Clinical efficacy of Buzhong Yiqi decoction (补中益气汤) in the treatment of hospital-acquired pneumonia with multi-drug resistant bacteria: a prospective, randomized, multicenter controlled trial

doi:10.19852/j.cnki.jtcm.20230713.002

Journal of Traditional Chinese Medicine ›› 2023, Vol. 43 ›› Issue (5): 1010-1018.DOI: 10.19852/j.cnki.jtcm.20230713.002

Clinical efficacy of Buzhong Yiqi decoction (补中益气汤) in the treatment of hospital-acquired pneumonia with multi-drug resistant bacteria: a prospective, randomized, multicenter controlled trial

XU Xiangru¹, ZHOU Yi², CHEN Gang³, LEI Ming³, ZHANG Wen¹, WU Xinxin¹, PU Yuting¹, CHEN Caiyu¹, SUN Yuting¹, ZHOU Shuang⁴(), FANG Bangjiang¹^,⁵()

1 Department of Emergency, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
2 School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
3 Department of Intensive Care Medicine, Seventh People’s Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai 200137, China
4 Acupuncture and Massage College, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
5 Institute of Critical Care, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

Received:2022-12-12 Accepted:2023-02-04 Online:2023-10-15 Published:2023-07-13
Contact: Prof. FANG Bangjiang, Department of Emergency, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. fangbji@163.com; ZHOU Shuang, Acupuncture and Massage College, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China. zhoushuang8008@163.com. Telephone: +86-21-64385700
Supported by:
Basic Research Program of Shanghai Municipal Science and Technology Commission: A Multicenter, Randomized, Controlled Clinical Study on Fuzheng Quxie Jing Prescription "Buzhong Yiqi Decoction" in the Treatment of Hospital-acquired Pneumonia caused by Multi-drug Resistant Bacteria(18401971600);Three-year Action Plan for the Development of Traditional Chinese Medicine in Shanghai: National TCM Emergency Medical Rescue Base Construction(ZY(2021-2023)-0101-01);East China Area and Municipal TCM Specialty Disease Alliance Construction(ZY(2021-2023)-0302)

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Abstract

Abstract:

OBJECTIVE: To evaluate the efficacy and safety of Buzhong Yiqi decoction (补中益气汤, BZYQ) in the treatment of hospital-acquired pneumonia (HAP) with multi-drug-resistant bacteria (MDRB).
METHODS: This 28-day study was conducted at 5 clinical centers in Shanghai. The eligible patients were randomly assigned (1:1) into the intervention group (BZYQ plus conventional Western Medicine therapy) and control group (conventional Western Medicine therapy). The primary outcomes were the clinical response, clinical pulmonary infection score (CPIS), and microbiologic response. The secondary outcomes were the 28-day all-cause mortality (ACM), Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ) score, ventilator weaning rate, length of mechanical ventilation (MV), length of hospital stay, and changes of infection indicators.
RESULTS: Altogether 83 subjects in the intervention group and 85 subjects in the control group were analyzed. The clinical success rate (48.2%) and the pathogen eradication rate (59.0%) of the intervention group were all better than those of the control group (32.9% and 38.9%, respectively) with statistically significant differences (P<0.05). The CPIS score of the intervention group (8.9 ± 1.7) was lower than that of the control group (9.6 ± 2.5) (P<0.05). The length of MV in the intervention group [(13.7 ± 6.4) d] was significantly shorter than that of the control group [ (17.2 ± 7.2) d] (P<0.05). The 28-day ACM of the intervention group (13.33%) was lower than that of the control group (21.2%) with no statistically significant difference (P>0.05). The differences between two groups in ventilator weaning rate, length of hospital stay, and APACHE Ⅱ score were not statistically significant (P > 0.05). The intervention group displayed decreases in white blood cell count, C-reactive protein, neutrophil percentage, and procalcitonin at day 28 compared with baseline (P<0.05). No serious adverse events occurred in either group during the 28-day follow-up.
CONCLUSION: BZYQ may be an effective therapeutic option for the management of HAP with MDRB.

