摘要
研究背景
尿失禁(Urinary Incontinenc, UI)是一种常见的疾病,以女性患者居多,可发生于所有年龄组,但以老年人为常见,其患病率随年龄增长而升高。在经济发达的国家,尿失禁比高血压、抑郁症和糖尿病等更常见,医疗费用已远高于冠心病、骨质疏松症和乳腺癌等,成为威胁妇女健康的5种最常见慢性疾病之一。2006年的一项大规模调查发现香港妇女尿失禁的患病率大幅增高,达40.7%,相等于10年前的两倍,与西方国家如法国、德国、英国等接近。尿失禁严重危害了患者的身心健康,可造成患者行动不便,不能胜任家务,影响正常社交活动等,容易导致与社会隔离,进而有消沉压抑、孤独、丧失自信等心理障碍等,也给家庭、社会带来了巨大的经济负担。因此,对尿失禁的的治疗刻不容缓。压力性尿失禁(Stress Urinary Incontinence, SUI)是女性尿失禁最常见的形式之一。其特点是正常状态下无遗尿,而腹压突然增高时(如咳嗽、喷嚏、用力、活动等)尿液不自主地自尿道内流出。
压力性尿失禁的西医治疗有非手术治疗和手术治疗,前者主要有药物治疗、行为疗法、运动疗法、生物反馈治疗和功能性电刺激等。若药物等保守治疗无法控制时,则选用手术治疗。药物治疗时间长,副作用较多,手术治疗风险较大,容易引起各种并发症,物理治疗副作用少,常被用作第一线保守治疗,但效果参差,故仍需不断寻找治疗SUI更好的方法。在香港治疗妇女压力性尿失禁皆以西医方法为主,就因失禁问题寻求中医治疗的病例极稀少。
尿失禁相当于中医的“遗溺”,古籍很早就有记载治疗遗溺的方法。祖国医学认为,尿失禁的基本病因病机是气血不足、脾肾亏虚,治疗以补虚为主。补中益气汤出自金代名医李东垣《脾胃论》的《内外伤辨惑论》卷中,该方补中有行,补而不滞,补中有升,升阳举陷,又可甘温除热,是为补气升阳、甘温除热的代表方。而中药对香港女性压力性尿失禁研究尚未见临床报道。因此,本次研究选用补中益气汤为基础方,加入固精缩尿的桑螵蛸、覆盆子、益智仁等药物,以达到补脾温阳,强肾固脬之目的,使膀胱开阖有度,小便得以固摄。
目的
1.通过文献研究,系统归纳总结西医学和中医学对压力性尿失禁疾病范畴、流行病学特征、病因病机、临床诊断和治疗的研究概况。
2.通过开展加味补中益气汤治疗压力性尿失禁的临床研究,采用加味补中益气汤与盆底肌运动治疗压力性尿失禁患者,观察两者临床疗效的差异。
3.评估加味补中益气汤治疗香港地区成年妇女压力性尿失禁的临床疗效。
方法
1.临床资料选取2010年11月至2011年10月施德中医中药针灸诊疗所及小美物理治疗工作室就诊的经临床症状和尿动力学检查诊断为SUI的香港地区成年女性患者58例。Gullen I度者27例、Ⅱ度25例、Ⅲ度5例、Ⅳ度1例；年龄最大者79岁,最小者41岁,平均60.71±10.61岁；病程最长者15年,最短者1年,平均5.81±3.09年。采取单纯随机法分A、B两组,两组受试者在年龄、病程及体重指数(BMI)方面无显著性差异(P>0.05)。58例患者中两组受试者的怀孕、生育次数、经产史、Gullen分度分布无差异(P>0.05)。
2.研究方法两组均进行两个阶段的治疗,A组为(Ⅰ)→(Ⅱ)试验顺序,第一阶段进行运动疗法2周(Ⅰ),经2周清洗期后进行第二阶段服用加味补中益气汤(Ⅱ)；B组为(Ⅱ)→(Ⅰ)试验顺序,先服用加味补中益气汤6剂或12剂,经2周清洗期后行运动疗法。中药组方为：补中益气汤18g,桑螵蛸1.5g,覆盆子1.5g,益智仁1.5g,麻黄1.5g,柴胡1.5g,每日1剂分3次服,6剂为一疗程。运动疗法采取盆底肌运动法,参考香港医院管理局辖下医院物理治疗部的尿失禁运动指引：①锻炼力量及耐力,②锻炼协调能力,以上运动每次10min,每日3次。每阶段结束后检测相关指标：①主观指标：在专员的指导下由患者进行填写问卷,自我评价,指标包括尿失禁问卷简表(ICI-Q-SF)、尿失禁生活质量量表(I-QOL)、泌尿生殖简表(UDI)、视觉模拟量表(VAS)、失禁频率、失禁程度及夜尿次数。②客观指标：咳嗽测试、终止测试、盆底肌力量、盆底肌耐力、协调能力。
3.统计学处理应用SPSS13.0软件进行统计分析。治疗前后的比较采用配对t检验,两组间比较采用t检验,考虑治疗前影响,组间比较采用协方差分析；二分类资料的组间比较采用Pearson χ2检验,治疗前后的比较采用McNemar检验,考虑治疗前影响,组间比较采用二分类Logistic回归分析；等级资料的组间比较采用Wilcoxon秩和检验,治疗前后的比较采用Wilcoxon符号秩检验,考虑治疗前影响,组间比较采用有序多分类Logistic回归分析；结果均以P<0.05为差异有统计学意义。
结果
1.加味补中益气汤改善患者生存质量及失禁症状的疗效观察第一阶段治疗结束后,加味补中益气汤的ICI-Q-SF评分、I-QOL评分、失禁频率、失禁程度及夜尿次数在治疗前后均有差异(P<0.05)；盆底肌运动法夜尿次数治疗前后无差异(P>0.05),其余指标差异有统计学意义(P<0.05)；中药与运动法治疗后的ICI-Q-SF评分、I-QOL评分、失禁频率、失禁程度及夜尿次数均有差异(P<0.05),加味补中益气汤在降低SUI患者的ICI-Q-SF评分、升高I-QOL评分、降低失禁频率、降低失禁程度、减少夜尿次数上均优于盆底肌运动。第二阶段治疗后,加味补中益气汤的各指标在治疗前后均有差异(P<0.05)；盆底肌运动法的失禁频率、失禁程度、夜尿次数治疗前后无差异(P>0.05), ICI-Q-SF评分及I-QOL评分差异有统计学意义(P<0.05)；中药与运动法治疗后的ICI-Q-SF评分、I-QOL评分、失禁程度及夜尿次数均有差异(P<0.05),失禁频率无差异(P>0.05),说明加味补中益气汤在降低SUI患者的ICI-Q-SF评分、升高I-QOL评分、降低失禁程度、减少夜尿次数上均优于盆底肌运动。
