本文選題：潤通湯　切入點：功能性便秘　出處：《福建中醫(yī)藥大學》2017年碩士論文

【摘要】：目的:針對目前功能性便秘(FC)患者逐年增加,通過研究潤通湯治療陰虛型功能性便秘在臨床上的療效觀察,對比治療前、后生活質(zhì)量評分及常規(guī)檢查的改變情況,評價潤通湯的有效性和安全性,以進一步探討中醫(yī)藥在治療本病的優(yōu)勢,更好地提高臨床療效、改善患者的生活質(zhì)量。方法:采用隨機對照試驗方法,共納入符合入組標準的陰虛型功能性便秘患者88例,隨機分治療組和對照組各44例,試驗觀察時間是10周,包括2周的導入期、4周的治療期和4周的隨訪期。兩組患者分別在治療前及治療后4周填寫便秘患者生活質(zhì)量量表(PAC-QOL)。治療期間,在生活調(diào)理的基礎上,治療組予潤通湯治療,對照組采用枯草桿菌二聯(lián)活菌腸溶膠囊聯(lián)合枸櫞酸莫沙必利片治療,兩組均以4周為一療程。隨訪期間,兩組均繼續(xù)生活調(diào)理并停用藥物治療。比較兩組患者臨床癥狀的改善情況及治療前、后生活質(zhì)量積分,觀察在藥物干預期間不良反應情況以評價其安全性。同時停藥后繼續(xù)隨訪4周,觀察治療后的遠期不良反應以評估其安全性,以及功能性便秘的復發(fā)情況。結(jié)果:1.本研究共納入88例患者,其中治療組脫落1例,對照組脫落3例,最后總共84人完成了臨床觀察,脫落率為5%。2.治療組與對照組治療前后的臨床癥狀均有統(tǒng)計學差異(P0.05),說明兩組患者臨床癥狀得到改善。兩組治療后生活質(zhì)量評分、用藥后首次排便時間、用藥后2周及用藥4周后排便次數(shù)比較有統(tǒng)計學差異(P0.05)。兩組患者用藥4周后糞便性狀比較有統(tǒng)計學差異(P0.05)。治療組隨訪復發(fā)率明顯低于對照組,兩組相比有顯著差異(P0.05)。3.在治療過程中,完成臨床觀察的84例患者均未出現(xiàn)不良事件,血常規(guī)、糞常規(guī)、生化全套、常規(guī)心電圖檢查均未見異常。結(jié)論:1.潤通湯可明顯改善陰虛型功能性便秘患者的臨床癥狀,縮短排便時間,增加排便次數(shù),改善糞便性狀,有效率高,復發(fā)率低,并且能有效提高患者的生活質(zhì)量。2.潤通湯無明顯不良反應,安全性良好。
[Abstract]:Objective: in view of the increasing number of patients with functional constipation (FCC) at present, the clinical efficacy of Runtong decoction in treating functional constipation with yin deficiency was observed, and the changes of quality of life score and routine examination before and after treatment were compared.To evaluate the efficacy and safety of Runtong decoction in order to further explore the advantages of traditional Chinese medicine in the treatment of this disease, improve the clinical efficacy and improve the quality of life of patients.Methods: a total of 88 patients with functional constipation of yin deficiency type were enrolled in a randomized controlled trial. The patients were randomly divided into treatment group (n = 44) and control group (n = 44). The observation time was 10 weeks.These include 2 weeks of introduction, 4 weeks of treatment and 4 weeks of follow-up.The quality of life scale (QOL) of constipation patients was completed before treatment and 4 weeks after treatment.During the course of treatment, the treatment group was treated with Runtong decoction on the basis of daily life conditioning, while the control group was treated with Bacillus subtilis combined with Bacillus subtilis enteric-coated capsule combined with mosapride citrate tablets. The two groups were treated with 4 weeks as a course of treatment.During the follow-up period, both groups continued to regulate their lives and stopped drug therapy.The improvement of clinical symptoms and the scores of quality of life before and after treatment were compared between the two groups, and adverse reactions during drug intervention were observed to evaluate their safety.All patients were followed up for 4 weeks to evaluate the safety and recurrence of functional constipation.The result is 1: 1.A total of 88 patients were included in the study, including 1 case in the treatment group and 3 cases in the control group. Finally, 84 patients completed the clinical observation, and the abscission rate was 5.2%.The clinical symptoms of the treatment group and the control group were significantly different before and after treatment, indicating that the clinical symptoms of the two groups were improved.The scores of quality of life, the time of first defecation, the times of defecation after 2 weeks and 4 weeks after treatment were significantly different between the two groups (P 0.05).There was a significant difference in fecal traits between the two groups after 4 weeks of treatment (P 0.05).The recurrence rate in the treatment group was significantly lower than that in the control group, and there was a significant difference between the two groups.In the course of treatment, no adverse events were found in 84 patients who completed clinical observation, blood routine, fecal routine, biochemical complete set and routine electrocardiogram were not abnormal.Conclusion 1.Runtong decoction can obviously improve the clinical symptoms of functional constipation patients with yin deficiency, shorten defecation time, increase defecation times, improve fecal traits, have high effective rate and low recurrence rate, and can effectively improve the quality of life of patients.Runtong decoction has no obvious adverse reaction and good safety.
【學位授予單位】：福建中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R256.35

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