Guagnano M T, Pace Palitti V, Merlitti D, Carrabs C, Santucci E, Sensi S
Institute of Internal Medicine, University of Chieti, Italy.
Clin Exp Hypertens. 1997 Apr;19(3):331-41. doi: 10.3109/10641969709080822.
Treatment of mild hypertension with an antihypertensive drug administered by means of a transdermal therapeutic system (TTS) could produce favorable results, when compared with a traditional oral regimen.
Using 24-h ambulatory blood pressure (BP) monitoring (ABPM) in mild hypertensive male subjects, to analyze three aspects which have not been completely clarified: a) whether a latency in the antihypertensive effect may be present, recording BP already from the first day of application of the patch, b) the eventual hazardous enhancement of circadian nocturnal fall in BP values in treated mild hypertensive patients and, c) the possible overlapping of antihypertensive effect between the administration of two consecutive patches.
In 12 caucasian male outpatients (yrs 55 +/- 3 SEM) with uncomplicated essential mild hypertension, a patch containing placebo was applied for the first week (T 0 period). At the end of the T 0 period, a 5 mg TTS-2 clonidine patch was applied for one week, and, subsequently, a new patch of 5 mg TTS-2 clonidine was kept for another week. ABPM was performed on the last day of the placebo period (T 0) and on the 1st day (T1), the 7th day (T2) and the 14th day (T3) of transdermal clonidine therapy.
Both systolic and diastolic BP (24 h mean, day-night-time) decreased on the 1st, 7th and 14th day, when compared with T0. However, no significant differences were documented between the BP levels on the 1st and the 7th day of treatment. The incidence of nocturnal fall in systolic and diastolic BP was evaluated and no significant differences were found, when compared with night-time reference values.
When compared with the placebo period, TTS-2 clonidine lowers SBP and DBP within the first 24 hours of application. The antihypertensive effect persists at the end of the first week, as well as after 14 days. The lowest values of systolic-diastolic BP documented were not below the levels reported in normotensive men. Therefore, TTS-2 clonidine seems to act as an antihypertensive agent rather than a hypotensive drug since it normalizes BP without lowering it below physiological levels.
与传统口服治疗方案相比，使用经皮治疗系统（TTS）给药的抗高血压药物治疗轻度高血压可能会产生良好效果。
在轻度高血压男性受试者中使用24小时动态血压监测（ABPM），分析三个尚未完全阐明的方面：a）是否可能存在降压作用的潜伏期，从贴片应用的第一天就开始记录血压；b）治疗的轻度高血压患者夜间血压值昼夜下降是否最终存在危险增加；c）连续两次贴片给药之间降压作用是否可能重叠。
在12名患有单纯性原发性轻度高血压的白种男性门诊患者（年龄55±3标准误）中，第一周应用含安慰剂的贴片（T0期）。在T0期结束时，应用一片5mg的TTS-2可乐定贴片一周，随后再保留一片5mg的TTS-2可乐定贴片一周。在安慰剂期（T0）的最后一天以及透皮可乐定治疗的第1天（T1）、第7天（T2）和第14天（T3）进行ABPM。
与T0相比，收缩压和舒张压（24小时平均值、白天-夜间）在第1天、第7天和第14天均下降。然而，治疗第1天和第7天的血压水平之间无显著差异。评估了收缩压和舒张压夜间下降的发生率，与夜间参考值相比未发现显著差异。
与安慰剂期相比，TTS-2可乐定在应用的前24小时内降低收缩压和舒张压。降压作用在第一周结束时以及14天后持续存在。记录到的收缩压-舒张压最低值未低于正常血压男性报告的水平。因此，TTS-2可乐定似乎起到抗高血压药物的作用而非降压药物的作用，因为它使血压正常化而不会将其降至生理水平以下。
