真实世界喜炎平注射液治疗3846例细菌性肠道感染患者临床用药特征分析

doi:10.19803/j.1672-8629.20220061

摘要/Abstract

摘要： 目的明确喜炎平注射液治疗细菌性肠道感染的临床用药特征,为该药的临床使用提供参考。方法选取2011年7月26日至2019年6月1日全国14家三甲医院临床信息系统中3 846例使用喜炎平注射液的细菌性肠道感染的患者,对临床一般用药记录信息、诊断方案信息、一般治疗信息及合并用药信息采用频数统计和关联规则分析方法进行分析。结果患者年龄1~3岁最多（2 378例）;男性患者多于女性。合并疾病类型分析中前3位包括其他形式心脏疾病、急性上呼吸道感染、代谢疾病。联合用药方面,联合西药类别以其他心脏病用药、肝素类药、第三代头孢菌素药、黏液溶解药、H2-受体拮抗药等为主;联合中药类别以清热剂、清热解毒剂为主。西药类别联合抗生素药物中最常见的是第三代头孢菌素、青霉素。结论通过合并疾病和关联规则发现,细菌性肠道感染患者还可能会合并或继发其他心脏疾病和急性上呼吸道感染,临床应注意检查患者是否出现此类疾病;使用喜炎平注射液时要注意避免药物联合应用导致的不良反应。

关键词: 真实世界, 喜炎平, 注射液, 细菌性肠道感染, 用药特征

Abstract: Objective To find out about the clinical characteristics of Xiyanping injection in the treatment of bacterial intestinal infections in order to provide reference for its clinical use. Methods A total of 3 846 patients with bacterial intestinal infections treated with Xiyanping injection were selected from clinical information systems of 14 big hospitals in China between July 26, 2011 and June 1, 2019. The records of clinical medications, diagnostic protocols, basic data on treatment and combined medications were analyzed using frequency statistics and association rules. Results Most of the patients were aged 1 to 3 (2 378 cases). Male patients outnumbered female ones. The top three comorbidities included other forms of heart disease, acute upper respiratory tract infections and metabolic disease. In terms of drug combinations, the main Western drugs were those for other forms of heart disease, heparin drugs, third-generation cephalosporins, mucolytic drugs and H2-receptor antagonists. Drug combinations with traditional Chinese medicine were dominated by heat-clearing agents. The third-generation cephalosporin and penicillin were the most common Western drugs combined with antibiotics. Conclusion Patients with bacterial intestinal infections may also be complicated with or vulnerable to secondary cardiac diseases and acute upper respiratory tract infections. It is critical to find out whether patients have such diseases. At the same time, clinicians should be alert to adverse reactions caused by Xiyanping injection when used in combination with other drugs.

Key words: real world, Xiyanping, injection, bacterial intestinal infection, drug characteristics

中图分类号:

R978
R994.11

史卜文, 李利寻, 谢雁鸣, 王志飞, 王淇. 真实世界喜炎平注射液治疗3846例细菌性肠道感染患者临床用药特征分析[J]. 中国药物警戒, 2023, 20(9): 1017-1021.

SHI Bowen, LI Lixun, XIE Yanming, WANG Zhifei, WANG Qi. Clinical characteristics of Xiyanping injection in 3846 patients with bacterial intestinal infection in the real world[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1017-1021.

