【摘要】：目的:本研究從中醫(yī)證候、遠(yuǎn)期療效、漢密爾頓抑郁量表評(píng)分等方面來評(píng)價(jià)加味下氣湯治療功能性腹脹伴抑郁狀態(tài)(肝郁脾虛型)的臨床療效以及本方案的安全性,為臨床應(yīng)用和中醫(yī)藥新藥開發(fā)提供較為科學(xué)的理論依據(jù)。方法:所有符合納入標(biāo)準(zhǔn),經(jīng)過排除標(biāo)準(zhǔn)篩選的患者作為受試對(duì)象,依據(jù)估計(jì)的樣本量,擬設(shè)樣本例數(shù)54例,按20%脫落病例考慮,擬納入64例患者,以患者就診順序編號(hào),采用完全隨機(jī)數(shù)字表法,按1:1匹配比例將所符合標(biāo)準(zhǔn)的64例患者隨機(jī)分為治療組32例和對(duì)照組32例。治療組給予加味下氣湯治療,對(duì)照組給予枸櫞酸莫沙必利片(快力)和米氮平片治療。兩組均以1周為1療程,共觀察3療程,療程結(jié)束后的3個(gè)月分別對(duì)兩組患者進(jìn)行回訪。觀察治療前后兩組患者的中醫(yī)證候、遠(yuǎn)期療效、總有效率以及不良反應(yīng)事件,同時(shí)在回訪時(shí)要注意觀察患者的復(fù)發(fā)率。結(jié)果:(1)經(jīng)過3個(gè)療程治療,在改善中醫(yī)證候積分方面,治療組優(yōu)于對(duì)照組(P0.05);(2)治療組在改善便溏方面療效不佳,對(duì)改善脹滿、多愁善感、矢氣等癥狀明顯優(yōu)于對(duì)照組,差異有統(tǒng)計(jì)學(xué)意義(P0.05);(3)經(jīng)3個(gè)療程治療,總體療效方面,兩組均有改善(P0.05);治療組與對(duì)照組在改善總體療效方面有差異,差異有統(tǒng)計(jì)學(xué)意義(P0.05);(4)漢密爾頓抑郁量表療效比較:治療后兩組HAMD評(píng)分均明顯降低,治療組療效優(yōu)于對(duì)照組(P0.05);(5)遠(yuǎn)期療效方面:治療組復(fù)發(fā)5例,復(fù)發(fā)率為17.9%,對(duì)照組復(fù)發(fā)12例,復(fù)發(fā)率為46.1%,治療組優(yōu)于對(duì)照組;(6)安全性方面:兩組患者治療前后安全性指標(biāo)檢測(cè)均未出現(xiàn)與藥物治療相關(guān)的異常改變。結(jié)論:加味下氣湯治療功能性腹脹伴抑郁狀態(tài)(肝郁脾虛型)療效確切,能顯著、全面改善功能性腹脹伴抑郁狀態(tài)患者的中醫(yī)證候、總有效率、漢密爾頓抑郁量表評(píng)分的情況,且遠(yuǎn)期療效良好,改善患者生活質(zhì)量,縮短治療時(shí)間,并能降低治療費(fèi)用,安全性高,是臨床上治療功能性腹脹伴抑郁狀態(tài)的有效方劑。
[Abstract]:Objective: to evaluate the clinical efficacy and safety of Jiawei Xiqi decoction in the treatment of functional abdominal distension with depression (liver depression and spleen deficiency type) from the aspects of TCM syndrome, long-term curative effect and Hamilton depression scale score. It provides a scientific theoretical basis for clinical application and new drug development of traditional Chinese medicine. Methods: all the patients who met the inclusion criteria and were screened by exclusion criteria were selected as subjects. According to the estimated sample size, the number of samples was 54. According to 20% of the falling off cases, 64 patients were included and numbered according to the order of treatment. According to the 1:1 matching ratio, 64 patients were randomly divided into treatment group (n = 32) and control group (n = 32). The treatment group was treated with Jiawei Xiaqi decoction, while the control group was treated with mosapride citrate tablets and mirtazapine tablets. Both groups were treated with 1 week as a course of treatment, a total of 3 courses of treatment were observed, and the patients in the two groups were visited back 3 months after the end of the course of treatment. The TCM syndrome, long-term curative effect, total effective rate and adverse reaction events of the two groups were observed before and after treatment, and the recurrence rate of the patients should be observed when returning to the visit. Results: (1) after three courses of treatment, the treatment group was superior to the control group in improving the syndrome score of traditional Chinese medicine (P 0.05). (2) the curative effect of the treatment group in improving loose stools was not good, and the symptoms such as swelling, sentimentality and sagittal qi in the treatment group were significantly better than those in the control group (P 0.05). (3) after three courses of treatment, the overall curative effect of the two groups was improved (P 0.05), and there was significant difference between the treatment group and the control group in improving the overall curative effect (P 0.05). (4) comparison of the efficacy of Hamilton depression scale: after treatment, the HAMD scores of the two groups were significantly decreased, and the curative effect of the treatment group was better than that of the control group (P 0.05). (5) long-term curative effect: the recurrence rate of the treatment group was 17.9%, and that of the control group was 46.1%. The recurrence rate of the treatment group was better than that of the control group. (6) Safety: there were no abnormal changes related to drug treatment in both groups before and after treatment. Conclusion: Jiawei Xiaqi decoction is effective in the treatment of functional abdominal distension with depression (liver depression and spleen deficiency type). It can improve the TCM syndrome, total effective rate and Hamilton depression scale score in patients with functional abdominal distension with depression. The long-term curative effect is good, the quality of life is improved, the treatment time is shortened, and the treatment cost is reduced, and the safety is high. It is an effective prescription for the treatment of functional abdominal distension with depression.
【學(xué)位授予單位】：河南中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R259

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