右美托咪定注射液用于下肢骨科手术患者的临床研究

Clinical trial of dexmedetomidine injection in the treatment of patients undergoing lower limb orthopaedic surgery

目的观察右美托咪定注射液用于下肢骨科手术患者的临床疗效及安全性。方法将80例择期进行下肢骨科手术患者随机分为对照组和试验组,每组40例。2组患者均用腰-硬联合麻醉方式进行麻醉。对照组给予0.5~2.5 mg·kg^(-1)1%丙泊酚,静脉注射,之后以1~4 mg·kg^(-1)·h^(-1)持续泵注给药至手术结束;试验组先给予4μg·mL^(-1)右美托咪定溶液,静脉注射,然后以0.4μg·kg^(-1)静脉泵注10 min,最后以0.2~0.7μg·kg^(-1)·h^(-1)速率持续泵注给药至手术结束。比较2组患者的血流动力学指标,白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)水平,以及药物不良反应的发生情况。结果试验过程中共脱落6例。手术开始后30 min时,试验组和对照组的心率(HR)分别为(82.82±6.27)和(96.51±12.64)beat·min^(-1),手术开始后60 min的HR分别为(94.10±5.33)和(109.12±16.37)beat·min-1,差异均有统计学意义(均P<0.05)。术后即刻,试验组和对照组的IL-6分别为(87.45±14.46)和(104.36±15.67)pg·mL^(-1),TNF-α分别为(17.83±2.20)和(26.34±3.31)pg·mL^(-1),差异均有统计学意义(P<0.05);术后3 d,试验组和对照组的IL-6分别为(78.92±12.37)和(89.02±13.35)pg·mL^(-1),TNF-α分别为(6.69±6.35)和(9.82±6.37)pg·mL^(-1),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有恶心呕吐、呼吸困难和躁动;对照组发生的药物不良反应有恶心呕吐、躁动、呼吸困难和舌根后坠。试验组和对照组的总药物不良反应发生率分别为10.53%和16.67%,差异无统计学意义(P>0.05)。结论右美托咪定注射液用于下肢骨科手术患者的临床疗效确切,其能维持术中血流动力学稳定,降低术后炎症因子水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of dexmedetomidine injection in the treatment of patients undergoing lower limb orthopaedic surgery.Methods A total of 80 patients undergoing lower limb orthopaedic surgery were randomly divided into control and treatment groups with 40 cases per group.Two groups were anesthetized by combined spinal-epidural anesthesia.The control group was given 0.5-2.5 mg·kg^(-1)1%propofol by intravenous injection,and then continued to pump at the rate of 1-4 mg·kg^(-1)·h-1 until the end of the operation.The treatment group was given 4μg·mL^(-1) dexmedetomidine solution by intravenous injection,and then given 0.4μg·kg^(-1) by intravenous pump for 10 min,and finally continued to pump at the rate of 0.2-0.7μg·kg^(-1)·h-1 until the end of the operation.The hemodynamic indexes,serum interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)levels,and adverse drug reactions were compared between two groups.Results A total of 6 cases fell off during the trial process.30 min after operation,heart rate(HR)of treatment and control groups were(82.82±6.27)and(96.51±12.64)beat·min^(-1),HR were(94.10±5.33)and(109.12±16.37)beat·min^(-1) at 60 min after operation,the differences were all statistically significant(all P<0.05).Immediately after operation,IL-6 of treatment and control groups were(87.45±14.46)and(104.36±15.67)pg·mL^(-1),TNF-αwere(17.83±2.20)and(26.34±3.31)pg·mL^(-1),the differences were all statistically significant(all P<0.05).3 d after operation,IL-6 of treatment and control groups were(78.92±12.37)and(89.02±13.35)pg·mL^(-1),TNF-αwere(6.69±6.35)and(9.82±6.37)pg·mL^(-1),the differences were all statistically significant(all P<0.05).The adverse drug reactions of treatment group were nausea and vomiting,dyspnea and restlessness,which in control group included nausea and vomiting,restlessness,dyspnea and retroglossia.The total incidences of adverse drug reactions in the treatment and control groups were 10.53%and16.67%without significant difference(P>0.05).Conclusion Dexmedetomidine injection has definite clinical effect in patients undergoing lower extremity orthopedic surgery,which can maintain the stability of intraoperative hemodynamics and reduce the levels of postoperative inflammatory factors,without increasing the incidence of adverse drug reactions.