Key words: healthcare-associated pneumonia, drug resistance, multiple, bacteria, Buzhong Yiqi decoction, randomized controlled trial

XU Xiangru, ZHOU Yi, CHEN Gang, LEI Ming, ZHANG Wen, WU Xinxin, PU Yuting, CHEN Caiyu, SUN Yuting, ZHOU Shuang, FANG Bangjiang. Clinical efficacy of Buzhong Yiqi decoction (补中益气汤) in the treatment of hospital-acquired pneumonia with multi-drug resistant bacteria: a prospective, randomized, multicenter controlled trial[J]. Journal of Traditional Chinese Medicine, 2023, 43(5): 1010-1018.

Figures/Tables 6

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Variable		Control group (n = 90)	Intervention group (n = 90)	P value
Age [years, n (%)]	<65	12 (13.3)	20 (22.2)	0.827
	≥65	78 (86.7)	70 (77.8)
	$\bar{x}±s$	76.5±10.2	75.9±12.3
Sex [n (%)]	Female	32 (35.6)	41 (45.6)	0.172
	Male	58 (64.4)	49 (54.4)
Mechanical ventilation [n (%)]		32 (35.6)	32 (35.6)	0.999
Hospitalization duration [days, Median (IQR)]		4.5 (2.0-7.0)	5.0 (3.0-8.0)	0.160
Vital signs ($\bar{x}±s$)	Temperature (℃)	37.5±0.8	37.3±0.8	0.079
	Respiratory rate (bpm)	21.5±12.9	19.1±3.3	0.048
	Heart rate (bpm)	89.4±17.1	90.5±14.2	0.959
	Systolic blood pressure (mm Hg)	132.4±20.9	135.7±20.3	0.319
	Diastolic blood pressure (mm Hg)	76.0±11.0	77.0±11.2	0.717
APACHE Ⅱ score	<15 [n (%)]	9 (10.7)	12 (14.0)	0.279
	≥15 [n (%)]	75 (89.3)	74 (86.0)
	$\bar{x}±s$	19.1±4.6	20.5±6.1
CPIS score	<6, n (%)	56 (62.2)	61 (67.8)	0.197
	≥6, n (%)	34 (37.8)	29 (32.2)
	$\bar{x}±s$	5.5±1.3	5.3±1.6
Baseline pathogen [n (%)]	Acinetobacter baumannii	21 (23.3)	31 (34.4)	0.100
	Klebsiella pneumoniae	31 (34.4)	24 (26.7)	0.257
	Pseudomonas aeruginosa	8 (8.9)	9 (10.0)	0.799
	Staphylococcus aureus	25 (27.8)	15 (16.7)	0.073
	Escherichia coli	0	7 (7.8)	0.014^a
Others resistant bacteria [n (%)]		5 (5.6)	4 (4.4)	0.999
Comorbidities [n (%)]	Cerebrovascular disease	59 (65.6)	51 (56.7)	0.221
	Hypertension	56 (62.2)	57 (63.3)	0.877
	Coronary heart disease	55 (61.1)	48 (53.3)	0.292
	Diabetes mellitus	34 (37.8)	37 (41.1)	0.647
	Chronic kidney disease	11 (12.2)	12 (13.3)	0.823
	Chronic pulmonary disease	6 (6.7)	9 (10.0)	0.418
	Hypoproteinemia	44 (48.9)	48 (53.3)	0.551

