發(fā)布時間：2018-07-31 09:40

【摘要】：背景高催乳素血癥是抗精神病藥物治療中出現(xiàn)的一種常見、嚴(yán)重的不良反應(yīng),近年來開始出現(xiàn)阿立哌唑用來改善高催乳素血癥報道,但結(jié)果不盡一致,雖然已有一篇相關(guān)系統(tǒng)綜述,但由于納入文獻少,具有較大局限性。目的對有關(guān)阿立哌唑輔助治療其他抗精神病藥物所致高催乳素血癥的有效性和安全性的所有隨機對照研究進行meta分析。方法檢索國內(nèi)外數(shù)據(jù)庫,收集2015年1月20日前已完成的所有關(guān)于阿立哌唑治療抗精神病藥物所致高催乳血癥的隨機對照臨床試驗;按照預(yù)先規(guī)定的納入及排除標(biāo)準(zhǔn)篩選相關(guān)研究,并根據(jù)Cochrane偏倚風(fēng)險評估工具對納入研究偏倚風(fēng)險情況進行評價,采用Cochrane GRADE評估證據(jù)質(zhì)量,使用Review Manager 5.3軟件進行數(shù)據(jù)分析。結(jié)果1.共納入21篇隨機對照臨床試驗共1853例樣本,其中在中國大陸開展的研究有19項。2.有11項提供了研究終點催乳素水平恢復(fù)正常的人數(shù),去除3個導(dǎo)致異質(zhì)性高的研究后對剩余8項研究共604例樣本進行meta分析,發(fā)現(xiàn)與對照組相比,加用阿立哌唑輔助治療后,催乳素水平恢復(fù)的患者比例顯著增加(RR=19.2,95%CI=11.0-33.5),差異有統(tǒng)計學(xué)意義。兩組患者在隨訪中出現(xiàn)不良反應(yīng)的總體比例沒有明顯差異,但阿立哌唑組報告嗜睡(RR=2.76,95%CI=1.34-5.69)和頭痛(RR=2.31,95%CI=1.08-4.92)的發(fā)生比例相對高。按照加用不同劑量阿立哌唑分組發(fā)現(xiàn),高劑量阿立哌唑(5mg/d)比低劑量(≤5mg/d)更有效(RR=30.0,95%CI=10.2-120.7比RR=15.1,95%CI=8.1-28.1),但這種差異無統(tǒng)計學(xué)意義。3.這些研究中有6項被評為“高”偏移風(fēng)險,而其他15項的偏移風(fēng)險“不清楚”。對21項研究57個研究結(jié)果的證據(jù)水平評估顯示只有7個是“高”質(zhì)量的。結(jié)論本研究結(jié)果提示加用阿立哌唑治療抗精神病藥物所致高催乳素血癥是安全有效的。而加用阿立哌唑的高劑量并不能進一步改善高催乳素血癥。加用阿立哌唑可能會增加嗜睡和頭痛的風(fēng)險,應(yīng)加強監(jiān)測。然而,一些研究的質(zhì)量較低,隨訪時間相對較短,這些都會影響研究結(jié)果的有效性。需要進一步實施具有完善設(shè)計的研究。
[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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