1.青岛市中医医院(市海慈医院),山东省青岛市市北区人民路4号,266033
2.山东中医药大学第一临床医学院
通信作者:hospitalbreathing@163. com
收稿:2025-07-25,
修回:2025-09-27,
纸质出版:2026-01-02
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孙英,胡海波,刘娜等.清肺渗湿汤联合西医治疗对支气管哮喘热哮证患者临床疗效及免疫功能的影响[J].中医杂志,2026,67(01):38-44.
SUN Ying,HU Haibo,LIU Na,et al.Effect of Qingfei Shenshi Decoction (清肺渗湿汤) Combined with Western Medicine on Clinical Effectiveness and Immune Function for Patients with Bronchial Asthma of Heat Wheezing Syndrome[J].Journal of Traditional Chinese Medicine,2026,67(01):38-44.
孙英,胡海波,刘娜等.清肺渗湿汤联合西医治疗对支气管哮喘热哮证患者临床疗效及免疫功能的影响[J].中医杂志,2026,67(01):38-44. DOI: 10.13288/j.11-2166/r.2026.01.007.
SUN Ying,HU Haibo,LIU Na,et al.Effect of Qingfei Shenshi Decoction (清肺渗湿汤) Combined with Western Medicine on Clinical Effectiveness and Immune Function for Patients with Bronchial Asthma of Heat Wheezing Syndrome[J].Journal of Traditional Chinese Medicine,2026,67(01):38-44. DOI: 10.13288/j.11-2166/r.2026.01.007.
目的
2
观察在西医治疗基础上联合应用清肺渗湿汤治疗支气管哮喘热哮证患者的临床疗效及安全性,并探讨可能的作用机制。
方法
2
将86例支气管哮喘热哮证患者随机分为治疗组和对照组,每组43例。对照组给予西医基础治疗,治疗组在对照组基础上加用清肺渗湿汤口服,每日1剂。两组均治疗14天。主要结局指标为治疗后临床疗效;次要结局指标包括中医证候评分、哮喘控制测试(ACT)量表评分、肺功能指标[包括第一秒用力呼气容积(FEV
1
)、用力肺活量(FVC)、呼气峰值流速(PEF)]、血清炎症因子水平[包括白细胞介素4(IL-4)、肿瘤坏死因子α(TNF-α)、高敏C反应蛋白(hs-CRP)]、免疫学指标(包括CD3
+
、CD4
+
、CD8
+
、CD4
+
/CD8
+
),分别于治疗前后各评价1次。于治疗前后监测生命体征,进行心电图、血常规、尿常规、肝功能、肾功能指标检测,并记录研究过程中不良事件及不良反应的发生情况。
结果
2
共80例患者完成试验,对照组与治疗组各40例。治疗组临床总有效率为97.5%(39/40),高于对照组的85.0%(34/40),差异有统计学意义(
P
<0.05)。治疗后两组患者中医证候评分、IL-4、TNF-α、hs-CRP及CD8
+
水平均降低,ACT评分、CD3
+
、CD4
+
、CD4
+
/CD8
+
、FEV
1
、FVC及PEF水平均升高(
P
<0.05或
P
<0.01),且治疗组上述各指标改善优于对照组(
P
<0.05或
P
<0.01)。两组患者治疗前后安全性指标均无明显异常,且未发生不良事件及不良反应。
结论
2
在西医治疗基础上联合应用清肺渗湿汤能有效改善支气管哮喘热哮证患者临床症状,提高患者肺功能和临床疗效,且安全性好,其机制可能与降低炎症因子水平、调节T淋巴细胞亚群改善免疫功能有关。
Objective
2
To observe the clinical effectiveness and safety of
Qingfei Shenshi Decoction
(清肺渗湿汤) combined with western medicine for patients with bronchial asthma of heat wheezing syndrome, and to explore its potential mechanism of action.
Methods
2
Eighty-six participants with bronchial asthma of heat wheezing syndrome were randomly divided into treatment group and control group, each group with 43 participants. The control group received conventional western medicine, and the treatment group was additional
ly administered
Qingfei Shenshi Decoction
orally on the basis of the control group, 1 dose per day. Both groups were treated for 14 days. The primary outcome measure was clinical effectiveness; secondary outcome measures included traditional Chinese medicine (TCM) syndrome score, asthma control test (ACT) score, pulmonary function indices such as forced expiratory volume in 1 second (FEV
1
), forced vital capacity (FVC), peak expiratory flow (PEF), serum inflammatory factor levels including interleukin-4 (IL-4), tumour necrosis factor-α (TNF-α), and high-sensitivity C-reactive protein (hs-CRP), and immune function indices including CD3
+
, CD4
+
, CD8
+
, CD4
+
/CD8
+
. All outcome measures were evaluated before and after treatment. Vital signs were monitored, and electrocardiography, blood routine, urine routine, liver function, and renal function tests were performed before and after treatment. Adverse events and reactions during the study were recorded.
Results
2
A total of 80 patients completed the trial with 40 in each group. The total clinical effective rate of the treatment group was 97.5% (39/40), which was significantly higher than that of the control group (85.0%, 34/40,
P
<0.05). After treatment, both groups showed decreased TCM syndrome scores, IL-4, TNF-α, hs-CRP, and CD8
+
levels, as well as increased ACT scores, CD3
+
, CD4
+
, CD4
+
/CD8
+
, FEV
1
, FVC, and PEF levels (
P
<0.05 or
P
<0.01). Moreover, the improvements in these indices were more significant in the treatment group than in the control group (
P
<0.05 or
P
<0.01). No significant abnormalities in safety indicators were observed in either group, and no adverse events or reactions occurred.
Conclusion
2
Qingfei Shenshi Decoction
combined with conventional western
medicine for patients with bronchial asthma of heat wheezing syndrome can effectively improve the clinical symptoms, pulmonary function, and clinical effectiveness, with good safety. Its mechanism may be related to reducing inflammatory factor levels and regulating T lymphocyte subsets to improve immune function.
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