推拿预防全膝关节置换后下肢深静脉血栓发生

Tuina prevents deep venous thrombosis of the lower limbs after total knee arthroplasty

背景:随着人工生物材料的更新及手术技术的进步,全膝关节置换已成为治疗重度膝关节骨关节炎的可靠方法,可有效解决膝关节骨关节炎患者的关节疼痛、关节僵硬,矫正关节畸形,恢复关节功能。但是,全膝关节置换后患者膝关节创口面积大,血液循环环境遭到破坏,血流缓慢凝滞易致机体形成高凝状态诱发深静脉血栓,严重影响手术疗效及患者满意度,甚则有发展为致死性肺栓塞的可能,是全世界关节外科专家共同关注的临床难题。目的:观察推拿预防膝关节骨关节炎患者全膝关节置换后下肢深静脉血栓的有效性。方法:采用随机对照设计,收集上海中医药大学附属光华医院关节矫形外科及关节外科收治的98例拟择期行全膝关节置换的膝关节骨关节炎患者(均为初次单膝置换),进行简单随机化分组:推拿组(n=49)和对照组(n=49)。对照组术后第1天开始予口服利伐沙班片治疗,推拿组术后第1天开始在口服利伐沙班片基础上给予点按下肢输穴治疗。干预时长设定为14 d,记录两组患者股总静脉瘀滞指数、下肢深静脉血栓发生率、D-二聚体值、压痛阈值、美国膝关节协会评分、大腿及小腿周径差值、不良事件发生情况等。试验方案于2020-05-16通过上海中医药大学附属光华医院伦理委员会审批(伦理批准号:2020-K-43)。参与试验患者对试验方案及过程均知情同意,并在试验开始前签署了《知情同意书》。该试验于2020-06-04在中国临床试验注册中心注册(http://www.chictr.org.cn/listbycreater.aspx,ChiCTR2000033537)。结果与结论:①干预第14天,推拿组股总静脉瘀滞指数低于对照组(P<0.05);②干预第14天,推拿组下肢深静脉血栓发生率低于对照组,但差异无显著性意义(P>0.05);③干预第14天,推拿组D-二聚体值低于对照组(P<0.05);④干预第14天,推拿组膝关节外侧点、内侧点压痛阈值高于对照组(P<0.05);⑤干预第14天,推拿组美国膝关节协会评分高于对照组(P<0.05);⑥干预第14天,推拿组大、小腿周径差值低于对照组(P<0.05);⑦干预期间两组均未发生不良事件;⑧结果表明,推拿可改善下肢股总静脉瘀滞状态,降低D-二聚体值,缩小大、小腿周径差值,改善关节疼痛,促进关节功能康复,安全可靠。

BACKGROUND:With the update of artificial biomaterials and surgical techniques,total knee arthroplasty has become a reliable surgical method for the treatment of severe knee osteoarthritis.It can effectively relieve joint pain and stiffness,correct joint deformity,and restore joint function in patients with knee osteoarthritis.However,total knee arthroplasty can produce a large wound in such patients,and destroy the blood circulation environment.The blood flow is then slow and coagulated,forming a hypercoagulable state in the body and further inducing deep vein thrombosis,which seriously impacts surgical efficacy and patient satisfaction.Serious patients have the risk of developing fatal pulmonary embolism,which is a clinical problem concerned by joint surgical experts all over the world.OBJECTIVE:To observe the efficacy of Tuina in preventing lower extremity deep venous thrombosis after total knee arthroplasty for knee osteoarthritis.METHODS:Using a randomized controlled design,98 patients with knee osteoarthritis scheduled for primary unilateral total knee arthroplasty were randomly divided into Tuina group and control group(n=49 per group).The control group was treated with oral rivaroxaban tablets after operation,and the Tuina group was treated with Tuina on the basis of oral rivaroxaban tablets.The intervention time was set from the 1st day to the 14th day after operation.The femoral vein stasis index,the incidence of deep venous thrombosis,D-dimer value,pressure pain thresholds,American Knee Society Score,thigh and calf circumference difference,and adverse events were recorded.The clinical trial protocol was approved by the Ethics Committee of Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine on May 16,2020(approval No.2020-K-43).Patients who participated in the clinical trial were fully informed of the study protocol and process.Informed consent was signed prior to the start of the clinical trial.This clinical trial was registered at Chinese Clinical Trial Registry on June 4,2020(http://www.chictr.org.cn/listbycreater.aspx,ChiCTR2000033537).RESULTS AND CONCLUSION:After 14 days of intervention,the total femoral vein stasis index in the Tuina group was significantly lower than that in the control group(P<0.05).After 14 days of intervention,the incidence of deep venous thrombosis in the Tuina group was lower than that in the control group,but there was no significant difference between the two groups(P>0.05).After 14 days of intervention,the D-dimer value of the Tuina group was significantly lower than that of the control group(P<0.05).After 14 days of intervention,pressure pain thresholds at medial and lateral points of the knee joint in the Tuina group were significantly higher than those in the control group(P<0.05).After 14 days of intervention,the American Knee Society Score of the Tuina group was significantly higher than that of the control group(P<0.05).After 14 days of intervention,the circumference difference of thigh and calf in the Tuina group was significantly lower than that in the control group(P<0.05).No adverse events occurred in both groups.To conclude,Tuina is safe and reliable,which can improve the lower limb femoral vein stasis state,reduce the D-dimer value,reduce thigh and calf circumference difference,improve joint pain,and promote joint function rehabilitation.