Department of Dermatology, Innsbruck Medical University, Anichstrasse 35, A-6020 Innsbruck, Austria.
Rheumatology (Oxford). 2010 Mar;49(3):583-7. doi: 10.1093/rheumatology/kep413. Epub 2009 Dec 29.
To investigate the efficacy of the endothelin receptor antagonist, bosentan, in patients with RP secondary to SSc without pre-existing digital ulcers.
Single-centre, randomized, prospective, double-blinded comparison of bosentan and placebo. Patients received either 62.5 mg bosentan twice daily for 4 weeks, followed by 125 mg twice daily for 12 weeks or matching doses of placebo.
Of the 17 patients enrolled, 16 completed the study and 1 withdrew from the study due to the reversible development of peripheral oedema. Compared with placebo, bosentan did not improve the frequency, duration, pain or severity of RP attacks. However, in contrast to placebo, bosentan significantly improved the functional scores. With respect to baseline, the scleroderma HAQ disability index changes were in favour of bosentan at Weeks 12 (P = 0.03) and 20 (P = 0.01), and the United Kingdom functional score changes at Weeks 8 (P = 0.038) and 16 (P = 0.039).
Bosentan is not effective in SSc-related RP without pre-existing digital ulcers, but it might benefit functional impairment in those patients.
European Union Drug Regulating Authorities Clinical Trials, https://eudract.emea.europa.eu, EudraCT-Nr 2004-002686-21.
研究内皮素受体拮抗剂波生坦治疗无预先存在的手指溃疡的系统性硬皮病相关的雷诺现象(RP)患者的疗效。
在这项单中心、随机、前瞻性、双盲的研究中,比较了波生坦和安慰剂的疗效。患者接受波生坦 62.5 mg,每日 2 次,共 4 周,随后改为 125 mg,每日 2 次,共 12 周,或给予匹配剂量的安慰剂。
17 例患者中,16 例完成了研究,1 例因可逆性外周水肿而退出研究。与安慰剂相比,波生坦并未改善 RP 发作的频率、持续时间、疼痛或严重程度。然而,与安慰剂相比,波生坦显著改善了功能评分。与基线相比,在第 12 周(P = 0.03)和第 20 周(P = 0.01),硬皮病 HAQ 残疾指数的变化对波生坦有利,在第 8 周(P = 0.038)和第 16 周(P = 0.039),英国功能评分的变化也对波生坦有利。
在无预先存在的手指溃疡的系统性硬皮病相关的 RP 患者中,波生坦无效,但可能对这些患者的功能障碍有益。
欧盟药品管理局临床研究,https://eudract.emea.europa.eu,EudraCT-Nr 2004-002686-21。