Hwang P, Auclair B, Beechinor D, Diment M, Einarson T R
Faculty of Pharmacy, University of Toronto, ON, Canada.
Urology. 1997 Jul;50(1):39-43. doi: 10.1016/S0090-4295(97)00110-6.
To determine the efficacy of pentosan polysulfate (Elmiron) compared to placebo in the treatment of interstitial cystitis.
The data sources used were MEDLINE, Excerpta Medica, and International Pharmaceutical Abstracts databases, and the manufacturer. Bibliographies of articles obtained were reviewed. The keywords used were pentosanpolysulfate, pentosanpolysulfate sodium, and pentosan. Inclusion criteria were blinded selection of English language, prospective, randomized, placebo-controlled comparative trials; > or = 8 weeks' duration; > or = 300 mg daily; adult humans with > or = 1 symptoms including pain, urgency, frequency, and nocturia; symptoms for > or = 12 months; normal urinalysis; negative findings for urine culture and cytology. Exclusion criteria were hemorrhagic cystitis; drug-, microbial-, or radiation-induced cystitis; carcinoma in situ; other influencing diseases. The outcome of success was defined as a > or = 50% decrease in pain, urgency, frequency, and nocturia. The number of successes was extracted by blinded investigators, treating withdrawals as failures. The percentage difference in success rates of pentosan polysulfate and placebo, and the number needed to treat (NNT) were determined for each variable; P values and 95% confidence intervals (CIs) were determined for combined data. Homogeneity of effect was determined by calculating Q (chi-squared). Article quality was assessed using the Chalmers scale to determine if quality affected outcome. Effective inter-rater reliability was determined using Rosenthal's method. Significance was set at P < 0.05.
Four studies were included. Data were extracted from all four studies for pain (n = 398), three for urgency (n = 306), two for frequency (n = 160), and one study for nocturia (n = 106). The differences (95% confidence limits) were pain: 16.6% (95% CI 8%, 25%), NNT = 7; urgency: 13.0% (1.0%, 25%), NNT = 7.5; frequency: 16.7% (2.3%, 31.1%), NNT = 6; nocturia: -1% (-19.8%, 21.8%). P values from homogeneity tests were not significant. Mean quality scores were 63.8%, 48.1%, 50.4%, and 65.6%, respectively, in the four studies; the effective inter-rater reliability was 0.96. Results did not differ when weighted by quality score.
Pentosan polysulfate is more efficacious than placebo in the treatment of pain, urgency, and frequency associated with interstitial cystitis. Pentosan polysulfate is not significantly different from placebo in treating nocturia associated with interstitial cystitis.
确定戊聚糖多硫酸盐（依美斯汀）与安慰剂相比治疗间质性膀胱炎的疗效。
使用的数据源为医学索引数据库（MEDLINE）、医学文摘数据库（Excerpta Medica）和国际药学文摘数据库以及制造商。对获取文章的参考文献进行了审查。使用的关键词为戊聚糖多硫酸盐、戊聚糖多硫酸酯钠和戊聚糖。纳入标准为盲法选择的英文前瞻性随机安慰剂对照比较试验；持续时间≥8周；每日剂量≥300毫克；有≥1种症状（包括疼痛、尿急、尿频和夜尿）的成年人类；症状持续≥12个月；尿液分析正常；尿培养和细胞学检查结果为阴性。排除标准为出血性膀胱炎；药物、微生物或辐射诱导的膀胱炎；原位癌；其他影响疾病。成功的结果定义为疼痛、尿急、尿频和夜尿减少≥50%。由盲法研究者提取成功的数量，将退出治疗者视为失败。确定每个变量的戊聚糖多硫酸盐和安慰剂成功率的百分比差异以及治疗所需人数（NNT）；确定合并数据的P值和95%置信区间（CI）。通过计算Q（卡方）确定效应的同质性。使用查尔默斯量表评估文章质量，以确定质量是否影响结果。使用罗森塔尔方法确定有效的评分者间信度。显著性设定为P<0.05。
纳入四项研究。从所有四项研究中提取疼痛数据（n = 398），三项研究提取尿急数据（n = 306），两项研究提取尿频数据（n = 160），一项研究提取夜尿数据（n = 106）。差异（95%置信限）为：疼痛：16.6%（95%CI 8%，25%），NNT = 7；尿急：13.0%（1.0%，25%），NNT = 7.5；尿频：16.7%（2.3%，31.1%），NNT = 6；夜尿：-1%（-19.8%，21.8%）。同质性检验的P值不显著。四项研究的平均质量得分分别为63.8%、48.1%、50.4%和65.6%；有效的评分者间信度为0.96。按质量得分加权时结果无差异。
戊聚糖多硫酸盐在治疗与间质性膀胱炎相关的疼痛、尿急和尿频方面比安慰剂更有效。戊聚糖多硫酸盐在治疗与间质性膀胱炎相关的夜尿方面与安慰剂无显著差异。
