Efficacy of intramuscular injection of Xiyanping injection for the treatment of acute bronchitis in children: a multicenter, randomized, parallel-controlled clinical study

CHEN Qiang; ZHU Xiao-Hua; LIU Yang; LI Lan; LUO Jing-Hua; ZHANG Yan-Yan; HUANG Juan; CAO Xiao-Chun; SONG Xiao-Hua; WAN Fang-Rui

doi:10.7499/j.issn.1008-8830.2305095

PDF(557 KB)

Chinese Journal of Contemporary Pediatrics ›› 2023, Vol. 25 ›› Issue (11) : 1107-1112. DOI: 10.7499/j.issn.1008-8830.2305095

CLINICAL RESEARCH

Efficacy of intramuscular injection of Xiyanping injection for the treatment of acute bronchitis in children: a multicenter, randomized, parallel-controlled clinical study

CHEN Qiang, ZHU Xiao-Hua, LIU Yang, LI Lan, LUO Jing-Hua, ZHANG Yan-Yan, HUANG Juan, CAO Xiao-Chun, SONG Xiao-Hua, WAN Fang-Rui

Author information +

History +

Abstract

Objective To study the efficacy and safety of Xiyanping injection through intramuscular injection for the treatment of acute bronchitis in children. Methods A prospective study was conducted from December 2021 to October 2022, including 78 children with acute bronchitis from three hospitals using a multicenter, randomized, parallel-controlled design. The participants were divided into a test group (conventional treatment plus Xiyanping injection; n=36) and a control group (conventional treatment alone; n=37) in a 1:1 ratio. Xiyanping injection was administered at a dose of 0.3 mL/(kg·d) (total daily dose ≤8 mL), twice daily via intramuscular injection, with a treatment duration of ≤4 days and a follow-up period of 7 days. The treatment efficacy and safety were compared between the two groups. Results The total effective rate on the 3rd day after treatment in the test group was significantly higher than that in the control group (P<0.05), while there was no significant difference in the total effective rate on the 5th day between the two groups (P>0.05). The rates of fever relief, cough relief, and lung rale relief in the test group on the 3rd day after treatment were higher than those in the control group (P<0.05). The cough relief rate on the 5th day after treatment in the test group was higher than that in the control group (P<0.05), while there was no significant difference in the fever relief rate and lung rale relief rate between the two groups (P>0.05). The cough relief time, daily cough relief time, and nocturnal cough relief time in the test group were significantly shorter than those in the control group (P<0.05), while there were no significant differences in the fever duration and lung rale relief time between the two groups (P>0.05). There was no significant difference in the incidence of adverse events between the two groups (P>0.05). Conclusions The overall efficacy of combined routine treatment with intramuscular injection of Xiyanping injection in the treatment of acute bronchitis in children is superior to that of routine treatment alone, without an increase in the incidence of adverse reactions.

Key words

Acute bronchitis / Xiyanping injection / Multicenter randomized controlled study / Efficacy / Child

Cite this article

EndNote

Ris (Procite)

Bibtex

Download Citations

CHEN Qiang, ZHU Xiao-Hua, LIU Yang, LI Lan, LUO Jing-Hua, ZHANG Yan-Yan, HUANG Juan, CAO Xiao-Chun, SONG Xiao-Hua, WAN Fang-Rui. Efficacy of intramuscular injection of Xiyanping injection for the treatment of acute bronchitis in children: a multicenter, randomized, parallel-controlled clinical study[J]. Chinese Journal of Contemporary Pediatrics. 2023, 25(11): 1107-1112 https://doi.org/10.7499/j.issn.1008-8830.2305095

