目的 观察双合汤联合关节腔药物注射治疗膝关节骨性关节炎临床观察及对肿瘤坏死因子-α(Tumor necro-sis factor alpha,TNF-α)的影响.方法 研究总计纳入膝关节骨性关节炎患者150例(2022年7月—2023年3月门诊及住院患者),以随机数字表法将纳入患者分为3组,治疗组(A组)患者采取双合汤联合玻璃酸钠关节腔注射治疗,西药对照组(B组)患者采取玻璃酸钠关节腔注射治疗,中药对照组(C组)患者采取双合汤治疗,各组50例,3组患者均治疗5周时间,治疗过程中A组脱落2例,B组脱落1例,C组未见脱落.观察比较3组患者临床治疗效果、治疗前后中医证候(关节肿胀僵硬、活动受限、时常口干等)积分变化、治疗前后3组患者视觉模拟疼痛评分法(Visual Analogue Scale,VAS)变化、西安大略和麦克马斯特大学骨关节炎指数量表(Western Ontario and McMaster Universities Osteoarthritis Index,WOMAC)评分变化、肿瘤坏死因子-α(Tumor necrosis factor alpha,TNF-α)水平变化、美国特种外科医院膝关节评分(hospital for special surgery knee score,HSS 评分)变化、健康状况调查简表(MOS item short from health survey,SF-36)评分变化、治疗不良反应情况.结果 A组患者治疗总有效率高于B组与C组患者,P＜0.05;B组与C组患者治疗总有效率比较差异无统计学意义,P＞0.05;治疗前3组患者中医证候(关节肿胀僵硬、活动受限、时常口干等)积分、VAS评分、WOMAC评分、TNF-α水平、HSS评分与SF-36评分比较,P＞0.05;较治疗前,治疗后3组患者中医证候(关节肿胀僵硬、活动受限、时常口干等)积分、VAS评分、WOMAC评分、TNF-α水平、HSS评分以及SF-36评分等指标均改善,P＜0.05;A组患者经治疗后中医证候(关节肿胀僵硬及活动受限、时常口干等)积分、VAS评分、WOMAC评分、TNF-α水平、HSS评分与SF-36评分均明显优于B组与C组,C组患者治疗后中医证候(关节肿胀僵硬、活动受限、时常口干等)积分、VAS评分、WOMAC评分、TNF-α水平、HSS评分与SF-36评分与B组患者相当,P＞0.05;3组患者治疗不良反应率均较低,且不良反应症状轻微,可自行缓解,P＞0.05.结论 双合汤联合关节腔药物注射治疗膝关节骨性关节炎效果佳,可一定程度降低TNF-α水平,改善患者病情,提升患者膝关节功能及生活质量,治疗不良反应少,治疗安全可靠.
Clinical Efficacy of Shuanghe Decoction(双合汤)Combined with Intra-Articular Injection Therapy for Knee Osteoarthritis and Its Effect on TNF-α
Objective To observe the clinical efficacy of Shuanghe Decoction(双合汤)combined with intra-articular injec-tion therapy for knee osteoarthritis and to detect its effect on tumor necrosis factor-alpha(TNF-α)level.Methods A total of 150 patients with knee osteoarthritis in both inpatient units and outpatient clinics of the hospital from July 2022 to March 2023 were included in this study,and assigned into three groups according to random number table methods,each with 50 cases.The patients in the treatment group(group A)were treated with Self-made Shuanghe Decoction combined with intra-articular injec-tion therapy of sodium hyaluronate,those in the western medicine control group(group B)were given intra-articular injection therapy of sodium hyaluronate,and those in the TCM control group(group C)were treated with Self-made Shuanghe Decoction.A five-week treatment regime was conducted in three groups.During the treatment,2 cases in group A,1 case in group B and 0 in group C were dropped out.Then the clinical efficacy rate,TCM syndrome scores including joint swelling and stiffness,restrict-ed movement and frequent dry mouth,Visual Analogue Scale(VAS),Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)score,TNF-α level,Hospital for Special Surgery(HSS)knee score,MOS 36-Item Short Form Health Survey(SF-36)and adverse reaction rate were compared between two groups.Results The total effective rate was the highest in group A compared with that in group B and C(P＜0.05),while the effective rate yielded no statistical difference between group B and C(P＞0.05).TCM syndrome scores including joint swelling and stiffness,restricted movement and frequent dry mouth,and the scores of VAS,WOMAC,HSS and SF-36 as well as TNF-α level at the baseline demonstrated no statistical difference among three groups(P＞0.05).while the above parameters after treatment were notably better in group A than those in group B and C(P＜0.05),and the improvement of above parameters in group B was comparable with those in group C,with no statistical differ-ence(P＞0.05).The rate of adverse reactions was low in all three groups,and the symptoms were mild and could be alleviated without additional interventions(P＞0.05).Conclusion The application of Shuanghe Decoction combined with intra-articular injection therapy for knee osteoarthritis can effectively reduce serum TNF-α level,improve the condition of patients,ameliorate the knee function and quality of life,with low incidence of adverse reactions and good safety profiles.
knee osteoarthritisShuanghe Decoction(双合汤)intra-articular injection therapyclinical effectadverse re-actionknee function
万方数据
维普
