Effectiveness and safety of Qidong Huoxue decoction (芪冬活血饮) in treatment of acute lung injury and acute respiratory distress syndrome: a randomized, controlled trial

doi:10.19852/j.cnki.jtcm.2024.02.003

Abstract

Abstract:

OBJECTIVE: To evaluate the efficacy of Qidong Huoxue decoction (芪冬活血饮，QDHX) in treating acute lung injury and acute respiratory distress syndrome (ALI/ARDS) when used as an adjunctive treatment.

METHODS: ALI/ARDS patients admitted to our medical intensive care unit were randomly allocated to the control group or the QDHX group and received standard therapy. The QDHX group received QDHX (50 mL per day for 14 d) orally or via a gastric tube. The primary outcome was measured according to Traditional Chinese Medicine (TCM) syndrome scores, with partial pressure of oxygen/fraction of inspired oxygen (PaO₂/FiO₂) levels as the secondary outcome.

RESULTS: A total of 73 patients completed the study (36 in the TCM and 37 in the conventional group), and their records were analyzed. After 14-d treatment, the TCM group showed a significant decrease in TCM syndrome scores (P < 0.05) and increased PaO₂/FiO₂ levels (P < 0.05). The therapeutic effect of integrated Chinese and western medicine was more significant than that of Western Medicine alone. No serious side effects were observed.

CONCLUSIONS: Our study results show that QDHX in combination with conventional drug therapy can significantly reduce some clinical symptoms in patients with ALI/ARDS.

Key words: acute lung injury, respiratory distress syndrome, Qidong Huoxue decoction, randomized controlled trial

YU Zhengqiu, YU Liuda, CHEN Ye, LI Mingjing, CAI Wanru. Effectiveness and safety of Qidong Huoxue decoction (芪冬活血饮) in treatment of acute lung injury and acute respiratory distress syndrome: a randomized, controlled trial[J]. Journal of Traditional Chinese Medicine, 2024, 44(2): 381-387.

Figures/Tables 6

Figure 1 TCM syndrome scores and PaO2/FiO2 levels A1: TCM syndrome scores on the 1st day; A2: TCM syndrome scores on the 7th day; A3: TCM syndrome scores on the 14h day; B1: PaO2/FiO2 levels on the 1st day; B2: PaO2/FiO2 levels on the 7th day; B3: PaO2/FiO2 levels on the 14th day; C: TCM syndrome scores on the 1st, 7th, and 14th day for the TCM treatment group and the conventional group; D: PaO2/FiO2 levels on the 1st, 7th, and 14th day for the TCM treatment group and the conventional group. The TCM group (n = 36) and conventional group (n = 37) received general standard treatment. In addition, TCM groups received 50?mL of QDHX per day for 14 d. TCM: Traditional Chinese Medicine; PaO2: oxygen tension; FiO2: fraction of inspired oxygen; crt: Conventional group; trt: Traditional Chinese Medicine group; QDHX: Qidong Huoxue decoction. All data is presented in the form of bar charts and scatter plots.

Table 1 Baseline clinical characteristics

Item	Overall (n = 73)	TCM group (n = 36)	Conventional group (n = 37)	P value
Sex [F/M, n (%)]	25/48 (34.2/65.8)	11/25 (30.6/69.4)	14/23 (37.8/62.2)	0.624
Age	73.00 (66.00, 81.00)	74.50 (68.00, 85.00)	70.00 (63.00, 80.00)	0.068
TCM syndrome scores	29.21 (9.01)	30.86 (8.80)	27.59 (9.03)	0.122
HGB (g/L)	109.00 (84.00, 125.00)	110.50 (91.00, 133.00)	104.00 (78.00, 123.00)	0.235
WBC (10⁹/L)	9.80 (6.91, 16.00)	9.80 (7.47, 12.60)	9.90 (6.40, 16.90)	0.783
PLT (10⁹/L)	160.00 (110.00, 230.00)	166.50 (133.50, 230.00)	147.00 (105.00, 199.00)	0.206
CRP (mg/L)	65.30 (32.00, 119.00)	81.12 (44.32, 141.77)	53.68 (20.90, 111.00)	0.077
D-D (mg/L)	3.38 (1.73, 6.46)	3.36 (1.90, 6.49)	3.67 (1.12, 6.46)	0.804
PCT (μg/L)	0.31 (0.13, 1.30)	0.26 (0.12, 1.79)	0.38 (0.14, 1.04)	0.749
Murray score	1.50 (1.00, 2.00)	1.62 (1.25, 2.00)	1.50 (1.00, 2.00)	0.493
APACHE II	17.00 (12.00, 24.00)	17.00 (12.75, 24.00)	17.00 (12.00, 22.00)	0.715
PaO₂/FiO₂	187.00 (153.00, 232.00)	192.50 (158.50, 240.50)	180.00 (145.00, 224.00)	0.110

Table 2 Comparison of TCM clinical syndromes in TCM group and Conventional group ($\bar{x}±s$)

Time	TCM group (n = 36)	Conventional group (n = 37)	t value	P value
Baseline	31±9	28±9	－1.57	0.122
After 7 d treatment	20±6	23±8	1.47	0.148
After 14 d treatment	11±4	20±8	5.73	< 0.001

Figure 2 Comparison between the TCM herb and control groups after treatment of 7 and 14 d A: comparison of TCM Syndrome Score between the TCM herb and control groups after treatment of 7 and 14 d; B: comparison of PaO2/FiO2 between the TCM herb and control groups after treatment of 7 and 14 d. TCM: Traditional Chinese Medicine; crt: conventional group; trt: TCM group. QDHX: Qidong Huoxue decoction; PaO2/FiO2: oxygen tension/fraction of inspired oxygen. The TCM group and conventional group received general standard treatment. In addition, TCM groups received 50?mL of QDHX per day for 14 d. Student t-test and one-way analysis of variance were used for comparison analysis. aP > 0.05, vs conventional group; bP < 0.0001 vs conventional group; cP < 0.01, vs conventional group;

Table 3 Comparison of PaO2/FiO2 levels in TCM group and conventional group (IQR)

Time	TCM group (n = 36)	Conventional group (n = 37)	W value	P value
Baseline	192.50 (158.50, 240.50)	180.00 (145.00, 224.00)	521	0.110
After 7 d treatment	255.50 (179.50, 327.25)	230.00 (168.00, 323.00)	660	0.947
After 14 d treatment	332.50 (239.25, 378.25)	250.00 (180.00, 313.00)	418.5	0.006

Figure 3 Spearman correlation analysis TCM: Traditional Chinese Medicine; HGB: hemoglobin; WBC: white blood cell; PLT: blood platelet; CRP: C-reactive protein; D-D: D-dimer; PCT: procalcitonin; APACHE II: Acute Physiology and Chronic Health Evaluation II; PaO2/FiO2: oxygen tension/fraction of inspired oxygen.

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