References

1 李井锋. 小儿急性支气管炎中药新药临床试验设计与评价技术指南[J]. 药物评价研究, 2015, 38(2): 113-119. DOI: 10.7501/j.issn.1674-6376.2014.05.001.
2 中华医学会, 中华医学会杂志社, 中华医学会全科医学分会, 等. 急性气管-支气管炎基层诊疗指南(2018年)[J]. 中华全科医师杂志, 2019, 18(4): 314-317. DOI: 10.3760/cma.j.issn.1671-7368.2019.04.003.
3 王思源, 平静, 谢宁, 等. 穿心莲内酯磺化物体外抗流感病毒药效学研究[J]. 中南药学, 2013, 11(5): 331-334.
4 平静, 王思源, 谢宁, 等. 穿心莲内酯磺化物体外抗腺病毒药效学研究[J]. 中国实验方剂学杂志, 2012, 18(21): 175-179. DOI: 10.13422/j.cnki.syfjx.2012.21.070.
5 Che S, Zhou N, Liu Y, et al. Andrographolide exerts anti-respiratory syncytial virus activity by up-regulating heme oxygenase-1 independent of interferon responses in human airway epithelial cells[J]. Mol Biol Rep, 2023, 50(5): 4261-4272. PMID: 36918433. PMCID: PMC10013987. DOI: 10.1007/s11033-023-08346-z.
6 张璐璐, 包梅, 杨伟峰, 等. 穿心莲内酯联合头孢西丁对耐甲氧西林金黄色葡萄球菌的协同抑制作用[J]. 世界科学技术-中医药现代化, 2020, 22(7): 2556-2562. DOI: 10.11842/wst.20190430002.
7 Zhang L, Wen B, Bao M, et al. Andrographolide sulfonate is a promising treatment to Combat methicillin-resistant Staphylococcus aureus and its biofilms[J]. Front Pharmacol, 2021, 12: 720685. PMID: 34603031. PMCID: PMC8481920. DOI: 10.3389/fphar.2021.720685.
8 Gu X, Gao R, Li Y, et al. Combination effect of azithromycin with TCM preparation Xiyanping injection against Klebsiella pneumoniae infection in rats[J]. Phytomedicine, 2022, 104: 154332. PMID: 35853301. DOI: 10.1016/j.phymed.2022.154332.
9 Peng S, Gao J, Liu W, et al. Andrographolide ameliorates OVA-induced lung injury in mice by suppressing ROS-mediated NF-κB signaling and NLRP3 inflammasome activation[J]. Oncotarget, 2016, 7(49): 80262-80274. PMID: 27793052. PMCID: PMC5348318. DOI: 10.18632/oncotarget.12918.
10 王美怡, 李艳华, 金蓉, 等. 穿心莲内酯磺化物对支气管哮喘小鼠肺泡灌洗液炎性细胞、白细胞介素-12及白细胞介素-13表达的影响[J]. 实用儿科临床杂志, 2012, 27(21): 1644-1646. DOI: 10.3969/j.issn.1003-515X.2012.21.008.
11 Guo W, Liu W, Chen G, et al. Water-soluble andrographolide sulfonate exerts anti-sepsis action in mice through down-regulating p38 MAPK, STAT3 and NF-κB pathways[J]. Int Immunopharmacol, 2012, 14(4): 613-619. PMID: 23036579. DOI: 10.1016/j.intimp.2012.09.002.
12 Gao F, Liu X, Shen Z, et al. Andrographolide sulfonate attenuates acute lung injury by reducing expression of myeloperoxidase and neutrophil-derived proteases in mice[J]. Front Physiol, 2018, 9: 939. PMID: 30174607. PMCID: PMC6107831. DOI: 10.3389/fphys.2018.00939.
13 丁彦, 刘惟优, 刘建芳, 等. 喜炎平注射液治疗急性支气管炎有效性和安全性的多中心、双盲、随机对照试验[J]. 中国中医基础医学杂志, 2023, 29(3): 432-437. DOI: 10.19945/j.cnki.issn.1006-3250.2023.03.032.
14 孙梦华, 吕健, 章轶立, 等. 喜炎平注射液治疗小儿急性支气管炎有效性和安全性的系统评价与Meta分析[J]. 中国中药杂志, 2019, 44(20): 4387-4396. PMID: 31872623. DOI: 10.19540/j.cnki.cjcmm.20190730.501.
15 谭晓勇, 牟必鸿, 马凌飞, 等. 喜炎平与炎琥宁治疗小儿急性支气管炎临床疗效和安全性对比的系统评价[J]. 西南医科大学学报, 2021, 44(1): 1-7. DOI: 10.3969/j.issn.2096-3351.2021.01.001.
16 邓剑雄, 王志飞, 谢雁鸣, 等. 喜炎平注射液上市后安全性再评价[J]. 药物不良反应杂志, 2018, 20(1): 15-22. DOI: 10.3760/cma.j.issn.1008-5734.2018.01.004.
17 江载芳, 申昆玲, 沈颖. 诸福棠实用儿科学[M]. 8版. 北京: 人民卫生出版社, 2015: 1251-1252.
18 李楠, 耿少怡, 王小芳, 等. 连花清咳片治疗小儿急性支气管炎痰热壅肺证有效性和安全性的随机、开放、平行对照、多中心临床观察[J]. 中国实验方剂学杂志: 2023. 网络首发. DOI: 10.13422/j.cnki.syfjx.20232124.
19 帅才. 过度输液存在四大危害: 损伤儿童肝肾产生严重耐药性[J]. 广西质量监督导报, 2016(7): 49-50. DOI: 10.3969/j.issn.1009-6310.2016.07.039.
20 高翔, 陈玲, 邓蓉蓉, 等. 过度静脉输液的现状、危害及管控措施[J]. 药学进展, 2016, 40(2): 141-144.
21 中华中医药学会急诊分会, 中国医师协会急诊医师分会, 世界中医药学会联合会急诊分会, 等. 喜炎平注射液急性感染性疾病临床应用专家共识[J]. 中华急诊医学杂志, 2020, 29(4): 470-477. DOI: 10.3760/cma.j.issn.1671-0282.2020022.003-1.
22 王志飞, 戎萍, 马融, 等. 喜炎平注射液临床应用专家共识（儿童版）[J]. 中国中药杂志, 2019, 44(14): 2932-2936. PMID: 31602835. DOI: 10.19540/j.cnki.cjcmm.20190521.502.
23 蒋春红, 曾君南, 戴岳, 等. 喜炎平注射液抗支气管炎和镇咳的作用研究[J]. 中国临床药理学杂志, 2023, 39(7): 956-960. DOI: 10.13699/j.cnki.1001-6821.2023.07.010.