Aki Semih, Eskiyurt Nurten, Akarirmak Ulkü, Tüzün Fikret, Eryavuz Merih, Alper Serap, Arpacioğlu Oktay, Atalay Fatma, Kavuncu Vural, Kokino Siren, Kuru Omer, Nas Kemal, Ozerbil Onder, Savaş Gürsoy, Sendur Omer Faruk, Soy Derya, Akyüz Gulseren
Department of Physical Medicine and Rehabilitation, Istanbul Medical Faculty, Istanbul, Turkey.
Yonsei Med J. 2003 Dec 30;44(6):961-7. doi: 10.3349/ymj.2003.44.6.961.
The aim of our study was to evaluate the upper gastrointestinal (GI) tract side effect profile in 759 female patients that had taken alendronate (10 mg/day), for at least 6 months, for the treatment of osteoporosis, in relation to the safety of alendronate and the compliance of patients to its absorption rules. This study was a multicentered retrospective, clinical, non- placebo controlled, study of 759 female subjects carried out at 26 centres in 6 different regions of Turkey. The mean age of our patients was 62.6 +/- 8.6, with 51.2%in the age range 60 to 69 years. 158 patients (20.8%) were considered to have upper GI tract complaints with nausea as the most often encountered symptom. Of the subjects with upper GI tract complaints, 20% reported discontinued drug use, and 30% reported the requirement of an additional drug in order to abolish their complaints. Approximately 537 (71%) of the patients stated they had been given written information about the administration of the drug, and at least 93 patients (12%) and 73 patients (18.4%) acknowledged non compliance with the safety and absorption rules, respectively. In our study, no significant difference was found between the adherence to the safety measures and upper GI tract complaints (p > 0.05), but that upper GI tract complaints were higher in patients taking additional medication to alendronate (p < 0.05).
我们研究的目的是评估759名服用阿仑膦酸钠（10毫克/天）至少6个月以治疗骨质疏松症的女性患者的上消化道（GI）道副作用情况，涉及阿仑膦酸钠的安全性以及患者对其吸收规则的依从性。本研究是一项多中心回顾性临床研究，未设安慰剂对照，在土耳其6个不同地区的26个中心对759名女性受试者进行。我们患者的平均年龄为62.6±8.6岁，其中51.2%年龄在60至69岁之间。158名患者（20.8%）被认为有上消化道不适，最常出现的症状是恶心。在上消化道不适的受试者中，20%报告停药，30%报告需要额外用药以消除不适。约537名（71%）患者表示他们已收到关于药物服用的书面信息，至少93名患者（12%）和73名患者（18.4%）分别承认未遵守安全和吸收规则。在我们的研究中，遵守安全措施与上消化道不适之间未发现显著差异（p>0.05），但服用阿仑膦酸钠并额外用药的患者上消化道不适情况更严重（p<0.05）。