参考文献

[1] JIA J.Etiological treatment of bacterial intestinal infection[J]. Chin J Practical Internal Medicine(中国实用内科杂志), 1994(3): 143-144.
[2] DU G, ZHAO J, BU SH, et al.Expert consensus on rational drug use for atomization therapy (2019 edition)[J]. Medical Review(医药导报), 2019, 38(2): 135.
[3] LOU Y.Compendium of Medicine(医学纲目)[M]. Beijing: China Medical Science Press, 2011.
[4] National Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China Part I(中华人民共和国药典一部)[S]. Beijing: China Medical Science Press, 2020.
[5] DENG DM, PI DD, LIU G.Epidemiological characteristics and etiological analysis of hand, foot and mouth disease in Neijiang City, Sichuan Province, 2010-2017[J]. Journal of Pediatric Pharmacy(儿科药学杂志), 2020, 26(2): 22.
[6] JIANG RM.Interpretation of expert consensus on diagnosis and treatment of herpangina (2019 edition)[J]. Journal of Western Medicine(西部医学), 2019, 31(12): 1810.
[7] WANG Y, SHEN CJ, ZHU WF.A method for analysis of drug combination rule based on SPSS Clementine association rule[J]. Journal of Practical Medicine and Clinic(实用药物与临床), 2019, 22(12): 1292.
[8] The State Bureau of Quality and Technical Supervision. National Standard of the People's Republic of China: Classification and Code of TCM diseases and Syndromes(中华人民共和国国家标准:中医病证分类与代码)[S]. Beijing: China Standards Press, 1996.
[9] MO FF.Application of the theory of "lung and large intestine surface and interior" based on ancient medical case analysis[D]. Beijing: Beijing University of Traditional Chinese Medicine, 2012.
[10] SUN YH, LIU L, ZHANG AQ.Drug safety of Chinese medicine injection[J]. China Medical Review(中国医药导报), 2007, 4(15): 106-107.
[11] WANG ZF, XIE YM.Clinical dose application analysis of Xiyanping injection based on real world[J]. China Journal of Traditional Chinese Medicine(中国中药杂志),2012,37(18): 2727.
[12] WANG ZF, RONG P, MA R, et al.Expert consensus on the clinical application of Xiyanping Injection (Children's Edition)[J]. China Journal of Traditional Chinese Medicine(中国中药杂志), 2019, 44(14): 2932-2936.
[13] State Food and Drug Administration. Adverse Drug Reaction Information Bulletin (Issue 48) (药品不良反应信息通报第48期)[R]. State Food and Drug Administration, 2012.
[14] JIANG P.Clinical application evaluation of Xiyanping injection[J].Chinese Patent Medicine(中成药),2014,36(1): 211-213.
[15] LI LX, WANG ZF, XIE YM, et al Clinical characteristics of Xiyanping injection in 194873 cases based on the real world[J]. Annals of Chinese Medicine(中国中药杂志), 2020, 45(15): 3518-3524.
[16] WANG YP, JIAO K, HE ZF.Systematic review of literature on adverse reactions of Xiyanping injection[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志), 2011, 17(24): 236-240.
[17] LIU HM, MA R.Expert consensus on the diagnosis and treatment of Mycoplasma pneumoniae pneumonia in children (formulated in 2017)[J]. Chin J Pediatr(中国实用儿科杂志), 2017, 32(12): 881.
[18] XIONG XD, QIAN YM, LU YM, et al.Expert consensus on the combination of traditional Chinese and Western medicine in the treatment of community acquired pneumonia[J]. Chinese Journal of Integrated Traditional and Western Medicine First Aid(中国中西医结合急救杂志), 2015, 22(1): 1.
[19] MA R, WANG XF, YU JE, et al.Expert consensus on the integrated treatment of traditional Chinese and western medicine for acute fever in[J]. Chinese Pediatrics of Integrated Traditional and Western Medicine(中国中西医结合儿科学), 2012, 4(1): 1-4.
[20] WANG SC, WANG L, SHANG LL.Clinical diagnosis and treatment guideline of pediatric Chinese medicine·Hand-foot-mouth disease (revision)[J]. World Journal of Chinese Medicine(世界中医药), 2016, 11(4): 734.
[21] LI ZH, LU XH, LONG XY, et al.Research progress on the total lactone of Andrographil[J]. Lishizhen Medicine and Materia Medica Research(时珍国医国药), 2012, 23(11): 2854.
[22] WU J.Ribavirin alone and combined with Xiyanping injection in the treatment of rotavirus enteritis in children[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志), 2013, 19(18): 323-325.
[23] YIN XP, XIE YM, ZHI YJ, et al.Clinical significance of Xiyanping injection in the treatment of pulmonary infection[J]. China Journal of Traditional Chinese Medicine(中国中药杂志), 2015, 40(12): 2440-2444.
[24] WU JL, LUO DS.Pharmacology: Case Edition(药理学:案例版) [M]. Beijing: Science Press, 2012.
[25] DU G, ZHAO J, BU SH, et al.Expert consensus on rational use of aerosol inhalation therapy (2019 edition)[J]. Medical Review(医药导报), 2019, 38(2): 135.
[26] WANG XC, CHEN ZG, XU S.Diagnosis and treatment of viral pneumonia in children[J]. Journal of Nanjing University of Traditional Chinese Medicine(南京中医药大学学报), 2011, 27(4): 304.
[27] YU T.Analysis of the incompatibility of Xiyanping injection with different drugs[J]. Asia-Pacific Traditional Medicine(亚太传统医药), 2015, 11(17): 130.
[28] WANG ZF, CHEN X, ZHANG W, et al.Evidence-based research on drugs of Xiyanping injection before and after the market[J]. Chinese Journal of Traditional Chinese Medicine(中国中药杂志), 2014, 39(18): 3637-3640.
[29] WANG LX, YANG W, XIE YM, et al.Real world clinical application and safety analysis of 4023 patients with Xiyanping injection[J]. Journal of Traditional Chinese Medicine(中医杂志), 2014, 55(7): 571-575.
[30] NMPA. Notice on further strengthening the management of the production and clinical use of Chinese medicine injectables [EB/OL]. (2008-12-24) [2022-09-27]. https://www.nmpa.gov.cn/xxgk/fgwj/qita/20081224120001195.html.