05);单用组VAS评分≤6分的患者占84.42%,多于联用组的67.73%,而单用组VAS评分7分的患者占15.58%,少于联用组的32.37%。联合用药中,使用频次前2位的药物是依托考昔(105次,27.63%)、甲钴胺(46次,12.11%),2种药物联用置信度与支持度最高的药物组合均为“依托考昔-甲钴胺”(置信度58.82%,支持度7.47%)。总体临床疗效评价显示,患者VAS评分明显下降(P<0.05),其中单用组平均下降(3.65±1.60)分,高于联用组的(3.51±1.32)分(P<0.05);西安大略麦克马斯特大学骨关节炎指数(WOMAC)评分明显下降(P<0.05),其中单用组平均下降(51.73±26.72)分,高于联用组的(50.39±21.55)分(P>0.05)。网络调控机制分析发现,单用恒古骨伤愈合剂能够改善膝骨关节炎缓解期疼痛、僵硬等症状,可能是通过恢复骨细胞代谢、矫正“免疫-炎症”失衡、调节细胞代谢功能以发挥补肾健骨、消肿止痛、松解粘连的综合功效。结论恒古骨伤愈合剂治疗膝骨关节炎缓解期疗效确切,临床中超过2/3的患者以单独应用为主,联合用药多因病情较重。在缓解膝关节疼痛、改善关节僵硬方面,单独用药优于联合用药。

Objective To explore the medication characteristics and clinical efficacy of Osteoking in the treatment of knee osteoarthritis(KOA)in remission stage in real-world research;To provide evidence for clinical rational medication.Methods Based on the data of“Osteoking for the treatment of knee osteoarthritis case registration system”,SPSS 25.0,SPSS Modeler 18.0(Apriori algorithm)and TCMIP 2.0 database were used to analyze the data in remission of knee osteoarthritis treated with Osteoking.Results A total of 526 patients with KOA in remission stage were treated with Osteoking,357 women(67.87%),and 169 men(32.13%),with a mean age of(64.32±12.87)years,mean BMI(23.18±3.18)kg/m^(2),mean duration of treatment(16.32±9.72)days.The K-L scale was dominated by GradeⅡ(50.38%)and GradeⅢ(26.05%).The median VAS score was 6.The VAS score was dominated by 6(39.92%)and 5(28.71%).There was no significant correlation between the VAS score and K-L scale(P>0.05).Through clustering analysis,the syndrome types of remission stage of KOA could be summarized into qi stagnation and blood stasis syndrome,cold and dampness obstruction syndrome,deficiency of liver and kidney syndrome.Among the 526 patients,353 cases(67.11%)in the single treatment group were more than 173 cases(32.89%)in the combined treatment group.The average course of treatment in the single treatment group was(15.48±6.96)days,which was less than that in the combined treatment group(16.68±10.80)days,with statistical significance(P<0.05),77.05%of patients with K-L GradeⅡor above in the single treatment group were lower than 89.60%in the combined treatment group(P<0.05).Patients with VAS score less than or equal to 6 in the single treatment group accounted for 84.42%,which was higher than that in the combined treatment group(67.73%);patients with VAS score of 7 in the single treatment group accounted for 15.58%,which was lower than that in the combined group(32.37%).Among the combination drugs,the top two drugs used frequently were etecoxi(105 times,27.63%)and mecobalamine(46 times,12.11%).The drug of two drugs was“etecoxi-mecobalamin”with the highest confidence(58.82%)and support(7.47%).Overall clinical efficacy evaluation showed that the VAS score was significantly reduced(P<0.05),the average decrease of single treatment group was(3.65±1.60)points,and that of combined treatment group was(3.51±1.32)points(P<0.05);WOMAC score was significantly reduced(P<0.05),the average decrease of single treatment group was(51.73±26.72)points,which was higher than that of combined treatment group(50.39±21.55)points(P>0.05).The network regulating mechanism analysis revealed that Osteoking could improve the symptom of pain and stiffness during the remission stage of KOA,possibly by restoring bone cell metabolism and regulating cellular metabolic function to exert the combined effects of tonifying the kidney and strengthening the bone,reducing swelling and pain,and loosening adhesions.Conclusion Osteoking is effective in treating KOA in remission stage.More than two-thirds of the patients in the clinic are mainly used alone,and the combined medication is mostly used due to more severe disease.In terms of relieving knee pain and improving joint stiffness,it is better to use alone than in combination.