中国中药杂志

2020, v.45(14) 3282-3291

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热炎宁合剂治疗急性扁桃体炎的随机对照双盲多中心试验
Randomized double-blind parallel controlled multicenter trial of Reyanning Mixture in treatment of acute tonsillitis

吕健;杨翠;王连心;谢雁鸣;余学庆;谷丽;高峰;张景肖;余小康;
LYU Jian;YANG Cui;WANG Lian-xin;XIE Yan-ming;YU Xue-qing;GU Li;GAO Feng;ZHANG Jing-xiao;YU Xiao-kang;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;Beijing First Integrated Traditional Chinese and Western Medicine Hospital;the First Affiliated Hospital of Henan University of Chinese Medicine;Beijing Chaoyang Hospital, Capital Medical University;Wangjing Hospital, China Academy of Chinese Medical Sciences;School of Statistics, Renmin University of Chin

摘要(Abstract):

该研究为热炎宁合剂(Reyanning Mixture,以下简称RYN)治疗急性扁桃体炎的随机对照试验,采用多中心区组随机的方法将患者按照1∶1∶1分为热炎宁合剂组(RYN组)、热炎宁合剂+阿莫西林胶囊组(Reyanning Mixture+Amoxicillin Capsules,以下简称RYN+Amoxil组)、阿莫西林胶囊组(Amoxicillin Capsules,以下简称Amoxil组),每组48例,共144例。以评价RYN单用或联用Amoxil治疗急性扁桃体炎的有效性和安全性,为中医药治疗感染性疾病减少抗生素使用提供高质量的循证证据。RYN:每次20 mL,每日3次,100 mL/瓶,口服7 d;Amoxil:每次0.5 g,每日3次,0.5 g×12粒/板,口服7 d。结果显示,RYN组在疾病痊愈时间、第3天发热消失率与治疗结束后扁桃体红肿消失率方面与Amoxil组比较有统计学差异;RYN+Amoxil组在疾病痊愈率、痊愈时间、体温复常时间、第3天发热消失率、治疗后咽部肿痛消失率、扁桃体红肿消失率方面与Amoxil组有统计学差异,且与RYN组比较在以上方面均没有统计学差异;RYN+Amoxil组的抗生素使用DDD值显著小于单用Amoxil组(P<0.01)。研究表明,RYN组在疾病痊愈时间、短期改善发热情况与改善扁桃体红肿方面优于Amoxil组;RYN组与RYN+Amoxil组比较时,在疾病痊愈率、痊愈时间、体温复常时间、短期改善发热情况、改善咽部肿痛与扁桃体红肿方面的作用无差异,且RYN+Amoxil组较Amoxil组有显著疗效优势。结果表明,RYN单用与联合Amoxil治疗急性扁桃体炎的临床疗效相当,且在疾病痊愈时间、短期改善发热情况与改善扁桃体红肿方面优于单独使用Amoxil,并且未发生不良事件或不良反应;RYN+Amoxil可显著降低抗生素使用DDD值,且较单用Amoxil有显著临床疗效优势。
This study is a randomized controlled trial of Reyanning Mixture in the treatment of acute tonsillitis. According to the ratio of 1∶1∶1, a total of 144 patients were randomly divided into Reyanning Mixture group(RYN), Reyanning Mixture+Amoxicillin Capsules group(RYN+Amoxil) and Amoxicillin Capsules group(Amoxil), with 48 cases in each group, in order to evaluate the efficacy and safety of RYN alone or combined with Amoxil in the treatment of acute tonsillitis, and provided high-quality evidences for treatment of infectious diseases with traditional Chinese medicine and reduced use of antibiotics. The dosage of RYN was 20 mL, 3 times a day, 100 mL/bottle, oral for 7 days, and Amoxil dosage was 0.5 g, 3 times a day, 0.5 g×12 tablets/plate, oral for 7 days. A total of 144 cases were included, 3 cases were excluded(1 case was mistakenly included, 2 cases did not take drugs after inclu-ded), and a total of 141 cases were included in the full analysis set(FAS). The results showed statistical differences in the recovery time of the disease, the disappearance rate of fever on the 3 rd day and the disappearance rate of tonsillar redness and swelling between RYN and Amoxil. There were statistical differences in the cure rate of disease, recovery time of disease, body temperature recovery time, fever disappearance rate on the 3 rd day, pharynx swelling and pain disappearance rate and tonsil swelling disappearance rate between the RYN+Amoxil and Amoxil, but with no significant difference in the above aspects compared with RYN. The DDD of antibiotic use in RYN+Amoxil was significantly lower than that in Amoxil(P<0.01). According to the findings, when RYN was used alone in the treatment of acute tonsillitis, it was superior to Amoxil in time of recovery, short-term improvement of fever and redness and swelling of tonsil. Compared with RYN+Amoxil, there was no difference in cure rate of disease, recovery time of disease, body temperature recovery time, short-term improvement of fever, swelling of pharynx and swelling of tonsil, with a better efficacy than Amoxil. The clinical effect of RYN was similar to that of combined Amoxil in the treatment of acute tonsillitis, and RYN was superior to Amoxil in the time of recovery, short-term improvement of fever and redness and swelling of tonsil, with no adverse event or adverse reaction. RYN+Amoxil can significantly reduce the DDD value of antibiotics in the treatment of acute tonsillitis, with significant clinical advantages over Amoxil.

关键词(KeyWords): 热炎宁合剂;急性扁桃体炎;随机对照试验;减少抗生素;DDD值;高质量证据
Reyanning Mixture;acute tonsillitis;randomized controlled trial;reduction of antibiotics;DDD value;high quality evidence

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2018YFC1707400);; 中央级公益性科研院所基本业务费项目(Z0546)

作者(Author): 吕健;杨翠;王连心;谢雁鸣;余学庆;谷丽;高峰;张景肖;余小康;
LYU Jian;YANG Cui;WANG Lian-xin;XIE Yan-ming;YU Xue-qing;GU Li;GAO Feng;ZHANG Jing-xiao;YU Xiao-kang;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;Beijing First Integrated Traditional Chinese and Western Medicine Hospital;the First Affiliated Hospital of Henan University of Chinese Medicine;Beijing Chaoyang Hospital, Capital Medical University;Wangjing Hospital, China Academy of Chinese Medical Sciences;School of Statistics, Renmin University of Chin

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