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[肥甘颗粒改善流感患者中医症状量表评分:一项前瞻性临床观察研究]

[Feigan granules improve traditional Chinese medicine symptoms scale scores for influenza patients: a prospective clinical observational study].

作者信息

Chen Weihao, Zheng Dongsheng, DU Shuangshuang, Li Qian, Wu Guolin, Hong Dongsheng, Zhao Qingwei

机构信息

Clinical Pharmacy Research Center of Zhejiang University, Hangzhou 310058, China.

Department of Clinical Pharmacy, the First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang Provincial Key Laboratory of Clinical Evaluation and Translation Research of Traditional Chinese Medicine, Hangzhou 310003, China.

出版信息

Zhejiang Da Xue Xue Bao Yi Xue Ban. 2025 May 25;54(3):289-296. doi: 10.3724/zdxbyxb-2024-0559.

Abstract

OBJECTIVES

To evaluate the clinical efficacy of hospital-prepared Chinese medicine Feigan granules for influenza patients. This study has been registered at the International Traditional Medicine Clinical Trial Registry platform (ITMCTR2025000162).

METHODS

A prospective observational study was conducted on influenza patients who visited the Fever Clinic of the First Affiliated Hospital, Zhejiang University School of Medicine between February and March 2024. Patients were divided into the observation group (Feigan granules combined with conventional Western medicine) and the control group (conventional Western medicine). Main symptoms (including fever, cough and sore throat) and secondary symptoms (including chest tightness, poor appetite, muscle soreness and dry mouth) were evaluated with traditional Chinese medicine (TCM) symptom scale on the first day of the patient's visit and the third day after treatment. The degrees of improvement in the TCM symptom scores before and after treatment were compared using paired rank-sum test, and the differences in the overall symptom efficacy index between two groups were compared using the Wilcoxon test.

RESULTS

A total of 217 influenza patients were included. After treatment, the TCM symptom scores of both groups were significantly improved compared with those before treatment (all <0.01). The median differences in the main symptom score before and after treatment in the observation and the control groups were 7 points (95%: 6.0-8.0) and 6 points (95%: 6.0-8.0), respectively. The median difference in the secondary symptom score was 3 points (95%: 2.0-4.0) in both groups. The median differences in the total score were 9 points (95%: 8.0-10.5) and 8 points (95%: 7.0-10.0) in the observation and control groups, respectively. In the subgroup with an initial cough score >2, the improvement rates of total score (97.06% . 92.59%) and secondary symptoms (92.31% . 85.11%) in observation group were significantly higher than those in the control group (<0.05); while there was no significant difference in the improvement rate of the main symptoms (95.59% . 90.74%, >0.05).

CONCLUSIONS

Feigan granules can improve the TCM syndromes of influenza patients, especially for patients with more severe cough.

摘要

目的

评估医院自制中药肺感颗粒对流感患者的临床疗效。本研究已在国际传统医学临床试验注册平台(ITMCTR2025000162)注册。

方法

对2024年2月至3月期间到浙江大学医学院附属第一医院发热门诊就诊的流感患者进行前瞻性观察研究。将患者分为观察组(肺感颗粒联合常规西药)和对照组(常规西药)。在患者就诊首日及治疗后第3天,采用中医症状量表评估主要症状(包括发热、咳嗽、咽痛)和次要症状(包括胸闷、食欲不振、肌肉酸痛、口干)。采用配对秩和检验比较治疗前后中医症状评分的改善程度,采用Wilcoxon检验比较两组总体症状疗效指数的差异。

结果

共纳入217例流感患者。治疗后,两组中医症状评分均较治疗前显著改善(均P<0.01)。观察组和对照组治疗前后主要症状评分的中位数差值分别为7分(95%CI:6.0 - 8.0)和6分(95%CI:6.0 - 8.0)。两组次要症状评分的中位数差值均为3分(95%CI:2.0 - 4.0)。观察组和对照组总分的中位数差值分别为9分(95%CI:8.0 - 10.5)和8分(95%CI:7.0 - 10.0)。在初始咳嗽评分>2的亚组中,观察组总分(97.06%对92.59%)和次要症状(92.31%对85.11%)的改善率显著高于对照组(P< .05);而主要症状改善率无显著差异(95.59%对90.74%,P>0.05)。

结论

肺感颗粒可改善流感患者的中医证候,尤其对于咳嗽较严重的患者。

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