胃病4号对功能性消化不良寒热错杂证患者生活质量的影响

Research of Gastrosis No.4 compound on life quality of patients with functional dyspepsia of cold heat complicated syndrome

目的:观察胃病4号复方对功能性消化不良寒热错杂证患者近期生活质量的影响。方法:采用多中心、随机、双盲、安慰剂对照的方法将101例功能性消化不良寒热错杂证患者分为试验组和对照组,分别给予中药胃病4号和安慰剂治疗,疗程4周,随访1个月;采用国际通用的SF-36量表对患者治疗前后及随访的生活质量进行评估。结果:试验组治疗后在生理功能(PF)、生理职能(RP)、总体健康(GH)3个维度及PCS改善方面均优于对照组(P<0.05);随访时在生理功能(PF)、情感职能(RE)两个维度和精神健康(MCS)改善优于对照组(P<0.05),生理职能(RP)、躯体疼痛(BP)、总体健康(GH)、社会功能(SF)4个维度与躯体健康(PCS)改善明显优于对照组(P<0.01)。结论:胃病4号复方能够改善功能性消化不良患者近期的生活质量,疗效优于安慰剂。

Objective： To evaluate the effects on life quality of patients with functional dyspepsia of cold heat complicated syndrome treated by the gastrosis No.4 compound. Methods： 101 patients were randomly divided into two groups with a multicenter, double-blind, placebo-contrasted study. The treatment group received the gastrosis No.4 compound and the control group received placebo. This trial included a 4-week treatment period and a 1-month follow-up period, Life quality of the patients was assessed with SF-36 scale. Results： After treatment, the treatment group was superior to the contol group on physical function（PF）, role physical（RP）, general health（GH）（P〈0.05）. At follow-up, superior on physical function（PF）, role emotional（RE） and （mental component summary） MCS（P〈0.05）. The treatment group was obviously superior to the contol group on role physical（RP）, bodily pain（BP）, general health（GH）, socialfunctioning（SF） and physical component summary（PCS）（P〈0.01）. Conclusion： The gastrosis No.4 compound could improve short-term life quality of patients with functional dyspepsia of cold heat complicated syndrome. The treatment group was superior to the contol group on many dimensions.