【目的】探究扶正和解方（由黄芩、金银花、藿香、柴胡、苍术、生甘草等组成）治疗儿童呼吸道病毒性感染的疗效及 对炎症因子和免疫功能的影响。【方法】将203例呼吸道病毒甲型H1N1感染患儿随机分为观察组101例和对照组102例。2组 患儿均给予退热、维持正常水电解质、保障足够睡眠等常规治疗，在此基础上，对照组患儿给予利巴韦林颗粒及布洛芬颗 粒治疗，观察组在对照组的基础上给予扶正和解方治疗，疗程为7 d。观察2组患儿治疗前后中医证候积分、免疫学指标和 炎症因子水平的变化情况，并比较2组患儿的临床疗效、临床症状消退时间和不良反应发生情况。【结果】（1）脱落情况：研 究过程中，观察组脱落1例，对照组脱落2例，最终观察组和对照组各有100例患儿纳入研究。（2）疗效情况：治疗7 d后，观 察组的总有效率为93.00%（93/100），对照组为88.00%（88/100），观察组的疗效优于对照组，但组间比较，差异无统计学意 义（χ2 = 1.454，P = 0.228）。（3）中医证候积分：治疗后，2组患儿的主症积分、次症积分和总积分均较治疗前降低（P＜ 0.05），且观察组的降低幅度均明显优于对照组（P＜0.01）。（4）临床症状消退时间：治疗后，观察组患儿的发热、咳嗽、咳 痰、咽痛等临床症状消退时间均较对照组明显缩短（P＜0.01）。（5）免疫学指标：治疗后，2组患儿的T淋巴细胞亚群CD3+、 CD4+水平均较治疗前升高（P＜0.05），CD8+、B细胞水平均较治疗前降低（P＜0.05），且观察组对CD3+、CD4+水平的升高幅度 及对CD8+、B细胞水平的降低幅度均明显优于对照组（P＜0.01）。（6）炎症因子水平：治疗后，2组患儿的血清淀粉样蛋白 （SAA）、C反应蛋白（CRP）、肿瘤坏死因子α（TNF-α）、可溶性白细胞介素2受体（SIL-2R）、白细胞介素6（IL-6）水平均较治 疗前明显降低（P＜0.05），白细胞介素2（IL-2）、干扰素γ（IFN-γ）水平均较治疗前明显升高（P＜0.05），且观察组对血清 SAA、CRP、TNF-α、SIL-2R、IL-6水平的降低幅度及对血清IL-2、IFN-γ水平的升高幅度均明显优于对照组（P＜0.01）。 （7）观察组的不良反应发生率为2.00%（2/100），低于对照组的8.00%（8/100），但组间比较，差异无统计学意义（χ2 = 3.789， P = 0.052）。【结论】扶正和解方治疗儿童呼吸道病毒甲型H1N1感染疗效确切，可有效改善患儿中医证候，调控炎症反应， 提高机体免疫功能，加快临床症状缓解并缩短病程。

Objective To investigate the efficacy of Fuzheng Hejie Prescription（composed of Scutellariae Radix， Lonicerae Japonicae Flos， Agastachis Herba， Bupleuri Radix， Atractylodis Rhizoma， Glycyrrhizae Radix et Rhizoma，etc.）in the treatment of respiratory viral infections in children and to observe its effect on inflammatory factors and immune function. Methods A total of 203 children with respiratory viral infection of H1N1 virus were randomly divided into 101 cases in the observation group and 102 cases in the control group. Both groups were 收稿日期：2023-06-09 作者简介：李欣旖（1990-），女，硕士，主治医师；E-mail：lixinyi9012@163.com 基金项目：国家自然科学基金面上项目（编号：81973700）；上海中医药大学紧急应对奥密克戎感染新冠肺炎科研攻关专项（编号：2022YJ-37） 广州中医药大学学报 Journal of Guangzhou University of Traditional Chinese Medicine 2024年3月第41卷第3期 March 2024，Vol. 41，No. 3 631 given the routine treatment for subsiding fever， maintaining water- electrolyte balance， and ensuring enough sleep. And additionally， the control group was given Ribavirin Granules and Ibuprofen Granules， and the observation group was given Fuzheng Hejie Prescription based on the treatment for the control group. The course of treatment covered 7 days. The changes of traditional Chinese medicine（TCM）syndrome scores and the levels of immunological indicators and inflammatory factors in the two groups were observed before and after the treatment. Moreover，the clinical efficacy，symptom resolution time and the incidence of adverse reactions were compared between the two groups of children. Results（1）In the course of the trial，one case fell off in the observation group and 2 cases fell off in the control group， and eventually 100 children in each group were included in the trial. （2）After 7 days of treatment，the total effective rate of the observation group was 93.00%（93/100），and that of the control group was 88.00%（88/100），and the intergroup comparison showed that the therapeutic effect of the observation group was superior to that of the control group，but the difference was not statistically significant（χ2 = 1.454，P = 0.228）.（3）After treatment，the scores of primary symptoms and secondary symptoms as well as the total TCM syndrome scores in the two groups were decreased compared with those before treatment（P＜0.05），and the decrease in the observation group was significantly superior to that in the control group（P＜0.01）.（4）After treatment，the time for the resolution of clinical symptoms such as fever，cough，expectoration and sore throat in the observation group was significantly shorter than that in the control group（P＜0.01）.（5）After treatment，the levels of immunological indicators of T lymphocyte subset CD3 + and CD4 + in the two groups were increased compared with those before treatment（P＜0.05），and the levels of CD8+ and B cells were decreased compared with those before treatment（P＜0.05）. The intergroup comparison showed that the increase in the levels of CD3+ and CD4+ as well as the decrease in the levels of CD8+ and B cells of the observation group was significantly superior to that of the control group（P＜0.01）.（6）After treatment，the levels of inflammatory factors of serum amyloid A（SAA），C-reactive protein（CRP），serum tumor necrosis factor alpha（TNF-α），soluble interleukin 2 receptor（SIL-2R），and interleukin 6（IL-6）in the two groups were significantly decreased compared with those before treatment（P＜0.05）， and the levels of interleukin 2（IL- 2） and interferon γ（IFN- γ） ls were all significantly increased compared with those before treatment（P＜0.05）. The intergroup comparison showed that the decrease of serum SAA，CRP，TNF-α，SIL-2R，and IL-6 levels and the increase of serum IL-2 and IFN-γ levels in the observation group were significantly superior to those in the control group（P＜0.01）.（7）The incidence of adverse reactions in the observation group was 2.00%（2/100），which was significantly lower than that of 8.00% （8/100） in the control group， but the difference was not statistically significant（χ2 = 3.789， P = 0.052）. Conclusion Fuzheng Hejie Prescription exerts certain effect in treating children with respiratory viral infection of H1N1 virus， which can effectively decrease children’s TCM syndrome scores， regulate the inflammatory response，improve the immune function，accelerate the relief of clinical symptoms and shorten the course of the disease.

R511.7；R272.5

国家自然科学基金面上项目（编号：81973700）；上海中医药大学紧急应对奥密克戎感染新冠肺炎科研攻关专项（编号：2022YJ-37）