Clerson P, Deltour L, Billaut P, Tarrade T, Berthet P, Pauchant M
AMPLSW, Wattrelos.
Arch Mal Coeur Vaiss. 1989 Nov;82 Spec No 4:113-8.
The effectiveness and safety of cicletanine hydrochloride, the first representative of the furopyridine family, were evaluated in a 90-day double-blind study involving 120 patients with moderate essential hypertension poorly controlled after at least one month of treatment with a beta-blocker. After a 30-day pre-inclusion period during which a placebo capsule was given together with a stable dose of the beta-blocker, the patients were randomised to one of three therapeutic groups: group 1 (placebo, n = 40), group 2 (cicletanine 50 mg/day, n = 41), group 3 (cicletanine 100 mg/day, n = 39). All three groups were matched in every respect. Eight patients in group I were excluded (5 for ineffectiveness, 2 for unexpected effect, 1 for intercurrent disease) as was 1 patient in group 3 for unexpected effect. On entering the active phase of treatment, supine blood pressures were 171.3 +/- 13.6/103.9 +/- 6.1 mmHg in group 1, 173.5 +/- 12.7/103.6 +/- 5.2 mmHg in group 2 and 171.8 +/- 15.4/104.5 +/- 5.9 mmHg in group 3. A significant (p less than 0.0001) treatment effect on SBP was found in groups 2 and 3 and on DBP in all three groups. The improvement observed in both SBP and DBP was similar in groups 2 and 3 and highly significant when compared with group 1 (p 0.001). At the end of the trial, 5% of group 1 patients, 51.2% of group 2 patients and 74.4% of group 3 patients had normal blood pressure values. The drug was well tolerated clinically and biochemically.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项为期90天的双盲研究中,对呋吡啶家族的首个代表药物盐酸西氯他宁的有效性和安全性进行了评估。该研究涉及120例中度原发性高血压患者,这些患者在接受β受体阻滞剂治疗至少1个月后血压控制不佳。在为期30天的预纳入期内,患者服用安慰剂胶囊并搭配稳定剂量的β受体阻滞剂,之后将患者随机分为三个治疗组:第1组(安慰剂组,n = 40)、第2组(西氯他宁50 mg/天,n = 41)、第3组(西氯他宁100 mg/天,n = 39)。三组在各方面均匹配。第1组有8例患者被排除(5例因无效、2例因意外效应、1例因并发疾病),第3组有1例患者因意外效应被排除。进入治疗活跃期时,第1组仰卧位血压为171.3±13.6/103.9±6.1 mmHg,第2组为173.5±12.7/103.6±5.2 mmHg,第3组为171.8±15.4/104.5±5.9 mmHg。第2组和第3组在收缩压上有显著(p<0.0001)治疗效果,三组在舒张压上均有显著治疗效果。第2组和第3组在收缩压和舒张压上观察到的改善相似,与第1组相比具有高度显著性(p<0.001)。试验结束时,第1组5%的患者、第2组51.2%的患者和第3组74.4%的患者血压值正常。该药物在临床和生化方面耐受性良好。(摘要截取自250字)