【目的】 分析热毒宁注射液联合人免疫球蛋白治疗重症病毒性肺炎（SVP）患者的临床疗效及其对免疫功能与调控 Toll 样受体4/核因子κ轻链增强子结合蛋白（TLR4/NF-κB）炎症信号通路的影响。【方法】 选取2023年1月至2024年12月南阳市中 心医院收治的 110 例风热犯肺型 SVP 患者作为研究对象，采用随机数字表法将患者随机分为对照组和观察组，每组各 55 例。对照组给予人免疫球蛋白及常规治疗，观察组在对照组的基础上联合热毒宁注射液治疗，2 组患者的总疗程均为 10 d。观察2组患者治疗前、治疗5 d后和治疗10 d后中医证候积分、免疫功能及血清TLR4、NF-κB水平的变化情况，并评 价 2组患者的临床疗效和用药安全性。【结果】（1）疗效方面，治疗 10 d 后，观察组的总有效率为 92.73%（51/55），对照组为 70.91%（39/55），组间比较（χ2 检验），观察组的疗效明显优于对照组（P＜0.01）。（2）中医证候积分方面，治疗5 d后，2组患者的 中医证候积分均较治疗前降低（P＜0.05），治疗10 d后又均较治疗5 d后降低（P＜0.05），且观察组在治疗5 d后和治疗10 d后 对中医证候积分的降低幅度均明显优于对照组（P＜0.05）。（3）免疫功能方面，治疗5 d后，2组患者的T淋巴细胞CD3+ 、CD4+ 及 CD4+ /CD8+ 水平均较治疗前升高（P＜0.05），治疗 10 d 后又均较治疗 5 d 后升高（P＜0.05），且观察组在治疗 5 d后和治疗 10 d后对T淋巴细胞CD3+ 、CD4+ 及CD4+ /CD8+ 水平的升高幅度均明显优于对照组（P＜0.05）。（4）TLR4/NF-κB炎症信号通路方 面，治疗 5 d 后，2 组患者的血清 TLR4、NF-κB 水平均较治疗前降低（P＜0.05），治疗 10 d 后又均较治疗 5 d 后降低（P＜ 0.05），且观察组在治疗5 d后和治疗10 d后对血清TLR4、NF-κB水平的降低幅度均明显优于对照组（P＜0.05）。（5）安全性方 面，治疗过程中，观察组的不良反应发生率为 7.27%（4/55），对照组为 3.64%（2/55），组间比较，差异无统计学意义（P＞ 0.05）。【结论】 热毒宁注射液联合人免疫球蛋白治疗风热犯肺型SVP患者疗效确切，安全性高，其机制可能与增强机体免疫 功能、调控TLR4/NF-κB炎症信号通路有关。

Objective To evaluate the clinical efficacy of Reduning Injection combined with human immunoglobulin in patients with severe viral pneumonia （SVP） of wind-heat invading the lung type and to observe its effects on immune function and the Toll-like receptor 4/nuclear factor-kappa B （TLR4/NF-κB） inflammatory signaling pathway. Methods A total of 110 SVP patients with wind-heat invading the lung type，admitted to Nanyang Central Hospital from January 2023 to December 2024，were selected and randomly divided into a control group and an observation group （n=55 each） using a random number table method. The control group received human immunoglobulin plus conventional therapy， while the observation group received additional Reduning Injection based on the control group’s treatment. The total treatment course for both groups covered 10 days. Changes in TCM syndrome scores， immune function，and serum TLR4 and NF-κB levels were observed before treatment，after 5 days of treatment， and after 10 days of treatment. The clinical efficacy and medication safety were evaluated for both groups. Results （1） Therapeutic effect：After 10 days of treatment，the total effective rate was 92.73% （51/55） in the observation group and 70.91% （39/55） in the control group，and the ingergroup comparison （by chi-square test） showed that the therapeutic effect in the observation group was superior to the control group （P＜0.01）.（2） TCM syndrome scores：After 5 days of treatment，the scores in both groups decreased compared to before treatment （P＜0.05）， and after 10 days，they further decreased compared to after 5 days （P＜0.05）. The observation group showed a significantly greater reduction in TCM syndrome scores than the control group at both 5 and 10 days （P＜0.05）. （3） Immune function：After 5 days of treatment，the levels of T lymphocyte subsets CD3+ ，CD4+ ，and the CD4+ / CD8+ ratio increased in both groups compared to before treatment （P＜0.05），and further increased after 10 days compared to after 5 days （P＜0.05）. The observation group demonstrated significantly greater increases in T lymphocyte subsets CD3+，CD4+，and the CD4+ /CD8+ ratio than the control group at both time points （P＜0.05）. （4） TLR4/NF- κB inflammatory signaling pathway：After 5 days of treatment，serum TLR4 and NF- κB levels decreased in both groups compared to before treatment （P＜0.05），and further decreased after 10 days compared to after 5 days （P＜0.05）. The observation group showed a significantly greater reduction in serum TLR4 and NF-κB levels than the control group at both 5 and 10 days （P＜0.05）.（5） Safety： the incidence of adverse reactions was 7.27% （4/55） in the observation group and 3.64% （2/55） in the control group， with no statistically significant difference between the groups （P＞0.05）. Conclusion Reduning Injection combined with human immunoglobulin is effective and safe for treating SVP patients of wind-heat invading the lung type. The mechanism may be related to enhancing immune function and modulating the TLR4/NF-κB inflammatory signaling pathway.

R259.631

河南省中医药科学研究专项课题（编号：2022ZY1200）