双氯芬酸钠盐酸利多卡因注射液治疗四肢急性创伤性骨折及软组织损伤的镇痛疗效和安全性评价

Analgesic efficacy and safety evaluation on diclofenac sodium and lidocaine hydrochloride injection in the treatment of acute traumatic limbs fracture and soft tissue injury

目的评价双氯芬酸钠盐酸利多卡因注射液治疗四肢急性创伤性骨折及软组织损伤的镇痛效果和安全性。方法选择四肢急性创伤性骨折及软组织损伤患者96例,采用单盲法将患者随机分成双氯芬酸钠盐酸利多卡因注射液组(试验组)48例和曲马多组(对照组)48例,根据视觉模拟评分法(visual analogue scales,VAS)来评价疼痛的严重程度及止痛效果。观察比较给药后0、15、30、60、120、180、240 min的疼痛缓解率及不良反应;评价给药前后患者生命体征的变化。结果试验组用药后15、30、60、120、180、240 min的疼痛缓解总有效率均比对照组高,但差异均无统计学意义(P>0.0083);试验组用药后15、30、60、120、180、240 min的VAS评分均低于对照组,但差异均无统计学意义(P>0.0083);试验组与对照组疼痛开始缓解平均时间分别为(15.9±10.2)min与(40.8±14.5)min;双氯芬酸钠盐酸利多卡因注射液组患者给药前后的生命体征除脉搏外,其他各项均无统计学意义(P>0.05)。结论双氯芬酸钠盐酸利多卡因注射液可用于治疗四肢急性创伤性骨折及软组织损伤,镇痛效果明确、安全可靠、起效快,值得临床推广。

Objective To evaluate analgesic efficacy and safety of diclofenac sodium and lidocaine hydrochloride injection treating acute traumatic limbs fracture and soft tissue injury. Methods 96 person suffering from acute traumatic limbs fracture and soft tissue injury were selected and divided into two groups,one group was treated with diclofenac sodium and lidocaine hydrochloride injection（ experimental group） and the other tramadol（ control group）. Visual analogue scales（ VAS） was applied to appraise the level of pain and the curative effect of acesodyne. Curative effect and adverse reaction of patients treated with diclofenac sodium and lidocaine hydrochloride injection and tramadol at 0,15,30,60,120,180,240 min were observed; changes of patients＇ vital signs of the two groups before and after the treatment. Results The total effective rate of pain relief of experimental group was higher than control group at 15,30,60,120,180,240 min after the drug was administered,but there was no difference between two groups（ P〉0. 0083）; VAS score of experimental group at 15,30,60,120,180,240 min were all higher than control group,but there was no difference between two groups（ P〉0. 0083）; The average time for experimental group completing pain relief was lower than that of control group（ 15. 9 ± 10. 2 min vs 40. 8 ± 14. 5 min）; vital signs of experimental group had no significant changes before and after the treatment. Conclusions Diclofenac sodium and lidocaine hydrochloride injection is effective and safe on pain management of patients with acute traumatic fracture and soft tissue injury in extremities. It would be more applicable as the analgesics in the future.