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中华肺部疾病杂志(电子版)

中华肺部疾病杂志(电子版) ›› 2023, Vol. 16 ›› Issue (03) : 306 -311. doi: 10.3877/cma.j.issn.1674-6902.2023.03.002

论著

丹龙口服液治疗轻中度慢性阻塞性肺疾病急性加重期的多中心及前瞻性研究
廖玥, 王可, 秦江月, 吴艳秋, 陈俊, 汪涛, 文富强†(), 王浩†()   
  1. 610044　成都，四川大学华西医院呼吸病学研究室
    610044　成都，四川大学华西医院呼吸病学研究室；610044　成都，四川大学华西医院呼吸与危重症医学科
    610044　成都，四川大学华西医院呼吸与危重症医学科
  • 收稿日期:2022-12-29 出版日期:2023-06-25
  • 通信作者: 文富强, 王浩

Efficacy of Danlong oral liquid in treatment of mild-to-moderate acute exacerbation of chronic obstructive pulmonary disease: A multicenter, prospective, observational cohort study

Yue Liao, Ke Wang, Jiangyue Qin, Yanqiu Wu, Jun Chen, Tao Wang, Fuqiang Wen†(), Hao Wang†()   

  1. Division of Pulmonary Disease, State Key Laboratory of Biotherapy of China, and Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu 610044, China
    Division of Pulmonary Disease, State Key Laboratory of Biotherapy of China, and Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu 610044, China; Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu 610044, China.
    Division of Pulmonary Disease, Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu 610044, China.
  • Received:2022-12-29 Published:2023-06-25
  • Corresponding author: Fuqiang Wen, Hao Wang
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引用本文：

廖玥, 王可, 秦江月, 吴艳秋, 陈俊, 汪涛, 文富强, 王浩. 丹龙口服液治疗轻中度慢性阻塞性肺疾病急性加重期的多中心及前瞻性研究[J]. 中华肺部疾病杂志(电子版), 2023, 16(03): 306-311.

Yue Liao, Ke Wang, Jiangyue Qin, Yanqiu Wu, Jun Chen, Tao Wang, Fuqiang Wen, Hao Wang. Efficacy of Danlong oral liquid in treatment of mild-to-moderate acute exacerbation of chronic obstructive pulmonary disease: A multicenter, prospective, observational cohort study[J]. Chinese Journal of Lung Diseases(Electronic Edition), 2023, 16(03): 306-311.

目的

分析丹龙口服液(Danlong oral liquid, DOL)联合西药常规疗法对轻中度慢性阻塞性肺疾病急性加重(acute exacerbation of chronic obstructive pulmonary disease, AECOPD)的疗效和安全性。

方法

选择2019年8月至2020年12月招募的中国16家医院AECOPD患者395例，随访7 d。治疗期间使用丹龙口服液联合常规西医疗法患者297例为观察组，只接受常规西医疗法患者98例为对照组。比较两组患者的AECOPD相关症状评分、中医症候评分和血清中的炎症因子水平，探讨药物疗效及安全性。

结果

观察组慢性阻塞性肺疾病评估量表(CAT)评分降低值大于对照组(3.24±2.90 vs. 2.47±2.62)，P<0.05。观察组治疗前后的中医证候评分下降分数大于对照组(4.62±3.73 vs. 3.62±3.22)，P<0.05。治疗期间使用全身性糖皮质激素观察组4例(1.35%)和对照组3例(3.62%)(P>0.05)。观察组不良事件发生率为8.75%，对照组为4.1%(P>0.05)。

结论

丹龙口服液联合西医常规疗法能有效安全缓解轻中度AECOPD临床症状，提高患者生活质量。

关键词: 急性加重，肺疾病，慢性阻塞性, 丹龙口服液, 前瞻研究, 中医，中成药, 临床疗效
Objective

To analyze the therapeutic effect and safety of Danlong oral liquid(DOL) combined with conventional western medicine exacerbations of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

Methods

A total of 395 patients with AECOPD were recruited from 16 hospitals in China from August 2019 to December 2020 and followed up for 7 days. 297 patients who received Danlong oral liquid combined with conventional Western medicine during treatment were the observation group, and 98 patients who only received conventional Western medicine were the control group. The AecopD-related symptom scores, TCM symptom scores and serum levels of inflammatory factors were compared between the two groups.

Results

The Chronic obstructive pulmonary Disease Assessment Scale (CAT) score reduction in the observation group was greater than that in the control group (3.24±2.90 vs. 2.47±2.62), P<0.05. The decrease of TCM syndrome score in the observation group before and after treatment was greater than that in the control group (4.62±3.73 vs. 3.62±3.22), P<0.05. Systemic glucocorticoids were used in 4 cases(1.35%) of observation group and 3 cases(3.62%) of control group during treatment (P>0.05). The incidence of adverse events was 8.75% in the observation group and 4.1% in the control group (P>0.05).

