芪实颗粒联合盆底肌训练治疗女性轻中度压力性尿失禁的临床观察

发布时间：2018-05-01 08:42

本文选题：芪实颗粒 + 盆底肌训练　；参考：《中国中医科学院》2016年博士论文

【摘要】：1研究目的1.1通过对中医药联合盆底肌训练治疗女性压力性尿失禁疗效的系统评价,为临床实践提供循证医学证据；1.2观察芪实颗粒治疗女性压力性尿失禁的ICI-Q-SF评分变化及尿垫试验变化,评价其疗效：观察芪实颗粒联合盆底肌训练治疗女性压力性尿失禁的ICI-Q-SF评分及I-QOL评分变化,24小时尿失禁频次评价其疗效。为中医药治疗女性压力性尿失禁提供临床依据；1.3研究芪实颗粒联合盆底肌训练治疗女性压力性尿失禁的症状时点缓解规律。2试验方法2.1检索中文数据库包括相关期刊论文(CNKI)、维普中文科技期刊全文数据库(VIP)、万方全文数据库、中国生物医学文献数据库(CBM)；外文数据库包括PubMed等。所有检索时间为各数据库建库时间至2016年1月。文献检索语言为中英文。手工检索相关杂志、会议的中英文文献,用谷歌(Google)等搜索引擎在互联网上查找相关文献并追查已检出文献的参考文献,查找灰色文献,所查文献包括期刊、会议文章汇编及研究生论文。系统评价中医药联合盆底肌训练治疗女性压力性尿失禁的疗效。2.2选择中国中医科学院西苑医院泌尿外科门诊轻中度压力性尿失禁(SUI)患者70例,按随机数字表法将患者随机分为两组,治疗组、对照组各35例。治疗组采用芪实颗粒；对照组采用盆底肌训练疗法。观察两组患者ICI-Q-SF评分、尿失禁量的变化和临床疗效比较,均连续治疗4周后统计疗效。2.3纳入西苑医院泌尿外科的成年女性轻中度SUI患者,共62例。进行平行对照、随机、双盲临床试验。治疗组选用芪实颗粒联合盆底肌功能训练治疗；对照组选用安慰剂联合盆底肌功能训练治疗。连续服药56天,每两周访视一次。通过ICI-Q-SF评分、I-QOL评分、24小时排尿日记的尿失禁频率记录进行疗效评估。3结果3.1中医药联合盆底肌训练治疗女性压力性尿失禁的meta分析结果中医药联合盆底肌训练治疗女性压力性尿失禁有效：中医药联合盆底肌训练治疗女性压力性尿失禁优于单纯使用盆底肌训练治疗。由于纳入的文献质量偏低,本研究得出结论的应用需要谨慎。尿失禁的病位以脾、肾为主,临床应用补脾益肾的中药联合盆底肌训练对于压力性尿失禁的预防和治疗有一定的疗效。但是由于目前研究的患者数量少,质量偏低,各家对结局的判定指标不统一等问题,不能完全说明中医药对治疗女性压力性尿失禁有一定的疗效,还需要大量的随机样本研究,统一的量化评定标准来进一步评价。3.1.1文献的一般情况从纳入文献的基本情况来看,文献发表的数量相对较少,文献的真实性和可信度较高,但目前文献的基金支持少,且多为单中心研究。3.1.2随机化、分配方案、盲法本系统评价纳入的4篇研究文献仅提及为随机分组,未显示分组方法,不能判定随机分组的正确性,随机化的整体质量不高。都未描述是否实施分配方案的隐匿,因此存在选择偏移的可能性大。均未描述盲法的具体应用,使用盲法率低,从质量评价标准来看,不可避免存在偏倚。3.1.3退出、失访、不良反应病例记录4篇研究文献均未提及随访时间的标准,均未描述退出与失访病例,从研究结果看无退出与失访病例。均未描述严重不良事件,无法判断使用药物的安全性。3.1.4疗效判定指标、统计学方法疗效观测指标不统一,影响疗效的判定和结论的分析,整体研究缺少中医特色。本研究4篇文章中未说明具体统计学方法,从报道提供的资料看4篇文献的统计方法正确,有具体的统计量和P值。3.2芪实颗粒及盆底肌训练对女性压力性尿失禁影响的临床观察结果3.2.1两组治疗后ICI-Q-SF评分与尿失禁量比较治疗后2周两组ICI-Q-SF评分与尿失禁量均较同组治疗前明显改善(P0.01)；治疗后4周与同组治疗后2周比较,治疗组差异有统计学意义(P0.01),对照组则无明显变化(P0.05)。治疗组治疗后2周、4周与对照组同时间段比较,差异有统计学意义(P0.05、P0.01)3.2.2临床疗效比较治疗后治疗组总有效率为67.7%,对照组为37.0%,两组总有效率比较,差异有显著性意义(P0.01)。3.3芪实颗粒联合盆底肌训练对Ⅰ-Ⅲ度女性压力性尿失禁ICI-Q-SF及I-QOL评分影响的临床观察结果3.3.1试验组和对照组ICI-Q-SF评分比较组内比较,试验组ICI-Q-SF分数从治疗后2周起,均与前一次访视时有减少,减少的分值具有统计学意义(2周时P值0.005,4周、6周、8周P值均0.0001)。对照组ICI-Q-SF分数在疗后2周时与基线相比,疗效变化无统计学意义,从疗后4周起与前一次访视相比,分数有所减少,减少值有统计学意义(P值均0.0001)试验组和对照组的ICI-Q-SF基线值比较,P值为0.6825,二者无统计学意义：自服药2周,直至4周后,试验组和对照组的ICI-Q-SF值比较均无统计学意义(P值分别为0.2625和0.1063)；但当服药至6周P值为0.0095,8周P值为0.0003,两组比较差异显著。3.3.2试验组和对照组I-QOL评分比较组内比较,试验组QOL分数从疗后2周起,均与前一次访视时有增加,增加的分值具有统计学意义(2周时P值0.05,4周、6周、8周P值均0.0001)。对照组QOL分数在疗后2周时与基线相比,疗效变化无统计学意义,从疗后4周起与前一次访视相比增加量有统计学意义(P值均0.0001)。试验组和对照组的I-QOL基线值比较,P值为0.687,二者无统计学意义；服药2周试验组和对照组的ICI-Q-SF值比较无统计学意义,P值为0.905；但当服药至4周、6周及8周后,P值为0.0317、0.0003、0.0001,统计学差异显著。3.3.3试验组和对照组24h尿失禁频次比较组内比较,试验组尿失禁频次从疗后2周起,均与前一次访视时有减少,减少的频次数具有统计学意义(2周、4周P值0.0005,6周、8周P值0.0001)。对照组尿失禁频次在疗后2周时与基线相比,变化无统计学意义,从疗后4周起与前一次访视相比,减少的尿失禁频次有统计学意义(P值均0.0001)。试验组和对照组的尿失禁频次基线值比较,P值为0.498,二者无统计学意义；服药2周、4周后试验组和对照组的尿失禁频次比较无统计学意义,P值为0.0938和0.078；但当服药至6周及8周后,P值为0.0071、0.0002,统计学差异显著。3.3.4治疗前后漏尿情况分析试验组在咳嗽或打喷嚏时漏尿和在活动或体育运动时漏尿两项的好转率大于对照组。4结论4.1 meta分析结果显示中医药联合盆底肌训练治疗女性压力性尿失禁有效；4.2单纯运用芪实颗粒治疗女性轻中度压力性尿失禁疗效优于盆底肌训练组；4.3芪实颗粒联合盆底肌训练可以改善轻中度女性压力性尿失禁的ICI-Q-SF评分、I-QOL评分及24小时尿失禁频次；且疗效优于盆底肌训练对照组；4.4芪实颗粒联合盆底肌训练治疗女性压力性尿失禁有明显的症状时点缓解规律。
[Abstract]:Objective 1.1 To provide evidence for evidence - based medicine in clinical practice through systematic evaluation of the curative effect of Chinese medicine combined with pelvic floor muscle training on female stress urinary incontinence ;
1.2 To observe the change of ICI - Q - SF score and the change of urinary pad test in female stress urinary incontinence , and evaluate its curative effect by observing the changes of the ICI - Q - SF score and I - QOL score in female stress urinary incontinence .
