匹维溴铵片联合马来酸曲美布汀分散片治疗肠易激综合征患者的临床研究

Clinical trial of pinaverium bromide tablets combined with trimebutine maleate dispersible tablets in the treatment of patients with irritable bowel syndrome

目的观察匹维溴铵片联合马来酸曲美布汀分散片治疗肠易激综合征(IBS)患者的临床疗效与安全性。方法将92例IBS患者随机分为对照组和试验组,每组46例。对照组给予匹维溴铵片每次50 mg,口服,tid;试验组在对照组治疗的基础上,给予马来酸曲美布汀分散片每次0.1~0.2 g,口服,tid。2组患者均治疗2个月。比较2组患者的临床疗效,血清核苷酸结合寡聚化结构域样受体家族热蛋白结构域3(NLRP3)炎性小体、白细胞介素-1β(IL-1β)和肿瘤坏死因子-α(TNF-α)含量,观察并记录2组患者治疗期间药物不良反应的发生情况。结果试验期间共脱落6例。治疗后,试验组和对照组的总有效率分别为88.37%(38例/43例)和62.79%(27例/43例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的NLRP3炎性小体分别为(54.47±10.69)和(76.24±9.36)pg·mL^(-1),IL-1β分别为(0.32±0.05)和(0.68±0.10)μg·mL^(-1),TNF-α分别为(20.93±3.24)和(33.75±3.88)pg·mL^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有头痛、皮疹、恶心、口干,对照组的药物不良反应主要有头痛、皮疹、恶心。试验组和对照组的总药物不良反应发生率分别为13.95%和16.28%,差异无统计学意义(P>0.05)。结论匹维溴铵片联合马来酸曲美布汀分散片治疗IBS患者的临床疗效显著,其能显著降低患者的炎症反应,且不增加药物不良反应发生率。

Objective To observe the clinical efficacy and safety of pinaverium bromide tablets combined with trimebutine maleate dispersible tablets in the treatment of patients with irritable bowel syndrome(IBS).Methods A total of 92 IBS patients were randomly divided into control group and treatment group,with 46 cases in each group.The control group was given pinaverium bromide tablets 50 mg each time,orally,tid.On the basis of treatment in the control group,the treatment group was given trimebutine maleate dispersible tablets 0.1-0.2 g each time,orally,tid.Two groups were treated for 2 months.The clinical efficacy,and the serum Nod-like receptor pyrin domain 3(NLRP3)inflammasome,interleukin-1β(IL-1β),tumor necrosis factor-α(TNF-α)were compared between two groups,and the adverse drug reactions during the treatment of the two groups were observed and recorded.Results A total of 6 cases were shed during the trial period.After treatment,the total effective rates of treatment group and control group were 88.37%(38 cases/43 cases)and62.79%(27 cases/43 cases),the difference was statistically significant(P<0.05).After treatment,the NLRP3inflammasomes of treatment and control groups were(54.47±10.69)and(76.24±9.36)pg·mL^(-1),IL-1βwere(0.32±0.05)and(0.68±0.10)μg·mL^(-1),TNF-αwere(20.93±3.24)and(33.75±3.88)pg·mL^(-1),and the differences in the above indicators were statistically significant(all P<0.05).The adverse drug reactions of treatment group mainly included headache,rash,nausea,and dry mouth.The adverse drug reactions of control group mainly included headache,rash,and nausea.The incidences of total adverse drug reactions in treatment group and control group were 13.95%and 16.28%without significant difference(P>0.05).Conclusion Pinaverium bromide tablets combined with trimebutine maleate dispersible tablets have a definitive clinical efficacy in the treatment of patients with IBS,which can significantly reduce the inflammatory response,without increasing the incidence of adverse drug reactions.