蒡勃乳蛾消颗粒治疗小儿急性扁桃体炎外感风热证的临床研究

doi:10.20274/j.cnki.issn.1674-3865.2025.03.005

Abstract

Abstract:

Objective To verify the efficacy and safety of Bangbo Ruexiao granule in the treatment of children with acute tonsillitis (external wind?heat syndrome). Methods This study was a multicenter, randomized, double?blind, double?dummy, positive drug parallel control design. A total of 520 children with acute tonsillitis (external wind?heat syndrome) treated in Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine, Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, Yunnan Province Hospital of Traditional Chinese Medicine and Hubei Province Hospital of Traditional Chinese Medicine from January 2010 to March 2012 were selected and randomly divided into observation group and control group by 3∶1. The observation group was treated with Bangbo Ruexiao granule, and the control group was treated with Xiaoer Qingyan granule. The course of treatment was 5 days. The following items were observed: clinical efficacy, TCM disease and syndrome efficacy, the disappearance rate of single symptoms and signs (pharyngalgia or odynophagia, tonsil swelling and congestion, pharyngeal mucosa congestion, fever, cough, aversion to wind and headache), the onset time of the effect on pharyngalgia, the disappearance time of pharyngalgia, the negative conversion rate of C-reactive protein and safety indicators. Results (1) There were 509 patients in the intention?to?treat set(ITTS), 491 patients in the per?protocol set(PPS), and 515 patients in the safety set(SS). (2) Effectiveness evaluation: the total effective rate of the observation group was 85.9%(329/383), which was significantly better than that of the control group (58.7%, 74/126), and the difference was statistically significant(P<0.001). The total rate of significant effect of TCM disease and syndrome was 89.8%(344/383) in the observation group, which was significantly better than 64.3% (81/126) in the control group, and the difference was statistically significant (P<0.001). The disappearance rate of sore throat or odynophagia, the disappearance rate of tonsil swelling and congestion, and the disappearance rate of pharyngeal mucosa congestion in the observation group were significantly higher than those in the control group, and the differences were statistically significant(P<0.05). There was no significant difference in the disappearance rate of other symptoms and signs(fever, cough, aversion to wind, headache) between the two groups(P>0.05). The median onset time of the effect on pharyngalgia and the median time of pharyngalgia disappearance in the observation group were lower than those in the control group, and the differences were statistically significant(P<0.001). There was no significant difference in the negative conversion rate of C-reactive protein between the two groups(P>0.05). (3) Safety evaluation: there were no significant differences in the incidence of adverse events, the incidence of combined medication or medication compliance between the two groups(P>0.05). Conclusions Bangbo Ruexiao granule has a good clinical effect in the treatment of children with acute tonsillitis(external wind?heat syndrome), which can improve the efficacy of TCM syndromes, shorten the duration of sore throat, and has good safety. It can provide a new alternative treatment for children with acute tonsillitis(external wind?heat syndrome).

Key words: Acute tonsillitis, External wind?heat syndrome, Bangbo Ruexiao granule, Child

CLC Number:

R725.6

Hongyan SHEN, Xuefeng WANG, Xinmin HAN, Bin YUAN, Siyuan HU, Xinmin LI, Lei XIONG, Ping HE, Ying ZHOU, Xuerong ZHANG, Jingwen MU. Clinical study on the treatment for children with acute tonsillitis (external wind⁃heat syndrome) with Bangbo Ruexiao granule[J]. Chinese Pediatrics of Integrated Traditional and Western Medicine, 2025, 17(3): 213-220.

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References 26

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组别	n	性别（男/女，n）	年龄（x±s，岁）	病程（x±s，h）	症状、体征总积分（x±s，分）	症状积分（x±s，分）
对照组	130	73/57	5.74±2.33	11.03±6.05	10.28±2.49	5.42±1.63
观察组	390	207/183	5.58±2.37	11.17±6.41	10.00±2.60	5.36±1.67

组别	n	临床痊愈	显效	进步	无效	总显效
对照组	126	28（22.2）	46（36.5）	44（34.9）	8（6.3）	74（58.7）
观察组	383	149（38.9）	180（47.0）	45（11.7）	9（2.3）	329（85.9）

组别	n	1～5岁
组别	n	临床痊愈	显效	进步	无效	总显效
对照组	56	14（25.0）	17（30.4）	21(37.5）	4（7.1）	31（55.4）
观察组	173	71（41.0）	79（45.7）	20（11.6）	3（1.7）	150（86.7）
组别	n	>5～10岁
组别	n	临床痊愈	显效	进步	无效	总显效
对照组	70	14（20.0）	29（41.4）	23（32.9）	4（5.7）	43（61.4）
观察组	210	78（37.1）	101（48.1）	25（11.9）	6（2.9）	179（85.2）

组别	n	临床痊愈	显效	进步	无效	总显效
对照组	126	57（45.2）	24（19.0）	34（27.0）	11（8.7）	81（64.3）
观察组	383	248（64.8）	96（25.1）	24（6.3）	15（3.9）	344（89.8）

组别	n	1～5岁
组别	n	临床痊愈	显效	进步	无效	总显效
对照组	56	24（42.9）	10（17.9）	16（28.6）	6（10.7）	34（60.7）
观察组	173	118（68.2）	44（25.4）	7（4.0）	4（2.3）	162（93.6）
组别	n	>5～10岁
组别	n	临床痊愈	显效	进步	无效	总显效
对照组	70	33（47.1）	14（20.0）	18（25.7）	5（7.1）	47（67.1）
观察组	210	130（61.9）	52（24.8）	17（8.1）	11（5.2）	182（86.7）

Clinical study on the treatment for children with acute tonsillitis (external wind⁃heat syndrome) with Bangbo Ruexiao granule

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组别	n		咽喉痛或吞咽痛		扁桃体肿大、充血		咽黏膜充血
对照组	126		79（62.7）		64（50.8）		49（38.9）
观察组	383		350（91.4）		270（70.5）		255（66.6）
χ²值			58.893		16.313		30.222
P值			<0.001		<0.001		<0.001
组别	n	发热	n	咳嗽	n	恶风	n	头痛
对照组	65	65（100.0）	103	60（58.3）	34	28（82.4）	32	31（96.9）
观察组	227	221（97.4）	315	196（62.2）	85	80（94.1）	91	86（94.5）
χ²值		-		0.515		-		-
P值		0.344		0.473		0.074		1.000

组别	咽痛起效			咽痛消失
组别	n	删失	起效时间	n	删失	消失时间
对照组	126	18（14.3）	43.0（24.0，60.0）	126	47（37.3）	96.0（72.0，110.0）
观察组	383	17（4.4）	24.0（15.0，49.0）	383	33（8.6）	72.0（52.0，96.0）
χ²值			15.533			51.959
P值			<0.001			<0.001

组别	n	治疗前阳性/治疗后阳性	治疗前阳性/治疗后阴性	治疗前阳性/治疗后缺失	总计
对照组	126	0(0.0)	1(100.0)	0(0.0)	1
观察组	383	5(62.5)	1(12.5)	2(25.0)	8

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