Bird H A, Hill J, Ardley R G, McEvoy M, Wright V
Clinical Pharmacology Unit, Royal Bath Hospital, Harrogate, England.
Curr Med Res Opin. 1988;11(1):4-9. doi: 10.1185/03007998809111124.
Faecal blood loss arising from two prolonged-release formulations of indomethacin was compared in a double-blind, parallel group study in 12 healthy male volunteers. After a 1-week run-in period on placebo, subjects were allocated at random to receive 150 mg indomethacin per day, either as controlled-release 'Flexin Continus' tablets or as slow-release 'Indocid' R capsules, for 2 weeks and followed up for a further 1 week. Faecal specimens were collected over a 4-day period in each week and blood loss calculated using a 51Chromium-labelled red cell count method. Mean blood loss during the placebo run-in period was 2.6 ml/4 days in both study groups. Mean blood loss during treatment Weeks 2 and 3 with 'Flexin Continus' was 8.6 ml/4 days and 7.9 ml/4 days, respectively, and during treatment with 'Indocid' R capsules was 13.9 ml/4 days and 14.2 ml/4 days, respectively. There was a carry-over effect from both preparations as seen by a steady decrease in blood loss during the week after treatment. The mean value for 'Flexin Continus' was 6.9 ml/4 days and for 'Indocid' R was 8.3 ml/4 days during the wash-out week. Faecal blood loss was not statistically significantly different between the two formulations. No significant deterioration in haematological or biochemical results occurred in either group. Adverse symptoms were less frequent with 'Flexin Continus' tablets.
在一项针对12名健康男性志愿者的双盲平行组研究中，对两种吲哚美辛缓释制剂引起的粪便失血情况进行了比较。在服用安慰剂的1周导入期后，受试者被随机分配，每天服用150毫克吲哚美辛，剂型为控释的“Flexin Continus”片或缓释的“Indocid”R胶囊，为期2周，并进一步随访1周。每周收集4天的粪便标本，并使用51铬标记红细胞计数法计算失血量。两个研究组在安慰剂导入期的平均失血量均为2.6毫升/4天。服用“Flexin Continus”期间，第2周和第3周的平均失血量分别为8.6毫升/4天和7.9毫升/4天；服用“Indocid”R胶囊期间，第2周和第3周的平均失血量分别为13.9毫升/4天和14.2毫升/4天。两种制剂均有残留效应，表现为治疗后一周内失血量稳步下降。在洗脱期，“Flexin Continus”的平均值为6.9毫升/4天，“Indocid”R的平均值为8.3毫升/4天。两种制剂之间的粪便失血量在统计学上无显著差异。两组的血液学或生化结果均未出现显著恶化。“Flexin Continus”片的不良症状较少见。