2.加味补中益气汤改善盆底肌及膀胱的控制和治疗SUI的临床疗效观察第一阶段治疗结束后,加味补中益气汤的UDI评分、VAS评分、咳嗽测试、终止测试、盆底肌力量、盆底肌耐力及协调能力在治疗前后均有差异(P<0.05)；盆底肌运动法咳嗽测试在治疗前后无差异(P>0.05),其余指标差异有统计学意义(P<0.05)；中药与运动法治疗后的UDI评分、VAS评分、咳嗽测试均有差异(P<0.05),终止测试、盆底肌力量、盆底肌耐力及协调能力无差异(P>0.05),说明加味补中益气汤在降低SUI患者的UDI评分、降低VAS评分、升高咳嗽测试评分上均优于盆底肌运动,但在升高终止测试评分、提高盆底肌力量、增加盆底肌耐力及提高协调能力上无优势。第二阶段治疗后,加味补中益气汤的各指标在治疗前后均有差异(P<0.05)；盆底肌运动法咳嗽测试在治疗前后无差异(P>0.05),其余指标差异有统计学意义(P<0.05)；中药与运动法治疗后的UDI评分、VAS评分、咳嗽测试均有差异(P<0.05),终止测试、盆底肌力量、盆底肌耐力及协调能力无差异(P>0.05),说明加味补中益气汤在降低SUI患者的UDI评分、降低VAS评分、升高咳嗽测试评分上均优于盆底肌运动,但在升高终止测试评分、、提高盆底肌力量增加盆底肌耐力及提高协调能力上无优势。
结论
1.加味补中益气汤与盆底肌运动法对不同程度的香港地区女性SUI患者均有疗效,能有效的缓解压力性尿失禁生理、心理症状,明显提高患者的生存质量,加味补中益气汤较盆底肌运动法疗效更佳,并且能更好的改善SUI患者的生存质量,但尚不能认为在改善患者身体机能方面优于盆底肌运动疗法。
2.本次研究的样本量不够大、对照组比较单一等,可能对疗效的比较有影响。此外,纳入的病例总体病情较为轻浅,而加味补中益气汤对于病情较重的患者是否有疗效仍有待进一步研究。
Background
Urinary Incontinence (UI) is a common disease, found mostly in female population, it happens in all age group, but more commonly found in elderly, the prevalence rate increases with age. In economic developed countries, Urinary Incontinence is more common than High Blood Pressure, Depression and Diabetics Mellitus, and the health care expenditures spend on it is far more than those spent on Coronary Heart disease, Osteoporosis and Breast Cancer. UI has become one of the five most common chronic diseases that threaten the health of women. In a large scale survey study made in2006, the prevalence rate of female UI in Hong Kong has largely increased to40.7%, two-fold of what has been reported ten years ago, the result was close to the findings in western countries such as France, Germany, and Britain. Urinary Incontinence is severely harmful to the health of the subjects physically, mentally and emotionally, resulting in immobility, failure to perform housework, affecting normal social activity, and causing psychological dysfunction such as withdrawal from the society, anxiety, depression, lonesome and loss of confidence etc.. Furthermore, it puts heavy financial burden to the family and the society. Therefore, there is an urgent need to find a better solution for treatment of urinary incontinence. Stress Urinary Incontinence is one of the most common female urinary incontinence. It is characterized by no leaking in normal circumstances but only when there is a sudden rise of intra-abdominal pressure (such as:coughing, sneezing, on effort or on physical exertion) there will be involuntary loss of urine through the urethra.
