Kolloch R E, Mehlburger L, Schumacher H, Göbel B O
Medizinische Universitäts-Poliklinik, Bonn, Germany.
Clin Auton Res. 1993 Dec;3(6):373-8. doi: 10.1007/BF01829456.
The efficacy and safety of two different galenic formulations of transdermal clonidine systems were compared in 905 patients with mild to moderate essential hypertension during a 12 weeks observation period. 449 patients were treated with the matrix controlled clonidine transdermal (C-TD) system and 456 patients with the membrane controlled clonidine system (C-TTS). The mean blood pressure was reduced from 168/102 mmHg to 146/87 mmHg in the C-TD and from 169/102 mmHg to 148/88 mmHg in the C-TTS group. There was no difference in the response rate. The pattern of systemic side-effects appeared to correspond to those seen during oral clonidine treatment but with a lower frequency and intensity. The C-TD patch improved skin tolerability and the drop-out rate due to skin reactions was 2.2 times lower compared with the C-TTS group. Local skin reactions led to withdrawal in 35 of 449 C-TD treated and in 79 of 456 C-TTS treated patients. In conclusion, the improved carrier system for the transdermal clonidine treatment reduced local side-effects which in turn may further enhance acceptability and compliance in treated patients.
在为期12周的观察期内，对905例轻至中度原发性高血压患者比较了两种不同剂型的可乐定透皮系统的疗效和安全性。449例患者接受了基质控释可乐定透皮（C-TD）系统治疗，456例患者接受了膜控释可乐定系统（C-TTS）治疗。C-TD组平均血压从168/102 mmHg降至146/87 mmHg，C-TTS组从169/102 mmHg降至148/88 mmHg。两组的有效率无差异。全身副作用的模式似乎与口服可乐定治疗时所见相似，但频率和强度较低。C-TD贴片改善了皮肤耐受性，因皮肤反应导致的脱落率比C-TTS组低2.2倍。局部皮肤反应导致449例接受C-TD治疗的患者中有35例停药，456例接受C-TTS治疗的患者中有79例停药。总之，改进的可乐定透皮治疗载体系统减少了局部副作用，这反过来可能会进一步提高治疗患者的接受度和依从性。
