中医微创针刀镜技术治疗早中期膝关节类风湿关节炎临床研究

A Clinical Study of TCM Minimally Invasive Needle Endoscope Technique for Treatment of Early-Middle Knee Rheumatoid Arthritis

目的:观察中医微创针刀镜技术治疗早中期类风湿关节炎的临床疗效和安全性。方法:将符合要求的200例早中期类风湿关节炎患者随机分为治疗组和对照组,每组100例。治疗组采用中医微创针刀镜技术联合甲氨蝶呤、美洛昔康口服治疗,对照组仅采用甲氨蝶呤和美洛昔康口服治疗。治疗后观察膝关节滑膜、积液变化,ACR20、ACR50、ACR70、DAS28以及不良反应发生情况。结果:①疗效指标:治疗组ACR20、ACR50、ACR70达标率均高于对照组。②肌骨超声检查:治疗24周后,治疗组膝关节滑膜较治疗前变薄,滑膜回声增强,绒毛状和结节状突起消失,滑膜血流信号较治疗前明显减少。两组比较有统计学差异。③DAS28:治疗24周DAS28均较治疗前下降。但治疗组低疾病活动度以及疾病缓解的比率明显高于对照组。④不良反应:研究中没有发生严重不良事件和病死的病例,治疗组中医微创针刀镜技术手术无感染、出血、延迟愈合等不良事件,两组试验过程中监测血常规、尿常规和肝肾功能等指标无严重不良事件。结论:采用中医微创针刀镜技术治疗早中期膝关节类风湿关节炎,能够明显减轻膝关节滑膜病变,改善和控制早中期类风湿关节炎病情,并且无严重并发症,安全性高。

Objective:To observe the clinical curative effects and safety of TCM minimally invasive needle endoscope technique for treatment of early-middle knee rheumatoid arthritis(RA). Methods:Two hundred patients with early-middle RA enrolled in the study were randomly divided into treatment group and control group,100 cases in each group. The patients in treatment group were treated with TCM minimally invasive needle endoscope technique combined with oral application of methotrexate and meloxicam,while the patients in control group were merely treated with oral application of methotrexate and meloxicam.The knee synovium and effusion changes,ACR20,ACR50,ACR70,DAS28 and adverse reactions were observed after the treatment. Results:The qualification rates of ACR20,ACR50 and ACR70 were higher in treatment group compared to control group. The knee synovium became thinner,the synovial echo enhanced,the villous and nodular apophyses disappeared and the synovium blood flow signal significantly decreased after 24-week treatment compared to pre-treatment in treatment group.There was statistical difference between the 2 groups. The DAS28 scores decreased after 24-week treatment compared to pre-treatment in the 2 groups. The low disease activity and disease-remission rate were obviously higher in treatment group compared to control group. No serious adverse events and deaths were found in the study,and no adverse events such as infection,bleeding and delayed union caused by TCM minimally invasive needle endoscope surgery were found in treatment group,and no serious adverse events were found in the 2 groups by monitoring the indexs of blood routine,urine routine and liver-kidney functions during the trial. Conclusion:TCM minimally invasive needle endoscope technique can obviously relieve the knee synovium lesion,improve and control the early-middle RA in patients with early knee RA,and it has high safety without serious complications.