消痔灵膀胱灌注治疗间质性膀胱炎的临床应用研究

发布时间：2018-01-14 23:10

本文关键词：消痔灵膀胱灌注治疗间质性膀胱炎的临床应用研究　出处：《湖北中医药大学》2014年硕士论文　论文类型：学位论文

【摘要】：目的：观察消痔灵膀胱灌注治疗间质性膀胱炎（Interstitial cystitis IC）的临床疗效及安全性；探寻一套具有中西医结合特色的优化治疗方案。方法：全部观察对象为2011年6月-2013年12月来我院就诊的住院患者，共39例，其中男性14例，女性25例，年龄40-60岁,符合诊断纳入标准及排除标准，自愿接受膀胱灌注治疗，并签署知情同意书。患者随机分为A组（消痔灵组）20例和B组（西施泰组）19例。 1.诊断纳入标准（1）年龄18岁，60岁；（2）膀胱区域周围疼痛（或）伴尿频、尿急症状6个月；（3）每日排尿次数8次；（4）无膀胱、尿道手术史；（5）同意在麻醉状态下接受膀胱镜检查；（6）近3个月未进行尿道操作史；（7）能够接受膀胱灌注治疗者；（8）签署知情同意书；（9）停止与该病相关的其它治疗。 2.排除标准（1）清醒状态下,膀胱容量350ml；（2）以30～100ml/min速度注水150ml后仍未出现急迫性排尿感；（3）膀胱灌注时出现周期性不自主收缩；（4）抗生素、胆碱能神经抑制剂或解痉剂、肌松剂有效；（5）近3个月内感染有细菌性膀胱炎、尿道炎；（6）有膀胱或下尿路结石、肿瘤、结核病变；（7）近期有妇科感染、肿瘤、结核病变。 3.试验方法： A组：消痔灵20mg+2%利多卡因20ml膀胱灌注 B组：西施泰40mg+生理盐水40ml膀胱灌注每周灌注1次，每次30分钟，连续灌注4周后，改为每月1次，直到6个月。灌注治疗1月、3月、6月，患者进行访视评估。 4.观察指标：（1）24小时排尿次数；（2）最大排尿容量；（3）疼痛程度评分；（4）生活质量评分；（5）不良反应情况；（6）实验室检查。 5.疗效判定：分别观测A、B两组灌注前与灌注1月、3月、6月各项指标的变化，并进行生物等效性比较。结果: 1.24小时排尿次数: A、B两组组间比较：（1）灌注治疗1月与灌注前差值比较，A组为1.85±0.81（次），B组为1.79±0.92（次），A、B两组无显著性差异（p=0.7710.05）,表明A组疗效等同于B组。（2）灌注治疗3月与灌注前差值比较，A组为11.64±1.40（次），B组为4.88±1.23（次），A、B两组有显著性差异（p=0.0000.05）,表明A组疗效优于B组。（3）灌注治疗6月与灌注前差值比较，A组为15.77±1.06（次），B组为15.26±1.33（次），A、B两组无显著性差异（p=0.1940.05）,表明A组疗效等同于B组。 A、B两组组内比较： A、B两组灌注后排尿次数均有不同程度的减少,灌注1月、3月、6月分别与灌注前比较，差异均有显著性（p=0.0000.05);同时灌注6月与灌注3月比较，组内差异也具有统计学意义（p=0.0000.05）。以上表明A、B两组灌注治疗均有疗效，灌注疗效与时间呈正相关。 2.最大排尿容量： A、B两组组间比较: （1）灌注治疗1月与灌注前差值比较，A组为0.59±0.36（ml），B组为0.53±0.33（ml），A、B两组无显著性差异（p=0.6870.05),表明A组疗效等同于B组。（2）灌注治疗3月与灌注前差值比较，A组为45.24±3.94（ml），B组为44.1±4.28（ml），A、B两组无显著性差异（p=0.0570.05）,表明A组疗效等同于B组。（3）灌注治疗6月与灌注前差值比较，A组为45.75±3.83（ml），B组为44.62±4.12（ml），，A、B两组有显著性差异（p=0.044＜0.05),表明A组疗效优于B组。 A、B两组组内比较: A、B两组灌注后最大排尿容量均有不同程度的增加,灌注1月与灌注前比较，A、B两组均无显著性差异（A组：p=0.6870.05，B组：p=0.1460.05）。灌注3月、6月分别与灌注前比较，A、B两组均有显著性差异（p=0.0000.05)。灌注6月与灌注3月比较，A组组内有显著性差异（p=0.0070.05）,B组组内差异无统计学意义（p=0.1090.05）。以上表明A、B两组灌注治疗均有疗效，灌注6月后A组疗效优于B组。 3.疼痛程度： A、B两组组间比较: （1）灌注治疗1月与灌注前差值比较，A组为0.35±0.12，B组为0.39±0.14，A、B两组无显著性差异（p=0.4110.05）,表明A组疗效等同于B组。