摘要
目的观察蒲地蓝消炎口服液治疗湿热型中度寻常痤疮的有效性和安全性。方法按照多中心、随机、双盲、安慰剂平行对照原则,共收集中度寻常痤疮病例210例,其中试验组105例,给予蒲地蓝消炎口服液+克林霉素凝胶治疗;对照组105例,给予蒲地蓝消炎口服液模拟剂+克林霉素凝胶治疗,共计4周。治疗结束后进行临床疗效评价。结果试验组有效率为86.54%,其中痊愈率为4.81%,对照组有效率为35.92%,痊愈率为0.00%,差异有统计学意义(P<0.05)。试验组患者皮损总计数及丘疹和脓疱症状的改善情况都明显优于对照组,差异有统计学意义(P<0.05)。试验组在改善舌苔厚腻、便秘方面疗效优于对照组,差异有统计学意义(P<0.05)。安全性方面,试验组及对照组均未观察到不良反应。结论蒲地蓝消炎口服液治疗湿热型中度寻常痤疮具有疗效显著、起效快、不良反应小的特点。
Objective To observe the efficacy and safety of Pudilan Xiaoyan oral liquid in the treatment of moderate acne vulgaris with dampness and heat.Methods A total of 210 cases of moderate acne vulgaris were collected according to the principles of multi-center,randomized,double-blind single simulation and placebo parallel control.Among them,105 cases in the experimental group were treated with Pudilan anti-inflammatory oral liquid+clindamycin gel,the control group(105 patients)were treated with Pudilan Xiaoyan oral liquid simulator+clindamycin gel for 4 weeks.The clinical efficacy was evaluated after the treatment.Results The effective rate of the experimental group was 86.54%,and the recovery rate was 4.81%,while the effective rate of the control group was 35.92%,and the recovery rate was 0.00%,and the difference was statistically significant(P<0.05).The total number of skin lesions and the improvement of papules and pustules in experimental group were significantly better than those in the control group,with statistical significance(P<0.05).The experimental group was better than the control group in improving the tongue coating and constipation,and the difference was statistically significant(P<0.05).In terms of safety,no adverse reactions were observed in the experimental group and the control group.Conclusion Pudilan Xiaoyan oral liquid in the treatment of moderate acne vulgaris of damp-heat type has obvious curative effect,quick effect and small adverse reaction.
作者
耿琳
徐亭亭
陈烨
李淼鑫
鲍捷
陈洁
周蓉
王一飞
田洪青
张宪
宋艳丽
李斌
GENG Lin;XU Tingting;CHEN Ye;LI Miaoxin;BAO Jie;CHEN Jie;ZHOU Rong;WANG Yifei;TIAN Hongqing;ZHANG Xian;SONG Yanli;LI Bin(Office of GCP,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Department of Dermatology,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Department of Dermatology,Shandong Dermatology Hospital,Jinan 250022,Shandong Province,China;Department of Dermatology,Qilu Hospital,Shandong University,Jinan 250063,Shandong Province,China;Department of Dermatology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Institute of Dermatology,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China)
出处
《世界临床药物》
CAS
2023年第11期1185-1189,共5页
World Clinical Drug
基金
上海市进一步加快中医药传承创新发展三年行动计划[ZY(2021-2023)-0302]。
关键词
蒲地蓝消炎口服液
中度寻常痤疮
湿热型
有效性
安全性
Pudilan Xiaoyan oral liquid
moderate acne vulgaris
damp heat type
effectiveness
safety