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目的以甲哌卡因临床研究为实例,研究临床等效试验设计方法,并对研究结果进行定量分析。方法以利多卡因注射液为对照,采用随机、双盲、多中心、平行对照、等效临床研究。甲哌卡因组、利多卡因组各120例。2药均为硬膜外腔注射用药,在注射15mL研究用药物后20min内,感觉阻滞平面上界达到T8判断为有效。以感觉阻滞有效率为主要疗效指标,等效界值δ=±0.10(10%)。结果甲哌卡因感觉阻滞有效率为99.2%;利多卡因感觉阻滞有效率99.1%,感觉阻滞有效率组间差为0.001(0.1%),其双向单侧97.5%CI(-0.022～0.024),提示试验组与对照组具有临床等效性。甲哌卡因不良反应发生率为4.2%,利多卡因不良反应发生率为5.0%。结论临床等效性试验重点在于主要疗效指标选取、等效界值确定和样本量估算,但安全性评价同样不能忽视。
Objective To study the design method of clinical equivalent test with mepivacaine clinical research, and to quantitatively analyze the research results. Methods Lidocaine injection as a control, randomized, double-blind, multicenter, parallel control, equivalent clinical study. Mepivacaine group, lidocaine group of 120 cases. 2 drugs are epidural injection, injection of 15mL 20min after the study drug, sensory block plane upper bound to T8 judged to be valid. To sensory block effective rate as the main efficacy indicators, equivalent threshold δ = ± 0.10 (10%). Results The effective rate of sensory block of mepivacaine was 99.2%, the effective rate of lidocaine block was 99.1%, the difference of effective sensory block rate was 0.001 (0.1%), and the bilateral unilaterally 97.5% CI (-0.022 ~ 0.024), suggesting that the experimental group and the control group have clinical equivalence. The incidence of adverse reactions of mepivacaine was 4.2% and the incidence of adverse reactions of lidocaine was 5.0%. Conclusion The clinical equivalence test focuses on the selection of the main efficacy index, the determination of the equivalent cutoff and the sample size estimation, but the safety evaluation can not be ignored.