消旋卡多曲联合蒙脱石散治疗小儿腹泻的临床研究

Clinical trial of racecadotril combined with montmorillonite powder in the treatment of infantile diarrhea

目的观察消旋卡多曲联合蒙脱石散治疗小儿腹泻的临床疗效及其对白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)等炎症因子的影响。方法 108例小儿腹泻患儿随机分为试验组和对照组,每组54例。对照组口服蒙脱石散治疗(<1岁患儿剂量每次0.3 g,每天3次;1~2岁患儿每次0.45 g,每天3次;2~3岁患儿每次0.9 g,每天3次)。试验组在对照组的基础上加入消旋卡多曲1.5 mg·kg^(-1),每天3次。观察2组患儿的临床疗效及IL-6、TNF-α水平变化,并观察2组药物不良反应发生情况。结果试验组的总有效率为96.30%(52/54例),对照组的总有效率为79.63%(43/54例,P<0.05)。试验组和对照组的退热时间分别为(3.25±0.67),(5.12±1.23)d;试验组和对照组的便检恢复正常时间分别为(3.97±0.63),(5.06±1.18)d;试验组和对照组的住院时间分别为(5.12±0.86),(6.02±1.33)d。试验组与对照组退热时间、便检恢复正常时间和住院时间差异有统计学意义(P<0.05)。治疗后,试验组IL-6为(8.52±3.56)pg·m L^(-1),TNF-α为(8.12±3.94)pg·m L^(-1);对照组IL-6为(10.56±5.24)pg·m L^(-1),TNF-α为(10.23±5.39)pg·m L^(-1),2组差异有统计学意义(P<0.05)。药物不良反应主要以便秘、皮疹为主,试验组的药物不良反应发生率为3.70%(2/54例),对照组为5.56%(3/54例,P>0.05)。2组患者均无严重药物不良反应发生。结论小儿腹泻患儿在常规治疗基础上用消旋卡多曲联合蒙脱石散治疗的临床效果显著,改善患儿的症状,减轻炎症反应,且安全性好。

Objective To observe the clinical effect of racecadotril combined with montmorillonite powder in the treatment of infant diarrhea and the influence on interleukin - 6 （ IL - 6 ） , tumor necrosis factor - （TNF-α）. Methods A total of 108 cases of diarrheal infants were randomly divided into treatment group and control group, 54 cases in each group. The control group was treated with montmorillonite powder alone （ less than 1 year old with 0.3 g one time, 3 times one day ; 1 to 2 years old with 0.45 g one time, 3 times one day and 2 to 3 years old with 0. 9 g one time, 3 times one day）. Patients in treatment group were given racecadotril 1.5 mg· kg^-1, three times a day on the basis of control group. The clinical effect, the levels of IL - 6 and TNF - α and the incidence of adverse drug reactions in two groups were observed. Results The effective rate in treatment group was 96.30% （52/54）, had significant difference with 79. 63% （43/54） in control group （P 〈 0. 05 ）. The cooling time, then check recovery time and hospitalization time in treatment group were （3.25 ±0. 67）, （3.97 ±0. 63）, （5.12 ±0. 86） d, had significant difference with （5.12 ± 1.23）, （5.06 ± 1.18）, （6. 02 ± 1.33 ） d in control group （P 〈 0. 05 ）. After treatment, the levels of IL - 6 and TNF - α in treatment group were （ 8.52 ± 3.56 ）, （ 8. 12 ± 3.94 ） pg ± mL - l, had significant difference with （ 10. 56 ± 5.24 ）, （ 10. 23 ± 5.39 ） pg · mL^- 1 in control group （P 〈 0. 05 ）. The maiti adverse drug reactions were constipation and rash. The incidence rate of adverse drug reactions was 3.70% （2/54） in treatment group, and was 5.56% （3/54） in control group （P 〉 0.05）. There were no serious adverse reactions in two groups. Conclusion Compared to routine treatment, the combination of raeeeadotril and montmorillonite powder has significant clinical efficacy in patients with infantile diarrhea, which can improve the symptoms of children and reduce the inflammatory response, with good safety.