（2）灌注治疗3月与灌注前差值比较，A组为2.18±0.61，B组为2.02±0.61，A、B两组无显著性差异（p=0.3960.05）,表明A组疗效等同于B组。（3）灌注治疗6月与灌注前差值比较，A组为3.88±0.95，B组为3.81±0.87，A、B两组无显著性差异（p=0.7710.05）,表明A组疗效等同于B组。 A、B两组组内比较: A、B两组灌注后患者疼痛症状均有不同程度的减轻，A、B两组灌注1月与灌注前比较无显著性差异（A组：p=0.1270.05，B组：p=0.1630.05）。灌注3、6月与灌注前比较，A、B两组组内均有显著性差异（p=0.0000.05）；灌注6月与灌注3月比较，A、B两组组内差异具有统计学意义（p=0.000＜0.05）。以上表明A、B两组灌注后均有疗效，灌注疗效与时间呈正相关。 4.生存质量评分： A、B两组组间比较: （1）灌注治疗1月与灌注前差值比较，A组为0.37±0.20，B组为0.37±0.23，A、B两组无显著性差异（p=1.0000.05）,表明A组疗效等同于B组。（1）灌注治疗3月与灌注前差值比较，A组为17.97±5.02，B组为15.52±2.21，A、B两组无显著性差异（p=0.1010.05）,表明A组疗效等同于B组。（2）灌注治疗6月与灌注前差值比较，A组为23.41±4.08，B组为21.75±3.10，A、B两组差异无显著性（p=0.6470.05）,表明A组疗效等同于B组。 A、B两组组内比较: A、B两组灌注后与灌注前比较，患者生存质量均有不同程度的提高。灌注1月与灌注前生存质量评分比较无显著性差异（A组：p=0.1020.05，B组：p=0.3390.05）。灌注3月、6月与灌注前比较，A、B两组组内均有显著性差异（p=0.0000.05）;灌注6月与灌注3月比较，A、B两组组内均有显著性差异（p=0.000＜0.05）。以上表明A、B两组灌注治疗后均有疗效，灌注疗效与时间呈正相关。 5.不良反应情况 A组出现膀胱刺激征4例、血尿4例；B组出现膀胱刺激征3例、血尿2例；A组略多于B组。 6.实验室检查患者灌注前后血尿常规、肝肾功能、心电图、胸片等常规检查均无临床意义性改变。结论：（1）消痔灵（A组）与西施泰（B组）灌注后，均能不同程度减少患者24小时排尿次数，增加最大排尿容量，减轻患者疼痛程度及提高生存质量，不良反应少见,常规检查均无临床意义性改变。（2）灌注3月，24小时排尿次数比较，消痔灵组疗效优于西施泰组；灌注6月，最大排尿容量比较，消痔灵组疗效优于西施泰组。消痔灵膀胱灌注治疗间质性膀胱炎安全、有效，具有中西医结合治疗优势，其疗效等同于西施泰，部分指标优于西施泰。
[Abstract]:Objective: To observe the effect of Xiaozhiling intravesical treatment of interstitial cystitis (Interstitial cystitis IC) the clinical efficacy and safety; to explore a has combined with the characteristics of Chinese and Western medicine treatment optimization.
Methods: all subjects were hospitalized patients in our hospital in December June 2011 -2013, a total of 39 cases, there were 14 males and 25 females, aged 40-60 years, consistent with the diagnosis of the inclusion criteria and exclusion criteria, the voluntary acceptance of intravesical therapy, and signed the informed consent. The patients were randomly divided into A group (Xiaozhiling group 20 cases) and B group (cystistat group) 19 cases.
