伊朗骨质疏松症患者服用 CinnoPar® 的安全性和有效性 IV 期研究。

IF 1.1 Q3 ORTHOPEDICS Journal of Osteoporosis Pub Date : 2021-05-31 eCollection Date: 2021-01-01 DOI:10.1155/2021/7584308
Ahmadreza Jamshidi, Farhad Gharibdoost, Sima Sedighi, Asghar Hajiabbasi, Amir-Hossein Salari, Alireza Khabbazi, Peyman Mottaghi, Ahmad Tahammoli Roudsari, Mehrdad Aghaei, Irandokht Shenavar Masooleh, Araz Sabzvari, Nassim Anjidani
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引用次数: 0

摘要

特立帕肽的安全性已在各种 III 期和 IV 期试验中进行了研究。然而,特立帕肽生物类似物 CinnoPar® 的上市后研究尚未在伊朗患者中开展。这是一项针对骨质疏松症患者进行的 IV 期研究,这些患者接受的是伊朗特立帕肽生物类似物,剂量为每天 20 微克。这项研究的主要结果是监测不良事件(AEs)。次要结果是疗效,采用 EQ-5D 生活质量问卷和背痛视觉模拟量表 (VAS) 评分进行测量。在2015年9月至2019年3月期间分析的193名患者中,最常见的AE为高钙血症(4%)、恶心和疼痛(3%)。本研究未出现死亡、严重AE或其他重大AE。疗程结束后,平均 EQ-5D 分数从基线的 2.3 ± 0.66 降至 2 ± 0.66。平均背痛 VAS 评分也从基线时的 4.9 ± 3.6 降至研究结束时的 1.8 ± 2.1。这两项变化均具有统计学意义(P < 0.001)。与之前的研究结果和药物专著一致,该生物仿制药特立帕肽未发现新的安全问题,而且根据骨质疏松症患者的 VAS 评分和 EQ-5D 值,该药物是有效的。
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A  Phase IV Study of the Safety and Efficacy of CinnoPar® in Iranian Patients with Osteoporosis.

The safety of teriparatide has been studied in various phase III and phase IV trials. However, a postmarketing study of the biosimilar of teriparatide, CinnoPar®, has not been conducted on Iranian patients. This was a phase IV study conducted on osteoporotic patients who received an Iranian teriparatide biosimilar with a dose of 20 μg daily. The primary outcome of this study was to monitor for adverse events (AEs). Effectiveness as the secondary outcome was measured using the EQ-5D quality-of-life questionnaire and back pain Visual Analogue Scale (VAS) score. Among 193 analyzed patients between September 2015 and March 2019, the most common AEs were hypercalcemia (4%), nausea, and pain (3%). No deaths, serious AEs, or other significant AEs occurred in this study. The mean EQ-5D scores decreased after the course of the treatment from 2.3 ± 0.66 at the baseline to 2 ± 0.66. The mean back pain VAS scores also decreased from 4.9 ± 3.6 at baseline to 1.8 ± 2.1 at the end of the study. Both changes were statistically significant (p < 0.001). Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients.

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CiteScore
3.60
自引率
0.00%
发文量
6
审稿时长
20 weeks
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