Variable		Control group (n = 90)	Intervention group (n = 90)	P value
Age [years, n (%)]	<65	12 (13.3)	20 (22.2)	0.827
	≥65	78 (86.7)	70 (77.8)
	$\bar{x}±s$	76.5±10.2	75.9±12.3
Sex [n (%)]	Female	32 (35.6)	41 (45.6)	0.172
	Male	58 (64.4)	49 (54.4)
Mechanical ventilation [n (%)]		32 (35.6)	32 (35.6)	0.999
Hospitalization duration [days, Median (IQR)]		4.5 (2.0-7.0)	5.0 (3.0-8.0)	0.160
Vital signs ($\bar{x}±s$)	Temperature (℃)	37.5±0.8	37.3±0.8	0.079
	Respiratory rate (bpm)	21.5±12.9	19.1±3.3	0.048
	Heart rate (bpm)	89.4±17.1	90.5±14.2	0.959
	Systolic blood pressure (mm Hg)	132.4±20.9	135.7±20.3	0.319
	Diastolic blood pressure (mm Hg)	76.0±11.0	77.0±11.2	0.717
APACHE Ⅱ score	<15 [n (%)]	9 (10.7)	12 (14.0)	0.279
	≥15 [n (%)]	75 (89.3)	74 (86.0)
	$\bar{x}±s$	19.1±4.6	20.5±6.1
CPIS score	<6, n (%)	56 (62.2)	61 (67.8)	0.197
	≥6, n (%)	34 (37.8)	29 (32.2)
	$\bar{x}±s$	5.5±1.3	5.3±1.6
Baseline pathogen [n (%)]	Acinetobacter baumannii	21 (23.3)	31 (34.4)	0.100
	Klebsiella pneumoniae	31 (34.4)	24 (26.7)	0.257
	Pseudomonas aeruginosa	8 (8.9)	9 (10.0)	0.799
	Staphylococcus aureus	25 (27.8)	15 (16.7)	0.073
	Escherichia coli	0	7 (7.8)	0.014^a
Others resistant bacteria [n (%)]		5 (5.6)	4 (4.4)	0.999
Comorbidities [n (%)]	Cerebrovascular disease	59 (65.6)	51 (56.7)	0.221
	Hypertension	56 (62.2)	57 (63.3)	0.877
	Coronary heart disease	55 (61.1)	48 (53.3)	0.292
	Diabetes mellitus	34 (37.8)	37 (41.1)	0.647
	Chronic kidney disease	11 (12.2)	12 (13.3)	0.823
	Chronic pulmonary disease	6 (6.7)	9 (10.0)	0.418
	Hypoproteinemia	44 (48.9)	48 (53.3)	0.551

Variable	Control group (n = 85)	Intervention group (n = 83)	P value
Primary outcome
Clinical success rate [n (%)]	28 (32.9)	40 (48.2)	0.044^a
Pathogen eradication rate [n (%)]	33 (38.9)	49 (59.0)	0.009^a
CPIS score ($\bar{x}±s$)	9.6±2.5	8.9±1.7	0.003^a
Secondary outcome
28-day ACM [n (%)]	18 (21.2)	11 (13.3)	0.174
Ventilator weaning rate [n (%)]	18 (56.3)	22 (68.8)	0.302
Length of MV [days, median (IQR)]	17.2±7.2	13.7±6.4	0.038^a
Length of hospital stay [days, median (IQR)]	24.6±8.6	23.1±8.3	0.271
APACHE II score ($\bar{x}±s$)	3.1±1.5	2.4±1.5	0.288

Variable	Control group (n = 85)	Intervention group (n = 83)	P value
Primary outcome
Clinical success rate [n (%)]	28 (32.9)	40 (48.2)	0.044^a
Pathogen eradication rate [n (%)]	33 (38.9)	49 (59.0)	0.009^a
CPIS score ($\bar{x}±s$)	9.6±2.5	8.9±1.7	0.003^a
Secondary outcome
28-day ACM [n (%)]	18 (21.2)	11 (13.3)	0.174
Ventilator weaning rate [n (%)]	18 (56.3)	22 (68.8)	0.302
Length of MV [days, median (IQR)]	17.2±7.2	13.7±6.4	0.038^a
Length of hospital stay [days, median (IQR)]	24.6±8.6	23.1±8.3	0.271
APACHE II score ($\bar{x}±s$)	3.1±1.5	2.4±1.5	0.288

Any adverse events	Control group (n = 85)	Intervention group (n = 83)
Stomachache	2 (2.4)	0
Diarrhea	3 (3.5)	0
Leukopenia	7 (8.2)	5 (6.0)
Anemia	10 (11.8)	12 (14.5)
Thrombocytopenia	6 (7.1)	5 (6.0)
Hypoproteinemia	18 (21.2)	17 (20.5)
Increased alanine aminotransferase	13 (15.3)	13 (15.7)
Increased aspartate aminotransferase	12 (14.1)	14 (16.9)
Increased blood bilirubin	4 (4.7)	4 (4.8)
Increased creatinine	4 (4.7)	7 (8.4)

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Clinical efficacy of Buzhong Yiqi decoction (补中益气汤) in the treatment of hospital-acquired pneumonia with multi-drug resistant bacteria: a prospective, randomized, multicenter controlled trial

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