本文關(guān)鍵詞：消痔靈膀胱灌注治療間質(zhì)性膀胱炎的臨床應(yīng)用研究　出處：《湖北中醫(yī)藥大學(xué)》2014年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 消痔靈 西施泰 間質(zhì)性膀胱炎 膀胱灌注

【摘要】：目的：觀察消痔靈膀胱灌注治療間質(zhì)性膀胱炎（Interstitial cystitis IC）的臨床療效及安全性；探尋一套具有中西醫(yī)結(jié)合特色的優(yōu)化治療方案。 方法：全部觀察對象為2011年6月-2013年12月來我院就診的住院患者，共39例，其中男性14例，女性25例，年齡40-60歲,符合診斷納入標準及排除標準，自愿接受膀胱灌注治療，并簽署知情同意書�；颊唠S機分為A組（消痔靈組）20例和B組（西施泰組）19例。 1.診斷納入標準 （1）年齡18歲，60歲； （2）膀胱區(qū)域周圍疼痛（或）伴尿頻、尿急癥狀6個月； （3）每日排尿次數(shù)8次； （4）無膀胱、尿道手術(shù)史； （5）同意在麻醉狀態(tài)下接受膀胱鏡檢查； （6）近3個月未進行尿道操作史； （7）能夠接受膀胱灌注治療者； （8）簽署知情同意書； （9）停止與該病相關(guān)的其它治療。 2.排除標準 （1）清醒狀態(tài)下,膀胱容量350ml； （2）以30～100ml/min速度注水150ml后仍未出現(xiàn)急迫性排尿感； （3）膀胱灌注時出現(xiàn)周期性不自主收縮； （4）抗生素、膽堿能神經(jīng)抑制劑或解痙劑、肌松劑有效； （5）近3個月內(nèi)感染有細菌性膀胱炎、尿道炎； （6）有膀胱或下尿路結(jié)石、腫瘤、結(jié)核病變； （7）近期有婦科感染、腫瘤、結(jié)核病變。 3.試驗方法： A組：消痔靈20mg+2%利多卡因20ml膀胱灌注 B組：西施泰40mg+生理鹽水40ml膀胱灌注 每周灌注1次，每次30分鐘，連續(xù)灌注4周后，改為每月1次，直到6個月。 灌注治療1月、3月、6月，患者進行訪視評估。 4.觀察指標： （1）24小時排尿次數(shù)； （2）最大排尿容量； （3）疼痛程度評分； （4）生活質(zhì)量評分； （5）不良反應(yīng)情況； （6）實驗室檢查。 5.療效判定： 分別觀測A、B兩組灌注前與灌注1月、3月、6月各項指標的變化，并進行生物等效性比較。 結(jié)果: 1.24小時排尿次數(shù): A、B兩組組間比較： （1）灌注治療1月與灌注前差值比較，A組為1.85±0.81（次），B組為1.79±0.92（次），A、B兩組無顯著性差異（p=0.7710.05）,表明A組療效等同于B組。 （2）灌注治療3月與灌注前差值比較，A組為11.64±1.40（次），B組為4.88±1.23（次），A、B兩組有顯著性差異（p=0.0000.05）,表明A組療效優(yōu)于B組。 （3）灌注治療6月與灌注前差值比較，A組為15.77±1.06（次），B組為15.26±1.33（次），A、B兩組無顯著性差異（p=0.1940.05）,表明A組療效等同于B組。 A、B兩組組內(nèi)比較： A、B兩組灌注后排尿次數(shù)均有不同程度的減少,灌注1月、3月、6月分別與灌注前比較，差異均有顯著性（p=0.0000.05);同時灌注6月與灌注3月比較，組內(nèi)差異也具有統(tǒng)計學(xué)意義（p=0.0000.05）。 以上表明A、B兩組灌注治療均有療效，灌注療效與時間呈正相關(guān)。 2.最大排尿容量： A、B兩組組間比較: （1）灌注治療1月與灌注前差值比較，A組為0.59±0.36（ml），B組為0.53±0.33（ml），A、B兩組無顯著性差異（p=0.6870.05),表明A組療效等同于B組。 （2）灌注治療3月與灌注前差值比較，A組為45.24±3.94（ml），B組為44.1±4.28（ml），A、B兩組無顯著性差異（p=0.0570.05）,表明A組療效等同于B組。 （3）灌注治療6月與灌注前差值比較，A組為45.75±3.83（ml），B組為44.62±4.12（ml），，A、B兩組有顯著性差異（p=0.044＜0.05),表明A組療效優(yōu)于B組。 