唑来膦酸5mg输注后中国绝经后骨质疏松症女性急性期反应观察的多中心研究
Multicenter Study on Observation of Acute-phase Responses After Infusion of Zoledronic Acid 5 mg in Chinese Women with Postmenopausal Osteoporosis.
作者信息
Ding Yue, Zeng Jian-Cheng, Yin Fei, Zhang Chun-Lin, Zhang Yan, Li Shi-Xun, Liu Xun, Zhang Chao, Xue Qing-Yun, Lin Hua, Pei Fu-Xing
机构信息
Department of Orthopaedics, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Department of Orthopaedics, West China Hospital, Sichuan University, Chengdu, China.
出版信息
Orthop Surg. 2017 Aug;9(3):284-289. doi: 10.1111/os.12338.
OBJECTIVE
It has been reported that acute-phase reactions (APR) after infusion of 5 mg zoledronic acid for the first time is common. This study surveyed the incidence and characteristics of APR in Chinese postmenopausal women receiving 5 mg zoledronic acid intravenously for osteoporosis and to evaluate the efficacy of non-steroidal anti-inflammatory drugs (NSAID) in preventing or alleviating APR following the first 5 mg zoledronic acid infusion.
METHODS
A total of 2601 patients with an average age of 68.14 ± 9.89 years and a mean body mass index of 22.90 ± 3.24 kg/m from 62 centers in China were treated with 5 mg zoledronic acid intravenously for the first time. The incidence of fever and pain were observed in these patients, and the time of fever or pain onset and duration, and the intensity of fever and grade of pain were also recorded. The dosage, duration, and efficacy of NSAID and safety outcomes were also documented.
RESULTS
At the end of the study, 18 patients are eliminated due to incomplete records of temperature. The incidence of fever was 28.65% (740/2583) within 7 days following zoledronic acid infusion; 98.34% (727/740) occurred at 1.03 ± 0.66 days after infusion and lasted 1.72 ± 0.93 days. A total of 456 (17.53%) patients had newly onset pain (312 of 1187, 26.28%) or experienced pain aggravation (144 of 1414, 10.18%), which mostly occurred within 3 days after zoledronic acid infusion. A total of 1246 (47.6%) patients had received NSAID for a median time of 2.63 ± 2.45 days. Using NSAID for at least 2 days could decrease body temperature by 0.54 ± 0.86°C, increase the percentage of pain-free patients by 6.17%, and reduce the percentage of patients with moderate to severe pain by 8.7%.
CONCLUSIONS
Compared with Western populations, Chinese patients had a higher rate of fever and pain after their first zoledronic acid infusion. These symptoms were often mild to moderate in intensity and transient in duration. NSAID could effectively reduce the incidence and severity of such APR.
目的
据报道，首次输注5毫克唑来膦酸后急性期反应（APR）很常见。本研究调查了中国绝经后女性静脉输注5毫克唑来膦酸治疗骨质疏松症时APR的发生率和特征，并评估非甾体抗炎药（NSAID）在预防或减轻首次输注5毫克唑来膦酸后APR方面的疗效。
方法
来自中国62个中心的共2601例患者，平均年龄68.14±9.89岁，平均体重指数22.90±3.24kg/m²，首次接受静脉输注5毫克唑来膦酸治疗。观察这些患者发热和疼痛的发生率，记录发热或疼痛的起始时间、持续时间，以及发热强度和疼痛分级。还记录了NSAID的剂量、使用时间和疗效以及安全性结果。
结果
研究结束时，18例患者因体温记录不完整被剔除。唑来膦酸输注后7天内发热发生率为28.65%（740/2583）；98.34%（727/740）发生在输注后1.03±0.66天，持续1.72±0.93天。共有456例（17.53%）患者出现新发疼痛（1187例中的312例，26.28%）或疼痛加重（1414例中的144例，10.18%），大多发生在唑来膦酸输注后3天内。共有1246例（47.6%）患者接受了NSAID治疗，中位治疗时间为2.63±2.45天。使用NSAID至少2天可使体温降低0.54±0.86°C，无痛患者百分比增加6.17%，中重度疼痛患者百分比降低8.7%。
结论
与西方人群相比，中国患者首次输注唑来膦酸后发热和疼痛发生率更高。这些症状强度通常为轻至中度，持续时间短暂。NSAID可有效降低此类APR的发生率和严重程度。
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