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

doi:10.3877/cma.j.issn.1674-6902.2023.03.002

Abstract

Abstract:

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

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.

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References 39

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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

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

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

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

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±5.09^a	17.10±4.64^a	0.884
治疗差值	3.24±2.90	2.47±2.62	0.010^b
中医症候评分
治疗前	13.78±3.95	13.27±3.56	0.317
治疗后	9.16±4.60^a	9.64±4.18^a	0.286
治疗差值	4.62±3.73	3.62±3.22	0.006^b
中医症候疗效[n(%)]			0.0218^b
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±1.48^a	3.32±1.41^a	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±0.76^a	1.86±0.73^a	0.573
治疗差值	0.4±0.59	0.37±0.58	0.460

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