Conclusion

Danlong oral liquid combined with conventional western medicine can effectively and safely relieve the clinical symptoms and improve the quality of life of patients with mild to moderate AECOPD.

Key words: Acute exacerbation of chronic obstructive pulmonary disease, Danlong oral liquid, Observational cohort study, Traditional Chinese medicine, Chinese patent medicine, Clinical effectiveness
表1 两组临床资料比较[n(%)]
临床资料 观察组(n＝297) 对照组(n＝98) P值
吸烟史     0.144
既往吸烟，现已戒烟 177 (59.60) 50 (51.02) －
从不吸烟 120 (40.40) 48 (48.98) －
酗酒史     0.070
既往酗酒，现已戒酒 92 (30.98) 23 (23.47) －
从不酗酒 205 (69.02) 75 (76.53) －
共病史      
高血压 84(28.28) 25(25.51) 0.594
冠心病 43(14.48) 9(9.18) 0.179
哮喘 20(6.73) 7(7.14) 0.889
糖尿病 25(8.42) 12(12.24) 0.259
药物过敏史 30(10.10) 9(9.18) 0.792
过去3月发生过上呼吸道感染 128(43.10) 50(51.02) 0.172
过去3月接受过COPD药物治疗 235(79.12) 79(80.61) 0.918
过去3月接受过COPD非药物治疗 33(11.11) 8(8.16) 0.407
过去1年发生过AECOPD 256(86.20) 81(82.65) 0.390
过去1年发生AECOPD的平均次数 1.85±1.07 1.77±1.13 0.343
肺功能参数      
FEV1/FVC(%) 54.20±11.25 55.47±10.81 0.380
FEV1(L) 1.42±0.69 1.49±0.70 0.336
动脉血气      
PaO2(mmHg) 75.07±13.63 75.82±13.79 0.790
PaCO2(mmHg) 40.11±5.27 40.89±5.18 0.374
氧合指数(mmHg) 358.42±68.09 366.45±70.24 0.796
表2 两组西药常规治疗比较[n(%)]
治疗方法   观察组(n＝297) 对照组(n＝98) P值
三联治疗 ICS+LABA+LAMA 40(13.47) 9(9.18) 0.265
二联治疗 ICS+LABA 101(34.01) 40(40.82) 0.222
  LAMA+LABA 4(1.35) 4(4.08) 0.096
单药治疗 LAMA 42(14.14) 14(14.29) 0.972
  茶碱 30(10.1) 12(12.24) 0.551
其他a   167(56.23) 55(56.12) 0.985
表3 症状相关评分(±s)
评分依据 观察组(n＝297) 对照组(n＝98) P值
CAT评分      
治疗前 20.36±4.59 19.57±4.03 0.158
治疗后 17.13±5.09a 17.10±4.64a 0.884
治疗差值 3.24±2.90 2.47±2.62 0.010b
中医症候评分      
治疗前 13.78±3.95 13.27±3.56 0.317
治疗后 9.16±4.60a 9.64±4.18a 0.286
治疗差值 4.62±3.73 3.62±3.22 0.006b
中医症候疗效[n(%)]     0.0218b
显效 27(9.09) 7(7.14)  
有效 130(43.77) 31(31.63)  
BCSS评分      
治疗前 4.75±1.54 4.55±1.39 0.254
治疗后 3.26±1.48a 3.32±1.41a 0.566
治疗差值 1.49±1.4 1.23±1.31 0.060
mMRC评分      
治疗前 2.32±0.71 2.22±0.68 0.284
治疗后 1.91±0.76a 1.86±0.73a 0.573
治疗差值 0.4±0.59 0.37±0.58 0.460
表4 中医症候单项症状评估(±s)
组　别 例数 咳　嗽 咳　痰 喘　息 胸　闷
治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后
观察组 297 2.72±1.13 1.83±1.07ab 2.42±1.00 1.54±1.07ab 2.86±1.23 2.01±1.26a 2.30±1.37 1.58±1.32a
对照组 98 2.63±0.98 2.02±0.97a 2.45±0.93 1.86±1.16a 2.71±1.12 1.98±1.20a 2.12±1.28 1.45±1.18a
组　别 例数 痰多色黄或白黏，咯痰不爽 发　烧 口渴喜冷饮 大便干结
治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后
观察组 297 1.42±0.58 0.89±0.67ab 0 0 1.29±0.75 0.82±0.76a 0.77±0.78 0.49±0.73a
对照组 98 1.46±0.58 1.07±0.68a 0 0 1.15±0.63 0.8±0.72a 0.73±0.67 0.47±0.58a
图1 不同亚组人群四项症状相关评估比较；注：柱状图中数字代表该亚组分析集人数；*，**，***表示P<0.05
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