伏诺拉生治疗幽门螺杆菌感染患者的临床研究OA

Objective To compare the efficacy and safety of vonoprazan tablets and rabeprazole tablets in the treatment of Helicobacter pylori(H.pylori)infection.Methods H.pylori-infected patients were divided into the treatment group and the control group based on different treatment regimens.The treatment group received a bismuth quadruple therapy containing vonoprazan tablets(20 mg each time,bid),while the control group received a bismuth quadruple therapy containing rabeprazole tablets(20 mg each time,bid).Both groups were treated for 14 days.After treatment,the clinical efficacy,symptom improvement,H.pylori eradication rate,digestive tract mucosal function,inflammation-related factors,Toll-like receptor(TLR4),nuclear factor κB(NF-κB)and safety of the two groups of patients were compared.Results A total of 80 patients were enrolled,with 42 cases in control group and 38 cases in treatment group.The total effective rates of the treatment group and the control group were 92.11％(35 cases/38 cases)and 73.81％(31 cases/42 cases),respectively,with statistically significant difference(P＜0.05).After treatment,the ulcer symptom improvement times of treatment group and control group were(2.59±0.48)and(2.85±0.46)d,respectively;the H.pylori eradication rates were 92.11％(35 cases/38 cases)and 88.10％(37 cases/42 cases),respectively;the positive rates of H.pylori re-examination at 6 months after treatment were 0％(0 cases/38 cases)and 11.90％(5 cases/42 cases),respectively;the positive rates at 12 months after treatment were 5.26％(2 cases/38)and 21.43％(9 cases/42 cases),respectively;the levels of gastrin-17(G-17)were(50.78±6.64)and(56.92±7.30)pmol·L-1,respectively;the levels of pepsinogen Ⅰ (PG Ⅰ)were(83.42±8.63)and(77.33±11.26)μg·L-1,respectively;the levels of PG Ⅱ were(9.69±2.91)and(12.22±2.74)μg·L-1,respectively;the levels of motilin(MTL)were(209.02±22.72)and(227.92±25.88)ng·L-1,respectively;the levels of interleukin(IL)-17 were(23.88±3.13)and(26.13±3.36)pg·mL-1,respectively;the levels of IL-33 were(36.74±7.03)and(40.25±6.83)ng·L-1,respectively;regulatory T cells(Treg)/helper T cells(Th17)were 0.83±0.18 and 0.74±0.13,respectively;the levels of TLR4 were(11.45±3.75)％and(14.84±4.57)％,respectively;NF-κB were(502.68±66.13)and(538.72±83.66)pg·mL-1,respectively.Except H.pylori eradication rate,the differences of above indicators were all statistically significant(P＜0.05,P＜0.01,P＜0.001).The main drug adverse drug reactions in the treatment group and the control group were nausea,vomiting,decreased appetite,diarrhea and constipation;the total incidence rates of adverse drug reactions were 5.26％(2 cases/38 cases)and 4.76％(2 cases/42 cases),respectively,without statistically significant difference(P＞0.05).Conclusion Vonoprazan tablets demonstrates significant clinical advantages in the treatment of patients with H.pylori infection.It effectively improves gastric mucosal functional status,regulates immune-inflammatory balance,and promotes tissue repair.The underlying mechanisms may involve its potent and prolonged acid-suppressive effects,which optimize the antibacterial microenvironment and further modulate inflammatory and immune responses,thereby achieving multi-level mucosal protection and functional recovery.