益气活血通脉方预防膝关节置换术后深静脉血栓的临床研究

目的观察益气活血通脉方预防膝关节置换术(TKA)后深静脉血栓(DVT)的有效性。方法将90例TKA术后患者随机分为中药组和利伐沙班组,每组45例。2组患者均行TKA治疗,术后均进行抗凝干预。中药组于术后第1天给予益气活血通脉方口服治疗,利伐沙班组则给予利伐沙班口服治疗,疗程为14 d。观察2组患者术后下肢DVT发生情况及术后24 h引流量、皮下瘀斑、皮下浅表感染的发生情况,评价2组患者手术前后的运动范围和中医证候积分情况,比较2组患者术前和术后2、7、14 d血浆D-二聚体水平和关节疼痛视觉模拟量表(VAS)评分的变化情况。结果(1)治疗14 d后,中药组和利伐沙班组的下肢DVT发生率分别为15.55%(7/45)和20.00%(9/45),以中药组的防治效果相对较好,但差异无统计学意义(P>0.05)。(2)中药组术后24 h引流量明显低于利伐沙班组(P<0.05);中药组术后皮下瘀斑、皮下浅表感染发生率分别为6.67%(3/45)和4.44%(2/45),明显低于利伐沙班组的22.22%(10/45)和20.00%(9/45),差异均有统计学意义(P<0.05)。(3)术后14 d,2组患者的运动范围均有所提高,中医证候积分均有降低,差异均有统计学意义(P<0.05);且中药组术后14 d与利伐沙班组比较,运动范围明显提高,中医证候评分明显降低,差异均有统计学意义(P<0.01)。(4)术后2 d,2组患者血浆D-二聚体水平和关节疼痛VAS评分均较术前明显升高(P<0.05);术后7 d和14 d,2组患者血浆D-二聚体水平和关节疼痛VAS评分均逐渐下降,与术后2 d比较,差异均有统计学意义(P<0.05);组间比较,术后各观察时点,中药组患者的血浆D-二聚体水平和关节疼痛VAS评分均明显低于对照组,差异均有统计学意义(P<0.05)。结论TKA术后早期口服益气活血通脉方预防DVT发生的临床效果与利伐沙班相当,可明显减少患者双下肢皮下瘀斑、皮下浅表感染的发生率,提高运动范围,缓解临床症状,减轻痛感,更利于促进患者TKA后的康复。

Clinical Observation on the Prevention of Deep Venous Thrombosis after Total Knee Arthroplasty with Yiqi Buxue Tongmai Formula

Objective To observe the clinical effectiveness of Yiqi Buxue Tongmai formula in preventing deep venous thrombosis(DVT)after total knee arthroplasty(TKA).Methods Ninety patients after TKA were randomly divided into Chinese medicine group(45 cases)and rivaroxaban group(45 cases).Both groups undergoing TKA received anticoagulation intervention.The traditional Chinese medicine group was given Yiqi Buxue Tongmai formula on the first day after operation.At the same time,the rivaroxaban group received conventional oral treatment with rivaroxaban.After 14 days of administration,the occurrence of lower extremity DVT in the two groups was observed,and the drainage volume,ecchymosis,and subcutaneous superficial infection were recorded for 24 h after surgery.The movement range and TCM syndrome score of the two groups were compared,and the plasma DDimer(D-D)level was detected at 2,7,and 14 day before and after surgery,and the pain degree of the patients was evaluated by visual analogue scale(VAS).Results(1)The incidence of lower limb DVT in the Chinese medicine group was 15.55%(7/45)and that of the rivaroxaban group was 20.00%(9/45).The Chinese medicine group has achieved good effect on prevention and treatment of DVT,but the difference between two groups was not statistically significant(P>0.05).(2)The 24 h postoperative drainage rate of the Chinese medicine group was significantly lower than that of the rivaroxaban group(P<0.05).The postoperative incidence of ecchymosis and subcutaneous superficial infection in the TCM group was 6.67%(3/45)and 4.44%(2/45),which was significantly lower than that in the rivaroxaban group of 22.22%(10/45)and 20.00%(9/45)(P<0.05).(3)Compared with rivaroxaban group,the movement range level of the TCM group was significantly increased 14 days after operation(P<0.05),and the TCM syndrome score was significantly decreased(P<0.01).(4)The D-Dimer level and VAS score of patients in both groups were significantly increased 2 days after operation(P<0.05).The D-Dimer level and VAS score of patients at 7 days and 14 days after operation showed significant decreased compared with those at 2 days after operation(P<0.05).And the D-Dimer level and VAS score of patients in the Chinese medicine group at2,7 and 14 days after surgery were significantly lower than those in the rivaroxaban group(P<0.05).Conclusion The clinical effect of oral administration of Yiqi Buxue Tongmai formula after TKA in preventing DVT is similar to that of rivaroxaban.The treatment of Yiqi Buxue Tongmai formula was found to significantly reduce the incidence of ecchyma and subcutaneous superficial infection of both lower extremities,improve the range of movement,alleviate clinical symptoms and pain,which is conducive to promoting the recovery of patients after TKA.