开胃理脾口服液治疗脾虚气滞证功能性消化不良的临床疗效及其安全性评价

Safety and clinical efficacy evaluation on Invigorating Stomach and Regulating Spleen Oral Liquid in the treatment of functional dyspepsia with syndrome of spleen deficiency and qi stagnation

目的考察开胃理脾口服液治疗脾虚气滞证功能性消化不良的临床疗效及安全性。方法将108例脾虚气滞证功能性消化不良患者分为治疗组(53例)和对照组(55例)。治疗组服用开胃理脾口服液,对照组服用开胃理脾丸,观察比较两组胃肠运动功能疗效、临床症状疗效、综合疗效及安全性评价。结果两组治疗后中医证候记分与治疗前比较,差异均有统计学意义(P治疗组<0.01,P对照组<0.05)。单个临床症状记分比较,两组治疗后胃脘或脘腹胀满、胃脘疼痛、餐后早饱、食欲不振、疲乏无力、嗳气症状与治疗前比较,差异均有统计学意义(P<0.05、P<0.01)。意图治疗分析(ITT)分析:治疗组总有效率为96.21%,对照组总有效率为96.36%。依从方案受试者分析(PPA)分析:治疗组总有效率为97.82%,对照组总有效率为96.23%。两组比较差异无统计学意义(P>0.05)。治疗组未出现不良事件,对照组出现3例不良事件。结论开胃理脾口服液对改善脾虚气滞证功能性消化不良患者胃排空功能、临床症状方面有较好疗效,可作为脾虚气滞证功能性消化不良患者的常用药物。

Objective To explore the safety and clinical efficacy on Invigorating Stomach and Regulating Spleen Oral Liquid in the treatment of functional dyspepsia with syndrome of spleen deficiency and qi stagnation.Methods 108 patients were divided into two groups randomly.The patients（n = 53） in treatment group received Invigorating Stomach and Regulating Spleen Oral Liquid and patients（n = 55） in control group received Invigorating Stomach and Regulating Spleen Pill.The efficacies of gastrointestinal motor activity,clinical symptoms,composite and the safety evaluation were compared between two groups.Results The scores of traditional Chinese medical syndrome in two groups after treatment compared with before treatment,there were significant differences（Ptreatment group 0.01,Pcontrol group 0.05）.Comparing on single clinical symptom scores,gastrectasis,abdominal distension,abdominal pain,eructation,anorexia,early satiety of two groups after treatment compared with before treatment,there were significant differences（P 0.05,P 0.01）.ITT analysis： The total effective rate of treatment group was 96.21%,the total effective rate of control group was 96.36%.PPA analysis： The total effective rate of treatment group was 97.82%,the total effective rate of control group was 96.23%,there were no significant differences of ITT analysis and PP analysis in two groups（all P 0.05）.There was no adverse events took place in treatment group,and 3 adverse events in control group.Conclusion Invigorating Stomach and Regulating Spleen Oral Liquid can improve the gastric emptying and has better effect on the clinical symptoms of functional dyspepsia patients with syndrome of spleen deficiency and qi stagnation.It will be the common drugs in the treatment of functional dyspepsia patients with syndrome of spleen deficiency and qi stagnation.