复方鱼腥草合剂治疗外感风热证咽喉肿痛的随机、双盲、安慰剂平行对照多中心临床研究  

A Randomized,Double-Blind,Placebo-Controlled Multicenter Clinical Study of Compound Yuxingcao Mixture(复方鱼腥草合剂)in Treatment of Throat Swelling and Pain Caused by Exogenous Wind Heat Syndrome

作　　者：张洪春[1] 于雪峰[2] 李颖[1] 魏莹[3] 严星 孙丽翠 张炜 常新勇 郭志宏 周敏 刘泽刚 ZHANG Hongchun;YU Xuefeng;LI Ying;WEI Ying;YAN Xing;SUN Licui;ZHANG Wei;CHANG Xinyong;GUO Zhihong;ZHOU Min;LIU Zegang(China-Japan Friendship Hospital,Beijing 100029,China;The Second Affliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110034,Liaoning,China;Dezhou People's Hospital,Dezhou 253052,Shandong,China;Huaian Hospital of Traditional Chinese Medicine,Huaian 223005,Jiangsu,China;Feicheng Hospital of Shandong Guoxin Yiyang Group,Feicheng 271608,Shandong,China;Nanyang Zhangzhongjing Hospital,Nanyang 473004,Henan,China;Luohe Hospital of Traditional Chinese Medicine,Luohe 462099,Henan,China;Luoyang Third People's Hospital,Luoyang 471002,Henan,China;Jinshan Branch of Shanghai Sixth Design&Research Institute,Shanghai 201599,China;Changxing County People's Hospital,Huzhou 313199,Zhejiang,China)

机构地区：[1]中日友好医院,北京100029 [2]辽宁中医药大学附属第二医院,辽宁沈阳110034 [3]德州市人民医院,山东德州253052 [4]淮安市中医院,江苏淮安223005 [5]山东国欣颐养集团肥城医院,山东肥城271608 [6]南阳市张仲景医院,河南南阳473004 [7]漯河市中医院,河南漯河462099 [8]洛阳市第三人民医院,河南洛阳471002 [9]上海市六院金山分院,上海201599 [10]长兴县人民医院,浙江湖州313199

出　　处：《辽宁中医杂志》2022年第10期62-66,共5页Liaoning Journal of Traditional Chinese Medicine

基　　金：浙江省科技计划项目(2020C02051)。

摘　　要：目的 观察复方鱼腥草合剂治疗急喉痹(急性咽炎)外感风热证引起的咽喉肿痛的有效性及安全性。方法 将264例急性咽炎的患者,随机按2:1分入试验组和对照组,试验组口服复方鱼腥草合剂,30 mL/次,3次/d,连续服药7 d。对照组口服复方鱼腥草合剂模拟剂,且用法用量与试验组完全相同。观察两组治疗期间咽痛消失率,临床缓解情况以及中医证候积分。结果 治疗3 d,试验组和对照组的咽痛消失率分别为40.48%(68/168)和16.87%(14/83)(P<0.05)。两组率差为23.61%(95%CI:12.92%,34.29%),试验组显著优于对照组。咽痛中位消失时间试验组为95.81 h,小于对照组的110.25 h(P<0.05)。两组咽痛VAS评分AUC的分析,试验组为(9.87±7.41),对照组为(12.87±7.36),两组组间比较差异有统计学意义。治疗3 d、5 d,试验组痊愈率分别为23.81%(40/168)、61.31%(103/168)。治疗3 d、5 d,对照组痊愈率分别为7.23%(6/83)、 42.17%(35/83)。试验组的痊愈率显著高于对照组。结论 复方鱼腥草合剂可以有效提高外感风热证引起的咽喉肿痛的痊愈率,缓解病痛,缩短治疗时间,并且没有明显副作用。Objective To observe the efficacy and safety of Compound Yuxingcao Mixture(复方鱼腥草合剂)in the treatment of throat swelling and pain caused by external wind-heat syndrome of acute laryngitis.Methods A total of 264 patients with acute pharyngitis were randomly divided into the experimental group and the control group according to 2:1.The experimental group took Compound Yuxingcao Mixture orally,30 mL once,three times a day for 7 days.The control group Compound Yuxingcao Mixture simulant orally,and the usage and dosage were the same as those of the experimental group.The disappearance rate of pharyngeal pain,clinical remission and TCM syndrome scores were observed.Results After 3 days of treatment,the disappearance rates of pharyngeal pain in the experimental group and the control group were 40.48%and 16.87%,respectively(P<0.05).The difference between the two groups was 23.61%(95%CI:12.92%,34.29%),and he experimental group was significantly better than the control group.The median disappearance time of pharyngeal pain in the test group was 95.81 h,which was less than 110.25 h in the control group(P<0.05).The AUC of Visual Analogue Scale(VAS)score of pharyngeal pain in the two groups was(9.87±7.41)in the experimental group and(12.87±7.36)in the control group.There was significant difference between the two groups.After 3 and 5 days of treatment,the cure rates of the experimental group were 23.81%and 61.31%,respectively.After 3 and 5 days of treatment,the cure rates of the control group were 7.23%and 42.17%,respectively.The cure rate of the experimental group was significantly higher than that of the control group.Conclusion Compound Yuxingcao Mixture can effectively improve the cure rate of throat swelling and pain caused by external wind-heat syndrome,alleviate the pain,shorten the treatment time,and has no obvious side effects.

关 键 词：复方鱼腥草合剂 急性咽炎 临床研究 

分 类 号：R254.2[医药卫生—中医内科学]