本文選題：混合性尿失禁 + 調(diào)理脾胃　； 參考：《中國中醫(yī)科學(xué)院》2016年博士論文

【摘要】：1.研究背景混合性尿失禁(MUI)是一種復(fù)雜的膀胱尿道功能障礙,同時具有壓力性尿失禁(SUI)和急迫性尿失禁(UUI)的臨床特征。對于此種疾病,現(xiàn)代醫(yī)學(xué)目前尚無標(biāo)準(zhǔn)化的治療手段。文獻(xiàn)報道,無論是手術(shù)治療還是藥物治療均存在有較高的治療失敗率。因此,探索一種確實、有效的治療手段具有重要意義。中醫(yī)學(xué)具有調(diào)節(jié)人體整體功能的作用,對很多慢性疾病具有獨特的療效。一些國內(nèi)學(xué)者嘗試采用中醫(yī)藥的方法治療MUI取得一定療效,但大部分報道均為個案報道和臨床經(jīng)驗總結(jié),有限的臨床研究也都僅僅從患者癥狀改善的角度對療效進(jìn)行單一的主觀評價,缺乏客觀評價指標(biāo)。因而無法提供有效的循證醫(yī)學(xué)證據(jù),限制了這些中醫(yī)治療手段在臨床中的推廣與應(yīng)用。本課題組通過繼承我院名老中醫(yī)的學(xué)術(shù)思想,嘗試應(yīng)用調(diào)理脾胃法治療MUI取得較好的療效。本研究在前期研究的基礎(chǔ)上,試圖通過嚴(yán)謹(jǐn)?shù)脑囼炘O(shè)計方案,采用國際公認(rèn)的評價指標(biāo),評價基于調(diào)理脾胃法的針刺聯(lián)合中藥療法對MUI的療效。2.研究目的(1)評價基于調(diào)理脾胃法所組方的中藥“益氣縮泉湯”和針刺療法對女性MUI的療效。(2)探索“益氣縮泉湯”和針刺療法在治療女性MUI方面是否存在增效作用。(3)探索針刺療法與抗膽堿能西藥在治療女性MUI方面是否存在增效作用。3.研究方法本研究采用前瞻性、隨機(jī)、多組平行對照的臨床研究設(shè)計,使用QUID中文翻譯版量表對女性MUI患者實現(xiàn)客觀、量化診斷。在依據(jù)前期研究結(jié)果對研究所需的樣本量進(jìn)行估算后,將符合研究納入標(biāo)準(zhǔn)的124例患者隨機(jī)分為單純針刺治療組、單純中藥治療組、針刺聯(lián)合中藥組和針刺聯(lián)合西藥治療組。其中,單純針刺治療組采用針刺治療,取穴包括雙側(cè)足三里、三陰交、次骼、會陽,其中次毼和會陽連接電針,采用疏密波(4/20hz)治療30分鐘,每周治療3次；單純中藥組采用中藥煎劑“益氣縮泉湯”(炙黃芪30g,人參10g,當(dāng)歸10g,白術(shù)l0g,益智仁l0g,烏藥6g,山藥10g,陳皮10g,升麻l0g,柴胡l0g,覆盆子15g,炒萊菔子l0g)治療,每次口服200ml,早晚分兩次服用。針刺聯(lián)合中藥治療組同時采用中藥“益氣縮泉湯”和針刺治療;針刺治療聯(lián)合西藥治療組在針刺治療的基礎(chǔ)上,聯(lián)合口服抗膽堿能藥物酒石酸托特羅定緩釋片4mg,每日1次。四組的治療周期均為8周。研究的主要終點指標(biāo)為通過24小時尿墊試驗評價的患者每日漏尿量。次要終點指標(biāo)包括：通過ICIQ-SF問卷評價的臨床癥狀,72小時排尿日記評價的尿失禁(UI)發(fā)作頻率,I-QOL問卷評價的患者生活質(zhì)量和通過尿動力學(xué)檢查評價的患者膀胱尿道功能。此外,研究過程中每組患者出現(xiàn)的不良事件以及不良事件的嚴(yán)重程度均被詳細(xì)記錄。對于主要終點指標(biāo)的評價主要參考以下標(biāo)準(zhǔn)：①治愈：24小時尿墊試驗轉(zhuǎn)陰；②改善：24小時尿墊試驗減低50%以上;③無效：24小時尿墊試驗減低50%以下。研究中有效患者指治愈和改善患者的總和。研究結(jié)果的統(tǒng)計分析皆基于意向性分析(ITT)。對于定量資料的組間比較,當(dāng)數(shù)據(jù)符合正態(tài)分布時4組間總體差異比較采用方差分析,非正態(tài)分布者采用Kruskal-Wallis H檢驗；對于定性資料的組間比較,4組間構(gòu)成比的比較采用R×C表Chi-Square檢驗。當(dāng)總體4組間存在顯著性差異時,則進(jìn)一步行任意兩組間比較。定量資料當(dāng)數(shù)據(jù)符合正態(tài)分布時采用兩獨立樣本t檢驗,非正態(tài)分布者采用Wilcoxon秩和檢驗；對于定性資料構(gòu)成比的比較采用Chi-Square檢驗或Fisher精確概率計算法,并采用Turky法調(diào)整檢驗水準(zhǔn)。對于定量資料的組內(nèi)比較,當(dāng)數(shù)據(jù)符合正態(tài)分布時采用配對t檢驗,非正態(tài)分布者采用Wilcoxon符號秩和檢驗。對于定性資料組內(nèi)構(gòu)成比的比較采用McNemar檢驗。所有檢驗均為雙側(cè)檢驗,以P0.05作為統(tǒng)計學(xué)顯著性差異指標(biāo)。4.結(jié)果4.1一般情況本研究共納入135名女性MUI患者,經(jīng)篩查后剔除7例患者,研究過程中脫落4例患者,共124例患者至少完成一次以上的療效評價,納入最終結(jié)果分析。其中,年齡最小者為32歲,最大者為65歲,平均年齡為53.22±8.99歲。體重指數(shù)平均為22.69±2.79�；颊呷虢M時平均病程為4.5年,最少1年,最長為14年。四組患者在年齡、體重指數(shù)、病程和尿動力學(xué)指標(biāo)等基線指標(biāo)方面組間比較無顯著差異(P0.05),提示四組患者資料具有良好的臨床可比性(表1)。注：BMI：體重指數(shù)；Qmax:最大尿流率；PVR：膀胱殘余尿量。a結(jié)果以x±s表示,組間比較采用方差分析;b結(jié)果以M(IQR)表示,組間比較采用Kruskal-Wallis H檢驗。4.2主要終點指標(biāo)經(jīng)過8周治療,在不同治療組中絕大多數(shù)患者均表現(xiàn)為改善和治愈,針刺聯(lián)合中藥治療組的治愈率和有效率分別為29%和87.1%；單純針刺治療組的治愈率和有效率分別為16.1%和77.4%；單純中藥治療組的治愈率和有效率分別為15.6%和75%；針刺治療聯(lián)合西藥治療組的治愈率和有效率分別為26.7%和83.3%。各治療組在疾病的治愈率和有效率方面無顯著性差異(P0.05)。就24小時尿墊試驗所測量的患者每日漏尿量而言,各組患者的基線漏尿量無顯著差異,表現(xiàn)為良好的臨床可比性。8周后結(jié)果提示,各種治療均能夠顯著降低患者的日漏尿量(表2)。其中,對比單純針刺或中藥治療,針刺聯(lián)合中藥治療能夠更顯著的降低患者的日漏尿量(P0.05)。雖然針刺聯(lián)合西藥治療也表現(xiàn)出比單純針刺或中藥治療更好的療效,但卻不具有統(tǒng)計學(xué)差異(P0.05)。4.3次要終點指標(biāo)變化4.3.1臨床癥狀評分變化治療前各組患者ICIQ-SF問卷中各問題評分和總分均無顯著性差異,提示各組患者基線癥狀的嚴(yán)重程度相似,具有良好的臨床可比性。治療8周后,各組患者的各項問題評分以及問卷總分均較基線值顯著降低(表3),提示患者臨床癥狀的改善。其中,針刺聯(lián)合中藥治療組表現(xiàn)出最優(yōu)的療效,使患者中位ICIQ-SF總分由16分降至7分,但與其他治療組相比無顯著性差異(P0.05)。4.3.2 UI發(fā)作頻率變化治療前各組患者中位UI發(fā)作頻率為4-5次/日,組間比較無顯著性差異,具有良好的臨床可比性。治療8周后,各組患者UI日發(fā)作頻率較基線水平均顯著減少(表4),提示患者癥狀的改善。盡管針刺聯(lián)合中藥治療更明顯地降低了患者的U1日發(fā)作頻率,由5次/日降為1次/日,但與其他治療組相比無顯著性差異(P0.05)。此外,8周治療分別使83.9%(針刺聯(lián)合中藥組),74.2%(單純針刺組),71.9%(單純中藥組)和83.3%(針刺聯(lián)合西藥組)的患者UI日發(fā)作頻率降低50%以上,組間比較無顯著性差異(P0.05)。