Efficacy and immune function of Lianhua qingfei granules combined with paramivir on viral acute upper respiratory tract infection in children

doi:10.3877/cma.j.issn.1673-5250.2023.03.016

Objective

To explore therapeutic effects and immune function of lianhua qingwen granules combined with peramivir on viral acute upper respiratory tract infection (ARI) in children.

Methods

A total of 126 children with viral ARI admitted in Department of Pediatrics of the Second People′s Hospital of Hefei City from January 2019 to January 2022 were selected in this study. By simple random sampling method, they were divided into research group (n=42), control group(n=42) and blank control group(n=42), respectively. Regime of research group was treated by peramivir combined with lianhua qingwen granules, control group was treated with peramivir, and blank control group was treated with conventional symptomatic treatment. Clinical symptom remission time, clinical efficacy, levels of serum CD4⁺, CD8⁺ values and CD4⁺ /CD8⁺, levels of serum immunoglobulin(Ig)M, IgG and IgA, and incidence of treatment-related adverse reactions were statistically analyzed among 3 groups before and on the 5th day atter treatment by different regimes. The procedure followed in this study is in line with the Helsinki Declaration of the World Medical Association as amended in 2013. Written informed consent was obtained from all research participants. There were no statistically significant differences in clinical data such as gender and age composition ratio, course and severity of viral ARI of children among 3 groups(P>0.05).

Results

①The time for body temperature to drop, the time for body temperature to return to normal, the time for sore throat to disappear, and the time for pulmonary rales to disappear in research group were all significantly shorter than those in control group and blank control group, and the differences were statistically significant (P<0.05). ②On the 5th day of treatment, compared within the group, the serum CD4⁺ level and CD4⁺ /CD8⁺ value, as well as the serum IgM, IgG and IgA levels in 3 groups were significantly higher than those before the treatment, but the serum CD8⁺ level was significantly lower than that before the treatment, and all the differences were statistically significant (P<0.05). ③ On the 5th day of treatment, among serum CD4⁺ level and CD4⁺ /CD8⁺ value, as well as serum IgM, IgG and IgA levels in research group were significant higher than those in control group and blank control group, while serum CD8⁺ level was significantly lower than those in control group and blank control group, and the above differences were also statistically significant (P<0.05). ④The incidences of treatment-related adverse reactions in 3 groups were all low, and there was no statistically significant difference among 3 groups (P>0.05).

Conclusions

The combination of lianhua qingwen granule combined with peramivir in treatment of viral ARI in children is helpful to improve clinical efficacy, significantly improve symptoms such as fever, and effectively improve their immune function, and have good safety.

Key words: Respiratory tract infections, Medicine, Chinese traditional, Immune indices, Lianhua qingwen capsule, Palamivir, Antiviral drug, Child

表1 3组病毒性ARI患儿临床症状缓解时间比较(±s)

组别	例数	体温开始下降时间(h)	体温恢复至正常所需时间(h)	咽喉肿痛消失时间(d)	肺啰音消失时间(d)
研究组	42	12.2±1.1	21.1±3.4	2.4±0.5	3.0±0.1
对照组	42	18.0±2.1	25.3±3.2	3.3±0.5	4.1±1.1
空白对照组	42	20.1±2.3	27.0±2.2	4.1±0.3	4.5±1.0
总体比较(F值/P值)		193.37/<0.001	43.62/<0.001	154.48/<0.001	23.54/<0.001
两两比较(q值/P值)
研究组vs对照组		19.71/<0.001	9.13/<0.001	13.15/<0.001	8.29/<0.001
研究组vs空白对照组		26.85/<0.001	12.83/<0.001	24.84/<0.001	11.30/<0.001
对照组vs空白对照组		7.14/<0.001	3.70/<0.001	11.69/0.035	3.01/0.035

表1 3组病毒性ARI患儿临床症状缓解时间比较(±s)

组别	例数	体温开始下降时间(h)	体温恢复至正常所需时间(h)	咽喉肿痛消失时间(d)	肺啰音消失时间(d)
研究组	42	12.2±1.1	21.1±3.4	2.4±0.5	3.0±0.1
对照组	42	18.0±2.1	25.3±3.2	3.3±0.5	4.1±1.1
空白对照组	42	20.1±2.3	27.0±2.2	4.1±0.3	4.5±1.0
总体比较(F值/P值)		193.37/<0.001	43.62/<0.001	154.48/<0.001	23.54/<0.001
两两比较(q值/P值)
研究组vs对照组		19.71/<0.001	9.13/<0.001	13.15/<0.001	8.29/<0.001
研究组vs空白对照组		26.85/<0.001	12.83/<0.001	24.84/<0.001	11.30/<0.001
对照组vs空白对照组		7.14/<0.001	3.70/<0.001	11.69/0.035	3.01/0.035