A、B兩組組內(nèi)比較: A、B兩組灌注后最大排尿容量均有不同程度的增加,灌注1月與灌注前比較，A、B兩組均無顯著性差異（A組：p=0.6870.05，B組：p=0.1460.05）。 灌注3月、6月分別與灌注前比較，A、B兩組均有顯著性差異（p=0.0000.05)。 灌注6月與灌注3月比較，A組組內(nèi)有顯著性差異（p=0.0070.05）,B組組內(nèi)差異無統(tǒng)計學(xué)意義（p=0.1090.05）。 以上表明A、B兩組灌注治療均有療效，灌注6月后A組療效優(yōu)于B組。 3.疼痛程度： A、B兩組組間比較: （1）灌注治療1月與灌注前差值比較，A組為0.35±0.12，B組為0.39±0.14，A、B兩組無顯著性差異（p=0.4110.05）,表明A組療效等同于B組。 （2）灌注治療3月與灌注前差值比較，A組為2.18±0.61，B組為2.02±0.61，A、B兩組無顯著性差異（p=0.3960.05）,表明A組療效等同于B組。 （3）灌注治療6月與灌注前差值比較，A組為3.88±0.95，B組為3.81±0.87，A、B兩組無顯著性差異（p=0.7710.05）,表明A組療效等同于B組。 A、B兩組組內(nèi)比較: A、B兩組灌注后患者疼痛癥狀均有不同程度的減輕，A、B兩組灌注1月與灌注前比較無顯著性差異（A組：p=0.1270.05，B組：p=0.1630.05）。 灌注3、6月與灌注前比較，A、B兩組組內(nèi)均有顯著性差異（p=0.0000.05）；灌注6月與灌注3月比較，A、B兩組組內(nèi)差異具有統(tǒng)計學(xué)意義（p=0.000＜0.05）。 以上表明A、B兩組灌注后均有療效，灌注療效與時間呈正相關(guān)。 4.生存質(zhì)量評分： A、B兩組組間比較: （1）灌注治療1月與灌注前差值比較，A組為0.37±0.20，B組為0.37±0.23，A、B兩組無顯著性差異（p=1.0000.05）,表明A組療效等同于B組。 （1）灌注治療3月與灌注前差值比較，A組為17.97±5.02，B組為15.52±2.21，A、B兩組無顯著性差異（p=0.1010.05）,表明A組療效等同于B組。 （2）灌注治療6月與灌注前差值比較，A組為23.41±4.08，B組為21.75±3.10，A、B兩組差異無顯著性（p=0.6470.05）,表明A組療效等同于B組。 A、B兩組組內(nèi)比較: A、B兩組灌注后與灌注前比較，患者生存質(zhì)量均有不同程度的提高。灌注1月與灌注前生存質(zhì)量評分比較無顯著性差異（A組：p=0.1020.05，B組：p=0.3390.05）。 灌注3月、6月與灌注前比較，A、B兩組組內(nèi)均有顯著性差異（p=0.0000.05）;灌注6月與灌注3月比較，A、B兩組組內(nèi)均有顯著性差異（p=0.000＜0.05）。 以上表明A、B兩組灌注治療后均有療效，灌注療效與時間呈正相關(guān)。 5.不良反應(yīng)情況 A組出現(xiàn)膀胱刺激征4例、血尿4例；B組出現(xiàn)膀胱刺激征3例、血尿2例；A組略多于B組。 6.實驗室檢查 患者灌注前后血尿常規(guī)、肝腎功能、心電圖、胸片等常規(guī)檢查均無臨床意義性改變。 結(jié)論： （1）消痔靈（A組）與西施泰（B組）灌注后，均能不同程度減少患者24小時排尿次數(shù)，增加最大排尿容量，減輕患者疼痛程度及提高生存質(zhì)量，不良反應(yīng)少見,常規(guī)檢查均無臨床意義性改變。 （2）灌注3月，24小時排尿次數(shù)比較，消痔靈組療效優(yōu)于西施泰組；灌注6月，最大排尿容量比較，消痔靈組療效優(yōu)于西施泰組。 消痔靈膀胱灌注治療間質(zhì)性膀胱炎安全、有效，具有中西醫(yī)結(jié)合治療優(yōu)勢，其療效等同于西施泰，部分指標優(yōu)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.

【學(xué)位授予單位】：湖北中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R277.5

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