從脾論治治療功能性腹瀉隨機(jī)、雙盲、安慰劑對(duì)照臨床觀察研究
發(fā)布時(shí)間:2018-05-28 11:56
本文選題:從脾論治 + 功能性腹瀉。 參考:《山西中醫(yī)學(xué)院》2016年碩士論文
【摘要】:目的:通過(guò)口服中藥治療功能性腹瀉(F-D/FDi)前后對(duì)照的臨床觀察試驗(yàn),客觀評(píng)價(jià)中醫(yī)藥從脾論治功能性腹瀉的有效性和安全性。以闡明“脾主運(yùn)化、統(tǒng)血”等脾臟藏象理論的基本科學(xué)內(nèi)涵,解釋功能性胃腸病“從脾論治”臨床療效產(chǎn)生的機(jī)制和規(guī)律,進(jìn)一步豐富和發(fā)展藏象理論。方法:選擇符合納入標(biāo)準(zhǔn)及排除標(biāo)準(zhǔn)的功能性腹瀉(F-D/FDi)患者60例,按照隨機(jī)、雙盲、安慰劑、對(duì)照的臨床研究設(shè)計(jì)原則對(duì)患者進(jìn)行臨床證候辨證分型,依據(jù)分型結(jié)果分為脾虛濕阻證和脾陽(yáng)虛證兩組,每組30例。兩組患者入組時(shí)均進(jìn)行安全性檢查,包括:血、尿、大便常規(guī)及潛血(用藥前、后各檢查一次);肝功能(ALT、AST)腎功能(Cr、BUN)(用藥前、后各檢查一次);心電圖(用藥前、后各檢查一次)。均統(tǒng)一服用由總課題組配發(fā)的中藥配方顆粒,每袋12g。對(duì)照組使用安慰劑治療,藥品發(fā)放嚴(yán)格按照隨機(jī)化、雙盲原則進(jìn)行。治療組:脾虛濕阻證組口服中藥復(fù)方顆粒劑:炙黃芪黨參炒白術(shù)茯苓煨木香砂仁薏苡仁姜炭車(chē)前子炙甘草;用法:1袋/次,3次/日,沖服。連續(xù)服用4周。脾陽(yáng)虛證組口服中藥復(fù)方顆粒劑為炙黃芪黨參炒白術(shù)茯苓煨木香砂仁炮附子姜炭肉豆蔻車(chē)前子炙甘草;用法:1袋/次,3次/日,沖服。連續(xù)服用4周。對(duì)照組:口服與中藥復(fù)方顆粒劑外觀、規(guī)格完全相同的安慰劑,安慰劑由輔料加原藥的1/20制作成。用法、用量及服用時(shí)間均與治療組相同。結(jié)果:1、治療組30例,痊愈0例,顯效5例,有效23例,無(wú)效2例,總有效率93%;對(duì)照組30例,痊愈0例,顯效1例,有效10例,無(wú)效19例,總有效率36%;提示治療組臨床綜合療效優(yōu)于對(duì)照組,治療組顯效率優(yōu)于對(duì)照組(P0.05),且總體印象治療組有效率(53%)優(yōu)于對(duì)照組(10%),兩者差異有統(tǒng)計(jì)學(xué)意義(P0.05);2、兩組證型治療組患者治療后中醫(yī)癥候總積分與治療前相比均有好轉(zhuǎn),與對(duì)照組比較差異有統(tǒng)計(jì)學(xué)意義(P0.05),且對(duì)于功能性腹瀉患者的大便次數(shù)和性狀均有明顯改善,治療組療效優(yōu)于對(duì)照組(P0.05);3、兩組證型治療組患者治療后生存質(zhì)量狀況均優(yōu)于對(duì)照組,差異有統(tǒng)計(jì)學(xué)意義(P0.05);治療后兩組患者大便潛血情況及腸鏡復(fù)查結(jié)果相比,治療組療效優(yōu)于對(duì)照組(P0.05);4、功能性腹瀉患者均存在不同程度的焦慮和抑郁癥狀;5、脾陽(yáng)虛證治療組患者治療后焦慮、抑郁狀態(tài)優(yōu)于對(duì)照組,差異有統(tǒng)計(jì)學(xué)意義(P0.05);脾虛濕組證患者治療后焦慮、抑郁狀態(tài)與對(duì)照組無(wú)明顯差異(P0.05);6、功能性腹瀉20-30歲人群占比較大,男性患者多于女性;7、兩組患者在治療期間均未發(fā)生明顯的不良反應(yīng),其治療前后實(shí)驗(yàn)室檢查血常規(guī)、尿常規(guī)、心電圖、肝功及腎功均未發(fā)現(xiàn)明顯異常,具備安全性。結(jié)論:中藥“從脾論治”治療功能性腹瀉在改善患者相關(guān)臨床癥狀、腹瀉次數(shù)、大便形狀、生存質(zhì)量狀況和焦慮、抑郁狀態(tài)方面,優(yōu)于對(duì)照組,其總有效率高于對(duì)照組。但對(duì)脾虛濕阻證患者焦慮、抑郁狀態(tài)效果不明顯。
[Abstract]:Objective: to evaluate the efficacy and safety of traditional Chinese medicine (TCM) in the treatment of functional diarrhea from spleen. In order to elucidate the basic scientific connotation of the theory of "spleen governing transportation, regulating blood" and so on, explain the mechanism and rule of clinical curative effect of functional gastrointestinal disease "treating from spleen", further enrich and develop the theory of Tibetan image. Methods: sixty patients with F D / F Dii, who met the inclusive and exclusion criteria, were selected and classified according to the principles of randomized, double-blind, placebo and control clinical study design. According to the results of classification, 30 cases in each group were divided into two groups: spleen deficiency dampness syndrome and spleen yang deficiency syndrome. The patients in both groups were examined for their safety, including: blood, urine, stool routine and occult blood (before and after treatment) and renal function (before and after treatment), renal function and renal function (before and after treatment) and electrocardiogram (before and after treatment). All of them were given the prescription granules of traditional Chinese medicine, each bag was 12g. The control group was treated with placebo, and the drug distribution was done strictly according to randomization and double blindness. Treatment group: spleen deficiency dampness blocking syndrome group oral Chinese compound granule: fried Astragalus Codonopsis Codonopsis Atractylodes Suckahoe simmer Amomum Seeds Coix seed Ginger charcoal Fructus Glycyrrhiza; use 1 bag 3 