4.3.3生活質(zhì)量變化治療前各組患者I-QOL問卷各方面評分和總分均無顯著性差異,提示各組患者在基線具有相似的生活質(zhì)量,具有良好的臨床可比性。經(jīng)過8周治療,各組患者各方面生活質(zhì)量均得到顯著改善(表5)。其中,對比單純針刺組,針刺聯(lián)合中藥組患者療后具有更高的I-QOL總分,提示患者具有相對更高的生活質(zhì)量。4.3.4膀胱尿道功能變化研究期間,共有43名MUI患者完成了基線和療后的尿動力學(xué)評價。其中,針刺聯(lián)合中藥組12例,單純針刺組13例,單純中藥組10例,針刺聯(lián)合西藥組8例。8周治療后,各組患者的腹壓漏尿點壓力和尿道閉合壓均得到顯著增加(表6),組間比較無顯著差異(P0.05)。其中,四組中各有41.7%,38.5%,40%和50%的患者腹壓漏尿點壓力恢復(fù)正常(150cmH2O)。然而,治療后四組患者逼尿肌過度活動的發(fā)生率與基線相比無顯著差異。4.3.5不良事件分析研究過程中共有11名患者報告了不良事件,但未發(fā)生嚴(yán)重不良事件。其中,針刺聯(lián)合西藥組具有更高的不良反應(yīng)發(fā)生率(P0.05),共有7名患者出現(xiàn)口干,1名患者發(fā)生便秘。相比之下,其他治療組僅有極少數(shù)患者報告不良事件。在針刺聯(lián)合中藥治療組內(nèi)1名患者描述一過性失眠；單純針刺組有1名患者出現(xiàn)針刺部位淤血疼痛,經(jīng)對癥處理后癥狀消失；單純中藥治療組內(nèi)1名患者出現(xiàn)頭暈,未經(jīng)治療自行緩解。5.結(jié)論(1)無論是基于調(diào)理脾胃法組方的益氣縮泉湯還是針刺療法都能夠顯著降低女性MUI患者的每日漏尿量,改善患者的臨床癥狀,提高生活質(zhì)量,并能夠顯著改善患者的膀胱尿道功能,具體表現(xiàn)為對腹壓漏尿點壓力和最大尿道閉合壓力的提高。(2)益氣縮泉湯與針刺療法治療MUI具有一定的協(xié)同增效作用,二者的聯(lián)合治療能夠更有效地降低患者的每日漏尿量,提高患者的生活質(zhì)量。(3)研究中未觀察到針刺療法與抗膽堿能西藥聯(lián)合治療對女性MUI的協(xié)同治療作用。
[Abstract]:1. study background mixed urinary incontinence (MUI) is a complex bladder and urethral dysfunction, with clinical features of stress urinary incontinence (SUI) and urgent incontinence (UUI). There is no standardized treatment for modern medicine. Therefore, it is of great significance to explore a true and effective means of treatment. Traditional Chinese medicine has the role of regulating the overall function of the human body and has a unique effect on many chronic diseases. Some domestic scholars have tried to treat MUI with traditional Chinese medicine, but most of the reports are case reports and clinical classics. The limited clinical study is only a single subjective evaluation of the curative effect from the angle of symptom improvement and lack of objective evaluation index. Therefore, it is impossible to provide effective evidence-based medical evidence and restrict the popularization and application of these traditional Chinese medicine methods in clinical practice. Think, try to use the method of regulating spleen and stomach for the treatment of MUI. On the basis of the previous study, this study tried to evaluate the effect of acupuncture combined with traditional Chinese medicine therapy based on the method of regulating spleen and stomach on the effect of.2. study on the effect of MUI based on the rigorous experimental design scheme and the internationally recognized evaluation index (1) to evaluate the group based on the method of regulating spleen and stomach. The effect of "Yiqi shigu Quan Tang" and acupuncture therapy on female MUI. (2) explore the effect of "Yiqi Jin Quan Tang" and acupuncture therapy on the treatment of female MUI. (3) explore whether acupuncture therapy and anti cholinergic western medicine have synergistic effect in the treatment of female MUI by using.3. method, this study is prospective, random, and more Group parallel control clinical research design, using the QUID Chinese version of the scale to achieve objective and quantitative diagnosis of female MUI patients. After estimating the sample size required by the previous research results, 124 patients were randomly divided into simple acupuncture treatment group, simple Chinese medicine treatment group, acupuncture combined with traditional Chinese medicine. Group and acupuncture combined with western medicine treatment group. Among them, the acupuncture treatment group was treated with acupuncture only. The acupoints included bilateral Zusanli, Sanyinjiao, iliac, and