Hansen N C, Skriver A, Brorsen-Riis L, Balsløv S, Evald T, Maltbaek N, Gunnersen G, Garsdal P, Sander P, Pedersen J Z
Department of Respiratory Diseases, Odense University Hospital, Denmark.
Respir Med. 1994 Aug;88(7):531-5. doi: 10.1016/s0954-6111(05)80337-3.
Oral N-acetylcysteine (NAC) exerts a beneficial action in chronic bronchitis by reducing the number of exacerbations. There have been few studies of the effect of NAC (or of any other drug) on general well-being in chronic bronchitis. We used an established psychiatric instrument (General Health Questionnaire; GHQ) and a visual analogue scale (VAS) to measure well-being in a 22-week, placebo-controlled, double-blind, parallel-group study of NAC administered as sustained release tablets 600 mg b.i.d., including during the winter months, to patients with mild chronic bronchitis. One hundred and fifty-three patients were accepted for randomized treatment, 129 finished the study (59 NAC, 70 placebo), and well-being was measured in 105 (46 NAC, 59 placebo). The number of observed exacerbations was unexpectedly low in both groups. The number was lowest in the NAC group, however, the difference did not reach statistical significance in the present study (P = 0.08). There were no statistically significant differences between NAC and placebo in subjective symptom scores, FEV1 or FVC. The distribution of GHQ score at baseline was uneven, but NAC was significantly superior to placebo in terms of a favourable effect on GHQ score. GHQ score correlated with the number of exacerbations, and VAS correlated with GHQ score. This study therefore demonstrates the validity of measuring general well-being in patients with mild chronic bronchitis. Future studies of the treatment of chronic bronchitis should use a battery of more specifically adapted instruments which are now becoming available to measure well-being.
口服N-乙酰半胱氨酸（NAC）通过减少慢性支气管炎急性加重的次数发挥有益作用。关于NAC（或任何其他药物）对慢性支气管炎患者总体健康状况影响的研究较少。在一项为期22周、安慰剂对照、双盲、平行组研究中，我们使用一种既定的精神科评估工具（一般健康问卷；GHQ）和视觉模拟量表（VAS）来测量总体健康状况，该研究中给患有轻度慢性支气管炎的患者服用600毫克每日两次的缓释片NAC，包括在冬季。153名患者被纳入随机治疗，129名完成研究（59名服用NAC，70名服用安慰剂），并对105名患者（46名服用NAC，59名服用安慰剂）进行了总体健康状况测量。两组观察到的急性加重次数意外地低。然而，NAC组的次数最低，但在本研究中差异未达到统计学显著性（P = 0.08）。NAC组和安慰剂组在主观症状评分、第一秒用力呼气容积（FEV1）或用力肺活量（FVC）方面没有统计学显著差异。基线时GHQ评分分布不均衡，但在对GHQ评分的有利影响方面，NAC组显著优于安慰剂组。GHQ评分与急性加重次数相关，VAS与GHQ评分相关。因此，本研究证明了测量轻度慢性支气管炎患者总体健康状况的有效性。未来关于慢性支气管炎治疗的研究应使用一系列现在可用的更具针对性的评估工具来测量总体健康状况。
