Abstract:
Objectives To investigate the effect of the Bioinformatics Infrared Liver Therapeutic (BILT) instrument on portal vein blood flow, liver stiffness, and spleen stiffness in patients with liver cirrhosis, and to preliminarily explore the therapeutic effect and mechanism of the BILT instrument. Methods A total of 78 patients with compensated liver cirrhosis who attended the outpatient service or were hospitalized in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from October 2017 to December 2021 were enrolled, among whom 68 patients completed the 12-week treatment and were randomly divided into BILT group and simulated instrument group, with 34 patients in each group. In addition to basic treatment, the patients in the BILT group received irradiation with the BILT instrument, while those in the simulated instrument group received irradiation with the simulated instrument, for 30 minutes each time, twice a day; the course of treatment was 12 weeks for both groups. The two groups were compared in terms of laboratory markers (liver function, renal function, and routine blood test results), liver and spleen ultrasound morphology, color Doppler blood flow detection (portal vein diameter, portal vein cross-sectional area, mean portal vein velocity, peak portal vein velocity, and mean portal vein flow), and liver/spleen stiffness measurement before and after treatment. The independent samples t-test was used for comparison of normally distributed continuous data between two groups, and the non-parametric Mann-Whitney U rank sum test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between groups. The paired samples correlation test was performed for the data before and after treatment within each group, and the paired samples t-test or the non-parametric Wilcoxon signed-rank test was performed for data with significant correlations. Results The paired samples correlation test showed no correlation in spleen attenuation parameter before and after treatment, suggesting that the results of spleen fat measured by FibroTouch could not be used for statistical analysis. After 12 weeks of treatment, compared with the control group, the treatment group had significantly greater increases in portal vein diameter, portal vein cross-sectional area, and mean portal vein flow and a significantly greater reduction in liver stiffness measurement (all P<0.05). At week 0 before treatment and after 12 weeks of treatment, comparison of the immediate effect after 30 minutes of BILT irradiation showed that the treatment group had significant increases in portal vein diameter, portal vein cross-sectional area, mean portal vein velocity, and mean portal vein flow (all P<0.05), while the control group showed no significant changes after irradiation (all P>0.05); compared with the control group, the treatment group had significantly greater changes in all indicators except peak portal vein flow at week 0 (all P<0.05). No adverse events were observed in either group. Conclusion The BILT instrument can improve portal vein blood flow in the liver and alleviate liver stiffness/fibrosis in patients with liver cirrhosis.