戊聚糖多硫酸钠(爱泌罗)治疗间质性膀胱炎的效果？

Interstitial cystitis (IC), also known as bladder pain syndrome (BPS), is a syndrome characterized by persistent pain related to the bladder, accompanied by urinary frequency or urgency, with diverse clinical manifestations. Population-based studies show that the ratio of women to men is about 5:1, or even higher, and is often accompanied by sleep dysfunction, anxiety, depression and sexual dysfunction, seriously affecting the patient's quality of life. (Amirol) is a semi-synthetic mucopolysaccharide with a structure similar to heparin. The US FDA has approved it for oral use to treat interstitial cystitis. So, how effective is pentosan polysulfate sodium (Amirol) in the treatment of interstitial cystitis?

Effect of Pentosan Polysulfate Sodium (Amerol) in the Treatment of Interstitial Cystitis

ELMIRON was evaluated in two clinical trials for pain relief in patients with chronic interstitial cystitis (IC). All patients met the NIH IC definition based on cystoscopy, cytology, and biopsy results. A blinded, randomized, placebo-controlled study evaluated 151 patients (145 women, 5 men, 1 unknown) with a mean age of 44 years (range, 18-81 years). Approximately the same number of patients received placebo or ELMIRON 100 mg three times daily for 3 months. Clinical improvement in bladder pain is based on the patient's own assessment. In this study, 28/74 (38%) patients receiving ELMIRON and 13/74 (18%) receiving placebo showed greater than 50% improvement in bladder pain (p = 0.005).

The second clinical trial (Physician Use Study) was a prospectively designed retrospective analysis including 2499 patients who received ELMIRON 300 mg/day without blinding. Among the 2,499 patients, 2,220 were female, 254 were male, and 25 were of unknown gender. The average age of patients is 47 years old, and 23% are over 60 years old. By 3 months, 1307 patients (52%) dropped out or were ineligible for analysis. Overall, 1192 patients (48%) received ELMIRON for 3 months; 892 patients (36%) received ELMIRON for 6 months; and 598 patients (24%) received ELMIRON for 1 year.

Patients underwent unblinded evaluations every 3 months to evaluate their ratings of overall change in pain from baseline and calculated differences in "pain/discomfort" scores. At baseline, the initial 2499 patients had pain/discomfort scores of severe or intolerable (60%), moderate (33%), and mild or none (7%). The degree of pain improvement in the patients is shown in Table 1.

Table 1: Pain scores relative to baseline in the open-label physician use study (N = 2499)

therapeutic parameters	3 months	6 months
Patient ratings of overall change in pain	N = 1161	N=724
(Recollect the difference between the current	Median = 3	Median = 4
pain and baseline pain)	average = 3.44	average = 3.91
	CI: (3.37, 3.51)	CI: (3.83, 3.99)
Changes in pain/discomfort scores	N=1440	N = 904
(Calculated current rating difference	Median = 1	Median = 1
point and baseline)	mean = 0.51	mean = 0.66
	CI: (0.45, 0.57)	CI: (0.61, 0.71)

At 3 months, 722/2499 patients (29%) initially enrolled in the study had improved pain scores by one or two categories. By 6 months, of the 892 patients who continued taking ELMIRON®, an additional 116/2499 (5%) patients had improved pain scores. After 6 months, the percentage of patients reporting first pain relief was lower than the 1.5% of patients who initially entered the study (see Table 2).

Table 2: Number of patients (%) with new relief* of pain/discomfort in open-label physician use study (N = 2499)

	At 3 months (n = 1192)	At 6 months (n = 892)
Only the following patients will be considered	722/1192 (61%)	116/892 (13%)
continue treatment
Consider all patients initially	722/2499 (29%)	116/2499 (5%)
Enrollment study

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