Adam Z, Pour L, Svobodník A, Scudla V, Salajka F, Vytrasová M, Bacovský J, Schützová M, Koza V, Sumná E, Franková H, Lehanka F, Gumulec J, Stavarová Y, Cahová S, Vránová M, Dostálová V, Kessler P, Walterová L, Meluzínová I, Seifertová N, Sláma O, Büchler T, Krejcí M, Bencíková V, Nykodýmová V, Dusek L, Hájek R
Interní hematoonkologická klinika FN Brno, pracovistĕ Bohunice, Brno.
Vnitr Lek. 2002 Mar;48(3):216-29.
Questionnaires on the quality of life and tolerance of different parts of maintenance treatment were sent to a total of 83 patients with multiple myeloma. All patients were for more than one year on maintenance treatment which involved either interferon alpha monotherapy (I), 3 million u. three times per week till signs of relapse developed or sequence administration of interferon alpha and dexamethazone 40 mg on day 1 to 4, 10 to 13 and 20 to 23 and then after a four-week interval again interferon alpha, again till progression of the disease occurred. The patients evaluated the presence or absence of different undesirable effects of treatment during the first two weeks of treatment and throughout the year and listed their intensity into four categories defined in the questionnaire. The quality of life was evaluated by means of a basic module of the questionnaire of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30). The results of the questionnaire are to a certain extent surprising as from the patients' answers ensues that this maintenance treatment is associated with more numerous undesirable effects than the physicians realized when in contact with the patient. In this summary we can list only the most frequent effects (deterioration of eyesight, impaired sleep, depressions, irritability and unrest, chill, pain in muscles and joints, general weakness and dyspnoea). From the questionnaires on the quality of life ensues a markedly poorer quality of life of these patients as compared with the healthy population. There are however no basic differences between individual groups. The questionnaires were handed only to patients who had maintenance treatment for more than one year and thus patients were eliminated where maintenance treatment was discontinued because of undesirable effects. To give a general idea of the tolerance of the above maintenance treatment the authors mention that to the date of Aug. 31, 2001 113 patients were randomized into one of the branches of maintenance treatment. Maintenance treatment had to be discontinued in 6% patients (in two instances on account of severe hypothyroidism, in one case on account of hallucinations, in three instances on account of severe mental depression caused by this treatment). Reduction of interferon doses in 20% patients usually because of cytopenia but also on account of psychic problem. To the question what length of prolongation of life compensates the undesirable effects of maintenance treatment the following replies were obtained from patients receiving ID, possibly I: 3 months--47.6 and 38.3%, 6 months--4.3 and 10.6%, 9 months--0 and 4.3%, 12 months--47.6 and 46.8% of the addressed patients. In reply to the question whether the patients would prefer, assuming equal effectiveness, a maintenance monotherapy with interferon alpha or dexamethazone more patients preferred interferon to dexamethasone. For practice ensues from this article informing on undesirable effects of maintenance treatment and the effect of maintenance treatment on the quality of life: 1. the necessity of thorough knowledge of physicians of all possible undesirable effects as only a doctor knowing possible undesirable effects of treatment can recognize them, 2. regular monitoring not only of the activity of the basic disease, but also undesirable effects of maintenance treatment and the influence of treatment on the patients' quality of life, 3. the necessity to assess the quality of life in clinical trials as an important parameter for deciding on the way of treatment.
我们向83例多发性骨髓瘤患者发放了关于维持治疗不同阶段生活质量和耐受性的调查问卷。所有患者均接受维持治疗超过一年,治疗方案包括:α干扰素单一疗法(I组),每周三次,每次300万单位,直至出现复发迹象;或α干扰素与地塞米松序贯给药,地塞米松40mg在第1至4天、第10至13天和第20至23天给药,之后间隔四周再次给予α干扰素,直至疾病进展。患者评估了治疗前两周及全年不同不良治疗反应的有无,并按照问卷中定义的四个类别列出其严重程度。生活质量通过欧洲癌症研究与治疗组织核心生活质量问卷第3.0版(EORTC QLQ-C30)的基本模块进行评估。问卷结果在一定程度上令人惊讶,因为从患者的回答中可以看出,这种维持治疗所带来的不良影响比医生在与患者接触时所意识到的要多得多。在本总结中,我们仅列出最常见的影响(视力下降、睡眠障碍、抑郁、易怒和不安、寒战、肌肉和关节疼痛、全身乏力和呼吸困难)。从生活质量调查问卷中可以看出,与健康人群相比,这些患者的生活质量明显较差。然而,各亚组之间没有根本差异。问卷仅发放给接受维持治疗超过一年的患者,因此排除了因不良影响而停止维持治疗的患者。为了大致了解上述维持治疗的耐受性,作者提到,截至2001年8月31日,113例患者被随机分配到维持治疗的一个分支组。6%的患者不得不停止维持治疗(2例因严重甲状腺功能减退,1例因幻觉,3例因该治疗导致的严重精神抑郁)。20%的患者减少了干扰素剂量,通常是因为血细胞减少,但也有精神方面的问题。对于“维持治疗的不良影响需要延长多长时间的生命来弥补”这个问题,接受ID方案(可能是I组方案)的患者给出了如下回答:3个月——47.6%和38.3%,6个月——4.3%和10.6%,9个月——0和4.3%,12个月——47.6%和46.8%。在回答“假设疗效相同,患者更倾向于选择α干扰素单一维持治疗还是地塞米松”这个问题时,更多患者选择了干扰素而非地塞米松。从本文中可以得出对临床实践有指导意义的结论,即维持治疗的不良影响以及维持治疗对生活质量的影响:1. 医生必须全面了解所有可能的不良影响,因为只有了解治疗可能出现的不良影响,医生才能识别它们;2. 不仅要定期监测基础疾病的活动情况,还要监测维持治疗的不良影响以及治疗对患者生活质量的影响;3. 在临床试验中,有必要将生活质量评估作为决定治疗方式的重要参数。