1. diagnostic inclusion criteria
(1) age 18, 60 years old;
(2) pain around the region of the bladder (or) with frequency of urine, acute symptoms of urine for 6 months;
(3) daily urination times 8 times;
(4) the history of urethral surgery without bladder and urethra;
(5) consent to undergo cystoscopy under anaesthetized state;
(6) the history of urethral operation was not carried out in the last 3 months.
(7) patients who were able to receive intravesical instillation;
(8) the signing of the informed consent;
(9) stop other treatments associated with the disease.
2. exclusion criteria
(1) the volume of bladder was 350ml in sober state.
(2) to 30 ~ 100ml/min after 150ml injection velocity has not yet appeared the urgency of the row of urine;
(3) periodic involuntary contraction occurs when the bladder is perfused.
(4) antibiotics, cholinergic nerve inhibitors or antispasmodic agents, muscle relaxants are effective;
(5) in the last 3 months, bacterial cystitis and urethritis were infected.
(6) calculi of bladder or lower urinary tract, tumor and tuberculosis;
(7) recently there are gynecologic infection, tumor, and tuberculosis.
3. the method of test:
Group A: 20mg+2% 20ml intravesical lidocaine Xiaozhiling
Group B: 40mg+ bladder perfusion in saline 40ml of Xishi Thailand
1 times a week, 30 minutes each time, after 4 weeks of continuous perfusion, and changed to 1 times a month until 6 months.
Perfusion therapy was conducted in January, March, and June, and the patients were interviewed and assessed.
4. the indicators of observation:
(1) the number of urination at 24 hours;
(2) maximum urination capacity;
(3) the score of pain degree;
(4) quality of life score;
(5) adverse reactions;
(6) laboratory examination.
5. evaluation of curative effect:
The changes in the indexes of A and B two groups before and after perfusion in January, March and June were observed respectively, and the bioequivalence was compared.
Result:
1.24 hours of urination times:
A, B two groups were compared.
(1) perfusion treatment in January compared with the difference before perfusion, group A is 1.85 + 0.81 (Times), group B is 1.79 + 0.92 (Times), A, B two group has no significant difference (p=0.7710.05), indicating A group curative effect is equal to B group.
(2) perfusion treatment in March compared with the difference before perfusion, group A is 11.64 + 1.40 (Times), group B is 4.88 + 1.23 (Times), A, B two group has significant difference (p=0.0000.05), indicating A group curative effect is better than B group.
(3) perfusion treatment in June compared with the difference before perfusion, group A is 15.77 + 1.06 (Times), group B is 15.26 + 1.33 (Times), A, B two group has no significant difference (p=0.1940.05), indicating A group curative effect is equal to B group.
A, B two groups were compared.
The number of micturition times in A and B two groups decreased to varying degrees. Perfusion in January, March and June showed significant difference compared with that before perfusion (p=0.0000.05), while perfusion in June and perfusion March showed significant difference (p=0.0000.05).
The above results showed that A, B two groups were effective in the treatment of perfusion, and the effect of perfusion was positively correlated with time.
2. the maximum capacity of urination:
A, B two groups were compared.
(1) perfusion treatment in January compared with the difference before perfusion, group A is 0.59 + 0.36 (ML), group B is 0.53 + 0.33 (ML), A, B two group has no significant difference (p=0.6870.05), indicating A group curative effect is equal to B group.
(2) perfusion treatment in March compared with the difference before perfusion, group A is 45.24 + 3.94 (ML), group B is 44.1 + 4.28 (ML), A, B two group has no significant difference (p=0.0570.05), indicating A group curative effect is equal to B group.
(3) perfusion treatment in June compared with the difference before perfusion, group A is 45.75 + 3.83 (ML), group B is 44.62 + 4.12 (ML), A, B two group has significant difference (p=0.044 < 0.05), indicating A group curative effect is better than B group.
A, B two groups were compared.
