Fodor G P, Guinot P
IPSEN International Ltd., London, UK.
Drugs Exp Clin Res. 1988;14(2-3):195-204.
A double-blind multicentre study was performed initially to assess the effect of 4 weeks' treatment of cicletanine in daily doses of 12.5, 25, 50 and 100 mg, for the treatment of 60 patients with mild to moderate essential hypertension. A significant reduction in blood pressure was achieved with each dosage. Analysis of the responder rate indicated a significant dose-response relationship which was clinically relevant only for the 50 and 100 mg doses. The minimum therapeutic dosage of cicletanine for the treatment of essential hypertension was concluded to be 50 mg daily. A further 12-week study was performed in 40 patients with mild to moderate essential hypertension, commencing with a daily dose of cicletanine (50 mg) and increasing the dosage if necessary to 100 mg and 200 mg daily after 4 and 8 weeks, respectively. Blood pressure control was achieved in all patients and in the majority (70%) with a daily dosage of 100 mg cicletanine. Treatment was continued in all patients until a total duration of 2 years had been completed. Cicletanine was shown to be very well tolerated and a significant reduction in blood pressure was achieved at 6, 9, 12, 18 and 24 months. During the second year of treatment, all the patients were stabilized with a daily dosage of 50 mg cicletanine. These results are consistent with a previously reported study in 25 patients with mild to moderate essential hypertension. Twelve weeks of treatment with cicletanine (50 mg daily) produced a significantly greater reduction in blood pressure than a combination of 5 mg amiloride hydrochloride and 50 mg hydrochlorothiazide daily. This reduction was more significant for the diastolic than the systolic blood pressure measurements. A diastolic blood pressure of 90 mmHg, or less, was achieved in all patients receiving treatment with cicletanine (50 mg daily), except for two patients where the dosage was increased to 100 mg daily.
最初进行了一项双盲多中心研究，以评估每日剂量为12.5、25、50和100毫克的西氯他宁治疗4周对60例轻度至中度原发性高血压患者的疗效。每种剂量均使血压显著降低。对有效率的分析表明存在显著的剂量反应关系，仅50毫克和100毫克剂量具有临床相关性。得出结论，西氯他宁治疗原发性高血压的最小治疗剂量为每日50毫克。对40例轻度至中度原发性高血压患者进行了为期12周的进一步研究，开始时每日服用西氯他宁（50毫克），必要时分别在4周和8周后将剂量增加至每日100毫克和200毫克。所有患者的血压均得到控制，大多数患者（70%）每日服用100毫克西氯他宁。所有患者持续治疗至总疗程达2年。结果显示西氯他宁耐受性良好，在6、9、12、18和24个月时血压显著降低。在治疗的第二年，所有患者每日服用50毫克西氯他宁病情稳定。这些结果与之前对25例轻度至中度原发性高血压患者的研究报告一致。每日服用西氯他宁（50毫克）治疗12周比每日联合服用5毫克盐酸阿米洛利和50毫克氢氯噻嗪能更显著地降低血压。舒张压的降低比收缩压测量值更显著。除两名患者剂量增至每日100毫克外，所有接受西氯他宁（每日50毫克）治疗的患者舒张压均降至90毫米汞柱或更低。
