【摘要】：目的:采用隨機(jī)對(duì)照試驗(yàn)的設(shè)計(jì)方案,通過(guò)觀察理腸方對(duì)腹瀉型腸易激綜合征(IBS-D)肝郁脾虛濕熱證患者臨床癥狀、中醫(yī)證候積分等有效性指標(biāo)及安全性指標(biāo)的改變情況,評(píng)價(jià)"理腸方"的有效性及安全性,以期為本方廣泛應(yīng)用于臨床提供有益參考。方法:采取隨機(jī)對(duì)照的研究方法,共納入符合入組標(biāo)準(zhǔn)的IBS-D患者72例,并隨機(jī)分為治療組與對(duì)照組各36例。治療組予中藥"理腸方"治療,對(duì)照組予西藥"匹維溴銨+枯草桿菌二聯(lián)活菌腸溶膠囊"治療,兩組均以4周為一療程。觀察患者的臨床癥狀、中醫(yī)證候積分和生活質(zhì)量評(píng)分表以及血常規(guī)、肝腎功能、心電圖等安全性指標(biāo)的改變,并進(jìn)行統(tǒng)計(jì)學(xué)分析,評(píng)價(jià)理腸方的有效性及安全性。結(jié)果:1.本研究共納入72例患者,其中有65例病人完成了臨床觀察,觀察組脫落3例,對(duì)照組脫落4例,總脫落率為9.72%。2.觀察組與對(duì)照組均能明顯改善患者臨床癥狀,而觀察組在腹瀉、腹痛、急躁易怒、喜嘆息、泄下急迫或不爽等幾方面的證候積分及IBS-QOL專(zhuān)用量表評(píng)分分值變化均明顯優(yōu)于對(duì)照組,兩組相比有非常顯著性差異(P0.05,P0.01);在改善中醫(yī)證候方面,觀察組總有效率為90.9%,明顯優(yōu)于對(duì)照組68.8%(P0.01)。3.治療過(guò)程中,所有受試者均未出現(xiàn)不良事件,且血常規(guī)、肝腎功及心電圖檢查等指標(biāo)均未見(jiàn)明顯異常變化。結(jié)論:1.理腸方治療IBS-D肝郁脾虛濕熱證療效確切。2.理腸方無(wú)明顯不良反應(yīng),具有良好安全性。
[Abstract]:Objective: to observe the effect of Lichang recipe on the clinical symptoms of patients with diarrhea type irritable bowel syndrome (IBS-D) such as liver stagnation and spleen deficiency dampness heat syndrome, TCM syndromes integral and safety index. To evaluate the efficacy and safety of Lichang recipe and to provide useful reference for its wide application in clinical practice. Methods: a randomized controlled study was conducted in 72 IBS-D patients who met the criteria of admission, and were randomly divided into treatment group (n = 36) and control group (n = 36). The treatment group was treated with traditional Chinese medicine "Lichang prescription", the control group was treated with the western medicine "pivimoammonium bromide bacilli combined with Bacillus subtilis enteric-coated capsule", both groups were treated with 4 weeks as a course of treatment. To observe the changes of clinical symptoms, score of TCM syndromes and quality of life, blood routine, liver and kidney function, electrocardiogram, and to evaluate the efficacy and safety of Lichang prescription. The result is 1: 1. A total of 72 patients were included in this study, 65 of whom completed the clinical observation. 3 cases in the observation group and 4 cases in the control group, the total abscission rate was 9.72%. 2. Both the observation group and the control group could significantly improve the clinical symptoms of the patients, while in the observation group, diarrhea, abdominal pain, irritability and irritability, sighing, The changes of symptom score and IBS-QOL scale score were obviously superior to those of the control group, and there was a significant difference between the two groups (P0.05, P0.01). In improving TCM syndromes, the total effective rate of the observation group was 90.9, which was significantly better than that of the control group (68.8%, P0.01). In the course of treatment, no adverse events occurred in all subjects, and there were no obvious abnormal changes in blood routine, liver and kidney function and electrocardiogram examination. Conclusion: 1. The curative effect of Lichang prescription on IBS-D liver stagnation and spleen deficiency dampness and heat syndrome is definite. 2. Lichang prescription has no obvious adverse reaction and has good safety.
【學(xué)位授予單位】：福建中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：R259

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