三种剂量静脉注射酮咯酸对急诊肾绞痛患者临床镇痛效果的比较

Comparison of the analgesic effects of three doses of intravenous ketorolac in the treatment of acute renal colic

目的探讨三种剂量的静脉注射酮咯酸对肾绞痛患者的镇痛效果。方法入选2020年1月—2022年1月在江南大学附属医院治疗肾绞痛患者153名,根据随机数字表法分为低剂量组、中剂量组和高剂量组,每组51人,低、中、高剂量组分别静脉注射剂量为10 mg、15 mg和30 mg的酮咯酸。对三组患者用药时间在15 min、30 min、45 min和60 min时进行视觉模拟疼痛评分,比较评分差异,并进行非劣效性分析,以15 mm为最小临床差异。记录60 min后三组患者不良反应发生的情况。结果三组患者治疗前VAS评分差异无统计学意义(均P>0.05),具有可比性。治疗后,低、中、高剂量组在0 min到60 min的时间内VAS评分逐渐降低,表明患者疼痛逐渐减轻,组间差异无统计学意义(P>0.05)。低剂量组的总体不良反应率低于高剂量组(P>0.05)。在15 min、30 min、45 min和60 min四个时间内,低剂量组和中剂量组的CI上限均低于非劣效极限,非劣效性假设成立,低剂量组和中剂量组的酮咯酸不劣于高剂量组。结论酮咯酸的三种剂量治疗急性肾绞痛均有显著镇痛效果,低剂量组和中剂量组的酮咯酸不劣于高剂量组。

Objective To investigate the analgesic effects of three doses of intravenous ketorolac in patients with renal colic.Methods 153 patients from the Affiliated Hospital of Jiangnan University with renal colic were randomly divided into 3 equal groups undergoing intravenous injection of 10 mg,15 mg and 30 mg of ketorolac respectively(low-dose,medium-dose and high-dose groups).visual analogue scale(VAS)was used 15 min,30 min,45 min,and 60 min after administration respectively and the adverse reactions(headache,vertigo,nausia,vomiting,indigestion,and itching)were recorded.Results There were not significant differences in the VAS value among the 3 groups(all P>0.05).The values of VAS of the 3 groups gradually decreased from 15 min to 60 min after treatment,showing that the symptom of colic in all patients was relieved gradually,however,there were not significant differences among the 3 groups(all P>0.05).The occurrence rates of different single adverse reactions and the utilization rates of morphine of the 3 groups were not significantly different(all P>0.05).The general adverse reaction ate of the low dose group was significantly lower than that of the high dose group(P<0.05).The values of CI upper limit at the 4 time points of the low and middle dose groups were all lower than the non-inferiority limit,showing that the hypothesis of non-inferiority was valid and that the qualities of ketorolac tromethamine of the low-and medium-dose groups were not inferior to that of the high dose group.Conclusion The 3 different doses of ketorolac aminotriol,10 mg,15 mg and 30 mg,are all effective to release acute renal colic,and even the low dose is not inferior to the high dose.