times a day take. Take it continuously for 4 weeks. Spleen yang deficiency syndrome group took oral Chinese medicine compound granules as fried Astragalus Codonopsis Codonopsis and Radix Atractylodes Amur to simmer Amomum Kernel Gun Ginger charcoal nutmeg cardamom plantain to burn licorice; use 1 bag / 3 times a day take it. Take it continuously for 4 weeks. Control group: placebo with the same appearance and specification as compound granules was prepared by adding excipient and 20 / 20 of the original medicine. The usage, dosage and duration were the same as those in the treatment group. Results in the treatment group, 30 cases were cured, 5 cases were markedly effective, 23 cases were effective, 2 cases were ineffective, the total effective rate was 93%, while in the control group, 30 cases were cured, 1 case was markedly effective, 10 cases were effective, 19 cases were ineffective. The total effective rate was 36%, which indicated that the clinical comprehensive curative effect of the treatment group was better than that of the control group. The effective rate of the treatment group was better than that of the control group (P0.05A, and the overall impression treatment group's effective rate was 53) better than that of the control group (105L). The difference between the two groups was statistically significant (P 0.05). The total score of TCM symptoms in the treatment group was better than that before treatment. Compared with the control group, the difference was statistically significant (P 0.05), and the defecation frequency and character of the patients with functional diarrhea were improved obviously. The curative effect of the treatment group was better than that of the control group (P 0.05). The quality of life of the patients in the treatment group was better than that in the control group after treatment. The difference was statistically significant (P 0.05), and the results of occult blood in stool and colonoscopy were compared between the two groups after treatment. The curative effect of the treatment group was better than that of the control group (P 0.05), the patients with functional diarrhea had different degree of anxiety and depression symptoms, and the patients in the treatment group of spleen yang deficiency syndrome were better than the control group in terms of anxiety and depression after treatment. There was no significant difference in post-treatment anxiety and depression between the patients with spleen deficiency and dampness group and the control group (P 0.05), and the patients aged 20-30 years old with functional diarrhea accounted for more than those in the control group. There were no obvious adverse reactions in the two groups during the treatment. The blood routine, urine routine, electrocardiogram, liver function and renal function were not abnormal in the laboratory before and after treatment. Conclusion: the treatment of functional diarrhea with "treating from spleen" is superior to the control group in improving the clinical symptoms, diarrhea times, stool shape, quality of life, anxiety and depression, and its total effective rate is higher than that in the control group. However, the effect of anxiety and depression in patients with spleen deficiency and dampness obstruction syndrome is not obvious.
【學(xué)位授予單位】:山西中醫(yī)學(xué)院
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2016
【分類(lèi)號(hào)】:R256.34
【參考文獻(xiàn)】
相關(guān)期刊論文 前10條
1 陳旭;y嚭晡,
本文編號(hào):1946612
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