【目的】评价加味普济消毒颗粒（由金银花、连翘、蒲公英、紫花地丁、荆芥、牛蒡子、皂角刺、赤芍、牡丹皮、芦根 等组成）内服联合消肿散结膏（由黄芩、黄连、黄柏、皂角刺等组成）外敷治疗儿童急性扁桃体炎（acute tonsillitis in children， ATC）的临床疗效及对免疫功能与相关炎症指标的影响。【方法】将116例ATC肺胃郁热证患儿随机分为对照组和观察组，每 组各58例。对照组给予头孢克肟分散片治疗，观察组给予加味普济消毒颗粒内服联合消肿散结膏外敷治疗，疗程为14 d并 随访6个月。观察2组患儿治疗前后中医证候积分、外周血中白细胞计数（WBC）、T淋巴细胞亚群CD3+、CD4+、CD8+和 CD4+/CD8+水平及血清肿瘤坏死因子α（TNF-α）、白细胞介素1β（IL-1β）、白细胞介素6（IL-6）、C反应蛋白（CRP）水平的变 化情况，比较2组患儿的临床疗效和各项临床症状消失时间，同时监测2组患儿的不良反应发生情况和扁桃体炎复发情 况。【结果】（1）研究期间，对照组有8例患儿脱落，观察组无脱落病例，最终对照组50例、观察组58例患儿完成全部疗程的 治疗。（2）治疗14 d后，观察组的总有效率为98.28%（57/58），对照组为90.00%（45/50）；组间比较（秩和检验），观察组的临 床疗效明显优于对照组（P＜0.05）。（3）治疗后，观察组患儿的咽痛消失时间、脓点消失时间、退热时间及扁桃体恢复正常时 间均较对照组明显缩短（P＜0.05）。（4）治疗后，2组患儿的主症积分、次症积分和中医证候总积分均较治疗前明显降低（P＜ 0.05），且观察组的降低幅度均明显优于对照组（P＜0.05）。（5）治疗后，2组患儿的T淋巴细胞亚群CD3+、CD4+和CD4+/CD8+水 平均较治疗前明显升高（P＜0.05），CD8+水平均较治疗前明显降低（P＜0.05），且观察组对T淋巴细胞亚群CD3+、CD4+和 CD4+/CD8+水平的升高幅度及对CD8+水平的降低幅度均明显优于对照组（P＜0.05）。（6）治疗后，2组患儿的WBC、TNF-α、 IL-1β、IL-6及CRP水平均较治疗前明显降低（P＜0.05），且观察组的降低幅度均明显优于对照组（P＜0.05）。（7）治疗期 间，2组患儿均未出现皮肤过敏及恶心、呕吐等胃肠道不良反应情况，具有较高的安全性。（8）随访6个月，观察组患儿的扁 桃体炎复发率为5.17%（3/58），明显低于对照组的24.00%（12/50），组间比较，差异有统计学意义（χ2 = 8.330，P＜0.05）。 【结论】加味普济消毒颗粒内服联合消肿散结膏外敷治疗ATC肺胃郁热证患儿疗效显著，可明显缩短病程，改善临床症状， 有效降低扁桃体炎复发率，其机制可能与增强机体免疫功能、抑制炎症反应有关。

Objective To evaluate the clinical efficacy of oral use of Jiawei Puji Xiaodu Granules（mainly composed of Lonicerae Japonicae Flos， Forsythiae Fructus， Taraxaci Herba， Violae Herba， Schizonepetae 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 638 March 2024，Vol. 41，No. 3 Herba， Arctii Fructus， Gleditsiae Spina， Paeoniae Radix Rubra， Moutan Cortex， and Phragmitis Rhizoma） combined with external application of Xiaozhong Sanjie Ointment（mainly composed of Scutellariae Radix，Coptidis Rhizoma， Phellodendri Chinensis Cortex， and Gleditsiae Spina， etc.）in the treatment of acute tonsillitis in children， and to observe their effects on the immune function and related inflammatory indexes of the patients. Methods A total of 116 children with acute tonsillitis of heat stagnation in the lung and stomach type were randomly divided into the control group and the observation group，with 58 cases in each group. The control group was treated with Cefixime Dispersible Tablets， while the observation group was treated with Jiawei Puji Xiaodu Granules for oral use and Xiaozhong Sanjie Ointment for external application. Both groups were treated for 14 days and then were followed-up for a period of 6 months. The changes of traditional Chinese medicine（TCM）syndrome scores，white blood cell（WBC）count，T lymphocyte subset CD3+，CD4+，CD8+ and CD4+/CD8+ levels，and serum levels of tumor necrosis factor α（TNF-α），interleukin 1β（IL-1β），interleukin 6（IL-6）and C-reactive protein（CRP）in the two groups were observed before and after the treatment. Moreover，the clinical efficacy and time for the disappearance of clinical symptoms were compared between the two groups， and the occurrence of adverse reactions and the recurrence of tonsillitis in the two groups were monitored at the same time. Results （1）During the trial，there were 8 cases falling off in the control group but none case falling off in the observation group，and eventually 50 cases in the control group and 58 cases in the observation group completed the full course of treatment.（2）After 14 days of treatment，the total effective rate of the observation group was 98.28%（57/58）， while that of the control group was 90.00%（45/50）. The intergroup（tested by rank sum test）showed that the clinical efficacy of the observation group was significantly superior to that of the control group（P＜0.05）.（3）After treatment，the time for the disappearance of sore throat，time for the disappearance of purulent spots，time for subsiding fever and time for the tonsils recovering to normal in the observation group were all significantly shorter than those in the control group（P＜0.05）.（4）After treatment，the scores of primary and secondary symptoms and the overall symptom scores in the two groups were significantly lower than those before treatment（P＜0.05），and the reduction of the scores in the observation group was significantly superior to that in the control group（P＜ 0.05）.（5）After treatment，the levels of T lymphocyte subset CD3+，CD4+ and CD4+/CD8+ in the two groups were significantly higher（P＜0.05） while the level of CD8 + was significantly lower（P＜0.05） than those before treatment，and the increase in the levels of CD3+，CD4+ and CD4+/CD8+ and the reduction of the CD8+ level of the observation group were significantly superior to those of the control group（P＜0.05）.（6）After treatment， the levels of WBC， TNF-α， IL-1β， IL-6 and CRP in the two groups were significantly lower than those before treatment（P＜0.05），and the reduction in the observation group was significantly superior to that in the control group（P＜0.05）.（7）During the treatment period， no skin allergy， nausea， vomiting or other gastrointestinal adverse reactions occurred in the two groups，which showed a high degree of safety.（8）The 6-month follow-up showed that the recurrence rate of tonsillitis in the observation group was 5.17%（3/58），which was significantly lower than that of 24.00%（12/50）in the control group， and the difference was statistically significant（χ2 = 8.330， P＜0.05）. Conclusion The efficacy of Jiawei Puji Xiaodu Granules combined with Xiaozhong Sanjie Ointment exert notable curative effect for children with acute tonsillitis of heat stagnation in the lung and stomach type. The combined therapy can significantly shorten the duration of the disease，improve the clinical symptoms of the children and effectively reduce the recurrence rate of tonsillitis. The therapeutic mechanism may be related to the enhancement of the immune function and the inhibition of inflammatory response.

R276.1

国家自然科学基金项目（编号：81571786）；兰州市科学技术局科研项目（编号：2019-ZD-92）