Aboumarzouk Omar M, Nelson Richard L
Deptartment of Urology, Wales Deanery, Cardiff, UK.
Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD009063. doi: 10.1002/14651858.CD009063.pub2.
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a condition that is detrimental to the quality of life of men. Evidence suggests that it may have a neuropathic origin and therefore medications such as pregabalin might have a role in the controlling of symptoms.
The primary objective was to compare pregabalin to other modalities of pain relief to alleviate men's symptoms of CP/CPPS.The secondary objective was to assess the safety and effectiveness of pregabalin to improve various individual symptoms consistent with CP/CPPS.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to May 2012), EMBASE (1980 to May 2012), CINAHL, clinicaltrials.gov, Google Scholar, and reference lists of articles and abstracts from conference proceedings, without language restriction for pregabalin treatment of Class III prostatitis and CP/CPPS.
Randomized controlled trials (RCTs) comparing pregabalin to placebo or other types of analgesics for the management of patients with CP/CPPS were included. Patients with known causes of pain/discomfort were excluded.
Only one RCT was included. The trial compared pregabalin to placebo for patients who had CP/CPPS.
For men who responded clinically (≥ 6-point improvement), there was no difference between the pregabalin (103/218; 47.2%) and placebo (38/106; 35.8%) arms (risk ratio (RR) 1.32; 95% CI 0.99 to 1.76). There was less pain with a higher point improvement in the pregabalin group compared to the placebo group (4.2 points versus 1.7 points, respectively; mean difference (MD) -2.3 points; 95% CI -4.0 to -0.7 points).Though 59% (191/324) of the patients developed side effects, no serious effects were experienced. There were significantly more neurologic side effects in the pregabalin group compared to the placebo group (38.5% (84/218) versus 22.6% (24/106), respectively; RR 1.7; 95% CI 1.15 to 2.51), and less pain in the pregabalin group than in the placebo group (17.4% (38/218) versus 33.3% (35/106), respectively; RR 0.53; 95% CI 0.36 to 0.78). However, no significant differences were seen between the pregabalin and placebo groups with regards to gastrointestinal disturbances (18.3% (40/218) versus 18.9% (20/106), respectively; RR 0.97; 95% CI 0.60 to 1.58), ocular/visual symptoms (6.9% (15/218) versus 2.8% (3/106), respectively; RR 2.43; 95% CI 0.72 to 8.22), and renal/genitourinary symptoms (5.5% (12/218) versus 1.9% (2/106), respectively; RR 3.03; 95% CI 0.67 to 13.79).
AUTHORS' CONCLUSIONS: There is evidence from one RCT that pregabalin does not improve CP/CPPS symptoms and causes adverse effects in a large percentage of men. However, research is required to assess further whether pregabalin has a role in patients with CP/CPPS for symptom control.
慢性前列腺炎/慢性盆腔疼痛综合征（CP/CPPS）是一种对男性生活质量有害的病症。有证据表明它可能起源于神经病变，因此像普瑞巴林这样的药物可能在控制症状方面发挥作用。
主要目的是比较普瑞巴林与其他缓解疼痛的方式，以减轻男性CP/CPPS的症状。次要目的是评估普瑞巴林改善与CP/CPPS一致的各种个体症状的安全性和有效性。
我们检索了Cochrane对照试验中心注册库（CENTRAL）、MEDLINE（1966年至2012年5月）、EMBASE（1980年至2012年5月）、护理学与健康照护领域数据库（CINAHL）、美国国立医学图书馆临床试验注册库（clinicaltrials.gov）、谷歌学术，以及会议论文的文章和摘要的参考文献列表，对普瑞巴林治疗Ⅲ类前列腺炎和CP/CPPS的研究无语言限制。
纳入比较普瑞巴林与安慰剂或其他类型镇痛药治疗CP/CPPS患者的随机对照试验（RCT）。排除有已知疼痛/不适原因的患者。
仅纳入了一项RCT。该试验比较了普瑞巴林与安慰剂治疗CP/CPPS患者的效果。
对于临床有反应（改善≥6分）的男性，普瑞巴林组（103/218；47.2%）和安慰剂组（38/106；35.8%）之间无差异（风险比（RR）1.32；95%置信区间0.99至1.76）。与安慰剂组相比，普瑞巴林组疼痛改善分数更高时疼痛减轻更明显（分别为4.2分对1.7分；平均差（MD）-2.3分；95%置信区间-4.0至-0.7分）。尽管59%（191/324）的患者出现了副作用，但未出现严重影响。与安慰剂组相比，普瑞巴林组的神经副作用明显更多（分别为38.5%（84/218）对22.6%（24/106）；RR 1.7；95%置信区间1.15至2.51），且普瑞巴林组的疼痛比安慰剂组少（分别为17.4%（38/218）对33.3%（35/106）；RR 0.53；95%置信区间0.36至0.78）。然而，普瑞巴林组和安慰剂组在胃肠道紊乱（分别为18.3%（40/218）对18.9%（20/106）；RR 0.97；95%置信区间0.60至1.58）、眼部/视觉症状（分别为6.9%（15/218）对2.8%（3/106）；RR 2.43；95%置信区间0.72至8.22）以及肾脏/泌尿生殖系统症状（分别为5.5%（12/218）对1.9%（2/106）；RR 3.03；95%置信区间0.67至13.79）方面无显著差异。
一项RCT的证据表明普瑞巴林不能改善CP/CPPS症状，且在很大比例的男性中会引起不良反应。然而，需要进一步研究以评估普瑞巴林在CP/CPPS患者症状控制中是否有作用。
