[關(guān)鍵詞]
[摘要]
目的 系統(tǒng)評價溴隱亭不同給藥方式治療高泌乳素血癥的療效與安全性。方法 計算機檢索Pubmed、Embase、The Cochrane Liabrary、中國學(xué)術(shù)期刊全文數(shù)據(jù)庫(CNKI)、中國生物醫(yī)學(xué)文獻數(shù)據(jù)庫(CBM)、萬方數(shù)據(jù)庫(WangFang)和維普中文科技期刊數(shù)據(jù)庫(VIP)等數(shù)據(jù)庫關(guān)于溴隱亭不同給藥方式治療高泌乳素血癥的隨機對照試驗(RCT),檢索時限均由建庫至2018年10月31日。觀察指標(biāo)為血清泌乳素(PRL)水平、月經(jīng)情況、妊娠率、溢乳情況、胃腸道不良反應(yīng)(ADR)、循環(huán)系統(tǒng)及神經(jīng)系統(tǒng)ADR。對符合要求的文獻進行數(shù)據(jù)提取及方法學(xué)質(zhì)量評價,采用RevMan 5.2軟件進行Meta-分析。結(jié)果 共納入23項RCTs,計1 964例患者。Meta-分析結(jié)果示:溴隱亭陰道給藥組與口服給藥組相比,陰道給藥組降低血清PRL[MD=-2.11,95% CI(-3.85,-0.37),P=0.02]、改善月經(jīng)率[RD=0.08,95% CI(0.03,0.14),P=0.002]、溢乳消失率[RD=0.06,95% CI(0.01,0.10),P=0.02]效果更好,胃腸道ADR發(fā)生率更低[OR=0.18,95% CI(0.12,0.26),P<0.000 01]、循環(huán)系統(tǒng)及神經(jīng)系統(tǒng)ADR發(fā)生率更低[OR=0.29,95% CI(0.17,0.49),P<0.000 01],這些指標(biāo)均優(yōu)于口服給藥組。但用藥后妊娠率方面兩組差異無統(tǒng)計學(xué)意義。溴隱亭經(jīng)直腸給藥與口服給藥比較,療效無明顯差異,但在ADR發(fā)生率方面[OR=0.10,95% CI(0.05,0.19),P<0.000 01],直腸給藥低于口服給藥,差異有統(tǒng)計學(xué)意義。結(jié)論 現(xiàn)有證據(jù)顯示溴隱亭陰道給藥較口服給藥效果顯著,安全性更高;在不宜使用陰道給藥的情況下,溴隱亭直腸給藥較口服給藥安全性更高,兩種給藥方式均值得臨床推廣。
[Key word]
[Abstract]
Objective To evaluate the efficacy and safety of different administration methods of bromocriptine in the treatment of patients with hyperprolactinemia. Methods Randomized controlled trials (RCTs) about bromocriptine tablets by vaginal administration or rectal administration (trial group) vs bromocriptine by oral administration (control group) in the treatment of patients with hyperprolactinemia were retrieved from PudMed, Embase, the Cochrane Library, CNKI, CBM, WanFang Database, and VIP Database. After data extraction, quality evaluation of included studies with Cochrane system evaluator manual 5.1.0, Metaanalysis of serum level of prolactin levels, the rate of menstruation improvement, the rate of pregnancy recovery, the rate of galactorrhea disappearance, the incidence of adverse drug reaction (ADR) in digestive tract and the incidence of ADR in circulatory system and nervous system was conducted by RevMan 5.2 statistical software. Results A total of 23 RCTs were included, involving 1 964 patients. The results of Meta-analysis showed that the decreasing serum level of prolactin levels[MD=22.11, 95%CI(-3.85, -0.37), P=0.02], the rate of menstruation improvement[RD=0.08, 95%CI(0.03, 0.14), P=0.002], the rate of galactorrhea disappearance[RD=0.06, 95%CI(0.01, 0.10), P=0.02], the incidence of ADR in digestive tract[OR=0.18, 95%CI(0.12, 0.26), P<0.000 01] and the incidence of ADR in circulatory system and nervous system[OR=0.29, 95%CI(0.17, 0.49), P<0.000 01] in vaginal administration group were better than those in control group, with statistical significance. But there was no statistical significance in pregnancy rate between vaginal administration group and control group. Moreover, there was also no statistical significance in efficacy between rectal administration group and control group. But the incidences of ADR[OR=0.10, 95%CI(0.05, 0.19), P<0.000 01] in rectal administration group were lower than control group. Conclusion Compared with oral administration, bromcriptine by vaginal administration and rectal administration were with better safety, they deserve to be clinically promoted.
[中圖分類號]
R954
[基金項目]