高丽红参干预虚证疲劳双盲、随机、安慰剂对照的临床研究  

Double-blind, randomized, placebo-controlled clinical study of Korean red ginseng intervention on fatigue with deficiency syndrome

作　　者：李燕兰 方泓[1] 成颜琦 陈希 李少滨[1] LI Yanlan;FANG Hong;CHENG Yanqi;CHEN Xi;LI Shaobin(Department of Traditional Chinese Medicine Preventive Health Care,Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Longhua Clinical Medical College,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属龙华医院中医预防保健科,上海200032 [2]上海中医药大学龙华临床医学院,上海201203

出　　处：《现代医学与健康研究电子杂志》2022年第20期31-37,共7页Modern Medicine and Health Research

摘　　要：目的探讨高丽红参对虚证疲劳患者疲劳状态与免疫功能的影响及安全性分析。方法选取2017年3月至2018年2月就诊于上海中医药大学附属龙华医院的180例虚证疲劳患者,按照随机数字表法分为A、B及C组,各60例,研究期间共有6名患者因不同原因脱落,揭盲后发现A组脱落4人,C组脱落2人,最后有效病例共174例(A、B、C组分别56、60、58例)。所有患者均接受常规治疗(包括免疫抑制剂、安眠药、镇静剂等药物治疗及音乐疗法、运动疗法、心理疏导等非药物治疗),A组患者在常规治疗的基础上口服安慰剂胶囊(4粒/次,2次/d),B组患者在常规治疗的基础上口服红参参粉胶囊(2粒/次,高丽红参净含量为0.9 g,2次/d)和安慰剂胶囊(2粒/次,2次/d),C组患者在常规治疗的基础上口服红参参粉胶囊(4粒/次,高丽红参净含量为1.8 g,2次/d),3组患者用药疗程均为4周,用药后每周定期进行随访。比较3组患者治疗4周后的临床总有效率,各项主症疗效,治疗前与治疗2、3、4周后疲劳症状积分变化,治疗前与治疗4周后不同维度疲劳状态评分变化,治疗前与治疗4周后血清白细胞介素-2(IL-2)、肿瘤坏死因子-α(TNF-α)、可溶性白细胞介素2受体(sIL-2R)水平,以及治疗前和治疗2、3、4周后火(热)症状积分变化。结果治疗4周后B、C组患者的临床治疗总有效率均显著高于A组(均P<0.05);治疗4周后C组患者精神不振和疲乏无力主症的治疗总有效率均显著高于A组,且C组患者疲乏无力主症的治疗总有效率显著高于B组(均P<0.05);与治疗前比,治疗1、2、3、4周后B、C组患者疲劳自评量表(FSAS)评分均呈显著降低趋势,且治疗2周后C组及治疗3、4周后B、C组患者均显著低于A组(均P<0.05);与治疗前比,治疗4周后3组患者躯体疲劳评分,B、C组患者精神疲劳、疲劳后果、疲劳对睡眠的反应、疲劳的情境性及C组患者疲劳的时间模式评分均显著降低,且�Objective To investigate the effect of Korean red ginseng on fatigue state and immune function in fatigue patients with deficiency syndrome, and analyse the safety. Methods A total of 180 cases of fatigue patients with deficiency syndrome who were treated in Longhua Hospital Shanghai University of Traditional Chinese Medicine from March 2017 to February 2018 were selected and divided into the groups A, B and C according to the random number table method, 60 cases in each group. During the study period, a total of 6 cases patients dropped out due to different reasons, after unblinding, the results found that, there were 4, 2 cases patients dropped out respectively in the groups A and C. Finally, there were 174 effective cases(Groups A, B, and C included 56, 60 and 58 cases, respectively). All patients received conventional treatment(including the drug treatments of immunosuppressants, sleeping pills, sedatives and so on, and the non-drug treatments of music therapy, exercise therapy, psychological counseling and so on), and patients in the group A were given oral placebo capsules(4 capsules per time, 2 times per day) on the basis of conventional treatment, while patients in the group B were given oral red ginseng powder capsules(2capsules per time, the net content of Korean red ginseng was 0.9 g, 2 times per day) and placebo capsules(2 capsules per time, 2 times per day)on the basis of conventional treatment, and patients in the group C patients were given oral red ginseng powder capsules(4 capsules per time,the net content of Korean red ginseng was 1.8 g, 2 times per day) on the basis of conventional treatment. The treatment course of patients in the three groups were all 4 weeks, and the followed up was performed weekly after the treatment. The total clinical effective rate and the curative effect of each main symptom of patients in the three groups 4 weeks after treatment, the changes of fatigue symptom score of patients in the three groups before treatment and 2, 3, and 4 weeks after treatment, the changes of

关 键 词：高丽红参 虚证 疲劳 免疫功能 

分 类 号：R259[医药卫生—中西医结合]