对于日本原发性骨质疏松症患者，每周一次阿仑膦酸钠口服凝胶与每周一次阿仑膦酸钠口服片剂治疗的比较：一项开放标签、前瞻性、观察性研究。
Treatment with once-weekly alendronate oral jelly compared with once-weekly alendronate oral tablet for Japanese patients with primary osteoporosis: An open-label, prospective, observational study.
作者信息
Okimoto Nobukazu, Uemura Yukari, Yoshioka Toru, Arita Shinobu, Tsurukami Hiroshi, Otomo Hajime, Nishida Satoshi, Ogawa Takayuki, Hirao Ken, Ikeda Satoshi, Matsumoto Hidehiro, Toten Yoriko, Katae Yuji, Okazaki Yuichi, Nakagawa Tsuyoshi, Sakai Akinori
机构信息
Okimoto Clinic Kure Japan.
Department of Biostatistics, Clinical Research Support Center University of Tokyo Hospital Bunkyo-ku Tokyo Japan.
出版信息
Health Sci Rep. 2018 Dec 12;2(1):e107. doi: 10.1002/hsr2.107. eCollection 2019 Jan.
BACKGROUND AND AIMS
Clinical data regarding alendronate jelly are limited. We compared the efficacy and safety of once-weekly alendronate oral jelly with once-weekly alendronate tablet formulations in the context of primary osteoporosis.
METHODS
In this 6-month, open-label, prospective, observational study, Japanese patients aged ≥60 years with primary osteoporosis were included from 14 primary care centres in Japan. The effects of once-weekly alendronate oral jelly and tablet formulations on bone mineral density (BMD), bone turnover markers, and quality of life related to gastrointestinal symptoms were assessed at baseline and 6 months. Treatment was allocated by patient preference. This potentially confounding factor was adjusted for statistically.
RESULTS
In total, 170 patients were enrolled (jelly, n = 97; tablet, n = 73). Mean percent changes in radius, lumbar spine, femoral neck, and hip BMD were similar in both treatment groups at 6 months. Both formulations decreased tartrate-resistant acid phosphatase 5b (TRACP-5b) and procollagen 1 N-terminal peptide (P1NP) between baseline and 6 months (by about 50% and 60%, respectively); no significant differences in mean changes were noted in these markers between groups. At 6 months, no significant differences were noted in visual analogue scale or EuroQOL five-dimension questionnaire scores between groups. The jelly group had significantly lower scores than the tablet group in the Izumo scale domains of heartburn (-0.81, = 0.0040), epigastralgia (-0.94, = 0.0003), and epigastric fullness (-0.49, = 0.044). During treatment, more patients discontinued for upper gastrointestinal symptoms in the tablet group (n = 4) than the jelly group (n = 1).
CONCLUSIONS
Once-weekly alendronate oral jelly 35 mg may be a suitable alternative therapeutic agent for primary osteoporosis in Japan.
背景与目的
关于阿仑膦酸盐凝胶的临床数据有限。我们在原发性骨质疏松症的背景下，比较了每周一次的阿仑膦酸盐口服凝胶与每周一次的阿仑膦酸盐片剂的疗效和安全性。
方法
在这项为期6个月的开放标签、前瞻性观察研究中，从日本14个初级保健中心纳入了年龄≥60岁的日本原发性骨质疏松症患者。在基线和6个月时评估每周一次的阿仑膦酸盐口服凝胶和片剂对骨密度（BMD）、骨转换标志物以及与胃肠道症状相关的生活质量的影响。治疗由患者偏好分配。对这一潜在的混杂因素进行了统计学调整。
结果
总共纳入了170例患者（凝胶组，n = 97；片剂组，n = 73）。6个月时，两个治疗组桡骨、腰椎、股骨颈和髋部BMD的平均百分比变化相似。两种制剂在基线至6个月期间均降低了抗酒石酸酸性磷酸酶5b（TRACP - 5b）和I型前胶原N端肽（P1NP）（分别降低约50%和60%）；两组之间这些标志物的平均变化无显著差异。6个月时，两组之间在视觉模拟量表或欧洲五维健康量表评分方面无显著差异。在烧心（-0.81，P = 0.0040）、上腹痛（-0.94，P = 0.0003）和上腹部饱胀（-0.49，P = 0.044）的出云量表领域，凝胶组的得分显著低于片剂组。治疗期间，片剂组因上消化道症状停药的患者（n = 4）多于凝胶组（n = 1）。
结论
每周一次35毫克的阿仑膦酸盐口服凝胶可能是日本原发性骨质疏松症的一种合适替代治疗药物。
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