In Western Medicine, SUI is treated by non-surgical intervention or surgical intervention, the previous one includes Medication, Behavior Modification, Exercise Therapy, Biofeedback Therapy and Functional Electrical Stimulation. Surgery will be recommended when conservative treatment fails. The period for medication is long and have more side-effect; the risk of surgery is comparatively higher and easy to cause complication, physical therapy has lesser side-effect and is commonly used as first-line of conservative treatment but the effect varies, thus there is a need to continue to find a better treatment for SUI. Treatment approach for female SUI in Hong Kong, is mainly from Western Medicine, patient seeking treatment from Traditional Chinese Medicine is extremely rare.
Urinary Incontinence means "leaking urine" in Chinese Medicine, and its treatment had been recorded in ancient writings long time ago. Chinese medicine of our mother country believed that the cause and mechanism of urinary incontinence is deficient in Chi and Blood, deficient in Spleen and Kidney, treatment mainly base on nourishing the insufficient."Bun Jong Yih Chih Tang" originally from "Pei Wai Lun" written by the famous doctor Lee Tung Wun in Jin period. This formula has the effect of nourishing and mobilizing, nourishing without causing stagnation; nourishing and raising, raising the yang and lifting the descended; and also removing the internal heat by its sweet and warm quality. It is a representative formula for nourishing the Chi and raising the Yang as well as removing internal heat by its sweet and warm quality. However, there is no clinical research reported on application of Chinese traditional medicine on treatment for Hong Kong Female Stress Urinary Incontinence. Therefore, Bun Jong Yih Chih Tang was taken as the basic formula with additional of Ootheca Mantidis, Fun Pern Tzyy, Alpiniae Oxyphyllae, Ma Hwang, in order to nourish the Spleen and warm the Yang, strengthen the Kidney and Bladder, so that the bladder can regulate its emptying and storage function, thus maintain the continence mechanism.
