Kohnen R, Färber L, Späth M
IMEREM Institute for Medical Research Management and Biometrics Ltd., Germany.
Scand J Rheumatol Suppl. 2004;119:67-71. doi: 10.1080/03009740410007096.
Vegetative and functional symptoms are, besides pain and tenderness of tender points, considered as additional information for the diagnosis of fibromyalgia (FM). In clinical trials, vegetative and functional symptoms have been included for selection of patients (e.g. sleep disturbances) and as secondary outcome parameters. Despite the relevance of these symptoms, no validated method is currently available but symptom lists are ad hoc developed by investigators. In this manuscript, data from a published double blind, randomised study are reanalysed which compared oral therapy over 10 days with 5 mg, 10 mg, and 15 mg to placebo in FM patients. This study applied a list of 17 vegetative and functional symptoms, which had to be scored by the patients by use of a 4-point severity scale (0 = none to 3 = severe). Factor analysis of the baseline data from 195 patients suggested to separate 6 sub-scales: Cardiovascular, gastrointestinal, psychiatric (sleep disturbance), nervous, autonomic system, and general disorders. Sleep disturbances, general symptoms (morning stiffness, fatigue) and autonomic symptoms (cold extremities, hyperhidrosis) were most severe in intensity. Analysis of sensitivity for treatment effects made use of differences between placebo and 5 mg tropisetron in changes between baseline and final assessment of the tropisetron trial. While, on the item level, differences in favour of tropisetron could only be demonstrated for sleep disorders, on the sub-scale level, also favourable effects of tropisetron could be shown for cardiovascular and nervous system complaints and, as a tendency, for general symptoms. On the other side, the sub-scale score of gastrointestinal symptoms worsened under tropisetron whilst it improved under placebo which effect was due to side effects of the active treatment. It is concluded that symptom clusters like sub-scales of a list of vegetative and functional symptoms will be more suitable for diagnostic purposes and evaluation of treatment outcome of clinical trials. Further research is urgently required which addresses the development of a FM-specific scale to assess vegetative and functional symptoms.
除了压痛点的疼痛和压痛外，植物神经症状和功能症状也被视为纤维肌痛（FM）诊断的附加信息。在临床试验中，植物神经症状和功能症状已被纳入患者的选择标准（如睡眠障碍），并作为次要结局参数。尽管这些症状具有相关性，但目前尚无经过验证的方法，症状清单由研究人员临时制定。在本手稿中，对一项已发表的双盲随机研究的数据进行了重新分析，该研究比较了FM患者口服10天的5毫克、10毫克和15毫克药物与安慰剂的效果。这项研究应用了一份包含17种植物神经和功能症状的清单，患者必须使用4级严重程度量表（0 = 无至3 = 严重）对这些症状进行评分。对195名患者的基线数据进行因子分析后建议将其分为6个亚量表：心血管、胃肠道、精神（睡眠障碍）、神经、自主神经系统和一般障碍。睡眠障碍、一般症状（晨僵、疲劳）和自主神经症状（四肢发冷、多汗）的强度最为严重。治疗效果敏感性分析利用了曲吡那敏试验中安慰剂组与5毫克曲吡那敏组在基线和最终评估之间变化的差异。虽然在项目层面上，仅在睡眠障碍方面能证明曲吡那敏具有优势，但在亚量表层面上，曲吡那敏对心血管和神经系统症状也有有利影响，对一般症状也有一定的有利趋势。另一方面，曲吡那敏治疗下胃肠道症状的亚量表评分恶化，而安慰剂治疗下则有所改善，这种影响是由于活性治疗的副作用所致。结论是，像植物神经和功能症状清单的亚量表这样的症状群将更适合用于诊断目的和评估临床试验的治疗结果。迫切需要进一步开展研究，以开发一种用于评估植物神经和功能症状的FM特异性量表。
