中樞神經病變的患者在使用治療膀胱過動症的藥物的療效及認知障礙的副作用
陳聖復、郭漢崇
花蓮慈濟醫院暨慈濟大學 泌尿部
Therapeutic efficacy and cognitive adverse events of OAB medication on patients with CNS lesion
Sheng-Fu Chen , Hann-Chorng Kuo
Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University Hualien, Taiwan
Objective:
Overactive bladder (OAB) is a common urological clinical problem in central nerve system (CNS) patients. This study investigated the therapeutic efficacy and monitor cognitive function and other side effects on common OAB medication for CNS patients.
Materials and Methods:
This is a prospective randomized control study. We enrolled the patients with CNS lesion, include Cerebrovascular accident (CVA), parkinsonism, and early dementia in 40-85 years old. All patients have OAB symptoms, such urgency and urge incontinence. We recorded Mini-Mental State Examination (MMSE). Patients with MMSE score less than 16 were excluded because it is difficult to evaluate subjective therapeutic efficacy. Patients were medicated with tamsulosin 0.4 mg QD for two weeks without adding any OAB medication (wash out period). Then they were randomized to one of the three subgroups and received (A) solifenacin 5mg QD, (B) mirabegron 50mg QD, and (C) combined solifenacin 5mg and mirabegron 50mg QD. Efficacy and safety parameters such as overactive bladder symptom score (OABSS), urgency severity score (USS), international prostate symptom score (IPSS) and subscore, maximum flow rate (Qmax), voided volume, postvoid residual (PVR) volume, and void efficiency (VE) were compared between baseline and 3 months after treatment.
Results:
102 patients, (including 63 CVA, 25 parkinsonism, and 14 dementia) with mean age of 71.84±8.68 completed the study. 35 received mirabegron monotherapy, 36 received solifenacin monotherapy, and 31 received combination therapy. The baseline characteristics and urodynamic parameters were similar among different CNS lesions. OAB symptoms significant improved in both CVA and parkinsonism group. There was no significant difference of symptom score changes among 3 groups. We also found increased PVR and decreased of VE in CVA group. Dry mouth (19%), and constipation(7%) were the most common side effects, especially in solifenacin and combined group. Mirabegron had little side effects. Among 35 patients received mirabegron monotherapy, only one patient had dry mouth and 2 patients complained constipation. We compared the MMSE after treatment which showed no significant difference between each medication group and different CNS lesion.
Conclusions:
In this study, we found CVA and parkinsonism patients with OAB symptoms had significant therapeutic efficacy. In this short-term study, OAB medication did not affect the cognitive function, and other side effects are mild. We concluded OAB medication on patients with CNS had good response and safe.
Table 1. Comparisons of parameters between baseline and 3 months after treatment on patients with CNS lesions.
|
|
CVA (n=63) |
Parkinsonism (n=25) |
dementia (n=14) |
P value |
OABSS |
Baseline |
8.89±3.26 |
10.84±2.87 |
8.50±3.44 |
0.211 |
|
3 months |
6.60±3.45* |
8.23±4.29* |
6.31±4.75 |
|
USS |
Baseline |
3.14±1.15 |
3.40±0.82 |
3.21±1.19 |
0.156 |
|
3 months |
2.17±1.49* |
2.64±1.33* |
1.62±1.85* |
|
IPSS |
Baseline |
13.52±6.50 |
15.84±6.56 |
13.43±7.99 |
0.320 |
|
3 months |
8.77±5.98* |
11.14±7.26* |
10.69±8.27 |
|
IPSS-V |
Baseline |
4.79±4.81 |
7.20±5.71 |
5.50±5.39 |
0.192 |
|
3 months |
2.98±4.31* |
4.91±5.76* |
4.38±5.08 |
|
IPSS-S |
Baseline |
8.73±3.67 |
8.64±2.89 |
7.93±3.56 |
0.757 |
|
3 months |
5.79±3.63* |
6.23±3.27* |
6.31±4.54 |
|
Qmax (ml/s) |
Baseline |
12.83±7.92 |
15.10±9.72 |
12.43±8.56 |
0648 |
|
3 months |
13.08±7.81 |
11.90±8.88 |
10.85±6.19 |
|
Voided Volume (ml) |
Baseline |
160.97±100.49 |
183.65±118.62 |
156.74±128.40 |
0.727 |
|
3 months |
180.02±101.40 |
181.76±156.84 |
149.76±116.45 |
|
PVR (ml) |
Baseline |
29.67±29.83 |
43.10±81.24 |
20.57±19.50 |
0.540 |
|
3 months |
70.91±95.15* |
70.90±84.06 |
39.03±51.75 |
|
VE |
Baseline |
0.848±0.128 |
0.809±0.274 |
0.859±0.151 |
0.264 |
|
3 months |
0.720±0.247* |
0.737±0.218 |
0.846±0.162 |
|
MMSE |
Baseline |
25.02±5.13 |
23.76±5.78 |
22.71±6.63 |
0.334 |
3 months |
26.05±4.88 |
24.33±5.01 |
23.78±5.52 |
* P-value <0.05 comparison with baseline and >3 months.
OABSS: Overactive Bladder Symptom Score, USS: urgency severity score, IPSS: International Prostate Symptom Score , Qmax: maximum flow rate, Vol: voided volume, PVR: post-void residual, VE: voiding efficiency, MMSE: Mini-Mental State Examination