醒脾解郁方对轻中度抑郁症肝郁脾虚证患者的临床疗效研究

目的研究醒脾解郁方对轻中度抑郁症肝郁脾虚证患者的临床疗效。方法选择2018年7月—2019年1月就诊于北京中医药大学东方医院的抑郁症肝郁脾虚证患者,共61例,按入组时间顺序编号,随机分为对照组30例和试验组31例,对照组给予中药安慰剂(醒脾解郁颗粒模拟剂),试验组给予醒脾解郁方配方颗粒。2组患者均每日服药1剂,上下午分服,共治疗6周,比较2组患者汉密尔顿抑郁量表(HAMD-24)、汉密尔顿焦虑量表(HAMA)、抑郁自评量表(SDS)、焦虑自评量表(SAS)、抑郁症中医证候要素量表分数变化情况,治疗前后外周血腺嘌呤核苷三磷酸(ATP)、腺嘌呤核苷二磷酸(ADP)、腺嘌呤核糖核苷酸(AMP)含量变化情况以及不良反应发生情况。结果临床疗效:与治疗前比较,对照组患者治疗后的HAMD-24总分以及焦虑/躯体化、认知障碍、日夜变化、阻滞、绝望感5类因子,SDS总分,中医证候气虚与气滞分数降低(P<0.05);试验组患者治疗后HAMD-24总分以及焦虑/躯体化、睡眠障碍、认知障碍、日夜变化、阻滞、绝望感6类因子,胃肠道症状、全身症状2个单项因子,HAMA总分及躯体性焦虑、精神性焦虑2类因子,SDS总分,SAS总分,中医证候气虚、气滞、痰湿分数均下降(P<0.05),HAMD-24评分总有效率为93.55%(显效率为70.97%)。在作用机制方面:与治疗前比较,对照组治疗后外周血AMP含量升高(P<0.05);试验组治疗后外周血ATP含量升高(P<0.05)。安全性指标:对照组1例患者出现恶心,试验组2例患者出现腹泻,均在短期内自愈(2~3 d),未出现肝肾功能损伤的病例。结论与中药安慰剂相比,醒脾解郁方可显著改善抑郁症患者抑郁情绪及躯体症状,且可以提高外周血ATP含量水平。

Clinical effect of Xingpi Jieyu Formula on mild to moderate depression of liver depression and spleen deficiency pattern

To study the effects of Xingpi Jieyu Formula on mild to moderate depression of liver depression and spleen deficiency pattern. Methods 61 patients with depression of liver depression and spleen deficiency pattern who volunteered to participate in the study from July 2018 to January 2019 were randomly divided into control group(30 cases) and experimental group(31 cases) according to the time sequence. The control group was treated with placebo(Xingpi Jieyu granule simulant) and the experimental group was treated with Xingpi Jieyu formula granules. Both groups took 1 dose daily and took separately in the morning and afternoon After 6 weeks of treatment, HAMD-24, HAMA, SDS, SAS, TCM syndrome factor scale scores of depression were compared between the two groups, and the changes of ATP, ADP, amp contents in peripheral blood of the two groups before and after treatment, as well as the occurrence of adverse reactions were compared. Results In terms of clinical efficacy: compared with before treatment, the total scores of HAMD-24, five factor scores of "anxiety/somatization, cognitive impairment, day and night change, block and sense of despair", SDS score, qi deficiency and qi stagnation pattern scores were reduced in the control group(P<0.05);the total scores of HAMD-24, six factor scores, gastrointestinal and general symptoms, HAMA total scores, somatic and psychological scores, SDS score, SAS score, and pattern scores of qi deficiency, qi stagnation and phlegm dampness were significantly lower than those before treatment in the experimental group(P<0.05). The total effective rate of HAMD score was 93.55%(70.97% markedly effective). In terms of mechanism of action: compared with before treatment, peripheral serum AMP increased in the control group(P<0.05);ATP increased in the experimental group after treatment(P<0.05);in terms of safety profile, 1 patient in control group had nausea, and 2 patients in the experimental group had nausea diarrhea. All symptoms disappeared on its own shortly(2-3 days). No cases of liver and kidney injury. Conclusion Compared with placebo, Xingpi Jieyu Formula could significantly improve depression and somatic symptoms of depressive patients, and can increase peripheral blood ATP level.