Marked Reduction in 28-day Mortality Among Elderly Patients with Severe Community-acquired Pneumonia: Post Hoc Analysis of a Large Randomized Controlled Trial

Figures & data

Table 1 Comparison of Demographic and Basal Clinical Characteristics of Patients Between XueBiJing Injection and Placebo Groups

Characteristics	Elder ≥65 Years			Nonelderly <65 Years
	Placebo Group	XBJ Group	P-value	Placebo Group	XBJ Group	P-value
Age, year, mean (SD)	70.4 (3.19)	70.6 (3.27)	0.684	49.6 (11.95)	49.9 (11.34)	0.786
Men, n (%)	97 (66.0)	93 (64.6)	0.802	126 (70.0)	127 (70.6)	0.908
BMI, kg/m^2, mean (SD)	22.4 (3.37)	22.4 (3.42)	0.929	23.4 (3.25)	23.3 (3.26)	0.749
Systolic blood pressure, mmHg, mean (SD)	134.9 (23.86)	132.8 (25.20)	0.470	125.7 (22.59)	127.7 (21.55)	0.387
Heart rate, beats/min, mean (SD)	105.3 (19.28)	106.7 (20.86)	0.564	111.7 (19.59)	113.5 (20.05)	0.387
Respiratory rate, breaths/min, mean (SD)	28.0 (6.02)	27.2 (6.32)	0.270	28.1 (6.43)	28.9 (6.26)	0.256
Temperature, °C, mean (SD)	37.8 (1.06)	37.9 (1.06)	0.280	38.3 (1.04)	38.3 (1.06)	0.790
PaO2/FiO2, median (Q1–Q3)	170.0 (132.0–210.0)	164.0 (120.0–207.5)	0.411	170.0 (130.5–199.5)	156.0 (127–189.5)	0.326
Glasgow score, median (Q1–Q3)	12.0 (9.0–15.0)	11.0 (9.0–15.0)	0.799	12.0 (10.0–15.0)	13.0 (10.0–15.0)	0.842
Comorbidities, n (%)
Diabetes mellitus (any type)	7 (4.76)	5 (3.47)	0.580	1 (0.56)	6 (3.33)	0.121
Chronic bronchitis	4 (2.72)	2 (1.39)	0.684	0 (0.00)	2 (1.11)	0.499
Coronary artery disease	7 (4.76)	5 (3.47)	0.580	2 (1.11)	1 (0.56)	>0.999
Hypertension	31 (21.09)	32 (22.22)	0.814	14 (7.78)	8 (4.44)	0.056
Parkinson’s disease	2 (1.36)	0 (0.00)	0.498	1 (0.56)	1 (0.56)	>0.999
Polytrauma	0	0		2 (1.11)	1 (0.56)	>0.999
Etiological agents, n (%)	57 (38.8)	50 (34.7)	0.473	88 (48.9)	89 (49.4)	0.916
C-reactive protein, mg/L, median (Q1–Q3)	66.0 (19.5–130.7)	61.6 (13.8–143.0)	0.792	51.1 (17.9–145.0)	51.6 (12.6–131.5)	0.521
Leucocytes, 109 cells/L, median (Q1–Q3)	11.6 (7.8–15.8)	11.7 (7.8–15.2)	0.804	12.7 (7.9–18.0)	13.8 (8.9–19.1)	0.161
Glucose, fasting morning, mmol/L, median (Q1–Q3)	7.6 (5.8–9.6)	7.2 (5.7–10.0)	0.975	7.0 (5.7–9.7)	7.1 (5.6–10.0)	0.932
PSI score^a, n (%)			0.741			0.462
Class II	1 (0.7)	2 (1.4)		19 (10.6)	20 (11.1)
Class III	18 (12.2)	13 (9.0)		39 (21.7)	33 (18.3)
Class IV	80 (54.4)	78 (54.2)		87 (48.3)	80 (44.4)
Class V	48 (32.7)	51 (35.4)		35 (19.4)	47 (26.1)
Total PSI score, mean (SD)	122.9 (28.99)	125.1 (31.41)	0.521	106.4 (29.17)	108.9 (32.79)	0.445
Sequential organ failure assessment score, median (Q1–Q3)	6.0 (4.0–7.0)	5.5 (4.0–7.5)	0.815	6.0 (5.0–8.0)	6.0 (4.0–8.0)	0.746
Acute physiology and chronic health evaluation II score, median (Q1–Q3)	16.0 (12.0–21.0)	15.0 (12.0–21.0)	0.435	14.0 (11.0–19.0)	14.5 (10.0–19.0)	0.938
Antibiotic susceptibility testing, n (%)	15 (39.5)	11 (35.5)	0.734	26 (41.9)	30 (56.6)	0.117
Mechanical ventilation, n (%)	93 (63.3)	91 (63.2)	0.990	109 (60.6)	111 (61.7)	0.829

Notes: ^aPSI risk class I corresponds to age ≤50 years, and no risk factors (≤50 points), risk class II to <70 points, risk class III to 71–90 points, risk class IV to 91–130 points, and risk class V to >130 points.

