双膦酸盐治疗骨质疏松症与总死亡率相关性的meta分析

doi:10.3877/cma.j.issn.2096-0263.2020.05.010

目的

系统评价临床随机对照试验是否能够证明双膦酸盐类药物的应用与骨质疏松症患者的死亡率降低相关。

方法

依据Meta分析要求，对CBM、CNKI、MEDLINE、PubMed、Springer、Embase、万方、维普、Cochrane Library、中国科技论文统计与分析网、专利数据库等进行检索，严格评价纳入以双膦酸盐药物作为主要干预措施治疗骨质疏松症的临床随机对照实验研究文献，并收录有效的相关的数据资料，检索年限从建库至2020年5月。采用NOS文献质量评价标准对符合纳入排除标准的文献进行质量评价。采用RR值及其95%可信区间评估关联强度。根据是否存在异质性，采用固定效应模型合并效应量，并根据单因素敏感性分析法进行敏感性分析。

结果

最终纳入21篇文献，受试者共42 849例，双膦酸盐组患者22 605例，死亡855例，安慰剂组20 244例，死亡880例。双膦酸盐治疗骨质疏松症与总死亡率相关性的为RR=0.949（95% CI：0.866，1.040，P=0.264）。阿仑膦酸盐治疗骨质疏松症与总死亡率相关性的为RR=0.996（95% CI：0.705，1.407，P=0.982），伊班膦酸盐为RR=0.802（95% CI：0.496，1.298，P=0.369），利塞膦酸盐为RR=0.915（95% CI：0.757，1.105，P=0.354），唑来膦酸盐为RR=0.898（95% CI：0.770，1.047，P=0.168），尚未发现双磷酸盐治疗骨质疏松症与总死亡率的关联性。

结论

经meta分析发现双膦酸盐治疗骨质疏松症患者的总死亡率未见明显降低。

关键词: 骨质疏松症, 双膦酸盐, 总死亡率

Objective

To systematically evaluate whether clinical randomized controlled trials can demonstrate that bisphosphonates, especially zoledronic acid, are associated with reduced mortality in patients with osteoporosis.

Methods

According to the requirements of meta-analysis, CBM, CNKI, MEDLINE, PubMed, Springer, EMBASE, Wanfang, VIP and Cochrane were analyzed Library, China Science and Technology Papers Statistics and analysis network, patent database, etc. were searched to strictly evaluate the included clinical randomized controlled trials with bisphosphonates as the main intervention measures in the treatment of osteoporosis, and included effective related data. The retrieval period was from the establishment of the database to may 2020. The NOS standard was used to evaluate the quality of the literatures that met the inclusion and exclusion criteria. RR and its 95% confidence interval were used to evaluate the association strength. According to the existence of heterogeneity, the fixed effect model was used to merge the effect amount, and the single factor sensitivity analysis method was used to analyze the sensitivity.

Results

A total of 21 articles including 42, 849 subjects, 22, 605 patients in the bisphosphonate group, 855 patients died, 20, 244 patients in the placebo group and 880 deaths in the placebo group were analyzed. The correlation between bisphosphonate therapy and total mortality was 0.949 (95% CI: 0.866, 1.040, P=0.264). The correlation between alendronate and total mortality was 0.996 (95% CI: 0.705, 1.407, P=0.982), ibandronate was RR=0.802 (95% CI: 0.496, 1.298, P=0.369), risedronate was RR=0.915 (95% CI: 0.757, 1.105, P=0.354) and zoledronate was RR=0.898 (95% CI: 0.770, 1.047, P=0.168). There was no association between bisphosphonate therapy and total mortality.

Conclusion

The meta-analysis showed that bisphosphonates did not reduce the overall mortality of patients with osteoporosis.

