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©The Author(s) 2022.
World J Hepatol. Aug 27, 2022; 14(8): 1667-1677
Published online Aug 27, 2022. doi: 10.4254/wjh.v14.i8.1667
Published online Aug 27, 2022. doi: 10.4254/wjh.v14.i8.1667
Table 1 Main indicators and drugs used of enrolled patients at inclusion by arms
| The test arm, n = 24 | The control arm, n = 16 | P value | |
| Age, yr | 48.5 (42.5-59.0) | 53.5 (44.5-59.0) | 0.730 |
| Body mass index, kg/m2 | 25.4 (22.3-27.9) | 26.5 (24.3-28.7) | 0.553 |
| Male/female | 8/16 | 9/7 | 0.134 |
| Etiology of cirrhosis: Alcohol | 12 (50.0) | 8 (50.0) | > 0.050 |
| Metabolically associated fatty liver disease | 2 (8.3) | 0 | |
| HBV | 2 (8.3) | 0 | |
| HCV | 3 (12.5) | 2 (12.5) | |
| Mixed | 3 (12.5) | 3 (18.8) | |
| Cryptogenic | 2 (8.3) | 3 (18.8) | |
| Child–Pugh score | 9 (8-10) | 9 (8-10) | 0.730 |
| Child–Pugh class, B/C | 17/7 | 12/4 | 0.533 |
| End-diastolic volume of the left ventricle, mL | 109 (84-116) | 100 (90-143) | 0.689 |
| Ejection fraction of the left ventricle, % | 61.5 (59.4-62.8) | 59.8 (57.5-62.0) | 0.263 |
| Stroke volume, mL | 67 (52-72) | 58 (55-82) | 0.689 |
| Heart rate, bpm | 71 (69-75) | 70 (69-74) | 0.709 |
| Cardiac output, L/min | 4.8 (3.6-5.2) | 4.4 (4.0-5.8) | 0.473 |
| Mean blood pressure, mmHg | 84.7 (80.3-89.7) | 87.3 (79.8-93.7) | 0.499 |
| Systemic vascular resistance, dyn· s· cm−5 | 1442 (1243-1874) | 1470 (1255-1744) | 0.945 |
| Mean pulmonary artery pressure, mmHg | 23.4 (22.1-25.8) | 23.4 (20.9-26.4) | 0.749 |
| Esophageal varices (Grade 1), n (%) | 8 (33.3) | 6 (37.5) | 0.338 |
| Esophageal varices (Grade 2-3), n (%) | 16 (66.7) | 7 (43.8) | |
| Minimal hepatic encephalopathy, n (%) | 18 (75.0) | 10 (62.5) | 0.484 |
| Overt hepatic encephalopathy, n (%) | 2 (8.3) | 2 (12.5) | |
| Hepatic encephalopathy, n (%) | 20 (83.3) | 12 (75.0) | 0.399 |
| Ascites, n (%) | 22 (91.7) | 12 (75.0) | 0.160 |
| Minimal ascites, n (%) | 15 (62.5) | 6 (37.5) | 0.249 |
| Clinically significant ascites, n (%) | 7 (29.2) | 6 (37.5) | |
| Red blood cells as 1012 cell/L | 3.7 (3.3-4.3) | 3.6 (3.1-4.1) | 0.689 |
| White blood cells as 109 cell/L | 4.3 (3.2-5.6) | 3.8 (2.6-7.2) | 0.553 |
| Platelets as 109 cell/ L | 94 (69-107) | 94 (48-104) | 0.669 |
| Serum total protein, g/L | 73 (63-77) | 70 (61-77) | 0.649 |
| Serum albumin, g/L | 33 (31-36) | 33 (29-37) | 0.967 |
| Serum total bilirubin, μmol/L | 37 (27-64) | 55 (29-67) | 0.499 |
| International normalized ratio | 1.48 (1.39-1.68) | 1.58 (1.31-1.73) | 0.978 |
