Clinical observation of phlegm-heat-clearing capsules in the adjuvant treatment of influenza with heat-toxin attacking lung syndrome

doi:10.3760/cma.j.cn441417-20250731-21013

Abstract

Abstract: Objective　To observe the clinical efficacy of phlegm-heat-clearing capsules in the adjuvant treatment of influenza with heat-toxin attacking lung syndrome. Methods　From September 2023 to September 2024, 72 patients with influenza of heat-toxin attacking lung syndrome in the Department of Respiratory and Critical Care Medicine, Jieshou Hospital of Traditional Chinese Medicine were selected, and were divided into a control group (36 cases) and an experimental group (36 cases) using the random number table method. In the experimental group, there were 19 males and 17 females, with a median age of 53.50 (42.50, 58.75) years old; in the control group, there were 20 males and 16 females, with a median age of 50.00 (35.00, 55.75) years old. The control group was given oral oseltamivir phosphate capsules, 75 mg each time, twice a day; the experimental group was additionally treated with phlegm-heat-clearing capsules, 0.8 g each time, three times a day. The treatment course was 5 days, with follow-up until complete recovery. The complete fever reduction time, total score of traditional Chinese medicine symptoms, clinical efficacy, C-reactive protein (CRP) level, abnormal rate of white blood cell count, abnormal rate of neutrophil percentage, and adverse reactions were observed. Statistical analysis was conducted using paired sample t test, independent sample t test, Welch-corrected t test, Mann-Whitney U test, χ² test, corrected χ² test, and Fisher's exact probability method. Results　The complete fever reduction time of the experimental group was (34.06±12.25) hours, which was shorter than that of the control group [(40.72±13.77) hours], with a statistically significant difference (t=-2.170, P=0.033). On the 4th day after treatment, the total score of traditional Chinese medicine symptoms of the experimental group was lower than that of the control group [(3.06±1.84) points vs. (5.75±2.75) points], with a statistically significant difference (t=-4.889, P<0.001); the total recovery rate of the experimental group was higher than that of the control group [80.56% (29/36) vs. 50.00% (18/36)], with a statistically significant difference (χ²=7.414, P=0.006); the CRP level, abnormal rate of white blood cell count, and abnormal rate of neutrophil percentage in the experimental group were all lower than those in the control group [(7.44±2.24) mg/L vs. (10.05±3.16) mg/L, 2.78% (1/36) vs. 22.22% (8/36), 11.11% (4/36) vs. 30.56% (11/36)] (all P<0.05). During the treatment process, one adverse reaction occurred in the experimental group (mild diarrhea), while there were no such cases in the control group. The incidences of adverse reactions in the two groups were compared using the Fisher's exact probability method, and the difference was not statistically significant (P=1.000). Conclusion　The combination of phlegm-heat-clearing capsules and oseltamivir phosphate capsules in the treatment of influenza with heat-toxin attacking lung syndrome outperforms the use of oseltamivir phosphate capsules alone in terms of fever reduction time, symptom relief, and improvement of inflammation.

Key words: Influenza, Heat-toxin attacking lung syndrome, Phlegm-heat-clearing capsules, Traditional Chinese medicine, Clinical observation

