安慰剂与住院时间对转氨酶的影响

目的观察住院时间10天以上并多次服用安慰剂后的健康志愿者引起的转氨酶变化趋势。方法在2个新药I期临床试验中，对多次服用安慰剂、住院时间为2天或13天的16名健康志愿者多次进行转氨酶检查。结果住院时间为13天且多次服用安慰剂的受试者，ALT呈逐渐升高的趋势；但AST无明显变化。多次服用安慰剂但住院时间为2天的受试者，ALT和AST均无明显变化。结论对住院时间长的新药I期临床试验，应考虑安慰剂可能引起的转氨酶升高，避免在判断试验药物是否产生肝损害时，出现偏差。

Influence of placebo and duration in hospital on transaminase

Objective To investigate the prevalence of transaminase change on placebo during phase I clinical trials in healthy volunteers hospitalized for long time. Methods Retrospective review of transaminase data collected on placebo during 2 phase I clinical trials in 16 healthy volunteers, who were either hospitalized for 2 days or 13 days. Transaminase was determined for many times in this 2 trials. Results The prevalence of ALT elevation on placebo took place in the volunteers who were hospitalized for 13 days , ALT and AST did not changed in the volunteers who were hospitalized for 2 days. Conclusion Transaminase change of phase I clinical trials should be interpreted with caution, in the light of data on placebo, to avoid premature discontinuation of the development of safe drugs wrongly believed to be hepatotoxic.