| Serum cholesterol, mmol/L | 4.1 (3.1-5.5) | 3.5 (2.6-4.6) | 0.230 |
| Serum triglyceride, mmol/L | 1.1 (0.7-1.4) | 1.0 (0.7-1.4) | 0.626 |
| Serum creatinine, mg/dL | 76 (65-88) | 78 (70-105) | 0.448 |
| Serum sodium, mmol/L | 140 (139-141) | 141 (140-142) | 0.235 |
| Serum potassium, mmol/L | 4.3 (4.0-4.8) | 4.4 (4.1-4.6) | 0.804 |
| Serum glucose, mmol/L | 4.7 (4.2-5.7) | 4.8 (4.6-5.4) | 0.464 |
| Serum iron, μmol/L | 13.9 (8.1-20.6) | 11.3 (7.3-22.0) | 0.761 |
| Alanine aminotransferase, U/L | 31 (20-46) | 26 (20-51) | 0.782 |
| Aspartate aminotransferase, U/L | 54 (34-72) | 52 (38-79) | 0.945 |
| Gamma glutamyl transferase, U/L | 82 (28-299) | 84 (49-118) | 0.934 |
| Alkaline phosphatase, U/L | 268 (221-395) | 214 (173-274) | 0.098 |
| Cholinesterase, U/L | 3650 (2861-3961) | 3803 (2778-4215) | 0.827 |
| C-reactive protein, mg/L | 9 (6-15) | 7 (2-20) | 0.347 |
| Beta blockers, n (%) | 17 (70.8) | 11 (68.8) | 0.580 |
| Spironolactone, n (%) | 22 (91.7) | 14 (87.5) | 0.529 |
| Loop diuretics, n (%) | 11 (45.8) | 7 (43.8) | 0.578 |
| Ademetionine, n (%) | 15 (62.5) | 9 (56.3) | 0.472 |
| Entecavir or tenofovir, n (%) | 2 (8.3) | 0 | 0.354 |
Table 2 Calculations of hemodynamic parameters
| Parameter | Calculation |
| End-diastolic and end-systolic volume of the left ventricle | Modified Simpson’s disk method |
| Ejection fraction of the left ventricle | [(End-diastolic volume) – (end-systolic volume)]/(end-diastolic volume) |
| Stroke volume | (Doppler velocity time integral) × (cross-sectional aorta area)[41] |
| Mean arterial pressure | [(systolic blood pressure)+2 × (diastolic blood pressure)]/3 |
| Cardiac output | (Stroke volume) × (heart rate) |
| Systemic vascular resistance | (Mean arterial pressure)/(cardiac output) |
| Systolic pulmonary artery pressure | (Right atrium pressure estimated from diameter of inferior vena cava and respiratory changes) + 4 × (the peak velocity of the tricuspid valve regurgitant jet)2[39,40] |
| Mean pulmonary artery pressure | 0.61 × (systolic pulmonary artery pressure) + 2 mmHg[42] |
Table 3 Changes of the main indicators of the included patients after treatment
| The test arm (n = 24) | The control arm (n = 16) | P value | |
| Body mass index, kg/m2 | -0.2 (-0.9-1.5) | 0.0 (0.0-0.5) | 0.281 |
| Child–Pugh score | -1.5 [-3.0-(-0.5)] | 0 (-0.5-1.5) | 0.001 |
| Child–Pugh class (from B or C to A), n (%) | 8 (33.3) | 1 (6.3) | 0.048 |
| End-diastolic volume of the left ventricle, mL | -13 [-17-(-10)] | 0 (-3-12) | < 0.001 |
| Ejection fraction of the left ventricle, % | 0.5 (-0.7-0.3) | 0.0 (0.0-0.3) | 0.590 |