摘要： 目的　观察痰热清胶囊辅治热毒袭肺证流行性感冒的临床疗效。方法　选择2023年9月至2024年9月界首市中医院呼吸与危重症学科热毒袭肺证流行性感冒患者72例，采用随机数字表法分为对照组（36例）和试验组（36例）。试验组男19例，女17例，年龄53.50（42.50，58.75）岁；对照组男20例，女16例，年龄50.00（35.00，55.75）岁。对照组给予磷酸奥司他韦胶囊口服，每次75 mg，每日2次。试验组在对照组基础上加用痰热清胶囊，每次0.8 g，每日3次。疗程5 d，随访至病情痊愈。观察完全退热时间、中医症状积分、临床疗效、C反应蛋白（CRP）、白细胞计数异常比例、中性粒细胞百分比异常比例及不良反应。采用配对样本t检验、独立样本t检验、Welch校正t检验、Mann-Whitney U检验、χ²检验、校正χ²检验、Fisher确切概率法进行统计学分析。结果　试验组的完全退热时间为（34.06±12.25）h，短于对照组的（40.72±13.77）h，差异有统计学意义（t=-2.170，P=0.033）。治疗后第4天，试验组中医症状积分低于对照组［（3.06±1.84）分比（5.75±2.75）分］，差异有统计学意义（t=-4.889，P<0.001）；试验组总愈显率高于对照组［80.56%（29/36）比50.00%（18/36）］，差异有统计学意义（χ²=7.414，P=0.006）；试验组CRP水平、白细胞计数异常比例、中性粒细胞百分比异常比例均低于对照组［（7.44±2.24）mg/L比（10.05±3.16）mg/L、2.78%（1/36）比22.22%（8/36）、11.11%（4/36）比30.56%（11/36）］（均P<0.05）。治疗过程中，试验组出现1例不良反应（轻度腹泻），对照组0例，采用Fisher确切概率法检验两组不良反应发生率，差异无统计学意义（P=1.000）。结论　痰热清胶囊联合磷酸奥司他韦胶囊治疗热毒袭肺证流行性感冒，在退热时间、症状缓解、炎症改善方面优于单用磷酸奥司他韦胶囊。

关键词: 流行性感冒, 热毒袭肺证, 痰热清胶囊, 中医药, 临床观察

Chen Shuowen, Xie Linna, Li Jiayao, Cheng Yaokang, Li Qiao. Clinical observation of phlegm-heat-clearing capsules in the adjuvant treatment of influenza with heat-toxin attacking lung syndrome[J]. International Medicine and Health Guidance News, 2025, 31(21): 3587-3591.

陈烁文谢琳娜李佳遥程耀慷李乔. 痰热清胶囊辅治热毒袭肺证流行性感冒临床观察[J]. 国际医药卫生导报, 2025, 31(21): 3587-3591.