Hui Yang, of which the secondary and Hui Yang were connected with electroacupuncture, the 4/20hz was used for 30 minutes and 3 times a week; the Dan Chunzhong medicine group was treated with Chinese medicine decoction "Yiqi Qi Quan Decoction" (Radix Astragali 30g, ginseng 1) 0g, Chinese angelica 10g, Atractylodes L0g, yizhi L0g, yam 6G, yam 10g, orange peel 10g, cohosh L0g, bupleurum L0g, raspberry 15g, and radish semen L0g) treatment, each time taking 200ml, two times in the morning and evening. The acupuncture combined with Chinese medicine treatment group and the Chinese medicine "Yiqi shigu Quan Decoction" and acupuncture treatment; acupuncture treatment group in the treatment group of Western medicine treatment group in the base of acupuncture treatment On the basis of the combined oral anticholinergic drug Tolterodine Tartrate Sustained Release Tablets 4mg, 1 times a day. The four groups were treated for 8 weeks. The main end point of the study was the daily leakage of urine in patients evaluated through the 24 hour urinary cushion test. Secondary end points included the clinical symptoms evaluated through the ICIQ-SF questionnaire and the 72 hour urination diary. Urinary incontinence (UI) attack frequency, I-QOL questionnaire evaluated the quality of life and urinary bladder urethral function evaluated by urodynamic examination. In addition, the adverse events and the severity of adverse events in each group were recorded in detail. The evaluation of the main final indicators was mainly referred to as following criteria: (1) Recovery: 24 hours of urine cushion test turned negative; (2) improvement: 24 hour urine cushion test decreased by more than 50%; 3. Invalid: 24 hour urine cushion test decreased by 50%. The effective patients in the study were the total of cured and improved patients. The statistical analysis of the results were based on the intentionality analysis (ITT). The total difference between the 4 groups was compared with the analysis of variance, and the non normal distribution used Kruskal-Wallis H test. For the comparison of the qualitative data, the comparison between the 4 groups was compared with the R x C Chi-Square test. When there was a significant difference between the 4 groups, the comparison between the two groups was further compared. Quantitative data was used as data Fu Hezheng The two independent sample t test is used in the state distribution, and the non normal distribution uses the Wilcoxon rank sum test. The comparison of the qualitative data composition ratio uses the Chi-Square test or the Fisher precision probability calculation method, and the Turky method is used to adjust the test level. For the quantitative data group comparison, when the data conforms to normal distribution, the paired t test is used. Wilcoxon sign rank sum test was used for non normal distribution. McNemar test was used to compare the constituent ratio of qualitative data group. All tests were bilateral test, and P0.05 was used as a statistical significant difference index of.4. results 4.1. A total of 135 female MUI patients were included in this study. 