McGraw B F, Walker S D, Hemberger J A, Gitomer S L, Nakama M
Pharmacotherapy. 1982 May-Jun;2(3):156-61. doi: 10.1002/j.1875-9114.1982.tb04527.x.
In a cooperative postmarketing study, 3,913 Japanese patients received diltiazem, an orally administered calcium channel blocking agent, for 30 to over 360 days. Drug safety was assessed by monthly evaluations of subjective symptoms, electrocardiographic recordings, adverse experiences, vital signs, and biochemical profiles. Original case report forms were processed and analyzed in the United States. None of the observed adverse experiences were serious or life threatening. They occurred in 1.8% of the patients and primarily involved the gastrointestinal system; anorexia and nausea were the most common adverse effects. The majority of the other adverse experiences were extensions of the drug's pharmacologic effects. Diltiazem appears to cause relatively minor clinical toxicity at a low frequency.
在一项合作的上市后研究中，3913名日本患者接受了口服钙通道阻滞剂地尔硫䓬治疗，疗程为30至360多天。通过每月对主观症状、心电图记录、不良事件、生命体征和生化指标进行评估来评定药物安全性。原始病例报告表在美国进行处理和分析。观察到的不良事件均不严重或危及生命。这些事件发生在1.8%的患者中，主要累及胃肠道系统；厌食和恶心是最常见的不良反应。其他不良事件大多是药物药理作用的延伸。地尔硫䓬似乎在低频率下引起相对轻微的临床毒性。
