Röder E, Berger M Y, de Groot H, Gerth van Wijk R
Section of Allergology, Department of Internal Medicine, Erasmus MC-University Medical Center Rotterdam, The Netherlands.
Clin Exp Allergy. 2008 Oct;38(10):1659-67. doi: 10.1111/j.1365-2222.2008.03060.x. Epub 2008 Jul 2.
Adherence is essential for effective treatment. Although several trials on the efficacy of sublingual immunotherapy (SLIT) in youngsters have been published, few contain data on medication intake.
We aimed to quantify adherence both to study protocol and medication intake as well as to identify factors that may influence adherence to SLIT in youngsters with rhinoconjunctivitis.
Two hundred and four youngsters (6-18 years) with hayfever participated in a randomized controlled trial and used grass pollen extract or placebo for 2 years. The primary outcome of the trial was the mean daily total rhinoconjunctivitis symptom score in the second grass pollen season. Participants having completed the follow-up were considered adherent to the study protocol. Adherence to medication intake was assessed by weighing the study medication. Participants who completed the follow-up and used > or = 80% of the prescribed medication were considered adherent to medication intake. Patient-, disease- and treatment-related factors were analysed.
One hundred and fifty-four youngsters completed the study. The main reason for discontinuation was the inability to take medication according to schedule. Drop-outs were older, had more difficulty following the medication instructions and their overall evaluation of the treatment effect was lower. The number and reasons for drop-out did not differ between treatment groups. In total, 77% of the participants was adherent to medication intake. Self-reported adherence was 99%. Non-adherent participants experienced more severe symptoms before the trial. Symptom scores did not differ between adherent and non-adherent participants. In adherent as well as non-adherent participants, no difference was found between verum and placebo group with respect to symptom scores.
Adherence to both study protocol and medication intake was good. Drop-out was affected by age, evaluation of the treatment effect and medication instructions. Non-adherence to medication intake was influenced by the severity of the disease before the trial. The ineffectiveness of SLIT could not be explained by non-adherence.
坚持治疗对于有效治疗至关重要。尽管已经发表了几项关于舌下免疫疗法（SLIT）在青少年中疗效的试验，但很少有试验包含药物摄入的数据。
我们旨在量化对研究方案和药物摄入的依从性，并确定可能影响患有鼻结膜炎的青少年对SLIT依从性的因素。
204名患有花粉症的青少年（6 - 18岁）参加了一项随机对照试验，使用草花粉提取物或安慰剂治疗2年。该试验的主要结局是第二个草花粉季节的每日鼻结膜炎症状总分均值。完成随访的参与者被视为依从研究方案。通过称量研究药物来评估药物摄入的依从性。完成随访且使用了≥80%规定药物的参与者被视为依从药物摄入。对患者、疾病和治疗相关因素进行了分析。
154名青少年完成了研究。停药的主要原因是无法按计划服药。退出者年龄较大，遵循药物说明有更多困难，并且他们对治疗效果的总体评价较低。治疗组之间退出的人数和原因没有差异。总体而言，77%的参与者依从药物摄入。自我报告的依从率为99%。不依从的参与者在试验前经历了更严重的症状。依从和不依从的参与者之间症状评分没有差异。在依从和不依从的参与者中，在症状评分方面，治疗组和安慰剂组之间没有发现差异。
对研究方案和药物摄入的依从性都很好。退出受年龄、对治疗效果的评价和药物说明的影响。试验前疾病的严重程度影响药物摄入的不依从性。SLIT的无效性不能用不依从来解释。
Zotero 插件