小儿柴桂退热颗粒治疗急性上呼吸道感染的疗效及安全性系统评价与meta分析

李云; 常文婧; 张煦东; 张居文; 陈薇

doi:10.16766/j.cnki.issn.1674-4152.003774

小儿柴桂退热颗粒治疗急性上呼吸道感染的疗效及安全性系统评价与meta分析

doi: 10.16766/j.cnki.issn.1674-4152.003774

北京中医药大学循证医学中心，北京 100029

基金项目:

国家中医药管理局中医药创新团队及人才支持计划项目 ZYYCXTD-D-202208

详细信息

通讯作者:
陈薇，E-mail: chenweibucm@163.com

中图分类号: R725.6
计量
- 文章访问数: 20
- HTML全文浏览量: 12
- PDF下载量: 1
- 被引次数: 0
出版历程
- 收稿日期: 2023-10-09
- 网络出版日期: 2024-12-31

Clinical efficacy and safety of Xiao' er Chaigui Tuire Granules in the treatment of acute upper respiratory tract infection: a meta-analysis

Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China

摘要

摘要: 目的系统评价小儿柴桂退热颗粒单用或联用西药治疗急性上呼吸道感染的临床疗效及安全性，为临床应用提供循证依据。方法检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed和Cochrane Library各大数据库中应用小儿柴桂退热颗粒的临床研究文献，检索时限均为建库至2023年1月。对纳入文献进行数据提取，并采用方法学质量评估工具评价文献质量，运用RevMan 5.4软件进行meta分析。结果共纳入20项随机对照试验，共计2 913例患者，meta分析结果显示，小儿柴桂退热颗粒联用利巴韦林可以缩短患儿的退热时间[MD=-0.75(d), 95% CI: -1.00~-0.50，P < 0.001]；小儿柴桂退热颗粒联用阿莫西林也可以缩短患儿的退热时间[MD=-1.78(h), 95% CI: -2.07~-1.48，P < 0.001]；与常规的抗生素、抗病毒治疗相比，小儿柴桂退热颗粒可缩短退热时间[MD=-0.95(d), 95% CI: -1.44~-0.46, P < 0.001]；与单用利巴韦林相比，单用小儿柴桂退热颗粒疗效指标无明显优势。结论小儿柴桂退热颗粒联用西药有较好的治疗效果，但由于临床研究数量较少且质量有待提高，未来应规范临床试验开展的过程，提高证据质量，以指导小儿柴桂更好地应用于临床实践。
- 急性上呼吸道感染 /
- 小儿柴桂退热颗粒 /
- Meta分析
Abstract: Objective To systematically evaluate the clinical efficacy and safety of Xiao' er Chaigui Tuire Granules alone or combined with Western medicine in the treatment of acute upper respiratory tract infection, and to provide evidence-based basis for clinical application. Methods The clinical literatures on the application of Xiao' er Chaigui Tuire Granules were searched in CNKI, Wanfang, VIP, SinoMed, PubMed and Cochrane Library, and the retrieval time was established until January 2023. Data extraction were extracted from the included literatures, and methodological quality assessment tools were used to evaluate literature quality. Meta-analysis was performed using RevMan 5.4 software. Results A total of 2 913 patients were included in 20 randomized controlled trials. The results of meta-analysis showed that Xiao' er Chaigui Tuire Granules combined with ribavirin could shorten the antipyretic time [MD=-0.75(d), 95% CI: -1.00 to-0.50, P < 0.001], Xiao' er Chaigui Tuire Granules combined with amoxicillin could also shorten the antipyretic time [MD=-1.78(h), 95% CI: -2.07 to-1.48, P < 0.001]. Compared with the conventional antibiotics and antiviral agents, Xiao' er Chaigui Tuire Granules could shorten the antipyretic time [MD=-0.95(d), 95% CI: -1.44 to-0.46, P < 0.001]. Compared with ribavirin, the therapeutic indexes of Xiao' er Chaigui Tuire Granules alone had no obvious advantage. Conclusion Xiao' er Chaigui Tuire Granules combined with Western medicine has a good therapeutic effect, whereas the number and quality of the relevant clinical studies remain to be improved. The process of clinical trial should be standardized to improve the quality of evidence, so to guide the better application of Xiao' er Chaigui Tuire Granules in clinical practice.
- Acute upper respiratory tract infection /
- Xiao' er Chaigui Tuire Granules /
- Meta-analysis

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图 1 文献筛选流程

Figure 1. Work flow of Literature screening

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图 2 纳入文献产生偏倚风险的项目占比

Figure 2. Percentages of items in the included literature that presented risks of bias

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图 3 小儿柴桂退热颗粒+利巴韦林vs.利巴韦林总有效率森林图

Figure 3. Forest plot of total response rate: Xiao' er Chaigui Tuire granules combined with ribavirin vs. ribavirin alon

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图 4 小儿柴桂退热颗粒+阿莫西林vs. 阿莫西林总有效率森林图

Figure 4. Forest plot of total response rate: Xiao' er Chaigui Tuire granules combined with amoxicillin vs. Amoxicillin alone

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图 5 小儿柴桂退热颗粒vs. 利巴韦林总有效率森林图

Figure 5. Forest plot of total response rate: Xiao' er Chaigui Tuire granules vs. ribavirin alone

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图 6 小儿柴桂退热颗粒vs. 常规抗生素、抗病毒治疗总有效率森林图