7 patients were removed after screening. In 4 patients, a total of 124 patients were evaluated at least one time and more. Among them, the youngest was 32 years old and the largest was 65 years old and the average age was 53.22 + 8.99 years. The average course of disease was 4.5 years, at least 1 years and the longest was 14 years when the body mass index was 22.69 + 2.79.. The four group was in age and weight. There were no significant differences in baseline indicators, such as index, course of disease and urodynamic indicators (P0.05), suggesting that four groups of patients had good clinical comparability (Table 1). Note: BMI: body mass index; Qmax: maximum urine flow rate; PVR:.A results of urinary bladder residual urine.A were shown in X + s, and variance analysis was used in groups; B results were in M (IQR) table. Kruskal-Wallis H test was used to test the main end point of.4.2 for 8 weeks. Most of the patients in the different treatment groups were improved and cured. The cure rate and the effective rate of the acupuncture combined with Chinese medicine treatment group were 29% and 87.1%, respectively, and the cure rate and the effective rate of the simple acupuncture group were 16.1% and 77.4%, respectively. The cure rate and the effective rate of the pure Chinese medicine treatment group were 15.6% and 75% respectively. The cure rate and the effective rate of the acupuncture treatment group with the western medicine treatment group were 26.7% and 83.3%., respectively, and there was no significant difference in the cure rate and the efficiency of the disease in each treatment group (P0.05). In terms of the daily leakage of urine in the patients measured by the 24 hour urine cushion test, the patients in each group were in each group. There was no significant difference in the amount of baseline leaking urine. The results showed a good clinical comparability after.8 weeks. All kinds of treatments could significantly reduce the daily leakage of urine in patients (Table 2). In comparison with the treatment of pure acupuncture or traditional Chinese medicine, acupuncture combined with traditional Chinese medicine could significantly reduce the daily leakage of urine (P0.05) in the patients. It also showed better curative effect than pure acupuncture or traditional Chinese medicine treatment, but it did not have statistical difference (P0.05).4.3 secondary end point index change of 4.3.1 clinical symptom score. There was no significant difference in the score and total score of various problems in the ICIQ-SF questionnaire before treatment, suggesting that the severity of baseline symptoms in each group was similar, and it was good. 8 weeks after treatment, the scores of all the patients in each group and the total score of the questionnaire were significantly lower than the baseline (Table 3), indicating the improvement of the clinical symptoms of the patients. Among them, the acupuncture combined with Chinese medicine treatment group showed the best effect, which reduced the total score of ICIQ-SF from 16 to 7, but was not significant compared with the other treatment groups. There was no significant difference between the groups in each group before the treatment of the difference (P0.05).4.3.2 UI frequency change. There was no significant difference between the groups. There was a good clinical comparability between the groups. After 8 weeks of treatment, the frequency of UI day in each group was significantly less than that of the baseline (Table 4), indicating the improvement of the patient's symptoms. Although the acupuncture combined with Chinese medicine, the treatment was more effective. The frequency of U1 daily seizures was significantly reduced from 5 times to 1 times per day, but there was no significant difference compared with other treatment groups (P0.05). In