Barkin J, Guimarães M, Jacobi G, Pushkar D, Taylor S, van Vierssen Trip O B
Humber River Regional Hospital/The Male Health Centres - CMX, Suite 404, 960 Lawrence Avenue West, Toronto, ON, Canada M6A 3B5.
Eur Urol. 2003 Oct;44(4):461-6. doi: 10.1016/s0302-2838(03)00367-1.
The Symptom Management After Reducing Therapy (SMART-1) study examined the combination of the dual action 5alpha-reductase inhibitor (5ARI) dutasteride, and alpha(1)-blocker tamsulosin, followed by withdrawal of tamsulosin in men with symptomatic BPH.
327 BPH patients were randomised to 0.5mg dutasteride and 0.4 mg tamsulosin for 36 weeks (DT36) or 0.5 mg dutasteride and 0.4 mg tamsulosin for 24 weeks followed by dutasteride and tamsulosin matched placebo for the remaining 12 weeks (DT24+D12). Patients' assessment of their symptoms, IPSS at weeks 24, 30, and drug safety were evaluated.
77% of DT24+D12 patients felt the same/better at week 30 compared with week 24 (changes in IPSS were consistent with this finding). Of those subjects with an IPSS <20 who changed to dutasteride monotherapy at week 24, 84% switched without a noticeable deterioration in their symptoms. In the 27% of men with severe baseline symptoms (IPSS >or=20) who had withdrawal of tamsulosin therapy at week 24, 42.5% reported a worsening of their symptoms compared with 14% in the DT36 group. The regimens were well tolerated.
Dutasteride can be used in a 24-week combination with tamsulosin, to achieve rapid onset of symptom relief in patients at risk of underlying disease progression. This symptom relief is maintained in the majority of patients after the alpha(1)-blocker is removed from the combination. Patients with severe symptoms may benefit from longer-term combination therapy.
“减药后症状管理（SMART-1）”研究探讨了双重作用的5α-还原酶抑制剂（5ARI）度他雄胺与α1受体阻滞剂坦索罗辛联合用药，随后在有症状的良性前列腺增生（BPH）男性患者中停用坦索罗辛的情况。
327例BPH患者被随机分为两组，一组接受0.5mg度他雄胺和0.4mg坦索罗辛治疗36周（DT36），另一组接受0.5mg度他雄胺和0.4mg坦索罗辛治疗24周，随后在剩余12周接受度他雄胺和与坦索罗辛匹配的安慰剂治疗（DT24+D12）。评估了患者对自身症状的评估、第24周、30周的国际前列腺症状评分（IPSS）以及药物安全性。
与第24周相比，77%的DT24+D12组患者在第30周感觉相同/更好（IPSS的变化与此结果一致）。在第24周改为度他雄胺单药治疗的IPSS<20的受试者中，84%的人症状没有明显恶化。在第24周停用坦索罗辛治疗的27%的基线症状严重（IPSS≥20）的男性中，42.5%的人报告症状恶化，而DT36组为14%。这些治疗方案耐受性良好。
度他雄胺可与坦索罗辛联合使用24周，以在有潜在疾病进展风险的患者中迅速缓解症状。在从联合用药中去除α1受体阻滞剂后，大多数患者的症状缓解得以维持。症状严重的患者可能从长期联合治疗中获益。
