翘芪组方治疗流行性感冒轻症患者36例有效性与安全性的随机对照试验  

Medicine,2024,Vol.65,No.7 Effectiveness and Safety of Qiaoqi Formula(翘芪组方)for Mild Influenza:A 36-case Randomized Controlled Trial

作　　者：孔德松[1] 赵峰[1] 张彦亮 张愉[2] 张敬华[1] 杨烨[3] 朱国雪 龚蕾蕾[4] 顾晓松[4] 虞鹤鸣 KONG Desong;ZHAO Feng;ZHANG Yanliang;ZHANG Yu;ZHANG Jinghua;YANG Ye;ZHU Guoxue;GONG Leilei;GU Xiaosong;YU Heming(Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine,Nanjing,210022;Affiliated Hospital of Nanjing University of Chinese Medicine;Nanjing University of Chinese Medicine;Nantong University)

机构地区：[1]南京中医药大学附属南京中医院,江苏省南京市210022 [2]南京中医药大学附属医院 [3]南京中医药大学 [4]南通大学

出　　处：《中医杂志》2024年第7期710-715,共6页Journal of Traditional Chinese Medicine

摘　　要：目的观察翘芪组方治疗流行性感冒(流感)轻症的有效性与安全性。方法采用随机对照研究设计,收集流感轻症患者74例,随机分为试验组和对照组。试验组口服翘芪组方,每次40 ml,每天2次;对照组口服连花清瘟胶囊,每次1.4 g,每天3次。两组均连续治疗3天,治疗结束后连续访视4天。比较两组患者治疗后退热时间(包括退热起效时间,完全退热时间,24 h、48 h及72 h退热率),于治疗前及治疗后第4、7天比较两组中医证候总积分,于治疗后第7天评价中医证候疗效,并观察安全性指标,记录不良反应发生情况。结果最终纳入患者65例,其中试验组36例,对照组29例。试验组退热起效时间为(15.49±23.47)h、完全退热时间为(21.37±30.06)h、24 h退热率为77.14%、48 h退热率为88.57%、72 h退热率为91.42%,对照组以上指标分别为(17.58±20.38)h、(24.30±21.87)h、61.29%、90.32%、96.77%,两组比较差异均无统计学意义(P>0.05)。治疗后第7天两组中医证候总积分均较本组治疗前降低(P<0.05),但两组间中医证候疗效痊愈率、显效率、有效率、总有效率比较,差异均无统计学意义(P>0.05)。对照组患者治疗后第4天淋巴细胞比值高于本组治疗前(P<0.05),两组治疗后丙氨酸氨基转移酶(ALT)、门冬氨酸氨基转移酶(AST)、尿素、肌酐水平均在正常范围内。两组出现的主要不良反应为头痛和头晕,均为轻度,未发生严重不良反应。结论翘芪组方治疗流感轻症疗效与连花清瘟胶囊相当,均可缩短退热时间,改善临床症状,且研究过程中未发生严重不良反应,安全性较好。Objective To evaluate the effectiveness and safety of Qiaoqi Formula(翘芪组方)for mild influenza.Methods A randomized controlled study was designed,recruiting 74 patients with mild influenza,who were ran⁃domly divided into trial group and control group.The trial group took Qiaoqi Formula orally,40ml each time,twice a day;the control group took Lianhua Qingwen Capsules(连花清瘟胶囊)orally,1.4 g each time,three times a day.Both groups were treated for 3 consecutive days and follow-up for 4 consecutive days after treatment.The time for fever reduction including onset of fever reduction,complete fever reduction time,fever reduction rates at 24,48 and 72 hours,improvement of influenza symptoms,total traditional Chinese medicine(TCM)symptom score,and safety indicators in two groups after treatment were recorded.Results Sixty-five patients were ultimately included,includ⁃ing 36 in the trial group and 29 in the control group.Onset time of fever reduction in the trial group was(15.49±23.47)h,the complete fever reduction time(21.37±30.06)h,and the 24 h,48 h,72 h,fever reduction rate was 77.14%,88.57%,91.42%respectively.The above indicators of the control group showed as(17.58±20.38)h,(24.30±21.87)h,61.29%,90.32%,96.77%respectively,with no statistically significant differences(P>0.05).On the 7th day after treatment,the total score of TCM syndromes in trial group and control group decreased compared to those before treatment(P<0.05).There was no statistically significant difference in the cure rate,sig⁃nificant effective rate,effective rate,and total effective rate of TCM syndromes between groups(P>0.05).On the 4th day,the lymphocyte ratio of patients in the control group was higher than before treatment,while alanine amino⁃transferase(ALT),aspartate aminotransferase(AST),urea,and creatinine of both groups before and after treatment were within the normal range.The main adverse reactions in both groups were mild headache and dizziness,and no serious adverse reactions observed.Conclusion The therapeutic

关 键 词：流行性感冒 翘芪组方 连花清瘟胶囊 退热 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]