Abstract:

BACKGROUND: Ulinastatin is a broad spectrum of trypsin inhibitor purified and extracted from human urine. Its main pharmacological mechanism is to inhibit the excessive release of lysosomal enzymes and to improve tissue perfusion and microcirculation. Studies addressing ulinastatin effects on acute and chronic pain after total knee arthroplasty and the incidence of postoperative deep vein thrombosis are rare.
OBJECTIVE: To observe the effects of ulinastatin on inflammatory mediators, postoperative pain, postoperative coagulation, incidence of deep vein and superficial vein thrombosis and the recovery of postoperative limb function in patients undergoing bilateral total knee arthroplasty using inflatable tourniquet.  
METHODS: A total of 72 patients receiving bilateral total knee arthroplasty were equally and randomly divided into control group and experimental group. Experimental group received intravenous infusion of ulinastatin and control group received an equal volume of normal saline. All patients received the same general and postoperative analgesia and rehabilitation protocols. The inflammation and coagulation indicators were recorded at different time points. The pain score at rest and activity and postoperative quality of recovery score were observed. According to the results of lower extremity vascular ultrasound, we analyzed the incidence of thrombosis.
RESULTS AND CONCLUSION: Levels of inflammatory cytokines of the experimental group were lower than that in the control group at partial time points (P < 0.05). Visual Analogue Scale score at rest and activity in the experimental group at 4 hours after the surgery was significantly lower than that in the control group (P < 0.05). No significant difference in coagulation parameters at each time point was found between the two groups (P > 0.05). Compared with the time of entering the operation room, fibrinogen levels were significantly lower at 4 and 24 hours after surgery in both groups, but significantly higher at 48 hours (P < 0.05). Activated partial thromboplastin time was significantly longer in both groups at 24 and 48 hours after surgery (P < 0.05). At 4-48 hours after surgery, D-Dimer expression was significantly increased in the two groups (P < 0.05). Compared with the control group, the number of thrombosis was reduced and total length of the thrombosis was significantly shorter in the experimental group (P < 0.05). Postoperative quality of recovery score was higher in the experimental group at 4 hours, 1, 3, 5, and 7 days after surgery than in the control group (P < 0.05). These data indicate that ulinastatin can alleviate inflammatory response and early postoperative pain scores at rest and activity, reduce quantity of inter-vein thrombosis of lower extremity muscle, slow the speed of thrombosis and improve the quality of postoperative recovery in patients undergoing total knee arthroplasty.   

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

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Key words: Arthroplasty, Replacement, Knee, Venous Thrombosis, Fibrinogen