胃病2号对功能性消化不良脾虚气滞证患者生活质量影响的研究

A trial on life quality of patients with functional dyspepsia of spleen deficiency and Qi stagnation syndrome treated by the gastrosis No.2 formula

[目的]评估胃病2号方对功能性消化不良(FD)脾虚气滞证患者生活质量的改善作用。[方法]多中心临床筛选,入组160例FD脾虚气滞证患者,将受试者随机分为试验组和对照组。试验组、对照组分别给予胃病2号方和安慰剂治疗4周,治疗结束后第4周进行随访;采用SF-36量表作为评价指标,评估患者生活质量。[结果]治疗4周后,试验组在SF-36量表的生理功能(PF)、生理职能(RP)、总体健康(GH)、社会功能(SF)、情感职能(RE)5个维度及精神健康总积分、躯体健康总积分改善优于安慰剂对照组(P<0.05);治疗结束后4周随访时,试验组在PF、RP、GH、SF、RE、躯体疼痛(BP)、生命活力(VT)7个维度与精神健康总积分、躯体健康总积分改善优于对照组(P<0.01或P<0.05)。[结论]胃病2号方能够改善FD脾虚气滞证患者近期的生活质量,且疗效优于安慰剂。

[Objective]To evaluate the effects on improving the quality of life of patients with functional dyspepsia of spleen deficiency and Qi stagnation syndrome treated by the gastrosis No.2 formula.[Methods]160 patients were randomly divided into two groups for a double-blind control study.The treatment group and the control group were administered with gastrosis No.2 formula and placebo for 4 weeks respectively.Follow-up was at 4-week after treatment.Life quality of the patients was assessed with SF-36 scale.[Results]After treatment,the treatment group was improved better than the contol group on physical function（PF）,role physical（RP）,general health（GH）,social function（SF）,role emotion（RE）and physical component summary（PCS）,mental component summary（MCS）（P0.05）.At follow-up,the treatment group was also obviously improved better than the contol group on PF,RP,BP,GH,VT,SF,RE and PCS,MCS（P0.01 or P0.05）.[Conclusion]The gastrosis No.2 formula could improve the recent quality of life of patients with functional dyspepsia of spleen deficiency and qi stagnation,and its efficacy is better than that of placebo.