Purpose
1. To summarize systematically the literatures in Western Medicine and Chinese Medicine on SUI, its epidemiology, pathophysiology, mechanism, clinical diagnosis and treatment.
2. To investigate the clinical effect of Bun Jong Yih Chih Tang, by studying the difference in clinical outcomes of Bun Jong Yih Chih Tang and pelvic floor muscle exercise in treating stress urinary incontinence.
3. To evaluate the clinical treatment outcomes of the "Bun Jong Yih Chih Tang"(TCM) in treating Hong Kong adult female SUI.
Method
1. Clinical data Select patients who received treatment at Sze Tak Chinese Medicine and Acupuncture clinic and Maisie Physiotherapy Studio from the period2010/11to2011/10with SUI diagnosed by Clinical Presentation and Urodynamic Studies, female adults in Hong Kong,58cases. Gullen Grading:Grade Ⅰ-27cases, Grade Ⅱ-25cases, Grade Ⅲ-5cases, Grade Ⅳ-1case; the eldest person at age79, minimum41years old, an average of60.71±10.61years old; longest duration15years, minimum1year, an average of5.81±3.09years. Subjects were randomly asigned to group A or B, age, course of disease and body mass index (BMI) of the subjects in two groups has no significant differences (P>0.05). The distribution in pregnancy, number of births, multiparous history, Gullen index of the subjects in two groups has no difference (P>0.05).
2. Methodology Both groups received two stages of treatment, Group A performs (Ⅰ)→(Ⅱ) testing sequence, the first stage is2weeks of exercise intervention (I), then take2weeks off for "wash out" and second stage is receiving Chinese herbal medicine intervention(Ⅱ). Group B performs (Ⅱ)→(Ⅰ) sequence with either1or2courses of Chinese herbal medicine intervention(II), then take2weeks off for "wash out", and then receive2weeks of exercise intervention(Ⅰ). Chinese Herbal Formula: Bun Jong Yih Chih Tang18g, Ootheca Mantidis1.5g, Fun Pern Tzyy1.5g, Alpiniae Oxyphyllae1.5g, Ma Hwang1.5g, Chair Hwu1.5g ldose per day divided into3times,6day as1course. Exercise Therapy follows the Pelvic Floor Muscle Exercise guidelines from Physiotherapy Department of Hospitals of Hong Kong Hospital Authority:φTraining muscle power and endurance;(?)Training co-ordination ability, exercise for10mins.,3times daily. Related index were collected after each stage, φ Subjective index:under the guidance of trained personnel, patients were to fill in the questionnaire and self evaluation form. Index include:Urinary Incontinence Questionnaire-Short Form (ICI-Q-SF), Urinary Incontinence Quality of Life Scale (I-QOL), Urinogenital Profile (UDI), Visual Analogue Scale (VAS), frequency of incontinence, severity of incontinence and frequency of Nocturia.②Objective index: cough test, stop test, pelvic floor muscle strength, pelvic floor muscle endurance, coordination ability.
3. Statistic analysis:SPSS13.0software was applied. Around treatment were compared using the Paired-Samples T Test, inter-group comparsion using Independent-Samples T Test, considering the effects before treatment, inter-group comparsion using the analysis of covariance (ANCOVA); two classification data between groups were compared using Pearson2test, around treatment were compared with McNemar test, considering the effects before treatment, inter-group comparison using two classification of Logistic regression analysis; ranking data were compared by Wilcoxon rank sum test, before and after treatment were compared by Wilcoxon signed rank test, considering the effects before treatment, inter-group comparsion using the ordinal Logistic regression analysis; level of significance were P<0.05.
