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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
硕士研究生。研究方向:内分泌与代谢性疾病(骨质疏松症)的诊治。E-mail:463435@163.com
主任医师,教授,博士生导师,博士。研究方向:内分泌与代谢性疾病(骨质疏松症)的诊治。E-mail:tlm7066@sina.com
纸质出版日期:2024-12-30,
收稿日期:2024-06-23,
修回日期:2024-10-04,
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姚娟娟,石春霞,张乐媛等.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[J].中国药房,2024,35(24):3059-3064.
YAO Juanjuan,SHI Chunxia,ZHANG Leyuan,et al.Effectiveness and safety of sequential therapy with parathyroid hormone analogues and bisphosphonates for osteoporosis: a meta-analysis[J].ZHONGGUO YAOFANG,2024,35(24):3059-3064.
姚娟娟,石春霞,张乐媛等.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[J].中国药房,2024,35(24):3059-3064. DOI: 10.6039/j.issn.1001-0408.2024.24.16.
YAO Juanjuan,SHI Chunxia,ZHANG Leyuan,et al.Effectiveness and safety of sequential therapy with parathyroid hormone analogues and bisphosphonates for osteoporosis: a meta-analysis[J].ZHONGGUO YAOFANG,2024,35(24):3059-3064. DOI: 10.6039/j.issn.1001-0408.2024.24.16.
目的
2
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
2
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
2
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
2
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。
OBJECTIVE
2
To evaluate the effectiveness and safety of sequential therapy with parathyroid hormone analogues and bisphosphonates for osteoporosis.
METHODS
2
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
2
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 significant difference was noted in the incidence of adverse reactions between the two groups [OR=1.21, 95%CI (0.99, 1.46),
P
=0.06
]
. Subgroup analysis based on intervention measures in the treatment group showed that switching from bisphosphonates to parathyroid hormone analogues [SMD=0.56, 95%CI (0.09, 1.03),
P
=0.02
]
or switching from parathyroid hormone analogues to bispho
sphonates [SMD=0.97, 95%CI (0.49, 1.46),
P
<0.001
]
both significantly potentiated lumbar spine bone mineral density compared to the control group. Switching from bisphosphonates to parathyroid hormone analogues also significantly promoted total hip bone mineral density compared to the control group [SMD=0.66, 95%CI
(0.18, 1.13),
P
=0.007
]
. Sensitivity analysis indicated that the results of this study were robust.
CONCLUSIONS
2
Sequential therapy with parathyroid hormone analogues and bisphosphonates can be recommended as an effective treatment for patients with osteoporosis, with good safety profiles. The medication sequences should be individually adjusted based on the patient’s particular situation and the different responses of various skeletal sites.
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
diphosphonatessequential therapyosteoporosisbone mineral density
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