表2 治疗第5天时，3组病毒性ARI患儿临床疗效比较[例数(%)]

组别	例数	临床痊愈	显效率	有效率	无效率	总有效率
研究组	42	9(21.4)	3(56.1)	9(21.4)	1(2.4)	1(97.6)
对照组	42	8(19.0)	18(42.9)	8(19.0)	8(19.0)	34(80.9)
空白对照组	42	7(16.7)	16(39.1)	9(21.4)	9(21.4)	33(78.5)
总体比较(χ²值/P值)		－	－	－	－	7.39/0.025
两两比较(χ²值/P值)
研究组vs对照组		－	－	－	－	6.10/0.014
研究组vs空白对照组		－	－	－	－	7.26/0.007
对照组vs空白对照组		－	－	－	－	0.07/0.786

表2 治疗第5天时，3组病毒性ARI患儿临床疗效比较[例数(%)]

组别	例数	临床痊愈	显效率	有效率	无效率	总有效率
研究组	42	9(21.4)	3(56.1)	9(21.4)	1(2.4)	1(97.6)
对照组	42	8(19.0)	18(42.9)	8(19.0)	8(19.0)	34(80.9)
空白对照组	42	7(16.7)	16(39.1)	9(21.4)	9(21.4)	33(78.5)
总体比较(χ²值/P值)		－	－	－	－	7.39/0.025
两两比较(χ²值/P值)
研究组vs对照组		－	－	－	－	6.10/0.014
研究组vs空白对照组		－	－	－	－	7.26/0.007
对照组vs空白对照组		－	－	－	－	0.07/0.786

表3 治疗前与治疗第5天时，3组病毒性ARI患儿血清免疫指标比较(`±s)

组别	例数	CD4⁺(%)		CD8⁺(%)		CD4⁺/CD8⁺
组别	例数	治疗前	治疗第5天时	治疗前	治疗第5天时	治疗前	治疗第5天时
研究组	42	32.9±2.8	44.3±3.8	32.0±2.8	25.4±2.8	1.03±0.10	1.71±0.25
对照组	42	33.7±3.3	39.1±4.2	32.9±2.1	27.1±3.0	1.03±0.11	1.44±0.27
空白对照组	42	32.6±2.5	36.3±4.0	33.0±2.2	29.6±3.2	1.05±0.12	1.31±0.22
总体比较(F值/P值)		1.79/0.171	42.31/<0.001	2.25/0.110	21.30/<0.001	0.46/0.632	28.54/<0.001
两两比较(q值/P值)
研究组vs对照组		1.93/0.175	8.29/<0.001	2.35/0.991	3.78/0.009	0.001/0.999	7.07/<0.001
研究组vs空白对照组		0.65/0.646	12.83/<0.001	2.78/0.510	9.18/<0.001	1.18/0.407	10.47/<0.001
对照组vs空白对照组		2.58/0.071	4.53/<0.001	0.44/0.758	5.41/<0.001	1.18/0.407	3.40/0.017
组内治疗第5天时vs治疗前(t值/P值)
研究组		5.71/<0.001		6.39/<0.001		25.33/<0.001
对照组		6.35/<0.001		5.88/<0.001		19.68/<0.001
空白对照组		6.00/<0.001		4.99/<0.001		16.32/<0.001

表3 治疗前与治疗第5天时，3组病毒性ARI患儿血清免疫指标比较(`±s)

组别	例数	CD4⁺(%)		CD8⁺(%)		CD4⁺/CD8⁺
组别	例数	治疗前	治疗第5天时	治疗前	治疗第5天时	治疗前	治疗第5天时
研究组	42	32.9±2.8	44.3±3.8	32.0±2.8	25.4±2.8	1.03±0.10	1.71±0.25
对照组	42	33.7±3.3	39.1±4.2	32.9±2.1	27.1±3.0	1.03±0.11	1.44±0.27
空白对照组	42	32.6±2.5	36.3±4.0	33.0±2.2	29.6±3.2	1.05±0.12	1.31±0.22
总体比较(F值/P值)		1.79/0.171	42.31/<0.001	2.25/0.110	21.30/<0.001	0.46/0.632	28.54/<0.001
两两比较(q值/P值)
研究组vs对照组		1.93/0.175	8.29/<0.001	2.35/0.991	3.78/0.009	0.001/0.999	7.07/<0.001
研究组vs空白对照组		0.65/0.646	12.83/<0.001	2.78/0.510	9.18/<0.001	1.18/0.407	10.47/<0.001
对照组vs空白对照组		2.58/0.071	4.53/<0.001	0.44/0.758	5.41/<0.001	1.18/0.407	3.40/0.017
组内治疗第5天时vs治疗前(t值/P值)
研究组		5.71/<0.001		6.39/<0.001		25.33/<0.001
对照组		6.35/<0.001		5.88/<0.001		19.68/<0.001
空白对照组		6.00/<0.001		4.99/<0.001		16.32/<0.001

