阿米替林联合透明质酸钠治疗膀胱疼痛综合征/间质性膀胱炎的临床研究(附58例报告)

The efficacy and safety of amitriptyline combined with sodium hyaluronate therapy for bladder pain syndrome(Report of 58 cases)

目的:探讨联合应用阿米替林和透明质酸钠治疗膀胱疼痛综合征/间质性膀胱炎(BPS/IC)的临床疗效和安全性。方法:对58例BPS/IC患者行膀胱灌注透明质酸钠和口服阿米替林治疗。所有患者在膀胱镜检+水扩张后,病理诊断为非特异性炎症者并且统计肥大细胞数目,然后膀胱灌注透明质酸钠。第1个月每周1次,连续灌注4周,然后每月1次,直到第6个月。观察用药前及用药1、3、6个月时的临床症状情况(每日排尿次数、最大排尿容量、膀胱区疼痛程度评分)和O’Leary-Sant间质性膀胱炎问卷表评分及生活质量评分(QOL)情况。在第一次灌注透明质酸钠的同时持续口服阿米替林25mg/每晚,1周后根据患者耐受情况增加阿米替林至每日口服25mg两次,6个月。实验期间均观察患者有无不良反应。到了治疗后第6个月所有入组患者复查膀胱尿道镜检时再次膀胱黏膜随机活检,观察膀胱黏膜炎症的变化,病理上再次统计肥大细胞数目,与治疗前的肥大细胞数目相比较有无统计学的差异。结果:58例总有效率62.1%(36/58),其中完全缓解率为39.7%(23/58),部分缓解率为22.4%(13/58),治疗无效率为37.9%(22/58)。治疗前所有患者平均每日排尿次数、每次排尿量、疼痛程度、O’Leary Sant评分、生活质量评分和膀胱黏膜下肥大细胞计数与治疗后相比均存在显著改善(均P值<0.001)。结论:阿米替林联合透明质酸钠治疗BPS/IC能有效缓解患者的临床症状和改善其生活质量。

Objective：To evaluate the efficacy and safety of the therapy treating patients with amitriptyline combined with intravesical sodium hyaluronate（CYSTISTAT;Sterile Sodium Hyaluronate Solution） for Bladder Pain Syndrome/Interstitial Cystitis（BPS/IC）. Method：Fifty-eight patients with BPS/IC were involved in this six-month,prospective trial.All 58 patients received oral amitriptyline（25 mg） 2 times daily for 24 weeks each;and intravesical sodium hyaluronate therapy once a week for 4 weeks,then once a month for 5 months.Clinical symptoms（micturition frequency per day,maximal micturition volume and cystodynia degree score）,O＇Leary-Sant IC symptom and problem index,and quality of life score,and quantifying mast cells were assessed at baseline and then again after 1,3 and 6 months of treatment.Side effects was recorded. Result：There were 16 male and 42 female patients in our study,the average age was（50.0±11.2）（range from 24 to 65）,the average duration of symptoms was（5.7±1.3） years（from 1-10 years）before treatment.The response rate was 62.1%（36/58）,Overall satisfaction was 39.7%（23/58）.Partial satisfaction was 22.4%（13/58）.None response was 37.9%（22/58）.For all patients,the mean voiding times,voiding volume,cystodynia degree score,average O＇Leary Sant score,quality of life score and quantifying mast cells and pre-treatment were statistically improved post-treatment respectively,P0.001. Conclusion：Treating BPS/IC patients with amitriptyline and intravesical sodium hyaluronate can effectively relieve clinical symptom of BPS/IC and improve BPS/IC patients＇ quality of life and is well tolerated.