Abbreviation: PSI, pneumonia severity index.

Table 2 Rate of Patients with Acute Respiratory Distress Syndrome and Septic Shock, The Baseline Settings of Mechanical Ventilation, and the Frequency of Antimicrobial Prescriptions for XueBiJing Group vs Placebo Group Using Descriptive Statistics for the Intention-to-treat Populations

Characteristics	Elderly ≥65 Years			Nonelderly <65 Years
	XBJ Group	Placebo Group	P-value	XBJ Group	Placebo Group	P-value
Mechanical ventilation, n (%)	93 (63.3)	91 (63.2)		111 (61.7)	109 (60.6)	0.829
Invasive ventilation, n (%)	63 (67.7)	64 (70.3)	0.704	82 (73.9)	85 (78.0)	0.476
Tidal volume, mean (SD)	457.0 (58.62)	463.9 (74.80)	0.486	474.8 (92.12)	469.9 (76.24)	0.667
Positive end expiratory pressure, median (Q1–Q3)	5.0 (5.0–6.0)	6.0 (5.0–8.0)	0.813	6.0 (5.0–8.0)	6.0 (5.0–8.0)	0.851
AC, n (%)	6 (6.5)	9 (9.9)		5 (4.5)	4 (3.7)
Bi-level positive airway pressure ventilation, n (%)	10 (10.8)	14 (15.4)		17 (15.3)	17 (15.6)
Continuous positive airway pressure, n (%)	5 (5.4)	2 (2.2)		4 (3.6)	3 (2.8)
Noninvasive ventilation, n (%)	21 (22.6)	11 (12.1)		19 (17.1)	9 (8.3)
PC, n (%)	8 (8.6)	8 (8.8)		14 (12.6)	6 (5.5)
PSV, n (%)	6 (6.5)	9 (9.9)		5 (4.5)	11 (10.1)
SIMV, n (%)	21 (22.6)	23 (25.3)		38 (34.2)	50 (45.9)
SIMV + PS, n (%)	13 (14.0)	12 (13.2)		7 (6.3)	6 (5.5)
SIMV + SIMV/AS, n (%)	0	0		0 (0.0)	1 (0.9)
SPMV + PS, n (%)	3 (3.2)	3 (3.3)		2 (1.8)	2 (1.8)
Antimicrobial treatment, n (%)
Beta-lactam	143 (97.28)	141 (97.92)	>0.999	170 (94.44)	172 (95.56)	0.629
Quinolones	51 (34.69)	64 (44.44)	0.089	59 (32.78)	59 (32.78)	0.067
Glycopeptide	30 (20.41)	20 (13.89)	0.141	50 (27.78)	29 (16.11)	0.008
Oxazolidinones	18 (12.24)	17 (11.81)	0.908	19 (10.56)	31 (17.22)	0.067
Antifungal agents	9 (6.12)	10 (6.94)	0.777	11 (6.11)	19 (10.56)	0.562
Tetracyclines	8 (5.44)	7 (4.86)	0.823	12 (6.67)	15 (8.33)	0.548
Macrolide	4 (2.72)	2 (1.39)	0.684	4 (2.22)	6 (3.33)	0.521
Aminoglycoside	3 (2.04)	2 (1.39)	>0.999	2 (1.11)	1 (0.56)	>0.999
Nitroimidazoles	1 (0.68)	4 (2.78)	0.211	6 (3.33)	4 (2.22)	0.521
Antivirals	2 (1.36)	1 (0.69)	>0.999	2 (1.11)	4 (2.22)	0.685
Lincomycin	1 (0.68)	2 (1.39)	0.620	1 (0.56)	1 (0.56)	>0.999
Sulfanilamide	0 (0.00)	2 (1.39)	0.244	1 (0.56)	1 (0.56)	>0.999
Cyclic peptides	0 (0.00)	0 (0.00)		0 (0.00)	1 (0.56)	>0.999

Table 3 The Primary and Two Secondary Outcomes

Characteristics	Elderly ≥65 Years			Nonelderly <65 Years
	Placebo Group	XBJ Group	P-value	Placebo Group	XBJ Group	P-value
28-day mortality, n (%)	41 (27.9)	23 (16.0)	0.014	41 (22.8)	28 (15.6)	0.082
The time of mechanical ventilation, d, median (Q1–Q3)	11.0 (7.0–24.0)	11.0 (6.0–18.0)	0.440	7.0 (5.0–15.0)	6.0 (4.0–13.0)	0.319
Total duration of ICU stay, d, median (Q1–Q3)	14.0 (9.0–23.0)	12.0 (8.0–16.5)	0.111	9.0 (7.0–17.0)	9.0 (7.0–15.0)	0.287

Figure 1 Kaplan–Meier survival curve of overall survival after XueBiJing (XBJ) and placebo for patients in (A) elderly group: patients with XBJ had a significantly inferior overall survival to those who with placebo. The HR of was 0.57 (95%CI, 0.34–0.95; P=0 0.029), (B) nonelderly group: the HR was 0.67 (95%CI, 0.41–1.08; P=0 0.0949).