References

[1] 国家疾病预防控制局.2023年全国法定传染病疫情概况[J].中国病毒病杂志,2024,14(6):600.
[2] 张萌萌,熊庆勇,李佳遥,等.热毒宁口服液治疗流行性感冒风热犯卫证有效性及安全性的研究[J].光明中医,2023,38(15):2894-2898. DOI:10.3969/j.issn.1003-8914.2023.15.008.
[3] 孔德松,赵峰,张彦亮,等.翘芪组方治疗流行性感冒轻症患者36例有效性与安全性的随机对照试验[J].中医杂志,2024,65(7):710-715. DOI:10.13288/j.11-2166/r.2024.07.009.
[4] Liu TY, Hao Y, Mao Q, et al. Tanreqing injection inhibits activation of NLRP3 inflammasome in macrophages infected with influenza a virus by promoting mitophagy[J]. Chin J Integr Med, 2025,31(1):19-27. DOI:10.1007/s11655-024-3905-3.
[5] 段乃凡,余圆圆,何玉蓉,等.基于"肺-肠轴"探讨痰热清胶囊对流感病毒感染小鼠的肺肠保护作用[J].中国中药杂志,2025,50(8):2270-2281. DOI:10.19540/j.cnki.cjcmm.20250105.501.
[6] 罗润军.痰热清注射液联合奥司他韦治疗流行性感冒的疗效观察[J].内蒙古中医药,2021,40(1):39-40. DOI:10.16040/j.cnki.cn15-1101.2021.01.024.
[7] 赵延平,吴百灵.麻杏石甘汤加减治疗热毒袭肺型流行性感冒临床疗效观察[J].中医药临床杂志,2022,34(8):1536-1539. DOI:10.16448/j.cjtcm.2022.0838.
[8] 中国医师协会急诊医师分会,中华医学会急诊医学分会,中国急诊专科医联体,等.成人流行性感冒诊疗规范急诊专家共识(2022版)[J].中国急救医学,2022,42(12):1013-1026. DOI:10.3969/j.issn.1002-1949.2022.12.001.
[9] 郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:119-123.
[10] 邓玲.中医病证诊断疗效标准[M].北京:中国医药科技出版社,2017.
[11] Flórido M, Chiu J, Hogg PJ. Influenza a virus hemagglutinin is produced in different disulfide-bonded states[J].Antioxid Redox Signal,2021,35(13):1081-1092. DOI:10.1089/ARS.2021.0033.
[12] Patel H, Kukol A.Integrating molecular modelling methods to advance influenza a virus drug discovery[J].Drug Discov Today,2021,26(2):503-510. DOI:10.1016/j.drudis.2020.11.014.
[13] Chen N, Jin J, Qiao B, et al. JNK kinase promotes inflammatory responses by inducing the expression of the inflammatory amplifier TREM1 during influenza a virus infection[J]. Virus Res,2025,356199577.DOI:10.1016/J.VIRUSRES.2025.199577.
[14] 王静,谷晓红,郭凯,等.中医药防治儿童流行性感冒的研究进展[J].云南中医药大学学报,2024,47(6):99-104.DOI:10.19288/j.cnki.issn.1000-2723.2024.06.021.
[15] 聂赛美,彭平,张辰浩,等.1034例甲型流行性感冒患者中医证候特点的回顾性分析[J].世界中医药,2024,19(16):2468-2472,2478. DOI:10.3969/j.issn.1673-7202.2024.16.016.
[16] Tiwary M, Rooney RJ, Liedmann S, et al. Eosinophil responses at the airway epithelial barrier during the early phase of influenza a virus infection in C57BL/6 mice[J]. Cells,2021,10(3):509. DOI:10.3390/cells10030509.
[17] Han XX, Tian YG, Liu XF, et al. Network pharmacology combined with pharmacodynamics revealed the antiinflammatory mechanism of Tanreqing capsule against acuteexacerbation chronic obstructive pulmonary disease[J].Sci Rep,2022,12(1):13967. DOI:10.1038/S41598-022-18326-1.
[18] 杨芝芝,杨洁,邓建军,等. 血常规指标及比值变化在新型冠状病毒肺炎和流感患者鉴别诊断中的价值研究[J]. 国际医药卫生导报,2022,28(20):2876-2880. DOI:10.3760/cma.j.issn.1007-1245.2022.20.013.
[19] 韩忠燕,李梦雪,唐瑶,等.KL-6联合CRP和血常规评估甲型流感患者早期肺损伤的意义[J].国际检验医学杂志,2025,46(7):840-844. DOI:10.3969/j.issn.1673-4130.2025.07.014.
[20] 苏右竹,王烁,刘清泉,等.以痰热清胶囊为代表的通治法治疗单纯性流行性感冒的多中心、双盲、安慰剂双模拟随机对照研究[J].中华中医药杂志,2025,40(6):3240-3245.
[21] Yang M, Ma L, Su R, et al. The extract of scutellaria baicalensis attenuates the pattern recognition receptor pathway activation induced by influenza a virus in macrophages[J].Viruses,2023,15(7):1524.DOI:10.3390/V15071524.
[22] Markus H, Kirstin M, Heike H, et al. Chloroquine does not inhibit infection of human lung cells with SARS-CoV-2[J].Nature,2020,585(7826):588-590. DOI:10.1038/s41586-020-2575-3.
[23] 武文星,刘睿,赵晶晶,等.山羊角药用价值的研究进展[J].中草药,2022,53(9):2825-2838. DOI:10.7501/j.issn.0253-2670.2022.09.027.
[24] Xie X, Gu L, Xu W, et al. Integrating anti-influenza virus activity and chemical pattern recognition to explore the quality evaluation method of lonicerae japonicae flos[J]. Molecules, 2022,27(18):5789. DOI:10.3390/molecules27185789.
[25] Xiao Z, Ziqi C, Shanshan S, et al. Forsythiaside a improves influenza a virus infection through tlr7 signaling pathway in the lungs of mice[J]. BMC Complement Med Ther,2022,22(1):164. DOI:10.1186/S12906-022-03644-8.
[26] 董伟,王艳彩.磷酸奥司他韦预防甲型H1N1流感时引起不良反应206例报道[J].中国临床药学杂志,2011,20(2):111-113. DOI:10.19577/j.cnki.issn10074406.2011.02.013.