疏风解毒胶囊治疗急性上呼吸道感染(风热证)2031例Ⅳ期临床研究  

Phase Ⅳ clinical trial of Shufeng Jiedu Capsule in the treatment of 2031 cases of acute upper espiratory infection of wind-heat syndrome

作　　者：徐艳玲[1] 张会红 薛云丽 杨景生[3] 周贤梅[4] 毛冰[5] 范伏元[6] 金维良 吕福云[8] 田正鉴[9] 邢之华[10] 

机构地区：[1]辽宁中医药大学附属医院,沈阳110032 [2]北京远博康惠医药信息咨询有限公司,北京100161 [3]安徽济人药业有限公司,亳州236800 [4]江苏省中医院,南京210029 [5]四川大学华西医院,成都610041 [6]湖南中医药大学第一附属医院,长沙410007 [7]聊城市中医医院,山东聊城252004 [8]内蒙古民族大学附属医院,通辽028007 [9]湖北省中医院,武汉430061 [10]中南大学湘雅医院,长沙410008

出　　处：《中华中医药杂志》2017年第1期356-360,共5页China Journal of Traditional Chinese Medicine and Pharmacy

摘　　要：目的:评价疏风解毒胶囊治疗急性上呼吸道感染(风热证)的临床疗效和安全性。方法:该试验为多中心、开放性研究,于2010年5月至2012年4月收集急性上呼吸道感染(风热证)患者2 031例,患者均给予疏风解毒胶囊,每次4粒,每日3次,餐后30min口服。治疗3d后评价疾病疗效、中医证候疗效、退热疗效、单项症状或体征疗效并观察治疗过程中实验室指标变化及不良反应发生率。结果:3d后疾病疗效痊愈率40.23%,总有效率87.40%;治疗前后疾病疗效积分比较,治疗0d疾病疗效积分(24.77±6.33),治疗3d疾病疗效积分(6.82±6.79),经配对t检验,组间差异有统计学意义(P<0.01)。3d后中医证候痊愈率为41.31%(FAS),中医证候总有效率为90.40%(FAS)。治疗前后中医证候积分比较治疗0d中医证候积分(23.16±5.99),治疗3d中医证候积分(6.24±6.39),经配对t检验,组间差异有统计学意义(P<0.05)。治疗3d体温疗效痊愈率56.23%,总有效率88.43%。中位体温起效时间为4.50h、中位体温解热时间为20.00h。治疗3d各单项症状的疗效均基本改善。试验期间未发生明显不良反应。结论:经多中心、开放性试验证实,疏风解毒胶囊治疗急性上呼吸道感染(风热证)安全、有效,值得临床推广应用。Objective：To explore the clinical effect and security of Shufeng Jiedu Capsule on patients with acute upper respiratory infection with wind-heat syndrome.Methods：This trial was multicenter and open-label,2031 patients with acute upper respiratory tract infection（wind heat syndrome） from May 2010 to April 2012 were collected and given Shufeng Jiedu Capsule,four capsules each time,3 times everyday,0.5h after meals.Total scores of disease and traditional Chinese medicine（TCM）symptom scores before and after treatment were calculated for two groups.Antifebrile effect,signs or symptoms curative effect,laboratory indexes and adverse reactions were evaluated.Results：After the treatment of 3 days,the cure rate was 40.23%,the total effective rate was 87.40%;The total scores of disease of 3-day treatment were（6.82±6.79） lower than that 0-day treatment（24.77±6.33）（P〈0.05）.After the treatment for 3 days,the cure rate of TCM syndrome was 41.31%（FAS）,the total effective rate of TCM syndromes was 90.40%（FAS）;the TCM syndrome integral of 3-day treatment were（6.24±6.39） lower than that of 0-day treatment（23.16±5.99）（P0.05）.The cure rate of temperature was 56.23%,the total effective rate of temperature was88.43%,after the treatment for 3 days.The median time to onset of antifebril was 4.50 h,the median antipyretic time was 20.00 h.The curative effect of each single symptoms were basiclly recovery after treatment of 3 days.No obvious adverse reaction was obsenved during the treatment.Conclusion：Shufeng Jiedu Capsule have a good effect on acute upper respiratory infection with wind-heat syndrome confirmed by multicenter,open-label trial.

关 键 词：疏风解毒胶囊 急性上呼吸道感染 风热证 安全性 

分 类 号：R259[医药卫生—中西医结合]