中医药联合抗生素治疗儿童急性扁桃体炎肺胃热盛证的随机对照研究

Chinese medicine combined with antibiotics in the treatment of acute tonsillitis with syndrome of lung-stomach exuberant heat in children:A randomized controlled study

目的观察清咽利膈汤或解毒利咽方联合抗生素治疗急性扁桃体炎肺胃热盛证患儿的临床疗效。方法纳入2020年11月—2021年11月在上海中医药大学附属龙华医院治疗的急性扁桃体炎肺胃热盛证患儿90例,采用双盲、随机对照方法将患儿分为对照组、治疗1组、治疗2组,每组30例。3组均给予抗生素治疗(首选阿莫西林,青霉素过敏者改用阿奇霉素),在此基础上对照组给予中药安慰剂颗粒口服,治疗1组给予清咽利膈汤颗粒口服,治疗2组给予解毒利咽方颗粒口服,3组疗程均为5 d。观察3组退热时间及治疗前后中医症状积分、外周血白细胞计数、中性粒细胞百分比、C反应蛋白水平和临床疗效、中医证候疗效。结果治疗2组退热时间明显快于治疗1组和对照组(P均<0.05),治疗1组明显快于对照组(P<0.05)。3组主症和次症积分均随治疗时间延长逐渐降低(对照组大便干积分无明显变化),且治疗1组和治疗2组治疗1,3,5 d后各项积分均明显低于对照组(P均<0.05);治疗2组治疗3 d后咽痛、咽黏膜充血、扁桃体肿大积分和治疗5 d后扁桃体肿大积分均明显低于同期治疗1组(P均<0.05),治疗1组治疗3 d后分泌物渗出积分和治疗5 d后咳嗽、大便干积分均明显低于同期治疗2组(P均<0.05)。治疗5 d后,3组外周血白细胞计数、中性粒细胞百分比、C反应蛋白水平比较差异均无统计学意义(P均>0.05);对照组、治疗1组、治疗2组的临床总有效率分别为73.3%(22/30)、93.3%(28/30)和96.7%(29/30),中医证候总有效率分别为73.3%(22/30)、96.7%(29/30)和96.7%(29/30),治疗1组和治疗2组均明显高于对照组(P均<0.05),治疗1组和治疗2组比较差异均无统计学意义(P均>0.05)。结论清咽利膈汤与解毒利咽方治疗儿童急性扁桃体炎肺胃热盛证可有效改善患儿临床症状,疗效显著优于单纯使用抗生素。

Objective It is to observe the efficacy of Qingyan Lige decoction or Jiedu Liyan decoction combined with antibiotics in the treatment of acute tonsillitis with syndrome of heat exuberant heat in lung and stomach in children.Methods Ninety children with acute tonsillitis with syndrome of heat exuberant heat in lung and stomach treated in Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from November 2020 to November 2021 were selected and randomly divided into a control group and two treatment group according to double blind randomized controlled method,with 30 cases in each group.All the three groups were treated with antibiotics(amoxicillin was preferred,and azithromycin was used instead for penicillin allergy),additionally,the control group was given herbal placebo granules orally,the treatment groupⅠwas given Qingyan Lige decoction granules orally,and the treatment groupⅡwas given Qingyan Lige decoction granules orally,all the three groups were treated for 5 days.The defervescence time and TCM symptom scores,peripheral blood leukocyte count,neutrophil percentage,and the level of C-reactive protein before and after treatment and clinical efficacy and TCM syndrome efficacy in the three groups were observed.Results The defervescence time was significantly shorter in the treatment groupⅡthan those in the treatment groupⅠand control group(both P<0.05),and the treatment groupⅠwas shorter than the control group(P<0.05).The scores of primary and secondary symptoms in all three groups were gradually decreased with the prolongation of treatment time(there was no significant change in the scores of dry stool in the control group),and the scores of treatment groupⅠand treatment groupⅡwere significantly lower than those of the control group after 1,3 and 5 d of treatment(all P<0.05).The scores of pharyngodynia,pharyngeal mucosal congestion,tonsillar enlargement after 3 days of treatment,and tonsillar enlargement after 5 days of treatment in the treatment groupⅡwere significantly lower than those in the treatment groupⅠat the same period(all P<0.05),the scores of secretion exudation after 3 days of treatment,and the scores of cough and dry stool after 5 days of treatment in the treatment groupⅠwere significantly lower than those in the treatment groupⅡat the same period(all P<0.05).After 5 d of treatment,the differences in peripheral blood leukocyte count,neutrophil percentage,and C-reactive protein level were not statistically significant among the three groups(all P>0.05).The total clinical effective rates of the control group,treatment groupⅠand treatment groupⅡwere 73.3%(22/30),93.3%(28/30),and 96.7%(29/30),respectively,and the total effective rates of TCM symptoms were 73.3%(22/30),96.7%(29/30)and 96.7%(29/30),respectively,the rates in the treatment groupⅠand treatment groupⅡwere significantly higher than those in the control group(all P<0.05),and there was no statistically significant differences between treatment groupⅠand treatment groupⅡ(all P>0.05).Conclusion Qingyan Lige decoction and Jiedu Liyan decoction can effectively improve the clinical symptoms of children with acute tonsillitis with syndrome of heat exuberant heat in lung and stomach,and their efficacy is significantly superior to antibiotics alone.