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阿立哌唑治疗抗精神病药物所致高催乳素血症的系统综述和meta分析

发布时间:2018-07-31 09:40
【摘要】:背景高催乳素血症是抗精神病药物治疗中出现的一种常见、严重的不良反应,近年来开始出现阿立哌唑用来改善高催乳素血症报道,但结果不尽一致,虽然已有一篇相关系统综述,但由于纳入文献少,具有较大局限性。目的对有关阿立哌唑辅助治疗其他抗精神病药物所致高催乳素血症的有效性和安全性的所有随机对照研究进行meta分析。方法检索国内外数据库,收集2015年1月20日前已完成的所有关于阿立哌唑治疗抗精神病药物所致高催乳血症的随机对照临床试验;按照预先规定的纳入及排除标准筛选相关研究,并根据Cochrane偏倚风险评估工具对纳入研究偏倚风险情况进行评价,采用Cochrane GRADE评估证据质量,使用Review Manager 5.3软件进行数据分析。结果1.共纳入21篇随机对照临床试验共1853例样本,其中在中国大陆开展的研究有19项。2.有11项提供了研究终点催乳素水平恢复正常的人数,去除3个导致异质性高的研究后对剩余8项研究共604例样本进行meta分析,发现与对照组相比,加用阿立哌唑辅助治疗后,催乳素水平恢复的患者比例显著增加(RR=19.2,95%CI=11.0-33.5),差异有统计学意义。两组患者在随访中出现不良反应的总体比例没有明显差异,但阿立哌唑组报告嗜睡(RR=2.76,95%CI=1.34-5.69)和头痛(RR=2.31,95%CI=1.08-4.92)的发生比例相对高。按照加用不同剂量阿立哌唑分组发现,高剂量阿立哌唑(5mg/d)比低剂量(≤5mg/d)更有效(RR=30.0,95%CI=10.2-120.7比RR=15.1,95%CI=8.1-28.1),但这种差异无统计学意义。3.这些研究中有6项被评为“高”偏移风险,而其他15项的偏移风险“不清楚”。对21项研究57个研究结果的证据水平评估显示只有7个是“高”质量的。结论本研究结果提示加用阿立哌唑治疗抗精神病药物所致高催乳素血症是安全有效的。而加用阿立哌唑的高剂量并不能进一步改善高催乳素血症。加用阿立哌唑可能会增加嗜睡和头痛的风险,应加强监测。然而,一些研究的质量较低,随访时间相对较短,这些都会影响研究结果的有效性。需要进一步实施具有完善设计的研究。
[Abstract]:Background Hyperprolactinemia is a common and severe adverse reaction in antipsychotic therapy. In recent years, aripiprazole has been reported to improve hyperprolactinemia, but the results are not consistent. Although there has been a review of relevant systems, there are many limitations due to the lack of literature. Objective to analyze the efficacy and safety of aripiprazole in the treatment of hyperprolactinemia induced by other antipsychotics by meta. Methods to search the domestic and foreign databases and collect all the randomized controlled clinical trials of aripiprazole in the treatment of hyperprolactinemia induced by antipsychotics before January 20, 2015. According to the pre-stipulated inclusion and exclusion criteria, the relevant studies were screened, and the risk of inclusion bias was evaluated according to Cochrane bias risk assessment tool. The quality of evidence was evaluated by Cochrane GRADE, and the data was analyzed by Review Manager 5.3 software. Result 1. A total of 1853 samples were included in 21 randomized controlled clinical trials, of which 19 were conducted in mainland China. Eleven subjects provided the number of people who had returned to normal levels of prolactin at the end of the study. After removing 3 studies that led to high heterogeneity, 604 samples of the remaining 8 studies were analyzed by meta. It was found that, compared with the control group, the adjuvant therapy with aripiprazole was used after the addition of aripiprazole. The proportion of patients who recovered prolactin level was significantly increased (RRN 19.2C95 CI 11.0-33.5), the difference was statistically significant. There was no significant difference in the overall incidence of adverse reactions between the two groups, but the incidence of drowsiness (RRN 2.76-95CII 1.34-5.69) and headache (RRR 2.3195 CI 1.08-4.92) was relatively high in aripiprazole group. According to different doses of aripiprazole, it was found that high dose aripiprazole (5mg/d) was more effective than low dose (鈮,

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