Blumenbach L, Kiesselbach N, Lehnert J
Arzneimittelforschung. 1976;26(5):931-43.
The oral antidiabetic agent 1-(hexahydro-1-H-azepin-1-yl)-3-(p-[2-(5-methyl-isoxazol-3-carboxamido)-ethyl]-phenylsulfonyl)-urea (glisoxepide, BS 4231, Pro-Diaban¿) was studied in a multi-centre open clinical trial comprising 4337 patients and was found to be an effective therapeutic agent for maturity-onset diabetics. About 66% of the patients had been pre-treated with oral antidiabetics. 54.7% of those 3572 patients treated with Pro-Diaban for at least 3 months achieved stabilization, which was classified according to strict criteria as "good", 73.4% achieved at least "satisfactory" stabilization. 12.5% of the cases dropped out after having received at least 12 mg/day because of inadequate efficacy of Pro-Diaban; 51.9% of these patients dropped out in the first 3 months (early failures 6.9% of the total case number). 61.9% received their daily dose in one portion, 29% in two and 10% in three portions. 98% received maximally 16 mg, 70% maximally 8 mg, and 42% 4 mg per day. Hypoglycaemic episodes led in 0.9% to a termination of the trial. In 1.22% of the cases the trial was terminated because of side effects, in 0.18% of cases they consisted of allergic or suspected allergic complaints and in 0.69% they consisted mainly of gastro-intestinal symptoms. Of the side-effects which did not lead to a termination of the trial, dizziness, headache and nausea were the relatively more frequent symptoms. An analysis of the laboratory data under consideration of pathological and normal initial and subsequent values showed that under the influence of Pro-Diaban pathological data reverted to normal more frequently than initially normal values changed to pathological ones. The analysis of laboratory and blood pressure data from 4 subgroups of patients, e.g. patients with diseases of the liver or the kidneys and hyperlipaemic or hypertensive patients, revealed that those data of special interest in each subgroup had mostly improved or remained unchanged under Pro-Diaban.
口服抗糖尿病药1-(六氢-1-H-氮杂环庚烷-1-基)-3-(对-[2-(5-甲基异恶唑-3-甲酰胺基)乙基]-苯磺酰基)-脲（格列波脲，BS 4231，Pro-Diaban®）在一项纳入4337例患者的多中心开放性临床试验中进行了研究，结果发现它是成年型糖尿病患者的一种有效治疗药物。约66%的患者曾接受口服抗糖尿病药预处理。在3572例接受Pro-Diaban治疗至少3个月的患者中，54.7%病情得到稳定，按照严格标准分类为“良好”，73.4%至少达到“满意”的病情稳定。12.5%的病例在接受至少12mg/天的治疗后因Pro-Diaban疗效不佳而退出；这些患者中有51.9%在最初3个月内退出（早期失败率占总病例数的6.9%）。61.9%的患者每日剂量一次服用，29%分两次服用，10%分三次服用。98%的患者最大日剂量为16mg，70%最大为8mg，42%最大为4mg。低血糖发作导致0.9%的患者试验终止。1.22%的病例因副作用而试验终止，0.18%的病例副作用为过敏或疑似过敏症状，0.69%的病例主要为胃肠道症状。在未导致试验终止的副作用中，头晕、头痛和恶心是相对较常见的症状。考虑到病理及正常的初始和后续值对实验室数据进行分析表明，在Pro-Diaban的影响下，病理数据恢复正常的频率高于初始正常的值变为病理值的频率。对4个患者亚组（例如患有肝脏或肾脏疾病的患者以及高脂血症或高血压患者）的实验室数据和血压数据进行分析发现，在Pro-Diaban治疗下，每个亚组中那些特别关注的数据大多有所改善或保持不变。
