清热拔毒膏外敷治疗湿热内蕴型膝骨关节炎临床研究

Clinical Study on External Application with Qingre Badu Plaster for Knee Osteoarthritis of Damp-Heat Accumulation Type

目的:观察清热拔毒膏外敷治疗膝骨关节炎(KOA)湿热内蕴型的临床疗效。方法:将符合纳入标准的KOA患者随机分为4组:手法按摩组(A组)23例,清热拔毒膏加手法按摩组(B组)25例,清热拔毒膏组(C组)27例,扶他林软膏对照组(D组)24例,最终共99例患者完成本课题研究,观察治疗前后西安大略和麦马斯特大学骨关节炎指数(WOMAC)、疼痛视觉模拟评分法(VAS)评分,酶联免疫吸附试验(ELISA)检测关节液肿瘤坏死因子-α(TNF-α)、白细胞介素-1β(IL-1β)、基质金属蛋白酶-1(MMP-1)指标。结果:B组和C组WOMAC、VAS评分优于A组及D组,差异均有统计学意义(P<0.05),TNF-α、IL-1β、MMP-1因子检测显示B组、C组和D组优于A组,差异均有统计学意义(P<0.05);临床疗效总有效率B组88.00%和C组85.19%均高于A组73.91%和D组79.17%,差异均有统计学意义(P<0.05)。在治疗过程中,4组患者均未见推拿手法和药物的不良反应。结论:以汉防己为君药的清热拔毒膏外敷治疗KOA湿热内蕴型患者临床疗效确切,改善患者临床不适症状,降低膝关节液炎症反应,患者安全性高。

Objective:To observe the clinical effect of Qingre Badu plaster for knee osteoarthritis(KOA)of damp-heat accumulation type.Methods:The KOA patients who met the inclusion criteria were randomly divided into four groups,namely the manual massage group(Group A),the Qingre Badu plaster and manual massage group(Group B),the Qingre Badu plaster group(Group C)and the control group with voltaren emulgel(Group D),23,25,27 and 24 cases in each group respectively.Finally,a total of 99 patients completed the study.Before and after treatment,the scores of Western Ontario and Mcmaster Universities Osteoarthritis Index(WOMAC)and Visual Analogue Scale(VAS)were observed;tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1β)and matrix metalloproteinase-1(MMP-1)in synovial fluid were detected by Enzyme Linked Immunosorbent Assay(ELISA).Results:The scores of WOMAC and VAS in Group B and Group C were better than those in Group A and Group D,differences being significant(P<0.05).The detection of TNF-α,IL-1βand MMP-1 showed that the levels in Group B,C and D were better than those in Group A,differences being significant(P<0.05).The total effective rate was 88.00%in Group B and 85.19%in Group C,higher than those of 73.91%in Group A and 79.17%in Group D,differences being significant(P<0.05).During treatment,there was no response to massage manipulation and no adverse reaction to drugs in the four groups.Conclusion:The external application of Qingre Badu plaster,with Radix Stephaniae Tetrandrae as the chief medicinal,has definite clinical effect for KOA patients of damp-heat accumulation type,and can improve clinical uncomfortable symptoms,reduce inflammatory responses in knee joint fluid with high safety.