Zempol P, Aogaichi K, Butler B, Tepper D, Somberg J C
Hoffmann-La Roche, Clinical Research Division, Nutley, New Jersey.
J Clin Pharmacol. 1987 Sep;27(9):666-72. doi: 10.1002/j.1552-4604.1987.tb03085.x.
Fifteen patients with ventricular premature complexes (VPCs) were included in this open study designed to assess the relative efficacy of bid (two times daily) and tid (three times daily) dosing regimens for cibenzoline as compared with qid (four times daily) administration. Patients started therapy with qid administration; this was followed in sequence by tid and bid administration at the maximum effective total daily dose determined during the qid administration. Of the nine patients evaluated for efficacy for suppression of VPCs, eight demonstrated a 75% or greater suppression of VPCs with cibenzoline administered qid (total daily dose of 130-325 mg). This effectiveness was maintained in four patients with a bid regimen and in three with a tid regimen. All four patients who had ventricular tachycardia (VT) had a decrease in the number of VT episodes while receiving cibenzoline (only one of these patients had satisfactory suppression of VPCs at the same dosage regimen). Twelve patients continued to receive extended therapy with cibenzoline for up to two years, as this was considered to be the optimum antiarrhythmic treatment for these patients. Two patients had to be removed from the study and two had the dosage lowered because of adverse reactions (dry mouth, blurred vision, dizziness, congestive heart failure) although in one instance, the congestive heart failure was subsequently considered to be unrelated to cibenzoline. One patient was able to complete the short-term phase of the trial, but was not given extended treatment because of persistent dry mouth. Two patients had treatment discontinued during the extended therapy phase because of adverse reactions (fever, nausea, vomiting, asthenia).(ABSTRACT TRUNCATED AT 250 WORDS)
本开放性研究纳入了15例室性早搏(VPC)患者,旨在评估昔苯唑啉每日两次(bid)和每日三次(tid)给药方案相对于每日四次(qid)给药的相对疗效。患者开始采用qid给药进行治疗;随后按照顺序在qid给药期间确定的最大有效日总剂量下依次采用tid和bid给药。在评估昔苯唑啉抑制VPC疗效的9例患者中,8例在qid给药(日总剂量130 - 325 mg)时VPC抑制率达到75%或更高。4例采用bid给药方案的患者和3例采用tid给药方案的患者维持了这种有效性。所有4例患有室性心动过速(VT)的患者在接受昔苯唑啉治疗时VT发作次数均减少(在相同给药方案下,这些患者中只有1例VPC得到满意抑制)。12例患者继续接受昔苯唑啉长达两年的延长治疗,因为这被认为是这些患者的最佳抗心律失常治疗方法。2例患者因不良反应(口干、视力模糊、头晕、充血性心力衰竭)不得不退出研究,2例患者因不良反应(尽管有1例充血性心力衰竭后来被认为与昔苯唑啉无关)而降低剂量。1例患者能够完成试验的短期阶段,但由于持续口干未接受延长治疗。2例患者在延长治疗阶段因不良反应(发热、恶心、呕吐、乏力)而停药。(摘要截选至250字)