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甲状旁腺激素类似物与双膦酸盐序贯治疗骨质疏松症有效性与
安全性的Meta分析
Δ
姚娟娟 1, 2, 3* ,石春霞 2, 3, 4 ,张乐媛 1, 2, 3 ,马 俊 1, 2, 3 ,齐鸣瑞 1, 2, 3 ,田利民 1, 2, 3 # (1.甘肃中医药大学第一临床医学院,
兰州 730000;2.甘肃省人民医院内分泌科,兰州 730000;3.甘肃代谢性疾病临床研究中心,兰州 730000;
4.江苏大学医学院,江苏 镇江 212000)
中图分类号 R979.9;R681 文献标志码 A 文章编号 1001-0408(2024)24-3059-06
DOI 10.6039/j.issn.1001-0408.2024.24.16
摘 要 目的 评价甲状旁腺激素类似物和双膦酸盐序贯治疗对骨质疏松症的有效性和安全性。方法 检索PubMed、Embase、the
Cochrane Library、Web of Science、中国知网、维普网、万方数据、中国生物医学文献服务系统等中英文数据库,检索时间自建库至
2024年3月25日。由2名研究员各自进行文献检索、筛选、数据提取。采用Review Manager 5.4软件进行Meta分析。针对可能的
异质性来源根据试验组不同给药顺序进行亚组分析及敏感性分析。结果 共纳入7项随机对照试验,包含2 461例受试者,其中试
验组 1 215 例,对照组 1 246 例。Meta分析结果显示,试验组采用甲状旁腺激素类似物与双膦酸盐序贯治疗对腰椎[SMD=0.90,
95%CI(0.44,1.35),P<0.001]、全髋关节[SMD=0.68,95%CI(0.14,1.21),P=0.01]、股骨颈[SMD=0.45,95%CI(0.04,0.86),P=
0.03]骨密度的改善效果均显著优于对照组,在降低治疗后骨折发生率方面显著优于对照组[OR=0.72,95%CI(0.54,0.97),P=
0.03],两组患者不良反应发生率比较差异无统计学意义[OR=1.21,95%CI(0.99,1.46),P=0.06]。根据试验组给药顺序进行亚组
分析,结果显示,双膦酸盐转换为甲状旁腺激素类似物组[SMD=0.56,95%CI(0.09,1.03),P=0.02]或甲状旁腺激素类似物转换为
双膦酸盐组[SMD=0.97,95%CI(0.49,1.46),P<0.001]腰椎骨密度改善效果均显著优于对照组,双膦酸盐转换为甲状旁腺激素类
似物组全髋关节骨密度改善效果显著优于对照组[SMD=0.66,95%CI(0.18,1.13),P=0.007]。敏感性分析提示本研究结果稳健。
结论 甲状旁腺激素类似物与双膦酸盐序贯治疗可被推荐为骨质疏松症患者的有效治疗方法,安全性良好,且序贯给药顺序应当
根据患者的具体情况和骨骼部位的不同反应进行个性化调整。
关键词 甲状旁腺激素类似物;双膦酸盐;序贯治疗;骨质疏松症;骨密度
Effectiveness and safety of sequential therapy with parathyroid hormone analogues and bisphosphonates
for osteoporosis: a meta-analysis
YAO Juanjuan 1, 2, 3 ,SHI Chunxia 2, 3, 4 ,ZHANG Leyuan 1, 2, 3 ,MA Jun 1, 2, 3 ,Qi Mingrui 1, 2, 3 ,Tian Limin 1, 2, 3 (1. The
First Clinical Medical College, Gansu University of Chinese Medicine, Lanzhou 730000, China;2. Dept. of
Endocrinology, Gansu Provincial Hospital, Lanzhou 730000, China;3. Gansu Clinical Research Center for
Metabolic Diseases, Lanzhou 730000, China;4. School of Medicine, Jiangsu University, Jiangsu Zhenjiang
212000, China)
ABSTRACT OBJECTIVE To evaluate the effectiveness and safety of sequential therapy with parathyroid hormone analogues and
bisphosphonates for osteoporosis. METHODS PubMed, Embase, the Cochrane Library, Web of Science, China National
Knowledge Infrastructure, VIP, Wanfang data, and SinoMed were searched in both English and Chinese databases from their
inception to March 25, 2024. Two researchers independently conducted literature searches, screening, and data extraction. Review
Manager 5.4 software was used for the meta-analysis. Subgroup analyses and sensitivity analyses were performed based on different
medication sequences in the treatment group to account for potential sources of heterogeneity. RESULTS A total of 7 randomized
controlled trials involving 2 461 participants were included, with 1 215 in the treatment group and 1 246 in the control group. The
meta-analysis results showed that the treatment group using sequential therapy with parathyroid hormone analogues and
bisphosphonates had superior effects on improving bone mineral density at the lumbar spine [SMD=0.90, 95%CI (0.44, 1.35),
P<0.001], total hip [SMD=0.68, 95%CI (0.14, 1.21), P=0.01], and femoral neck [SMD=0.45, 95%CI (0.04, 0.86), P=0.03]
compared to the control group. It also significantly outperformed the control group in reducing the incidence of fractures post-
treatment [OR=0.72, 95%CI (0.54, 0.97), P=0.03]. No
Δ 基金项目 甘肃省卫生健康行业科研计划项目(No.GSWSK-
significant difference was noted in the incidence of adverse
Y2020-08);兰州市人才创新创业项目(No.2018-RC-79) reactions between the two groups [OR=1.21, 95%CI (0.99,
*第一作者 硕士研究生。研究方向:内分泌与代谢性疾病(骨质
1.46), P=0.06]. Subgroup analysis based on intervention
疏松症)的诊治。E-mail:463435@163.com
# 通信作者 主任医师,教授,博士生导师,博士。研究方向:内分 measures in the treatment group showed that switching from
泌与代谢性疾病(骨质疏松症)的诊治。E-mail:tlm7066@sina.com bisphosphonates to parathyroid hormone analogues [SMD=
中国药房 2024年第35卷第24期 China Pharmacy 2024 Vol. 35 No. 24 · 3059 ·