目的 探讨槐杞黄颗粒与枯草杆菌二联活菌治疗小儿功能性便秘的临床疗效。方法 选择2021年1月-2022年1月在南京医科大学附属儿童医院诊治的96例功能性便秘患儿,随机分为对照组和治疗组,每组各48例。对照组口服枯草杆菌二联活菌颗粒,1袋/次,2次/d。在对照组的基础上,治疗组口服槐杞黄颗粒,1袋/次,2次/d。两组用药7 d。观察两组患儿临床疗效,比较治疗前后两组患儿症状缓解时症状改善时间,血清胃泌素(GAS)、胃动素(MLT)、胃肠激素P物质(SP)指标、白细胞介素-6(IL-6)、γ干扰素(IFN-γ)、肿瘤坏死因子-α(TNF-α)和C反应蛋白(CRP)水平,及不良反应。结果 治疗后,对照组和治疗组临床有效率分别为79.17%和97.92%,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组症状改善时间均明显短于对照组(P<0.05)。治疗后,两组患儿GAS、MLT、SP指标均明显高于治疗前,而IL-6、IFN-γ、TNF-α和CRP水平均明显低于治疗前,且治疗组患儿这些指标水平明显好于对照组(P<0.05)。治疗期间,治疗组不良反应发生率(6.25%)明显低于对照组(14.58%,P<0.05)。结论 枯草杆菌二联活菌联合槐杞黄颗粒治疗儿童功能性便秘症状改善明显,能有效调节胃肠道功能,促使炎性反应降低。

Objective To investigate the clinical efficacy of Huaiqihuang Granules combined with Combined Bacillus Subtilis and Enterococcus Faecium Granules with Multivitamines, Live in treatment of functional constipation in children. Methods Children (96 cases) with constipation in Children's Hospital of Nanjing Medical University from January 2021 to January 2022 were randomly divided into control and treatment group, and each group had 48 cases. Children in the control group were po administered with Combined Bacillus Subtilis and Enterococcus Faecium Granules with Multivitamines, Live, and 1 bag/time, twice daily. Children in the treatment group po administered with Huaiqihuang Granules on the basis of the control group, 1 bag/time, twice daily. Children in two groups were treated for 7 d. After treatment, the clinical evaluation was evaluated, the relief time of symptom, the levels of GAS, MLT, SP, IL-6, IFN-γ, TNF-α and CRP, and the adverse reactions in two groups before and after treatment were compared. Results After treatment, the clinical effective rates of the control group and the treatment group were 79.17% and 97.92% respectively, and the difference between the two groups was statistically significant (P＜0.05). After treatment, the time of symptom improvement in the treatment group was significantly earlier than that in the control group (P＜0.05). After treatment, the levels of GAS, MLT and SP in two groups were significantly higher than those before treatment, while the levels of IL-6, IFN-γ, TNF-α and CRP were significantly lower than those before treatment (P＜0.05), and the levels of these indexes in the treatment group were significantly better than those in the control group (P＜0.05). During the treatment, the incidence of adverse reactions in the treatment group (6.25%) was significantly lower than that in the control group (14.58%, P＜0.05). Conclusion Huaiqihuang Granules combined with Combined Bacillus Subtilis and Enterococcus Faecium Granules with Multivitamines, Live can significantly improve the symptoms of functional constipation in children, which can effectively regulate gastrointestinal function and reduce inflammatory reaction.

R914

江苏省药学会-恒瑞医院药学基金资助项目(H202028)