A and B two groups increased the maximal voiding capacity after perfusion. There was no significant difference between perfusion group and B group in the two groups (A group: p=0.6870.05 group, B group: p=0.1460.05) compared with that before perfusion in perfusion group in the same time. There was no significant difference between the two groups (A group).
In March, in June, there were significant differences in A and B between the two groups (p=0.0000.05).
In the group A group, there was a significant difference in the group A group (p=0.0070.05), and there was no significant difference in the group B group (p=0.1090.05).
The above results showed that A, B two groups were effective in the treatment of perfusion, and the effect of group A was better than that of group B after June.
3. degree of pain:
Comparison between two groups of A and B:
(1) perfusion treatment in January compared with the difference before perfusion, group A is 0.35 + 0.12, group B is 0.39 + 0.14, A, B two group has no significant difference (p=0.4110.05), indicating A group curative effect is equal to B group.
(2) perfusion treatment in March compared with the difference before perfusion, group A is 2.18 + 0.61, group B is 2.02 + 0.61, A, B two group has no significant difference (p=0.3960.05), indicating A group curative effect is equal to B group.
(3) perfusion treatment in June compared with the difference before perfusion, group A is 3.88 + 0.95, group B is 3.81 + 0.87, A, B two group has no significant difference (p=0.7710.05), indicating A group curative effect is equal to B group.
A, B two groups were compared.
A, B two groups of patients after perfusion pain symptoms were reduced to varying degrees, A, B two groups of perfusion in January compared with before perfusion no significant difference (group A: p=0.1270.05, B group: p=0.1630.05).
Perfusion 3,6 months compared with before perfusion, A, B two groups of groups have significant difference (p=0.0000.05); perfusion in June compared with March perfusion, A, B two groups of the difference was statistically significant (p=0.000 < 0.05).
The above results showed that A, B two groups were effective after perfusion, and the effect of perfusion was positively correlated with time.
4. quality of life score:
A, B two groups were compared.
(1) perfusion treatment in January compared with the difference before perfusion, group A is 0.37 + 0.20, group B is 0.37 + 0.23, A, B two group has no significant difference (p=1.0000.05), indicating A group curative effect is equal to B group.
(1) perfusion treatment in March compared with the difference before perfusion, group A is 17.97 + 5.02, group B is 15.52 + 2.21, A, B two group has no significant difference (p=0.1010.05), indicating A group curative effect is equal to B group.
(2) perfusion treatment in June compared with the difference before perfusion, group A was 23.41 + 4.08, group B was 21.75 + 3.10, A and B two group had no significant difference (p=0.6470.05), indicating that the efficacy of A group was the same as B group.
A, B two groups were compared.
The quality of life of patients in A and B two groups was increased after perfusion compared with that before perfusion. There was no significant difference in quality of life between January perfusion and pre perfusion (A group: p=0.1020.05, B group: p=0.3390.05).
Perfusion in March and June were compared with those before perfusion. There were significant differences in A and B between two groups (p=0.0000.05). Compared with perfusion March, there were significant differences between A and B in two groups (p=0.000 < 0.05).
The above results showed that A, B two groups were effective after perfusion, and the effect of perfusion was positively correlated with time.
5. adverse reactions
There were 4 cases of bladder irritation in group A, 4 cases of hematuria, 3 cases of bladder irritation in group B, 2 cases of hematuria, and a little more than group B in A group.
6. laboratory examination
Routine examination of hematuria, liver and kidney function, electrocardiogram and chest X-ray before and after perfusion had no clinical significance.
Conclusion:
(1) after the perfusion of Xiao Zhi Ling (group A) and Xishi Tai (B group), the micturition frequency of patients in 24 hours, the maximum voiding capacity, the degree of pain and the quality of life were reduced to some extent. There were few adverse reactions. Routine examination showed no significant change in clinical significance.
(2) in March, compared with 24 hours of urination, Xiaozhiling group was better than that of cystistat group; perfusion in June, maximum voiding volume, Xiaozhiling group was better than that of cystistat group.
Xiaozhiling intravesical treatment of interstitial cystitis is safe, effective, has the advantage of combining traditional Chinese and Western medicine treatment, the curative effect is equivalent to Yu Xishi Thailand, some indicators better than cystistat.

【学位授予单位】：湖北中医药大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R277.5

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