表4 治疗前与治疗第5天时，3组病毒性ARI患儿血清IgM、IgG与IgA水平比较(g/L ，±s)

组别	例数	IgM		IgG		IgA
组别	例数	治疗前	治疗第5天时	治疗前	治疗第5天时	治疗前	治疗第5天时
空白对照组	42	1.05±0.15	1.16±0.11	5.63±1.52	6.19±1.36	1.22±0.21	1.40±0.23
对照组	42	1.05±0.13	1.22±0.10	5.37±1.17	7.26±2.01	1.21±0.23	1.59±0.37
研究组	42	1.06±0.15	1.37±0.12	5.86±1.32	9.57±1.84	1.24±0.20	1.77±0.21
总体比较(F值/P值)		0.07/0.934	40.39/<0.001	1.40/0.251	40.54/<0.001	0.22/0.807	20.06/<0.001
两两比较(q值/P值)
研究组vs对照组		0.001/0.999	3.52/0.014	1.25/0.377	3.94/0.006	0.30/0.830	4.41/0.002
研究组vs空白对照组		0.45/0.750	12.34/<0.001	1.11/0.434	12.46/<0.001	0.61/0.669	8.59/<0.001
对照组vs空白对照组		0.45/0.750	8.81/<0.001	2.36/0.097	8.51/<0.001	0.91/0.521	4.18/0.004
组内治疗第5天时vs治疗前(t值/P值)
研究组		7.59/<0.001		6.35/<0.001		9.65/<0.001
对照组		8.32/<0.001		8.01/<0.001		10.29/<0.001
空白对照组		9.66/<0.001		8.54/<0.001		11.03/<0.001

表4 治疗前与治疗第5天时，3组病毒性ARI患儿血清IgM、IgG与IgA水平比较(g/L ，±s)

组别	例数	IgM		IgG		IgA
组别	例数	治疗前	治疗第5天时	治疗前	治疗第5天时	治疗前	治疗第5天时
空白对照组	42	1.05±0.15	1.16±0.11	5.63±1.52	6.19±1.36	1.22±0.21	1.40±0.23
对照组	42	1.05±0.13	1.22±0.10	5.37±1.17	7.26±2.01	1.21±0.23	1.59±0.37
研究组	42	1.06±0.15	1.37±0.12	5.86±1.32	9.57±1.84	1.24±0.20	1.77±0.21
总体比较(F值/P值)		0.07/0.934	40.39/<0.001	1.40/0.251	40.54/<0.001	0.22/0.807	20.06/<0.001
两两比较(q值/P值)
研究组vs对照组		0.001/0.999	3.52/0.014	1.25/0.377	3.94/0.006	0.30/0.830	4.41/0.002
研究组vs空白对照组		0.45/0.750	12.34/<0.001	1.11/0.434	12.46/<0.001	0.61/0.669	8.59/<0.001
对照组vs空白对照组		0.45/0.750	8.81/<0.001	2.36/0.097	8.51/<0.001	0.91/0.521	4.18/0.004
组内治疗第5天时vs治疗前(t值/P值)
研究组		7.59/<0.001		6.35/<0.001		9.65/<0.001
对照组		8.32/<0.001		8.01/<0.001		10.29/<0.001
空白对照组		9.66/<0.001		8.54/<0.001		11.03/<0.001

表5 治疗第5天时，3组病毒性ARI患儿治疗相关不良反应总发生率比较[例数(%)]

组别	例数	腹泻	恶心	总发生率
研究组	42	3(7.1)	2(4.8)	5(11.9)
对照组	42	2(4.8)	1(2.4)	3(7.1)
空白对照组	42	2(4.8)	0(0)	2(4.8)
总体比较(P值)		－	－	0.468

表5 治疗第5天时，3组病毒性ARI患儿治疗相关不良反应总发生率比较[例数(%)]

组别	例数	腹泻	恶心	总发生率
研究组	42	3(7.1)	2(4.8)	5(11.9)
对照组	42	2(4.8)	1(2.4)	3(7.1)
空白对照组	42	2(4.8)	0(0)	2(4.8)
总体比较(P值)		－	－	0.468

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