蓝芩口服液联合抗菌药物治疗急性扁桃体炎有效性与安全性的系统评价与Meta分析

doi:10.19803/j.1672-8629.20230685

摘要/Abstract

摘要： 目的系统评价蓝芩口服液联合抗菌药物治疗急性扁桃体炎的有效性与安全性。方法检索Cochrane Library、PubMed、EMbase、SinoMed、中国知网、万方数据、维普网,收集蓝芩口服液治疗急性扁桃体炎的随机对照试验（RCTs）,检索时限从建库至2023年1月1日,采用RevMan 5.3软件进行数据分析。结果 5项随机对照试验（RCTs）,共计640例急性扁桃体炎患者。Meta分析结果显示,蓝芩口服液联合抗生素治疗急性扁桃体炎,在退热时间（MD=-20.21, 95%CI[-25.18,-15.24], P<0.001）,咽痛缓解时间（MD=-22.62, 95%CI[-30.48, -14.75], P<0.001）,有效率（RR=3.07, 95%CI[1.92, 4.89], P<0.001）方面优于单用抗菌药物,差异具有统计学意义。结论临床试验质量不高,以上结论仍需更多高质量临床试验进一步证明,且需要关注不良反应的问题。

关键词: 蓝芩口服液, 扁桃体炎, 抗菌药, 系统评价, Meta分析, 有效性, 安全性, 退热, 咽痛

Abstract: Objective To systematically evaluate the efficacy and safety of Lanqin oral liquid combined with antibiotics in the treatment of acute tonsillitis. Methods Literature about randomized controlled trials (RCTs) of Lanqin oral liquid in the treatment of acute tonsillitis that was published between the inception and January 1, 2023 was retrieved from Cochrane Library, EMbase, PubMed, SinoMed, CNKI, Wanfang and Weipu. Two researchers independently conducted literature screening and data retrieval according to the classification criteria. The Cochrane manual was used for quality evaluation while RevMan 5.3 software was used for data analysis. Results 5 RCTs were included involving a total of 640 patients. The results of meta-analysis showed that the treatment of acute tonsillitis with oral liquid combined with antibiotics was far more effective than antimicrobials alone in terms of shortened time of sore throat relief (MD = -20.21, 95%CI[-25.18, -15.24], P<0.001) (MD = -22.62, 95%CI[-30.48, -14.75], P<0.001) and response rate (RR = 3.07, 95%CI[1.92, 4.89], P<0.001). Conclusion However, due to the low quality of clinical trials, the above findings need to be confirmed by more high-quality clinical trials, and related adverse reactions deserve attention.

Key words: Lanqin oral liquid, tonsillitis, antibiotics, systematic review, Meta-analysis, effectiveness, safety, abatement of fever, sore throat

中图分类号:

R978.1

刘倩, 李博, 疏欣扬. 蓝芩口服液联合抗菌药物治疗急性扁桃体炎有效性与安全性的系统评价与Meta分析[J]. 中国药物警戒, 2024, 21(8): 916-920.

LIU Qian, LI Bo, SHU Xinyang. Lanqin oral liquid combined with antibacterial drugs for the treatment of acute tonsillitis: a systematic review and Meta-analysis[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 916-920.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.20230685

