维持性血液透析患者继发性甲状旁腺功能亢进阿法骨化醇冲击治疗的Meta分析

Meta analysis of pulse alfacalcidol for the treatment of secondary hyperparathyroidism in haemodialysis patients

目的:了解阿法骨化醇冲击治疗的有效性及安全性,为治疗继发性甲状旁腺功能亢进(SHPT)提供临床依据。方法:通过制定检索策略,计算机检索PubMed、EMbase、Ovid、EBSCO、CNKI、中国生物医学文献、维普中文科技期刊、万方数据知识服务平台等数据库,检索时间均从建库至2013年9月,同时检索相关文献的参考文献,纳入所有研究阿法骨化醇治疗维持性血液净化患者SHPT的随机对照研究,并对文献进行评价,应用Review Manager 5.2软件对资料进行Meta分析。结果:共18个随机对照研究,最终12篇纳入Meta分析,包括阿法骨化醇冲击治疗组340例,对照组323例。试验组与对照组观察指标[全段甲状旁腺激素(iPTH)、钙、磷、钙磷乘积、碱性磷酸酶]治疗前后变化值通过效应量SMD(Standard Mean Difference)进行说明,对iPTH进行分层分析时以OR作为效应指标。Meta分析结果示阿法骨化醇冲击治疗组与对照组治疗前后iPTH比较SMD=-0.30;95%CI为[-0.53,-0.07],P=0.01,差异有统计学意义。阿法骨化醇冲击治疗组较对照组iPTH下降更明显。对纳入文章的异质性通过敏感性分析进行检测,剔除样本量少(n≤30)及低质量文章后结果与之前无明显变化。分别对iPTH<500 pg/ml和iPTH>500 pg/ml进行亚组分析,结果提示无论iPTH位于哪个水平,阿法骨化醇冲击治疗组iPTH均较对照组下降明显(P<0.05)。试验组与对照组治疗后血钙、血磷均升高,两组比较差异无统计学意义。结论:阿法骨化醇冲击治疗使iPTH下降更明显,且不会导致高钙血症及高磷血症等不良反应。

Objective：Evaluating the effectiveness and safety of alfacalcidol pulse treatment, and providing a new therapeutic strategy for the treatment of secondary hyperparathyroidism. Methodology：Original literatures for this review were searched with databases of PubMed, Embase, CNKI and CBMdisc from databases establishment to September 2013. At the same time, the relevant literature references were to retrieved. All the randomized control studies on the pulse alfacalcidol for the treatment of secondary hyperparathyroidism in patients haemodialysis were included. Meta-analysis was conducted using Review Manager 5.2 software. Results：Eighteen randomized controlled studies were included, finally 12 articles were received in the Meta-analysis, including 340 patients with pulse alfacalcidol treatment, and 323 patients for control. The change value was explained by SMD before and after treatment of the observation target （ the product of iPTH, calcium,phosphate, calcium phosphorous and alkaline phosphatase） in treatment group and control group. When analyzing stratifiedly iPTH, the paper took OR as effect indicators. Meta showed the SMD of the treatment group and the control group before and after treatment of parathormone （ - 0. 30 ; 95% CI is - 0. 53, - 0. 07 ） , P = 0. 01 〈 0. 05, and the difference had statistical significance. Compared with the control group, the level of iPTH was declines obviously in the treatment group. The heterogeneity of articles was tested by analyzing sensitivity, and no changes were found before and after treatment after removing a few articles with inferior quality. After subgroup analyzing iPTH 〈 500 pg/ml and〉 500 pg/ml, the experiment made a conclusion that no matter which level iPTH was. Compared with the control group,the levels of iPDH was decreased more obviously,and the difference has the statistical significance. It showed that the SMD of serum calcium in treatment group before and after treatment and control （-0. 10;95% C I was -0. 25 - 0. 06, P = 0. 22） was no significant difference. It also showed that the SMD of serum phosphate in treatment group before and after treatment and control （0. 04;95%CI is -0. 30- 0. 37, P= 0. 830 was no statistical significance. Conclusion：Pulse alfacalcidol treatment resulted in decreasing iPTH more obviously in patients with hemodialysis, and did not cause hypercalcemia, hyperphosphatemia and other side effects.