Result
1. Treatment effect of Bun Jong Yih Chih Tang in improving quality of life and incontinence symptoms After first stage of treatment, the before and after reading in the ICI-Q-SF score, I-QOL score, frequency of incontinence, intensity of incontinence and frequency of nocturia in the Bun Jong Yih Chih Tang treated group show significant difference (P<0.05); in the pelvic floor muscle exercises treated group, there is no difference only in the number of nocturia (P>0.05), otherwise all other indexes had a significant difference (P<0.05); post treatment reading in ICI-Q-SF score, I-QOL score, frequency of incontinence, intensity of incontinence and frequency of nocturia between the traditional Chinese medicine and pelvic floor muscle exercise treated group were different (P<0.05), Bun Jong Yih Chih Tang is superior than pelvic floor muscle exercises in increasing I-QOL score, reducing ICI-Q-SF score, frequency of incontinence, intensity of incontinence, frequency of nocturia. After second stage of treatment, the before and after reading in the Bun Jong Yih Chih Tang treated group had significant difference (P<0.05); in the pelvic floor muscle exercise treated group, the before and after reading in frequency of incontinence, intensity of incontinence, frequency of nocturia had no difference (P>0.05), the ICI-Q-SF score and I-QOL score differences are statistically significant (P <0.05); post treatment reading in ICI-Q-SF score, I-QOL score, intensity of incontinence and frequency of nocturia between the traditional Chinese medicine and pelvic floor muscle exercise treated group were different (P<0.05), frequency of incontinence had no no difference (P>0.05), showing that Bun Jong Yih Chih Tang is superior than the pelvic floor muscle exercise in increasing I-QOL score, reducing ICI-Q-SF score, severity of incontinence, frequency of nocturia.
2. Effect of Bun Jong Yih Chih Tang in improving pelvic floor muscle performance and bladder control and its treatment effect on SUI After first stage of treatment, the UDI score, VAS score, cough test, stop test, pelvic floor muscle strength, pelvic floor muscle endurance and coordination capacity around treatment of Bun Jong Yih Chih Tang treated group were significantly different (P<0.05); the before and after reading of cough test in the pelvic floor muscle exercise treated group, had no difference (P>0.05), otherwise, all other indexes were statistically significant (P<0.05); post treatment reading in UDI score, VAS score, cough test between the traditional Chinese medicine and pelvic floor muscle exercise treated group were different (P<0.05), stop test, pelvic floor muscle strength, pelvic floor muscle endurance and coordination ability had no difference (P>0.05), indicating that Bun Jong Yih Chih Tang is superior than pelvic floor muscle exercise in reducing UDI score, VAS score, and increasing cough test score but its effect on increasing the stop test score, improving pelvic floor muscle strength, increasing pelvic floor muscle endurance and improving coordination ability is similar to that by pelvic floor muscle exercise. After Second stage of treatment, the before and after treatment reading of all indexes in Bun Jong Yih Chih Tang treated group showed significant difference (P <0.05); cough test in pelvic floor muscle exercise had no difference (P>0.05), otherwise, all other indexes had a significant difference (P<0.05); post treatment reading between the Bun Jong Yih Chih Tang group and pelvic floor muscle exercise group in UDI score, VAS score, cough test, had significant difference (P<0.05), stop test, pelvic floor muscle strength, pelvic floor muscle endurance and coordination ability had no difference (P>0.05), indicating that Bun Jong Yih Chih Tang is superior than pelvic floor muscle exercise in reducing UDI score, VAS score, and increasing cough test score, but its effect in the increasing the stop test score, pelvic floor muscle power, pelvic floor muscle endurance and coordination ability did not show any advantage.
Conclusion
1. Modified Bun Jong Yih Chih Tang and Pelvic Floor Muscle Exercise have noticeable curative effect for different grade of SUI of Hong Kong adult female sufferer. Both can effectively reduce the physiological and psychological symptoms of SUI, significantly improve the quality of life, and reduce suffering. Modified Bun Jong Yih Chih Tang showed better results when compare with pelvic floor muscles exercise, and can better improve the quality of life of the incontinence. However, one cannot conclude that it has better effect in improving the performance of the Pelvic Floor Muscles Exercise when compare with the exercise group
2. The drawback of this study is that the number of subjects is not big and the control is not diversified, which may affect the results of comparison of curative effect. In addition, the cases in the study have less severe symptoms, and the therapeutic effect of modified Bun Jong Yih Chih Tang in more severe cases requires further investigation.
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