Key words: Osteoporosis, Bisphosphonates, Total mortality

图1 纳入文献流程图

表1 纳入文献特征表

编号	第一作者	发表年份	药物	用药时间，年	治疗组		安慰剂组		年龄	评分
编号	第一作者	发表年份	药物	用药时间，年	死亡	全部	死亡	全部	年龄	评分
1	Liberman^[14]	1995	阿仑膦酸盐	3	3	579	2	397	64（45～80）	7
2	Black^[15]	1996	阿仑膦酸盐	3	24	1 022	21	1 005	71（55～81）	8
3	Ravn^[16]	1996	伊班膦酸盐	1	1	150	40	2 218	68（54～81）	9
4	Cummings^[17]	1998	阿仑膦酸盐	4.5	37	2 214	0	280	65（≤85）	7
5	Harris^[18]	1999	利塞膦酸盐	3	15	813	249	2 796	80（≥75）	9
6	Reginster^[19]	2000	利塞膦酸盐	3	11	407	1	30	65（<75）	6
7	McClung^[20]	2001	利塞膦酸盐	3	167	3 104	10	975	69（55～80）	8
8	Chesnut^[21]	2004	伊班膦酸盐	3	19	1 954	13	949	67（55～76）	8
9	Recker^[22]	2004	伊班膦酸盐	3	23	1 911	0	83	54（45～60）	6
10	McCloskey^[23]	2007	氯膦酸盐	3	264	2 796	3	63	51（NA）	6
11	V?lim?ki^[24]	2007	利塞膦酸盐	2	0	115	16	815	69（≤85）	7
12	Black^[25]	2007	唑来膦酸盐	3	130	3 862	17	407	71（≤85）	7
13	Lyles^[26]	2007	唑来膦酸盐	1.9	101	1 054	178	3 134	78（70～100）	9
14	Yan^[27]	2009	阿仑膦酸盐	1	0	280	0	55	66（NA）	6
15	McClung^[28]	2009	伊班膦酸盐	1	0	77	3	93	61（36～84）	6
16	Boonen^[29]	2009	利塞膦酸盐	2	2	191	112	3 852	73（65～89）	9
17	Smerud^[30]	2012	伊班膦酸盐	1	0	66	141	1 057	75（≥50）	7
18	Boonen^[31]	2012	唑来膦酸盐	2	15	588	18	611	NA（50～85）	7
19	Greenspan^[32]	2015	唑来膦酸盐	2	14	89	12	92	85（≥65）	6
20	Nakamura^[33]	2017	唑来膦酸盐	2	2	333	3	332	74（65～89）	7
21	Reid^[34]	2018	唑来膦酸盐	6	27	1 000	41	1 000	71（>65）	8

表1 纳入文献特征表

编号	第一作者	发表年份	药物	用药时间，年	治疗组		安慰剂组		年龄	评分
编号	第一作者	发表年份	药物	用药时间，年	死亡	全部	死亡	全部	年龄	评分
1	Liberman^[14]	1995	阿仑膦酸盐	3	3	579	2	397	64（45～80）	7
2	Black^[15]	1996	阿仑膦酸盐	3	24	1 022	21	1 005	71（55～81）	8
3	Ravn^[16]	1996	伊班膦酸盐	1	1	150	40	2 218	68（54～81）	9
4	Cummings^[17]	1998	阿仑膦酸盐	4.5	37	2 214	0	280	65（≤85）	7
5	Harris^[18]	1999	利塞膦酸盐	3	15	813	249	2 796	80（≥75）	9
6	Reginster^[19]	2000	利塞膦酸盐	3	11	407	1	30	65（<75）	6
7	McClung^[20]	2001	利塞膦酸盐	3	167	3 104	10	975	69（55～80）	8
8	Chesnut^[21]	2004	伊班膦酸盐	3	19	1 954	13	949	67（55～76）	8
9	Recker^[22]	2004	伊班膦酸盐	3	23	1 911	0	83	54（45～60）	6
10	McCloskey^[23]	2007	氯膦酸盐	3	264	2 796	3	63	51（NA）	6
11	V?lim?ki^[24]	2007	利塞膦酸盐	2	0	115	16	815	69（≤85）	7
12	Black^[25]	2007	唑来膦酸盐	3	130	3 862	17	407	71（≤85）	7
13	Lyles^[26]	2007	唑来膦酸盐	1.9	101	1 054	178	3 134	78（70～100）	9
14	Yan^[27]	2009	阿仑膦酸盐	1	0	280	0	55	66（NA）	6
15	McClung^[28]	2009	伊班膦酸盐	1	0	77	3	93	61（36～84）	6
16	Boonen^[29]	2009	利塞膦酸盐	2	2	191	112	3 852	73（65～89）	9
17	Smerud^[30]	2012	伊班膦酸盐	1	0	66	141	1 057	75（≥50）	7
18	Boonen^[31]	2012	唑来膦酸盐	2	15	588	18	611	NA（50～85）	7
19	Greenspan^[32]	2015	唑来膦酸盐	2	14	89	12	92	85（≥65）	6
20	Nakamura^[33]	2017	唑来膦酸盐	2	2	333	3	332	74（65～89）	7
21	Reid^[34]	2018	唑来膦酸盐	6	27	1 000	41	1 000	71（>65）	8

图3 双磷酸盐治疗骨质疏松症与总死亡率相关性的发表偏倚漏斗图

图6 伊班膦酸盐总死亡率的森林图

图8 唑来膦酸盐治疗骨质疏松症与总死亡率相关性的森林图

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The relationship between bisphosphonates and total mortality in patients with osteoporosis: A Meta-Analysis

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The relationship between bisphosphonates and total mortality in patients with osteoporosis: A Meta-Analysis