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羅格列酮安全性再評(píng)價(jià):一項(xiàng)基于隨機(jī)對(duì)照研究、隊(duì)列研究、病例對(duì)照研究及病例報(bào)告的系統(tǒng)評(píng)價(jià)

發(fā)布時(shí)間:2018-05-10 16:08

  本文選題:糖尿病 + 羅格列酮 ; 參考:《中國(guó)醫(yī)院藥學(xué)雜志》2017年21期


【摘要】:目的:評(píng)價(jià)與其他抗糖尿病口服藥物相比,羅格列酮治療2型糖尿病患者的安全性。方法:按照檢索策略在EMbase、MEDLINE、The Cochrane library等6個(gè)數(shù)據(jù)庫(kù)中進(jìn)行電子檢索,并人工進(jìn)行補(bǔ)充檢索。按納入排除標(biāo)準(zhǔn)進(jìn)行篩選,對(duì)納入文獻(xiàn)進(jìn)行偏倚風(fēng)險(xiǎn)評(píng)估,并使用Revman 5.3軟件進(jìn)行統(tǒng)計(jì)學(xué)Meta分析。結(jié)果:共納入63篇研究,其中隨機(jī)對(duì)照試驗(yàn)17篇。研究結(jié)果顯示,羅格列酮組的總不良反應(yīng)發(fā)生率與其他口服糖尿病藥物相比無(wú)顯著差異,然而RCT研究結(jié)果提示羅格列酮組因不良反應(yīng)退出的比例高于非TZD類(lèi)藥物組,但低于吡格列酮組。對(duì)于心腦血管不良反應(yīng)發(fā)生率,RCT研究和隊(duì)列研究結(jié)果都支持羅格列酮與其他糖尿病藥物相比無(wú)統(tǒng)計(jì)學(xué)意義,但病例對(duì)照研究結(jié)果認(rèn)為羅格列酮暴露組心腦血管不良反應(yīng)發(fā)生率高于未暴露組。羅格列酮組的低血糖發(fā)生率與二甲雙胍組無(wú)顯著差異,且低于磺脲類(lèi)。RCT研究結(jié)果提示羅格列酮組體質(zhì)量升高的患者比例和水腫發(fā)生率高于其他口服降糖藥。隊(duì)列研究結(jié)果顯示羅格列酮組的骨折發(fā)生率高于其他藥物,但低于吡格列酮。對(duì)于膀胱癌的發(fā)病率,隊(duì)列研究結(jié)果顯示羅格列酮組發(fā)病率低于吡格列酮組以及其他非TZD類(lèi)糖尿病藥物組,而病例對(duì)照研究卻得到了相反的結(jié)果。結(jié)論:應(yīng)用羅格列酮治療2型糖尿病,總體不良反應(yīng)發(fā)生率不高于其他口服降糖藥,且尚無(wú)確切證據(jù)證明該藥致心腦血管事件的風(fēng)險(xiǎn)高于其他抗糖尿病藥物,但應(yīng)對(duì)其水腫、體質(zhì)量增加、骨折的風(fēng)險(xiǎn)加以預(yù)防,并警惕其致腫瘤風(fēng)險(xiǎn)。
[Abstract]:Objective: to evaluate the safety of rosiglitazone in the treatment of type 2 diabetes. Methods: according to the retrieval strategy, electronic retrieval was carried out in 6 databases such as EMbase MEDLINEN and the Cochrane library, and supplementary retrieval was carried out manually. According to the inclusion exclusion criteria, the bias risk of the inclusion literature was evaluated, and the statistical Meta analysis was carried out using Revman 5.3 software. Results: a total of 63 studies were included, of which 17 were randomized controlled trials. The results showed that there was no significant difference in the incidence of total adverse reactions between rosiglitazone group and other oral diabetic drugs. However, the RCT study showed that rosiglitazone group had a higher rate of withdrawal due to adverse reactions than that of non-TZD drugs. But lower than pioglitazone group. Results of RCT and cohort studies support that rosiglitazone has no statistical significance compared with other diabetic drugs. Case-control study showed that the incidence of adverse cardiovascular and cerebrovascular reactions in rosiglitazone exposure group was higher than that in unexposed group. The incidence of hypoglycemia in rosiglitazone group was not significantly different from that in metformin group, and was lower than that in sulfonylurea .RCT study. The results showed that the proportion of patients with elevated body mass and the incidence of edema in rosiglitazone group were higher than those in other oral hypoglycemic drugs. The cohort study showed that rosiglitazone had a higher fracture rate than other drugs, but less than pioglitazone. Cohort studies showed that the incidence of bladder cancer in rosiglitazone group was lower than that in pioglitazone group and other non-diabetic drug groups, but the case-control study showed the opposite results. Conclusion: the overall adverse reaction rate of rosiglitazone in the treatment of type 2 diabetes is not higher than that of other oral hypoglycemic drugs, and there is no definite evidence to prove that the risk of cardiovascular and cerebrovascular events caused by rosiglitazone is higher than that of other antidiabetic drugs, but it should be treated with edema. Increased body mass, fracture risk to prevent, and to guard against its cancer risk.
【作者單位】: 山東大學(xué)藥學(xué)院;山東省千佛山醫(yī)院藥學(xué)部;
【分類(lèi)號(hào)】:R977.15
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本文編號(hào):1869972

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