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戊聚糖多硫酸钠(爱泌罗)不良反应？
Interstitial cystitis (IC) is a syndrome characterized by frequent urination, urgency, bladder or pelvic and perineal pain as the main clinical manifestations. At the same time, the pain may worsen when the bladder is full and improve after emptying urine. Pentosan sulfate sodium (Elmiron) is the only oral drug approved by the US FDA for the treatment of interstitial cystitis so far. It can repair the damaged, thin, or "leaky" bladder surface. These surfaces (aminoglucose or GAG layer) are composed of a layer of mucous membrane, which can protect the bladder wall from infection by bacteria and corrosives in urine. So, what are the adverse reactions of sodium pentosan polysulfate (Amerol)?
Pentosan polysulfate sodium (Amirol) adverse reactions
A total of 2627 patients (2343 women, 262 men, 22 unknown) with a mean age of 47 years were evaluated in clinical trials for ELMIRON ® [range 18-88 years, 581 (22%) older than 60 years]. Among 2627 patients, 128 patients participated in the 3-month trial, and the remaining 2499 patients participated in the long-term, open-blind trial.
Death occurred in 6/2627 (0.2%) patients receiving drug treatment for 3-75 months. Deaths appeared to be related to other intercurrent illnesses or procedures, except for 1 patient whose cause of death was unknown.
Serious adverse events occurred in 33/2627 patients (1.3%). Two patients developed severe abdominal pain or diarrhea and dehydration, requiring hospitalization. Because there were no control groups that also evaluated patients with interstitial cystitis, it is difficult to determine which events are related to ELMIRON and which are related to concurrent disease, medications, or other factors.
Adverse Experience in a Placebo-Controlled Clinical Trial of ELMIRON® 100 mg Three Times Daily for 3 Months
|
Body systems/adverse experiences |
ELMIRON ®n = 128 |
placebo n = 130 |
|
CNSTotal number of patients* |
3 |
5 |
|
insomnia |
1 |
0 |
|
headache |
1 |
3 |
|
Severe mood instability/depression |
2 |
1 |
|
Nystagmus/dizziness |
1 |
1 |
|
Excessive exercise |
1 |
1 |
|
GI Total number of patients* |
7 |
7 |
|
Disgusting |
3 |
3 |
|
Diarrhea |
3 |
6 |
|
Indigestion |
1 |
0 |
|
Jaundice |
0 |
1 |
|
vomiting |
0 |
2 |
|
Skin/Allergy Total number of patients* |
2 |
4 |
|
rash |
0 |
2 |
|
itching |
0 |
2 |
|
shed tears |
1 |
1 |
|
rhinitis |
1 |
1 |
|
increased sweating |
1 |
0 |
|
Other Total number of patients* |
1 |
3 |
|
amenorrhea arthralgia vaginitis |
0 0 1 |
1 1 1 |
|
total number of events |
17 |
27 |
|
Total number of patients reporting adverse events |
13 |
19 |
|
* Within a body system, the total number of individual events does not equal the total number of patients because patients may have multiple events. |
||
The following adverse events were reported in an open-label clinical trial of 2499 patients with interstitial cystitis treated with ELMIRON®. Of the original 2499 patients, 1192 (48%) received ELMIRON for 3 months; 892 (36%) for 6 months; 598 (24%) for 1 year, 355 (14%) for 2 years, and 145 (6%) for 4 years.
Pentosan polysulfate sodium adverse reaction frequency
Frequency (1-4%): Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), abnormal liver function (1%), dizziness (1%).
Frequency (≤1%):
1. Vomiting, oral ulcers, colitis, esophagitis, gastritis, flatulence, constipation, anorexia, and gum bleeding.
2. Anemia, ecchymosis, increased prothrombin time, increased partial thromboplastin time, leukopenia, and thrombocytopenia.
3. Allergic reactions and photosensitivity reactions. Respiratory system: pharyngitis, rhinitis, epistaxis, dyspnea. Skin and appendages: itching, urticaria.
4. Conjunctivitis, tinnitus, optic neuritis, amblyopia, and retinal hemorrhage.
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