Chinese Journal of Tissue Engineering Research ›› 2016, Vol. 20 ›› Issue (20): 3012-3021.doi: 10.3969/j.issn.2095-4344.2016.20.017
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Liu Lei, Tao Sheng-xiang
Received:
2016-02-20
Online:
2016-05-13
Published:
2016-05-13
Contact:
Tao Sheng-xiang, M.D., Associate professor, Department of Orthopedics, Zhongnan Hospital of Wuhan University, Wuhan 430071, Hubei Province, China
About author:
Liu Lei, Studying for master’s degree, Department of Orthopedics, Zhongnan Hospital of Wuhan University, Wuhan 430071, Hubei Province, China
CLC Number:
Liu Lei, Tao Sheng-xiang. Ibandronate for postmenopausal osteoporosis: a Meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(20): 3012-3021.
2.3 纳入研究的内容 将失访人群进行删减后,10篇RCT纳入本研究,共计725例患者,其中379例采用伊班膦酸钠、346例采用阿仑膦酸钠。两组患者在年龄、体质量指数、绝经周期、腰椎骨密度、股骨骨密度等基础资料上均未见显著差异。所有患者均完善血常规、凝血常规及生化检验以排除凝血功能及肝肾功能异常的患者,治疗同时适度口服补充钙剂。两组患者就以下主要结局指标的差异性进行了比较(相关RCT≥7篇):①腰椎骨密度。②随访期骨折发生率。 2.4 伊班膦酸钠与阿仑膦酸钠在治疗绝经后骨质疏松对腰椎骨密度的影响 所有RCT均对两组患者接受双膦酸盐治疗后的腰椎骨密度进行了报道[24-33]。如图4示,Meta分析的Galbraith图上部分点(随访1年)分布在2条回归线平行线之外,表明各研究时限结果之间存在一定异质性。Cochran's Q检验示P=0.645、I2=0%,提示各"
研究间存在显著异质性,尚需应用随机效应模型进行Meta分析。再由Galbraith图可看出随访1年的RCT分布于两条回归线平行线之外,于是将随访半年与随访1年时的腰椎骨密度含量分别进行亚组分析用以消除异质性。如森林图所示:①随访半年亚组的Cochran’s Q检验示P=0.174、I2=29.4%,WMD=0.03、95%CI=(0.01,0.04)。②随访1年亚组的Cochran’s Q检验示P=0.0、I2=80.3%,WMD=0.01、95%CI=(-0.03,0.05)。即与对照组相比,实验组患者经治疗半年后腰椎骨密度显著升高,但经治疗1年后,两组患者腰椎骨密度比较没有显著差异性,如图5所示。 针对两亚组的分析结果分别绘制漏斗图,随访半年亚组在漏斗图上各点呈现倒置状对称分布,随访1年亚组则不呈现倒置状对称分布,表明随访1年亚组的结果存在一定的发表偏倚,如图6所示。考虑到此次Meta分析所纳入RCT的数量相对较少,亚组分析后又有一定耗损,故采用Egger法对各亚组的发表偏倚性评价:①随访半年亚组,bias_p=0.054、bias_95 CI=(-4.157 785 1,5.479 325)。②随访1年亚组,bias_p= 0.692、bias_ 95 CI=(-8.267 46,11.500 7),上述结果显示两亚组较明显的发表偏倚性,其线性回归检验图如图7所示。 将此次整合研究的固定效应模型和随机效应模型进行互换后,不同效应模型的结果并未发生逆转,进而计算失安全系数:①随访半年亚组,Nfs0.05=3.75,表明尚需近4篇阴性研究的纳入方能改变本次Meta分析的结果;②随访1年亚组Nfs0.05=3.04,表明尚需至少3篇阴性研究的纳入方能改变本次Meta分析的结果。"
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