复方芙蓉叶凝胶膏剂工艺优化及临床疗效与安全性的验证

Process optimization of compound cotton rose hibiscus leaf ointment and its clinical efficacy and safety verification

背景:复方芙蓉叶凝胶膏剂是在传统伤科名方"消肿散"基础上,通过对贴膏基质制作工艺的不断优化发展而来。"消肿散"在上海交通大学医学院附属瑞金医院使用已超过40年,具有良好的临床疗效。目的:通过对制作工艺优化后的复方芙蓉叶凝胶膏剂的临床研究,验证其临床疗效与安全性,为其治疗急性软组织损伤的应用奠定基础。方法:将112例急性软组织损伤患者按随机数字表法分为试验组55例和对照组57例,试验组选用复方芙蓉叶凝胶膏剂,对照组选用复方紫荆消伤巴布膏。结果与结论:(1)2组在治疗前、治疗第3天、治疗第7天以及治疗后的疼痛、压痛、肿胀、功能障碍等主要指标以及瘀斑、失眠、口干、便秘、舌苔、脉象等次要指标方面差异无显著性意义(P> 0.05);(2)2组在治疗急性软组织损伤方面都具有明显的疗效,但2组临床疗效差异无显著性意义(P> 0.05);(3)2组在血尿便常规以及肝肾功能方面都未见明显异常,(4)在并发症方面仅有5例轻微皮肤过敏,其中试验组2例,对照组3例;(5)结果说明复方芙蓉叶凝胶膏剂具有良好的临床疗效与安全性,值得临床推广应用。

BACKGROUND:Compound cotton rose hibiscus leaf ointment is developed from the continuous optimization of the preparation process of traditional famous prescription“Xiaozhong San”.Xiaozhong San has been used in Ruijin Hospital Affiliated to School of Medicine of Shanghai Jiaotong University for over 40 years and has achieved good clinical outcomes.OBJECTIVE:To verify the clinical efficacy and safety of compound cotton rose hibiscus leaf ointment,laying a foundation for its popularization and application in the treatment of acute soft tissue injury.METHODS:112 cases of acute soft tissue injury were divided into trial group(n=55)and control group(n=57)according to the random number table method.The experimental group selected the compound cotton rose hibiscus leaf ointment,and the control group selected the compound Zijing ointment.RESULTS AND CONCLUSION:(1)There were no statistical differences in the primary outcomes,such as pain,tenderness,swelling,dysfunction and in the secondary outcomes,such as ecchymosis,insomnia,dry mouth,constipation,tongue coating and pulse condition,between the two groups before treatment,at 3 and 7 days of treatment and after treatment termination(P>0.05).(2)The two groups achieved obvious clinical outcomes in the treatment of acute soft tissue injury,but there was no difference in the clinical efficacy between the two groups(P>0.05).(3)The two groups had no obvious abnormalities in the routine of hematuria and stool and the function of the liver and kidney.(4)There were only five cases of mild skin allergy,including two cases in the trial group and three cases in the control group.To conclude,the compound cotton rose hibiscus leaf ointment has good clinical efficacy and safety,which is worthy of clinical application.