| The main symptoms of idiopathic fatigue include the mental weariness and malaise, without the organic diseases, which may greatly impair the daily life, working and social activities of patients. There has been no specific treatment for the idiopathic fatigue in Western medicine, but the traditional Chinese medicine has the certain effect in its treatment. To further improve the prevention and treatment of idiopathic fatigue, the syndrome elements and their combination, evaluation methods of fatigue and influencing factors on the curative effect of TCM treatment were explored in this study.Objective:To study the clinical characteristics of idiopathic fatigue (syndrome elements and their combination), prepare the digital rating scale of fatigue and determine the clinical value of rating scale through the clinical study.Methods:1. Study on the syndrome elements and their combination of idiopathic fatigue: the syndrome elements were collected from 268 patients with the idiopathic fatigue treated in this hospital from 2010 to 2013 to analyze the syndrome elements and their combination using the clustering method.2. Study on digital scale of idiopathic fatigue:it referred to the pain scale to prepare the digital scale with three dimensions of physical strength, memory and spirit. The flow-adjustment method was employed to investigate 142 cases. Meanwhile, FS-14 scale was adopted as the gold standard for the scale evaluation to study the sensitivity, specificity, accuracy and reliability of digital scale of fatigue.3. Evaluation on clinical application of digital rating scale of fatigue:the scale was adopted in the double-blind randomized placebocontrol trial.90 patients with idiopathic fatigue were included in this trial and they were divided into the treatment group and control one by the ratio of 2:1, namely 60 cases in the treatment group and 30 cases in the control group. Patients in the treatment group were given the oral administration of TCM decoction; while patients in the control group were given the oral administration of placebo (the ingredients were one twentieth of the one in the treatment group). In addition to the evaluation on the curative effect using FS-14 scale and TCM Symptom Score, the evaluation on the curative effect was also performed using the digital rating scale of fatigue to analyze the influencing factors on the curative effect using the above methods, as well as the correlation between FS-14 and digital scale in the evaluation of curative effect.Results:1. Results of analysis on the syndrome elements and their combination of idiopathic fatigueAccording to the analysis on the syndrome elements of 268 patients with idiopathic fatigue (including 170 males and 98 females, with the average age of 33.75±8.46year-old),8 syndrome elements were collected, including 246 patients with Qi stagnation (91.79%),236 patients with Qi deficiency (88.06%),180 patients with fire heat (67.16%),85 patients with Yin deficiency (31.72%),40 patients with blood deficiency (14.93%),35 patients with Yang deficiency (13.06%),33 patients with phlegm (8.58%) and 20 patients with blood stasis (7.46%) from high to low frequency.According to the combination of syndrome elements, the cluster analysis was performed on 3 types,4 types and 5 types. When it was divided as 3 types, there were 162 patients with the Qi stagnation-caused fire and Qi deficiency,22 patients with phlegm-heat stagnation and Qi deficiency and 84 patients with the Qi stagnation and Qi deficiency. When it was divided as 4 types, there were 34 patients with Qi stagnation-caused fire and Qi deficiency and phlegm stagnation,119 patients with Qi stagnation-caused fire and Qi deficiency,83 patients with Qi stagnation-caused fire and Qi and Yin deficiency, and 32 patients with Qi stagnation and Qi (Yang) deficiency. When it was divided as 5 types, there were 17 patients with Qi stagnation-caused fire and Qi deficiency and blood stasis,108 patients with Qi stagnation-caused fire and Qi deficiency,83 patients with Qi stagnation-caused fire and Qi and Yin deficiency,30 patients with Qi stagnation and Qi (Yang) deficiency and 30 patients with Qi stagnation and phlegm stagnation-caused fire. According to the detection rate of each syndrome element in every syndrome, the combination of Qi stagnation-caused fire and Qi deficiency was most frequent among three kinds of classification, followed by the Qi stagnation and Qi deficiency and Qi stagnation-caused fire and Qi and Yin deficiency.2. Results of evaluation using the digital rating scale of fatigueThe preliminary survey on 142 samples (including 43 males and 99 females, with the average age of 32.27±7.69year-old) indicated that, excluding the organic diseases that might cause the fatigue,122 patients had the fatigue and 20 cases were healthy according to FS-14 scale. According to Youden index, the score of fatigue digital scale over 7 points could be diagnosed as the fatigue. Taking FS-14 scale as the gold standard, the sensitivity, specificity and accuracy of digital scale were 86%,65% and 83% respectively.After remeasuring 52 samples,32 of them had the fatigue, while 20 of them did not. Results:the correlation coefficient of the total scales.physical strength, memory and spirit of digital scale was 0.83.0.729,0.76 and 0.801 respectively; while the correlation coefficient of the total scales,physical strength, and memoryof F-14 scale was 0.666,0.801 and 0.357 respectively3. Influencing factors on the curative effect of TCM treatment and the evaluation of digital scale on curative effectAccording to the study of TCM treatment on 90 patients with idiopathic fatigue using the randomized placebo-controlled trail, the response rate of TCM syndrome in the treatment group was 93.3%, while the response rate of TCM syndrome in the control group was 70.0%. The score of FS-14 was reduced by 5.27±3.00 points, the score of TCM syndrome was reduced by 16.23±7.12 points and the score of digital scale was reduced by 6.96±3.79 points in the treatment group, while the score of FS-14 was reduced by 3.80±3.23 points, the score of TCM syndrome was reduced by 10.83±9.78 points and the score of digital scale was reduced by 4.72±3.47 points. The effect in the treatment group was significantly higher than that in the control group (P<0.05). Influencing factors on curative effect:By analyzing the effect of different factors on the decrease of TCM syndrome score after the treatment, decrease of digital scale score after the treatment and decrease of FS-14 scale score after the treatment, it could be indicated that these three were all related to the group and their own baselines. According to the analysis on the correlation between the digital scale and FS-14, the correlation of the total scales between the digital scale and FS-14 was good with r=0.624, as well as the correlation of physical strength between them with r=0.644 and the correlation of spirit between them with r=0.296.Conclusion:1. The syndrome elements of idiopathic fatigue were ordered from the high to low frequency as:Qi stagnation, Qi deficiency, fire heat, Yin deficiency, blood deficiency, Yang deficiency, phlegm, and blood stasis. According to the detection rate of each syndrome element in every syndrome, the combination of Qi stagnation-caused fire and Qi deficiency was most frequent among three kinds of classification, followed by the Qi stagnation and Qi deficiency and Qi stagnation-caused fire and Qi and Yin deficiency.2.The diagnostic ability of digital scale was good and the score over 10 points could be diagnosed as the fatigue. The remeasured reliability of digital scale was higher than that of F-14 scale, which indicated the good consistency. According to the analysis on diagnostic results using F-14 scale as the gold standard, the digital scale of fatigue had the relatively high sensitivity and accuracy and the correlation in the total scores and physical strength between the digital scale and FS-14 scale was good. The preliminary results could be used in the preliminary screening and curative effect evaluation of clinical fatigue.3.For TCM in the treatment of idiopathic fatigue, the curative effect of patients in TCM treatment group was significantly better than that in the control group. After taking the medicine, the scores of SDS, SAS, FS-14 scale and digital scale of patients were all significantly reduced, with the certain correlation to the improvement of TCM symptoms. The curative effect of TCM syndrome score, digital rating scale of fatigue and FS-14 scale was affected by the grouping of treatment and their own baselines. |
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