Lindvall K, Eriksson S V, Lagerstrand L, Sjögren A
Department of Medicine, Karolinska Institute, Danderyd Hospital, Stockholm, Sweden.
Eur Heart J. 1988 Apr;9(4):373-9. doi: 10.1093/oxfordjournals.eurheartj.a062513.
The efficacy of transdermal nitroglycerin was investigated in 18 patients with moderate to severe congestive heart failure in a placebo-controlled, double-blind, crossover study. Treatment periods were of four weeks, following a one week dose titration period during which the maximum tolerated dose within the range of 5-15 mg was estimated. Therapeutic effects were evaluated by clinical examination (NYHA class), treadmill exercise, echocardiography and patient subjective scaling of general well being, cardiac symptoms and dyspnoea. Both patient and investigator analogue scaling of general well being showed improved scores indicating an improvement throughout the study. This tendency was even more marked when comparing inclusion values with those after each treatment period (P less than 0.05). However, when comparing values before with those after each treatment period, only the investigator scaling of heart failure level proved significantly higher after the placebo period (P less than 0.05). No other findings of significance were observed. We conclude that transdermal nitroglycerin given in the present doses over four weeks fails to improve the clinical situation in patients with moderate to severe congestive heart failure.
在一项安慰剂对照、双盲、交叉研究中，对18例中重度充血性心力衰竭患者研究了经皮硝酸甘油的疗效。治疗期为四周，在一周的剂量滴定期之后估计5 - 15毫克范围内的最大耐受剂量。通过临床检查（纽约心脏协会分级）、平板运动试验、超声心动图以及患者对总体健康状况、心脏症状和呼吸困难的主观评分来评估治疗效果。患者和研究者对总体健康状况的类似评分均显示得分改善，表明在整个研究过程中有所改善。将纳入值与每个治疗期后的数值进行比较时，这种趋势更为明显（P小于0.05）。然而，当比较每个治疗期前后的数值时，仅在安慰剂期后研究者对心力衰竭程度的评分显著更高（P小于0.05）。未观察到其他有显著意义的结果。我们得出结论，以当前剂量给予经皮硝酸甘油四周未能改善中重度充血性心力衰竭患者的临床状况。
