Combination of alendronate sodium tablets and ossotide for injection for primary osteoporosis: a meta-analysis

doi:10.3969/j.issn.2095-4344.1051

Abstract

Abstract:

BACKGROUND: Alendronate combined with injection of ossotide has been extensively applied in the treatment of primary osteoporosis, but there is still lack of evidence-based medicine.

OBJECTIVE: To systematically evaluate the efficacy and safety of alendronate combined with injection of ossotide for primary osteoporosis.

METHODS: Cochrane, Web of Science, PubMed, CBM, CNKI, WanFang, and VIP databases were retrieved for the articles published from August 2008 to August 15, 2018. Literature screening, data extraction, and quality evaluation were conducted by two reviewers. Meta-analysis was undergone on Review manager 5.3 software.

RESULTS AND CONCLUSION: (1) Thirteen randomized controlled trials involving 1 579 patients were included, including trial group (n=792, alendronate sodium tablets + ossotide for injection + calcium carbonate and vitamin D3 tablets, or alendronate sodium tablets + ossotide for injection) and control group (n=787, alendronate sodium tablets + calcium carbonate and vitamin D3 tablets, or calcium carbonate and vitamin D3 tablets). The results of meta-analysis showed that the OR value of cohort effect was 5.67, and 95%CI was [4.02, 8.00]. The efficacy between two groups was differently different (P < 0.000 01). The effective rate in the trial group (94.44%) was higher than that in the control group (74.97%). The total curative efficacy of alendronate sodium tablets combined with ossotide for injection in the treatment of primary osteoporosis was significantly superior to the control group. (2) Alendronate sodium tablets combined with ossotide for injection can improve the curative efficacy in the treatment of primary osteoporosis. However, due to the low quality of literature, unclear clinical trial randomized methods, and follow-up deficiency, the treatment outcome of the combination of alendronate sodium tablets and ossotide for injection for primary osteoporosis still needs a further investigation.

Key words: Diphosphonates, Osteoporosis, Meta-Analysis, Tissue Engineering

CLC Number:

R452

Lin Jiyong, Huang Lan, Liang Fengzhen, Shang Yuzhi, Zhang Qinghuai, Fang Gang, Pang Yuzhou. Combination of alendronate sodium tablets and ossotide for injection for primary osteoporosis: a meta-analysis [J]. Chinese Journal of Tissue Engineering Research, doi: 10.3969/j.issn.2095-4344.1051.

Figures/Tables 3

2.3 文献质量评估结果在纳入的13篇文献研究中，1个RCT以随机数字表及就诊顺序基础上实行随机分组[20]，3个RCT以随机数字表进行随机分组[7，11，18]，1个RCT进行随访报道[13]，其余文献未就随机分组进行详细说明，没有对盲法及随访等予以报道，因此纳入文献质量偏低，但都为当前较佳数据。 2.4 疗效分析 2.4.1 纳入文献的总有效率比较此次研究的总有效率以计数资料二分法表示，纳入的13篇文献使用临床综合疗效标准[7-19]，其中总有效率定义为治愈患者或效果显著及好转。首先对纳入的13篇文献进行异质性定性检验，结果显示P=0.59 > 0.1，I2=0%，研究间无统计学差异性，同质性较好，使用固定效应模型进行Meta分析；研究效应量进行整合显示OR=5.67，95%CI为[4.02，8.00]，治疗组和对照组疗效比较，差异有统计学意义(Z=9.88，P < 0.000 01)。Meta分析结果可以观察到置信空间落在垂直线的右侧，治疗效果治疗组优于对照组，表明口服阿伦膦酸钠片联合注射用骨肽能够有效治疗骨质疏松症，见图2。 2.4.2 治疗前后骨密度比较共有8篇文献使用治疗前后骨密度进行临床疗效的评价，其中2篇文献未说明某个区域骨密度测量的对比[12，15]，1篇文献采用腰椎骨密度测量对比[19]，5篇详细说明取股骨Ward三角区骨密度进行比较[7-9，11，17]，通过统计学t 检验的方式进行统计；进一步对其进行异质性检验，结果为P=0.82，I2=0%，表明研究间无统计学异质性，采用固定效应模型，做进一步分析，整合效应量SMD=0.60，95%CI为[0.46，0.73]，两组疗效相比差异有显著性意义(Z=8.79，P=0.000 01 < 0.01)，森林图显示置信区间落在无效线右边，提示治疗组的效应量大于对照组，差异有显著性意义，骨密度得到改善，见图3。 2.5 发表性偏倚的评价采用漏斗图检测该研究发表偏倚情况，倒漏斗图显示研究纳入文献分布及对称较好，表明纳入研究文献的发表性偏倚较小，提示研究文献存在阴性结果的可能性较小，见图4。"

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