| Stroke volume, mL | -7 [-12-(-4)] | 0 (-3-8) | < 0.001 |
| Heart rate, bpm | 2 (-4-8) | -2 (-7-7) | 0.234 |
| Cardiac output, L/min | -0.5 [-1.0-(-0.1)] | 0.3 (-0.3-0.9) | 0.026 |
| Mean blood pressure, mmHg | 1.8 (-1.7-7.5) | 3.8 (-3.3-15.3) | 0.847 |
| Systemic vascular resistance, dyn· s· cm−5 | 237 (39-358) | 30 (-200-227) | 0.026 |
| Mean pulmonary artery pressure, mmHg | 0.0 (-2.1-0.6) | 1.2 (0.0-1.8) | 0.043 |
| Esophageal varices, a decrease in grade, n (%) | 2 (4.3) | 0 | 0.354 |
| Esophageal varices, an increase in grade, n (%) | 0 | 0 | - |
| Regression hepatic encephalopathy, n (%) | 8 (33.3) | 1 (6.3) | 0,048 |
| Ascites, a decrease in degree, n (%) | 15 (62.4) | 4 (25.0) | 0.022 |
| Ascites, an increase in degree, n (%) | 1 (4.2) | 3 (18.8) | 0.167 |
| Red blood cells as 1012 cell/L | 0.2 (-0.1-0.5) | 0.2 (-0.1-0.4) | 0.730 |
| White blood cells as 109 cell/L | 0.1 (-1.2-0.6) | -0.1 (-2.1-0.7) | 0.782 |
| Platelets as 109 cell/ L | 11 (4-32) | -6 (-14-1) | < 0.001 |
| Serum total protein, g/L | -0.2 (-4.2-8.9) | -1.4 (-3.5-5.6) | 0.793 |
| Serum albumin, g/L | 3.0 (0.6-7.7) | -3.1 (-5.1-2.4) | 0.001 |
| Serum total bilirubin, μmol/L | -5.1 [-23.9-(-0.9)] | -3.7 (-10.0-17.2) | 0.181 |
| International normalized ratio | 0.0 (-0.1-0.1) | 0.0 (-1.0-0.1) | 0.544 |
| Serum cholesterol, mmol/L | 0.2 (-0.4-1.2) | 0.5 (-1.0-2.0) | 0.571 |
| Serum triglyceride, mmol/L | 0.1 (-0.2-0.2) | 0.1 (-0.6-0.4) | 0.836 |
| Serum creatinine, mg/dL | 2.4 (-9.1-8.1) | -3.5 (-11.2-4.2) | 0.264 |
| Serum sodium, mmol/L | 1.5 (0.5-3.0) | -1 (-3-2) | 0.048 |
| Serum potassium, mmol/L | 0.0 (-0.4-1.2) | 0.1 (-0.2-0.3) | 0.523 |
| Serum glucose, mmol/L | 0.4 (-0.1-0.7) | 0.0 (-0.9-0.8) | 0.423 |
| Alanine aminotransferase, U/L | -1 (-15-6) | 2 (-15-8) | 0.740 |
| Aspartate aminotransferase, U/L | -9 (-32-1) | -2 (-26-20) | 0.116 |
| Gamma glutamyl transferase, U/L | -8 (-171-11) | 6 (-15-23) | 0.039 |
| Alkaline phosphatase, U/L | -40 (-95-3) | 26 (-57-91) | 0.016 |
| Cholinesterase, U/L | 257 (28-734) | -155 [-239-(-68)] | 0.016 |
| C-reactive protein, mg/L | -3.0 [-4.5-(-0.5)] | 1.0 (-2.0-4.5) | 0.044 |
- Citation: Maslennikov R, Efremova I, Ivashkin V, Zharkova M, Poluektova E, Shirokova E, Ivashkin K. Effect of probiotics on hemodynamic changes and complications associated with cirrhosis: A pilot randomized controlled trial. World J Hepatol 2022; 14(8): 1667-1677
- URL: https://www.wjgnet.com/1948-5182/full/v14/i8/1667.htm
- DOI: https://dx.doi.org/10.4254/wjh.v14.i8.1667