1.3 To study the rule of point relief in the treatment of female stress urinary incontinence by the combination of Qi - solid granule and pelvic floor muscle training . The test method 2.1 retrieves Chinese database including Chinese journal full - text database ( CNKI ) , full - text database ( VIP ) of Vip Chinese sci - tech periodicals , full - text database of Wanfang , Chinese Biomedical Literature Database ( CBM ) ;
The literature search language is Chinese and English . The literature search language is Chinese and English . The literature search language is Chinese and English . The literature search language is Chinese and English . The literature search language is Chinese and English . According to the Chinese and English literature of the conference , the author searches the relevant literature on the Internet and looks up the literature references . The system evaluates the curative effect of Chinese medicine combined with pelvic floor muscle training on female stress urinary incontinence .
In the control group , pelvic floor muscle training was used to observe the effects of ICI - Q - SF score , urinary incontinence and clinical curative effect in two groups .
In the control group , the therapeutic effect of traditional Chinese medicine combined with pelvic floor muscle training on the prevention and treatment of female stress urinary incontinence was discussed . The results showed that the clinical application of traditional Chinese medicine combined with pelvic floor muscle training was superior to the treatment of female stress urinary incontinence .
Compared with the control group , the total effective rate was 67.7 % in the treatment group and 37.0 % in the control group . Compared with the control group , the total effective rate was 67.7 % in the treatment group and 37.0 % in the control group .
Compared with baseline , the QOL scores of the control group were significantly different from baseline ( P < 0.05 , 4 weeks , 6 weeks , 8 weeks P < 0.0001 ) . Compared with baseline , the scores of QOL in the control group were statistically significant ( P < 0 . 0001 ) .
The ICI - Q - SF values of the two week test group and the control group were not statistically significant , and the P value was 0.905 ;
Compared with baseline at 2 weeks after treatment , the frequency of urinary incontinence decreased significantly ( P < 0.0001 ) . Compared with baseline in the control group , the frequency of urinary incontinence decreased significantly ( P < 0.0001 ) . Compared with baseline in the control group , the frequency of urinary incontinence decreased significantly ( P < 0.0001 ) .
The frequency of urinary incontinence in the test group and the control group was not statistically significant after 2 weeks , 0 . 0938 and 0.078 , respectively .
The results showed that the combined pelvic floor muscle training in the treatment of female stress urinary incontinence was effective in the treatment of female stress urinary incontinence .
4.2 The curative effect of treating female with mild and moderate pressure urinary incontinence was better than that of pelvic floor muscle training group .
4 . The ICI - Q - SF score , I - QOL score and 24 - hour urinary incontinence frequency of female stress urinary incontinence in women with mild and moderate pressure were improved by the combination of Qi - solid granule and pelvic floor muscle .
and the curative effect is superior to that of the pelvic floor muscle training control group ;
4.4 Qi - solid granule combined with pelvic floor muscle training in the treatment of female stress urinary incontinence has obvious symptom time point relief rule .

【学位授予单位】：中国中医科学院
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R711.59

【参考文献】