跌打七厘片治疗急性软组织损伤疗效研究

Curative effect study on treatment of acute soft tissue injury with Dieda Qili tablet

目的:评价跌打七厘片用于急性软组织损伤气滞血瘀证患者的有效性和安全性。方法:选取236例急性软组织损伤患者作为研究对象,随机将病例分为试验组118例及对照组118例,采取双盲双模拟、平行对照的临床试验方法,比较两组患者的治疗效果和安全性。结果:治疗后,试验组患者的主要疗效指标疼痛消失率为51.69%(FAS集)、56.44%(PPS集),疼痛消失率优于对照组(P<0.05)。试验组患者的主要疗效指标疾病愈显率为75.42%(FAS集)、79.21%(PPS集),疾病愈显率优于对照组(P<0.05)。试验组总有效率为93.22%(FAS集)、94.06%(PPS集),与对照组比较差异无统计学意义(P>0.05)。结论:跌打七厘片在治疗急性软组织损伤气滞血瘀证显示出明显的临床优势,能显著改善疼痛、肿胀、功能障碍等临床症状、体征,临床安全性高。

Objective:Evaluate the effectiveness and safety of Dieda Qili tablet for patients with acute soft tissue injury with syndrome of qi stagnation and blood stasis.Methods:236 patients with acute soft tissue injury diagnosed and treated in 5 central hospitals were selected as the research subjects.The cases were randomized divided into an experimental group of 118 cases and a control group of 118 cases.A double blind,double simulated,and parallel controlled clinical trial method was used to compare the treatment efficacy and safety of the two groups of patients.Results:After treatment,the main efficacy indicators of the experimental group patients were pain relief rates of 51.69%(FAS set)and 56.44%(PPS set),with a better pain relief rate than the control group(P<0.05).The main efficacy indicators of the experimental group patients were 75.42%disease recovery rate(FAS set)and 79.21%disease recovery rate(PPS set),which were better than those of the control group(P<0.05).The total effective rates of the experimental group were 93.22%(FAS set)and 94.06%(PPS set),with no statistically significant difference compared to the control group(P>0.05).Conclusion:Dieda Qili tablet has obvious clinical advantages in treating acute soft tissue injury with syndrome of qi stagnation and blood stasis,and can significantly improve the clinical symptoms and signs of pain,swelling,dysfunction,with high clinical safety.