Noble R
Cathedral Hill Obesity Clinic, San Francisco, CA 94013.
Drug Intell Clin Pharm. 1988 Apr;22(4):296-9. doi: 10.1177/106002808802200403.
Two hundred eighty-eight healthy normotensive volunteers with various degrees of obesity participated in a double-blind, placebo-controlled evaluation of the acute effects of phenylpropanolamine hydrochloride (PPA) and caffeine on blood pressure, pulse, and subjective effects. Dosage forms studied were PPA 75 mg sustained-release (SR), PPA SR 75 mg with caffeine 200 mg, caffeine 200 mg, and placebo. Data analysis indicated no significant cardiovascular or subjective effects due to PPA. Caffeine, however, was associated with statistically reliable though clinically insignificant changes from baseline diastolic blood pressure in both supine and standing positions. The rank order of the change indicated larger increases for the subjects who received caffeine, either alone or in combination with PPA, as compared with those who received PPA alone or placebo. No statistically significant differences between PPA and placebo were observed. Subjects in the heavier weight categories had higher blood pressure levels throughout the session as compared with those of normal weight. There was no difference among the study groups in subjective effects. These results provide evidence supporting the safety of currently recommended doses of sustained-release PPA, either alone or in combination with small doses of caffeine in healthy individuals.
288名患有不同程度肥胖症的健康血压正常志愿者参与了一项双盲、安慰剂对照试验，以评估盐酸苯丙醇胺（PPA）和咖啡因对血压、脉搏及主观感受的急性影响。研究的剂型包括75毫克缓释PPA（SR）、含200毫克咖啡因的75毫克PPA SR、200毫克咖啡因及安慰剂。数据分析表明，PPA对心血管或主观感受无显著影响。然而，咖啡因与仰卧位和站立位时舒张压较基线值出现的具有统计学可靠性但临床意义不显著的变化相关。变化的排序显示，与单独服用PPA或安慰剂的受试者相比，单独服用咖啡因或与PPA联合服用咖啡因的受试者血压升高幅度更大。未观察到PPA与安慰剂之间存在统计学显著差异。与正常体重受试者相比，体重较重类别的受试者在整个试验过程中的血压水平更高。各研究组在主观感受方面无差异。这些结果为目前推荐剂量的缓释PPA单独使用或与小剂量咖啡因联合用于健康个体的安全性提供了证据支持。
