Abstract:

Objective: To evaluate the intervention effects of probiotic supplementation based on standardized antituberculosis regimens combined with enteral nutrition on nutritional status, clinical symptoms and treatment related gastrointestinal adverse reactions in patients with intestinal tuberculosis. Methods: A prospective, randomized, controlled, openlabel trial was performed. A total of 235 hospitalized patients diagnosed with intestinal tuberculosis at The Sixth People’s Hospital of Xinjiang Uygur Autonomous Region from January 2019 to December 2021 were enrolled and randomly assigned to the observation group (118 cases) and the control group (117 cases). The control group received the standardized antituberculosis regimen 2H-R-Z-E/4H-R (H: isoniazid; R: rifampicin; Z: pyrazinamide; E: ethambutol) plus routine enteral nutrition support (intactprotein formula, caloric supply 30-40 kcal·kg^-1·d^-1 for 28 days). On the basis of the control group regimen, the observation group was additionally given compound probiotic preparation (containing Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus rhamnosus, Lactobacillus paracasei) at 4 g/d for 28 days. Serum total protein, albumin, hemoglobin, body mass index, abdominal pain and diarrhea symptoms, inflammatory factors (tumor necrosis factorα, interleukin-1, interleukin-10, C-reactive protein), and the incidence of gastrointestinal adverse reactions were compared between the two groups before and after treatment. Results: After 28 day treatment, serum total protein, albumin, hemoglobin and body mass index in the observation group were significantly higher than those in the control group ((70.56±5.48) g/L vs. (65.38±5.92) g/L, (38.92±5.63) g/L vs. (33.27±4.85) g/L, (106.83±15.46) g/L vs. (99.85±17.62) g/L, (19.35±2.28) kg/m² vs. (18.21±2.58) kg/m², respectively), with statistically significant differences (t=6.918, 8.120, 3.186, 3.552; all P<0.001); the changes of these indicators were also significantly greater in the observation group. The markedresponse rate of clinical symptoms in the observation group was significantly higher than that in the control group (47.5% (56/118) vs. 20.5% (24/117)), with statistically significant difference (χ²=19.285, P<0.001). Repeatedmeasures analysis of variance revealed significant differences in the timedependent trends of serum tumor necrosis factorα, interleukin-1, interleukin-10 and C-reactive protein between the two groups (timebygroup interaction effect, all P<0.01). Levels of these inflammatory factors were significantly lower in the observation group at day 14 and day 28 of treatment (all P<0.001). The incidences of abdominal distension (4.2% (5/118) vs. 16.2% (19/117)), newonset or aggravated diarrhea (2.5% (3/118) vs. 12.8% (15/117)) and constipation (3.4% (4/118) vs. 14.5% (17/117)) in the observation group were markedly lower than those in the control group (χ²=9.151, 9.211, 9.022; P=0.003, 0.002, 0.003, respectively). The length of hospital stay in the observation group was (21.5±6.8) d, which was significantly shorter than (26.8±7.5) d in the control group (t=5.684, P<0.001). Conclusion: Probiotic supplementation on the basis of enteral nutrition support can remarkably improve nutritional status, accelerate the relief of clinical symptoms, reduce systemic inflammatory burden, and mitigate antituberculosisrelated gastrointestinal adverse reactions in patients with intestinal tuberculosis.

Key words: Tuberculosis, gastrointestinal, Enteral nutrition, Nutritional support, Treatment outcome, Randomized controlled trial