夜寒苏煎剂干预气虚体质人群疲劳状态的随机对照研究

A randomized controlled study on the intervention of the Yehansu decoction on the fatigue of people with Qi deficiency

目的:探讨夜寒苏(姜花,别名夜寒苏、姜黄等,根茎部入药)煎剂调治气虚体质人群疲劳状态的临床疗效及安全性。方法:将120例患者分为夜寒苏组、党参组和紫薯组,每组40例,分别给予夜寒苏、党参、紫薯汤剂治疗。各组患者每日服用1剂,每日2袋,服用时间为饭后40 min。治疗1个月后,评价患者疲劳状况、血常规、尿常规以及肝肾功能相关指标。结果:疲劳量表-14(Fatigue Scale-14,FS-14)得分显示,干预后夜寒苏组、党参组疲劳均显著降低;三组间疲劳得分比较结果表明,夜寒苏组、党参组明显低于紫薯组。临床控制人数,夜寒苏组高于紫薯组;显效人数夜寒苏组、党参组均高于紫薯组;无效人数,夜寒苏组、党参组均低于紫薯组(P<0.05)。干预后,党参组血红蛋白含量(Hemoglobin,Hb)、谷草转氨酶(Aspartate Aminotransferase,AST)和补体成分3(Complement Component 3,C3)均低于夜寒苏组和紫薯组;夜寒苏组补体成分4(Complement Component 4,C4)高于党参组(均P<0.05)。结论:夜寒苏可改善气虚体质人群疲劳状态,并未发现不良影响。

Objective:To discuss the clinical efficacy and safety of the Yehansu decoction(夜寒苏煎剂)on fatigue in patients with Qi(气)deficiency.Methods:A total of 120 patients were divided into three groups:the Yehansu(Radix Curcumae)group,the Dangshen(Radix Codonopsis)group,and the Solanum tuberdsm group,with 40 patients in each group.The patients were administered the Yehansu decoction,the Dangshen decoction,and the Solanum tuberdsm decoction,respectively.The dosage was set at one dose per day,with 2 bags taken 40 minutes after meals.After one month of treatment,the fatigue status,blood routine,urine routine,liver and kidney function-related indicators were evaluated.Results:The Fatigue Assessment Scale-14 scores was significantly decreased in the Yehansu group and the Dangshen group after intervention.The fatigue scores in both the Yehansu and Dangshen groups were significantly lower than in the Solanum tuberdsm group.The number of clinically controlled cases was higher in the Yehansu group than the Solanum tuberdsm group.The number of significantly effective cases was higher in both the Yehansu and Dangshen groups than the Solanum tuberdsm group.The number of ineffective cases was lower in both the Yehansu and Dangshen groups than the Solanum tuberdsm group(P<0.05).After intervention,the Dangshen group had lower hemoglobin(Hb)levels than the Yehansu and the Solanum tuberdsm groups.The Yehansu and Solanum tuberdsm groups had higher aspartate aminotransferase(AST)levels than the Dangshen group.The Dangshen group had lower complement component 3(C3)levels than the Yehansu and the Solanum tuberdsm groups.The Yehansu group had higher complement component 4(C4)levels than the Dangshen group(P<0.05).Conclusion:Yehansu can improve the fatigue status of individuals with Qi deficiency constitution without adverse effects.