https://zgywjj.magtechjournal.com/CN/Y2024/V21/I8/916

参考文献

[1] TIAN YQ.Otorhinolaryngology—head and neck surgery[M]. Beijing: People’s Medical Publishing House, 2003: 128.
[2] MCNCK H, JORGENSEN AW, KLUG TE.Antibiotics for recurrent acute pharyngo-tonsillitis:systematic review[J]. European Journal of Clinical Microbiology & Infectious Diseases, 2018, 37: 1221-1230.
[3] XU YQ, HU SY, LI MF, et al.New understanding of clinical trial design of Chinese medicine for acute pharyngitis and tonsillitis in children[J]. Journal of Tianjin University of Chinese Medicine(天津中医药大学学报), 2023, 42(1): 35-38.
[4] HU SY.Technical Guidelines for the design and evaluation of TCM clinical trials in acute pharyngitis and tonsillitis[J]. Drug Evaluation Research(药物评价研究), 2019, 46(2): 245-250.
[5] ABDUL-AZIZ MH, ALFFENAAR JC, BASSETTI M, et al.Antimicrobial therapeutic drug monitoring in critically ill adult patients: a position paper[J]. Intensive Care Med, 2020, 46(6): 1127-1153.
[6] KONG WH, FENG JJ, ZHANG Q, et al.Progress of rational use of antimicrobials in China[J]. Chinese Journal of Rational Use of Drugs(临床合理用药), 2022, 19(8): 1-7.
[7] JIANG XQ, WEI B, CHE J, et al.Investigation and analysis on the cognition of antimicrobial agents and bacterial resistance among urban residents in Changping District, Beijing[J]. Disease Surveillance(疾病监测), 2018, 38(1): 45-50.
[8] ELTOM EH, ALANAZI AL, ALENEZI JF, et al.Self-medication with Antibiotics and awareness of antibiotic resistance among population in Arar city, Saudi Arabia[J]. J Infect Dev Ctries, 2022, 16(11): 1762-1767.
[9] RODRÍGUEZ-BAN OJ, ROSSOLINI GM, SCHULTS ZC, et al. Key considerations on the potential impacts of the COVID-19 pandemic on antimicrobial resistance research and surveillance[J]. Trans R Soc Trop Med Hyg, 2021, 115(10): 1122-1129.
[10] KNIGHT GM, GLOVER RE, MCQUAID CF, et al.Antimicrobial resistance and COVID-19: intersections and implications[J]. eLife, 2021, 10: e64139.
[11] JIANG YY, YANG YR, CHENG J.Investigation on antibiotic related cognition and self-medication behavior of urban and rural residents in Lu’an city[J]. Chinese Pharmacy, 2021, 32(1): 98-103.
[12] YUAN Y, DONG XLI, WANG W, et al.A qualitative study on attitudes and behaviors of antibacterial knowledge of residents in Jiangsu and Zhejiang counties[J]. China Health Education, 2022, 38(7): 658-661.
[13] XIONG DJ, LIU P.Traditional Chinese otolaryngology(中医耳鼻咽喉科学)[M]. Beijing: China Traditional Chinese Medicine Press, 2012: 154.
[14] “Guidelines for Clinical Application of proprietary Chinese Medicines in the Treatment of Advantageous Diseases”standardization project team. Clinical application guide of Chinese patent medicine in treatment of acute upper respiratory tract infection in children[J]. Chinese Journal of Integrated Traditional and Western Medicine(中国中西医结合杂志), 2021, 41(2): 143-150.
[15] FAN CZ.Advantages and evidence of traditional Chinese medicine in prevention and treatment of acute tonsillitis in adults[J]. Chinese Journal of Traditional Chinese Medicine(中国中药杂志), 2017, 42(8): 1430-1438.
[16] MA C, FAN JC, MIAO Q.Implementation effect evaluation of the Clinical Practice Guide of Traditional Chinese Medicine for the Treatment of acute tonsillitis with single/combined antibiotics[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2018, 43(24): 4771-4775.
[17] MENG FL.Clinical observation on TCM diagnosis and treatment of acute moth disease[D]. Chengdu: Chengdu University of Traditional Chinese Medicine, 2013.
[18] MAIRPAD Y, SHAMBAT S, BRUGGER SD, et al.Antibiotic resistance and persistence-Implications for human health and treatment perspectives[J]. EMBO reports, 2020, 21(12): e51034.
[19] KONG WH, FENG JJ, ZHANG Q.Progress of rational use of antimicrobials in China[J]. Chinese Journal of Rational Drug Use,(中国合理用药探究) 2022, 19(8): 1-7.
[20] HU YM, JIANG ZF. ZHU FT. Practical Pediatrics (诸福棠实用儿科学)[M]. Beijing: People’s Medical Publishing House, 2005: 251-252.
[21] State Administration of Traditional Chinese Medicine. Criteria of curative effect in diagnosis of TCM diseases (中医病症诊断疗效标准) [S]. Nanjing: Nanjing University Press, 1994: 126-127.
[22] YAN YM, YANG XJ, ZHAO CX.Systematic review and meta-analysis of Lianhua Qingwen preparation combined with oseltamivir phosphate in the treatment of influenza[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2019, 47(15): 4238-4247.
[23] BIN YY.Clinical effect of amoxicillin and clavulanate potassium combined with Lanqin oral liquid in the treatment of acute suppurative tonsillitis[J]. Journal of Clinical Medicine Literature(临床医药文献杂志), 2019, 6(18): 158-159.
[24] LI H.Effect of Lanqin oral liquid combined with amoxicillin and clavulanate potassium dispersive tablets in the treatment of acute tonsillitis in children and regulation of cellular immune factors[J]. Drug Evaluation Research(药物评价研究), 2021, 44(1): 147-151.
[25] CHI XY.Effect of cefuroxime combined with Lanqin oral liquid on acute tonsillitis in children[J]. Chinese Convalescent Medicine(中国疗养医学), 2016, 25(4): 418-419.
[26] WANG SM.Clinical effect of Lanqin oral liquid on tonsillitis fever[J]. Medical Food Therapy and Health(医学食疗与健康), 2022, 1(1): 57-59.
[27] CUI N.Effect of Chinese and Western medicine in the treatment of acute tonsillitis[J]. Journal of Practical Chinese Medicine, 2014, 30(12): 1127-1128.
[28] ZHANG TS.Rational use of funnel plot in traditional meta-analysis[J]. Chinese Hospital Statistics(中国医院统计), 2023, 30(4): 304-308.
[29] HE JT, YU S.Application of proprietary Chinese medicine in children with acute tonsillitis[J]. Jiangsu Chinese Medicine, 2012, 44(6): 73-75.
[30] LI N.Systematic review and meta-analysis of randomized controlled trial of Lanqin oral liquid in treatment of chronic pharyngitis[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2017, 42(8): 1489-1494.
[31] YANG ZE.Systematic evaluation of efficacy and safety of Lanqin oral liquid in the treatment of children with hand, foot and mouth disease[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2020, 45(15): 3547-3555.
[32] PING JT, HUANG GX, ZHANG YH.Analysis of curative effect of Lanqin oral liquid on 56 cases of chronic pharyngitis with lung and stomach hyperthermia[J]. Inner Mongolia Traditional Chinese Medicine(内蒙古中医药), 2012, 18(9): 13.
[33] JIANG YY, YANG YR, CHENG J.Investigation on antibiotic related cognition and self-medication behavior of urban and rural residents in Lu‘an City[J]. Chinese Pharmacy(中国药房), 2021, 32(1): 98-103.
[34] YUAN Y, DONG XL, WANG W, et al.A qualitative study on attitudes and behaviors of antibacterial knowledge of residents in Jiangsu and Zhejiang counties[J]. Chinese Journal of Health Education(中国健康教育), 2022, 38(7): 658-661.
[35] FAN CZ, MIAO Q, ZHANG Q.Advantages and evidence of traditional Chinese medicine in prevention and treatment of acute tonsillitis in adults[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2017, 42(8): 1430-1438.