Lai Y H, Guh J Y, Chen H C, Hwang S J, Tsai J C, Tsai J H
Department of Internal Medicine, Kaohsiung Medical College, Taiwan, Republic of China.
Gaoxiong Yi Xue Ke Xue Za Zhi. 1993 Nov;9(11):625-31.
Manidipine hydrochloride (MH) is a new calcium channel antagonist which is not yet available in Taiwan. Thus, a clinical trial was performed. The clinical effects and adverse effects of MH were compared with those of nifedipine hydrochloride retard monotherapies. Sixty-three out-patients with mild to moderate hypertension and no advanced systemic diseases were randomly divided into 2 groups. Twenty patients remained in each group after some patients withdrew from the study. Blood pressure decreased significantly after treatment in both groups (p < 0.01). In the manidipine group, systolic blood pressure (SBP) decreased from 164 +/- 14 to 140 +/- 18 mmHg and diastolic BP (DBP) decreased from 99 +/- 6 to 87 +/- 7 mmHg by the 8th week. In the nifedipine group, SBP decreased from 163 +/- 11 to 134 +/- 17 mmHg and DBP decreased from 101 +/- 10 to 88 +/- 9 mmHg by the 8th week. Pulse rates did not change significantly. Antihypertensive efficacy was 18/20 (90%) and 19/22 (86.4%) in the manidipine and nifedipine groups, respectively. There were a few adverse effects in both groups, the reaction was severe as to lead to the discontinuation of medication in two patients in the nifedipine group. No significant changes in laboratory tests were identified in either group, except for minimal decreases of lactate dehydrogenase and creatine kinase in the nifedipine group. We conclude that MH was equally safe and effective as nifedipine and it may have less severe side effects compared to nifedipine.
盐酸马尼地平（MH）是一种新型钙通道拮抗剂，在台湾尚未上市。因此，进行了一项临床试验。将MH的临床疗效和不良反应与盐酸缓释硝苯地平单药治疗的疗效和不良反应进行比较。63例轻度至中度高血压且无晚期全身性疾病的门诊患者被随机分为2组。在一些患者退出研究后，每组各有20名患者。两组治疗后血压均显著下降（p < 0.01）。在马尼地平组，至第8周时收缩压（SBP）从164±14降至140±18 mmHg，舒张压（DBP）从99±6降至87±7 mmHg。在硝苯地平组，至第8周时SBP从163±11降至134±17 mmHg，DBP从101±10降至88±9 mmHg。脉搏率无显著变化。马尼地平组和硝苯地平组的降压有效率分别为18/20（90%）和19/22（86.4%）。两组均有一些不良反应，硝苯地平组有两名患者的反应严重到需要停药。除硝苯地平组乳酸脱氢酶和肌酸激酶略有下降外，两组实验室检查均无显著变化。我们得出结论，MH与硝苯地平同样安全有效，且与硝苯地平相比，其副作用可能较轻。
