Ukena D, Rentz K, Reiber C, Sybrecht G W
Medizinische Universitätsklinik, Homburg, Germany.
Respir Med. 1995 Jul;89(6):441-4. doi: 10.1016/0954-6111(95)90214-7.
Zardaverine is a selective inhibitor of phosphodiesterase (PDE) III and IV isozymes. It has been shown to exert potent bronchodilator effects in animals. In order to study the efficacy and safety in man, a phase II clinical trial in 10 patients with partially reversible chronic airflow obstruction was carried out. The trial was designed as a double-blind, randomized, five-period change-over study. Zardaverine (at single doses of 1.5 mg, 3.0 mg, or 6.0 mg), salbutamol (0.3 mg) and placebo were administered by metered dose inhaler on separate days. As evaluated by spirometry over a time period of 4 h, salbutamol induced a significant bronchodilatation. In contrast, zardaverine did not improve airway function in these patients. Unwanted effects of the study medication were not observed.
扎达维林是磷酸二酯酶（PDE）III和IV同工酶的选择性抑制剂。已证明它在动物中具有强大的支气管扩张作用。为了研究其在人体中的疗效和安全性，对10例部分可逆性慢性气流阻塞患者进行了II期临床试验。该试验设计为双盲、随机、五阶段交叉研究。扎达维林（单剂量为1.5毫克、3.0毫克或6.0毫克）、沙丁胺醇（0.3毫克）和安慰剂在不同日期通过定量吸入器给药。通过肺活量测定法在4小时的时间段内评估，沙丁胺醇引起了显著的支气管扩张。相比之下，扎达维林在这些患者中并未改善气道功能。未观察到研究药物的不良影响。