Figure 6. Forest plot of total response rate: Xiao' er Chaigui Tuire granules vs. conventional antibiotics and antiviral treatment

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图 7 小儿柴桂退热颗粒vs. 小儿氨酚黄那敏颗粒总有效率森林图

Figure 7. Forest plot of total response rate: Xiao' er Chaigui Tuire granules vs. children acetaminophen yellow namin granules

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表 1 纳入文献的基本特征

Table 1. Basic features of the included literature

纳入研究	样本量(例) (T/C)	年龄(岁) (T/C)	干预措施 (T vs. C)	常规治疗描述	疗程	结局指标
李艳华2022^[10]	104/103	1~12	小儿柴桂退热颗粒+头孢呋辛酯胶囊vs.头孢呋辛酯胶囊	多饮水休息和物理降温(＞38.5 ℃药物退热)	5 d	①②⑤⑥⑦
李杰2020^[11]	58/58	3.85±0.51/3.90±0.52	小儿柴桂退热颗粒+利巴韦林颗粒vs.利巴韦林颗粒	维生素C片口服，体温＜38.5 ℃物理降温，体温≥38.5 ℃对乙酰氨基酚滴剂退热	6 d	①②⑦
刘晶2019^[8]	70/70	4.1±1.3/4.2±1.4	小儿柴桂退热颗粒vs.常规治疗	常规抗生素、抗病毒制剂治疗	12 d	①②⑤
李德宇2019^[12]	45/45	7个月~12	小儿柴桂退热颗粒vs.小儿氨酚黄那敏颗粒	NR	5 d	①③
徐长艳2018^[13]	60/60	4.21±0.92/4.16±0.87	小儿柴桂退热颗粒vs.小儿氨酚黄那敏颗粒	NR	5 d	①②③
赵朋飞2018^[14]	69/69	6.7±1.5/6.8±1.7	小儿柴桂退热颗粒+利巴韦林注射液vs.利巴韦林注射液	补液、营养支持等常规治疗	3 d	①②⑤⑥⑦
兰爵荣2018^[15]	60/60	5.8±1.2/5.4±1.5	小儿柴桂退热颗粒+阿莫西林vs.阿莫西林	NR	3 d	①②③
王霞2018^[16]	80/80	3.45±0.90/3.31±0.89	小儿柴桂退热颗粒+利巴韦林注射液vs.小儿柴桂退热颗粒vs.利巴韦林注射液	＜38 ℃不做任何处理；体温过高或惊厥予物理降温: 冰袋冷敷头部, 服对乙酰氨基酚退热	3 d	①②③
黄德志2017^[17]	25/25	6.1±2.1/6.2±2.1	小儿柴桂退热颗粒+利巴韦林注射液vs.利巴韦林注射液	常规抗感染、退热治疗	NR	①②③⑤⑥⑦
管志河2017^[18]	55/55	4.0±2.3/4.1±2.3	小儿柴桂退热颗粒vs.小儿氨酚黄那敏颗粒	体温>39 ℃，口服布洛芬或对乙酰氨基酚	5 d	①③
任娅娜2017^[19]	62/62	6.34±2.6/6.25±2.48	小儿柴桂退热颗粒+炎琥宁注射液vs.炎琥宁注射液	常规治疗，如果出现持续高热采取物理降温	NR	①②⑦
齐卫斌2016^[20]	75/75	4.7±3.3/4.3±3.2	小儿柴桂退热颗粒+小儿氨酚黄那敏颗粒vs.小儿氨酚黄那敏颗粒	NR	3 d	①④⑦
李智永2016^[21]	70/70	3.6±1.2/3.5±1.3	小儿柴桂退热颗粒+小儿氨酚烷胺颗粒vs.小儿氨酚烷胺颗粒	NR	3 d	①②④
张华梅2016^[22]	115/115	2~7	小儿柴桂退热颗粒+阿莫西林vs.阿莫西林	NR	3 d	①②
杜江滨2016^[23]	60/60	3.5±0.9/3.3±0.9	小儿柴桂颗粒+利巴韦林注射液vs.小儿柴桂颗粒vs.利巴韦林注射液	发热38 ℃以上高热、惊厥患儿，给予物理降温同时配合扑热息痛退热处理	7 d	①②③⑦
刘义红2016^[24]	50/50	2.8±1.6/2.8±1.5	小儿柴桂退热颗粒+对乙酰氨基酚混悬滴剂vs.对乙酰氨基酚混悬滴剂	NR	3 d	①②④
周春清2016^[25]	98/98	3.8±1.6/3.7±1.5	小儿柴桂退热颗粒+布洛芬混悬液vs.布洛芬混悬液	抗炎、抗病毒等常规基础治疗	3 d	①④⑦
吴赛君2015^[26]	52/52	4.7±1.2/4.3±1.5	柴桂退热颗粒vs.常规治疗	给予西医常规抗生素、抗病毒制剂治疗	12 d	①②⑤⑥
赵瑞青2012^[27]	150/88	NR	小儿柴桂退热颗粒vs.利巴韦林注射液	加服头孢羟氨苄	NR	①②⑦
甘雨新2011^[28]	60/60	NR	小儿柴桂退热颗粒vs.泰诺林口服液(对乙酰氨基酚口服液)	给予相同的常规治疗	3 d	①②④
注：T为试验组；C对照组；NR为未报告。结局指标如下，①总有效率；②临床症状消失时间；③治愈时间；④治疗后体温；⑤炎性指标；⑥免疫指标；⑦不良反应。

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