柴胡桂枝汤治疗肝郁脾虚型慢性疲劳综合征临床研究
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摘要
目的:观察柴胡桂枝汤治疗肝郁脾虚型慢性疲劳综合征的临床疗效。方法:将72例入组病例随机分为治疗组与对照组各36例。治疗组予以柴胡桂枝汤颗粒剂,每袋12 g,每次1袋,日2次,早晚餐后半小时开水冲服;对照组给予安慰剂,外包装以及药物形状均与治疗组相似,服用方法同治疗组。两组均治疗28 d,随访1个月。观察两组患者临床疗效,分别于治疗前后对患者进行疲劳量表(Fatigue Scale-14,FS-14)评分。入组患者于治疗前后分别检测肿瘤坏死因子(tumor necrosis factor-α,TNF-α),白细胞介素-1β(interleukin-1β,IL-1β),白细胞介素-6(interleukin-6,IL-6),干扰素-γ(interferon-γ,IFN-γ)的含量。结果:治疗组治疗前、治疗2周后的FS-14评分与对照组比较差异无统计学意义(P> 0. 05);治疗后、随访时的FS-14评分与对照组比较差异有统计学意义(P <0. 01)。治疗组治疗后IL-1β、IFN-γ与对照组治疗后比较,差异有统计学意义(P <0. 05)。两组患者经过4周的治疗后,治疗组治愈2例,显效8例,有效22例,无效4例,有效率为88. 89%;对照组治愈1例,显效2例,有效10例,无效23例,有效率为36. 11%。两组有效率经Wilcoxon检验统计分析有统计学意义(P <0. 01)。结论:柴胡桂枝汤可以改善肝郁脾虚型慢性疲劳综合征患者细胞因子水平,减轻其疲劳、乏力、低热、失眠等症状。
Objective: To observe the clinical curative effect of Cinnamon Twig Decoction on chronic fatigue syndrome(CFS) with syndrome of liver depression and spleen deficiency. Methods: A total of 72 cases were randomly divided into the treatment group and the control group,with 36 cases in each group. The treatment group was given Bupleurum and Cinnamon Twig granule,12 g/bag,one bag each time,twice a day,taken half an hour after breakfast and dinner,while the control group was given placebo,outer packing and drug shape similar to the treatment group,taking the same method as the treatment group. Both groups were treated for 28 days and followed up for one month. The clinical efficacies of the two groups were observed before and after the treatment. The patients were scored by Fatigue Scale-14(FS-14) and TCM Syndrome Scale before and after the treatment. The levels of tumor necrosis factor-A(TNF-a),interleukin-1 beta(IL-1β),interleukin-6(IL-6),interferon-γ(IFN-γ) were measured before and after the treatment. Results: There were no significant differences in the scores of FS-14 and TCM syndrome scale between the treatment group and the control group before the treatment and 2 weeks after the treatment(P > 0. 05). There were significant differences in FS-14 score and TCM Syndrome Scale score between the two groups after the treatment and during the follow-up(P < 0. 01). After the treatment,IL-1βand IFN-γin the treatment group were significantly different from those in the control group,and all the differences were statistically significant(P < 0. 05). After 4 weeks of treatment,2 cases were cured in the treatment group,8 cases were markedly effective,22 cases were effective and 4 cases were ineffective,the effective rate was 88. 89%. In the control group,one case was cured,2 cases were markedly effective,10 cases were effective and 23 cases were ineffective,the effective rate was 36. 11%. The effective rates of the two groups were statistically significant by Wilcoxon test(P < 0. 01). Conclusion: Bupleurum and Cinnamon Twig Decoction can improve the level of cytokines and alleviate the symptoms of fatigue,weakness,low fever and insomnia in patients with chronic fatigue syndrome of liver depression and spleen deficiency.
Objective: To observe the clinical curative effect of Cinnamon Twig Decoction on chronic fatigue syndrome(CFS) with syndrome of liver depression and spleen deficiency. Methods: A total of 72 cases were randomly divided into the treatment group and the control group,with 36 cases in each group. The treatment group was given Bupleurum and Cinnamon Twig granule,12 g/bag,one bag each time,twice a day,taken half an hour after breakfast and dinner,while the control group was given placebo,outer packing and drug shape similar to the treatment group,taking the same method as the treatment group. Both groups were treated for 28 days and followed up for one month. The clinical efficacies of the two groups were observed before and after the treatment. The patients were scored by Fatigue Scale-14(FS-14) and TCM Syndrome Scale before and after the treatment. The levels of tumor necrosis factor-A(TNF-a),interleukin-1 beta(IL-1β),interleukin-6(IL-6),interferon-γ(IFN-γ) were measured before and after the treatment. Results: There were no significant differences in the scores of FS-14 and TCM syndrome scale between the treatment group and the control group before the treatment and 2 weeks after the treatment(P > 0. 05). There were significant differences in FS-14 score and TCM Syndrome Scale score between the two groups after the treatment and during the follow-up(P < 0. 01). After the treatment,IL-1βand IFN-γin the treatment group were significantly different from those in the control group,and all the differences were statistically significant(P < 0. 05). After 4 weeks of treatment,2 cases were cured in the treatment group,8 cases were markedly effective,22 cases were effective and 4 cases were ineffective,the effective rate was 88. 89%. In the control group,one case was cured,2 cases were markedly effective,10 cases were effective and 23 cases were ineffective,the effective rate was 36. 11%. The effective rates of the two groups were statistically significant by Wilcoxon test(P < 0. 01). Conclusion: Bupleurum and Cinnamon Twig Decoction can improve the level of cytokines and alleviate the symptoms of fatigue,weakness,low fever and insomnia in patients with chronic fatigue syndrome of liver depression and spleen deficiency.