addition, 8 weeks of treatment made 83.9% (acupuncture combined with Chinese medicine group), 74.2% (simple acupuncture group), 71.9% (pure Chinese medicine group) and 83.3% (acupuncture combined western medicine group) decreased more than 50% of UI day attack frequency. There was no significant difference between the groups (P0.05) and there was no significant difference in the score and total score of the I-QOL questionnaire in each group before the treatment of.4.3.3. It suggested that the patients in each group had a similar quality of life in the baseline and had a good clinical comparability. After 8 weeks of treatment, the quality of life in each group had been significantly improved. Table 5). Among them, compared with the simple acupuncture group, the patients with acupuncture combined with Chinese medicine group had a higher total score of I-QOL after treatment, suggesting that during the study of a relatively high quality of life of the patients with a higher quality of life.4.3.4, a total of 43 MUI patients completed the baseline and postoperative urodynamic evaluation. Among them, 12 cases were combined with acupuncture combined with traditional Chinese medicine group and 1 of pure acupuncture group. 3 cases, pure Chinese medicine group 10 cases, acupuncture combined with Western Medicine Group 8 cases of.8 weeks after treatment, all groups of abdominal pressure leakage urine point pressure and urethral closure pressure were significantly increased (Table 6), there was no significant difference between groups (P0.05). Among the four groups, 41.7%, 38.5%, 40% and 50% of the patients with abdominal pressure leak pressure recovered normal (150cmH2O). However, four after treatment, four There was no significant difference in the incidence of detrusor overactivity in the group of patients compared with the baseline. 11 patients reported adverse events in the.4.3.5 adverse event analysis, but there were no serious adverse events. Among them, acupuncture combined with western medicine group had a higher incidence of adverse reactions (P0.05), a total of 7 patients had a dry mouth and 1 patients occurred. Constipation. In comparison, only a few patients in other treatment groups reported adverse events. 1 patients in the acupuncture combined with Chinese medicine treatment group described a sexual insomnia; in the simple acupuncture group, 1 patients had pain in the acupuncture site and the symptoms disappeared after the treatment, and 1 patients in the treatment group were dizzy and untreated themselves. The relieving.5. conclusion (1) whether it is based on the prescription of regulating spleen and stomach and the acupuncture therapy can significantly reduce the daily leakage of urine in women's MUI patients, improve the clinical symptoms and improve the quality of life, and can significantly improve the bladder urethral function of the patients, specifically for the pressure of abdominal pressure leakage and the maximum urethral closure. 2. (2) Yiqi Quan Tang and acupuncture therapy have a certain synergistic effect on the treatment of MUI. The combined treatment of the two can effectively reduce the daily leakage of urine and improve the quality of life of the patients. (3) no observation of the synergistic effect of acupuncture therapy and anti cholinergic western medicine on female MUI.
【學(xué)位授予單位】：中國中醫(yī)科學(xué)院
【學(xué)位級別】：博士
【學(xué)位授予年份】：2016
【分類號】：R711.59

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