引文
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[10]DJABALLAH-IDER F,CHAIB S,BELGUENDOU Z H,et al.Tcells activation and interferon-γ/nitric oxide production during Behet disease:a study in Algerian patients[J].Ocul Immunol Inflamm,2012,20(3):215-217.
[11]ANNUNZIATO F,ROMAGNANI C,ROMAGNANI S.The 3 major types of innate and adaptive cell-mediated effector immunity[J].J Allergy Clin Immunol,2015,135(3):626-635.
[12]HARDCASTLE S L,BRENU E W,JOHNSTON S,et al.Serum Immune Proteins in Moderate and Severe Chronic Fatigue Syndrome/Myalgic Encephalomyelitis Patients[J].Int J Med Sci,2015,12(10):764-772.
[13]HARDCASTLE S,BRENU E,JOHNSTON S,et al.Analysis of the relationship between immune dysfunction and symptom severity in patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis(CFS/ME)[J].J Clin Cell Immunol,2014,34(5):266-232.
[14]NEU D,MAIRESSE O,MONTANA X,et al.Dimensions of pure chronic fatigue:psychophysical,cognitive and biological correlates in the chronic fatigue syndrome[J].Eur J Appl Physiol,2014,114(9):1841-1851.
[15]SMYLIE A L,BRODERICK G,FERNANDES H,et al.A comparison of sex-specific immune signatures in Gulf War illness and chronic fatigue syndrome[J].BMC Immunol,2013,14(8):29-39.
[2]FUKUDA K,STRAUS S E,HICKIE I,et al.The chronic fatigue syndrome:a comprehensive approach to its definition and study.International Chronic Fatigue Syndrome Study Group[J].Ann Intern Med,1994,121(12):953-959.
[3]郑筱萸.中药新药临床研究指导原则[S].北京:中国医药科技出版社,2002:361-392.
[4]STRINGER E A,BAKER K S,CARROLL I R,et al.Daily cytokine fluctuations,driven by leptin,are associated with fatigue severity in chronic fatigue syndrome:evidence of inflammatory pathology[J].Jouranl of Translational Medicine,2013,11(1):93-98.
[5]MAES M,TWISK F N,KUBERA M.Ringel K:Evidence for inflammation and activation of cell-mediated immunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome(ME/CFS):increased interleukin-1,tumor necrosis factor-a,PMN-elastase,lysozyme and neopterin[J].J Affect Disord,2012,136(12):933-939.
[6]BANSAL A S,BRADLEY A S,BISHOP K N,et al.Chronic fatigue syndrome,the immune system and viral infection[J].Brain,Behavior,and Immunity,2012,26(1):24-31.
[7]MILRAD S F,HALL D L,JUTAGIR D R,et al.Poor sleep quality is associated with greater circulating pro-inflammatory cytokines and severity and frequency of chronic fatigue syndrome/myalgic encephalomyelitis(CFS/ME)symptoms in women[J].J Neuroimmunol,2017,303(1):43-50.
[8]EVEREKLIOGLU C,ER H,TüRK Z Y,et al.Serum levels of TNF-α,IL-2R,IL-6,and IL-8 are increased and associated with elevated lipid peroxidation in patients with Beh?et's disease[J].Mediators of inflammation,2002,52(11):87-93.
[9]PATARCA R.Cytokines and chronic fatigue syndrome[J].Annals of the New York Academy of Sciences,2001,33(9):185-200.
[10]DJABALLAH-IDER F,CHAIB S,BELGUENDOU Z H,et al.Tcells activation and interferon-γ/nitric oxide production during Behet disease:a study in Algerian patients[J].Ocul Immunol Inflamm,2012,20(3):215-217.
[11]ANNUNZIATO F,ROMAGNANI C,ROMAGNANI S.The 3 major types of innate and adaptive cell-mediated effector immunity[J].J Allergy Clin Immunol,2015,135(3):626-635.
[12]HARDCASTLE S L,BRENU E W,JOHNSTON S,et al.Serum Immune Proteins in Moderate and Severe Chronic Fatigue Syndrome/Myalgic Encephalomyelitis Patients[J].Int J Med Sci,2015,12(10):764-772.
[13]HARDCASTLE S,BRENU E,JOHNSTON S,et al.Analysis of the relationship between immune dysfunction and symptom severity in patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis(CFS/ME)[J].J Clin Cell Immunol,2014,34(5):266-232.
[14]NEU D,MAIRESSE O,MONTANA X,et al.Dimensions of pure chronic fatigue:psychophysical,cognitive and biological correlates in the chronic fatigue syndrome[J].Eur J Appl Physiol,2014,114(9):1841-1851.
[15]SMYLIE A L,BRODERICK G,FERNANDES H,et al.A comparison of sex-specific immune signatures in Gulf War illness and chronic fatigue syndrome[J].BMC Immunol,2013,14(8):29-39.