本文選題：魯拉西酮　切入點(diǎn)：精神分裂癥　出處：《南昌大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

【摘要】：目的:魯拉西酮是由美國食品藥品監(jiān)督管理局(FDA)2010年批準(zhǔn)上市的非典型抗精神病藥物,在精神科臨床廣泛使用。雖然該藥效果肯定,但魯拉西酮的臨床療效及不良代謝反應(yīng)的循證醫(yī)學(xué)證據(jù)較少�；趪鴥�(nèi)外關(guān)于魯拉西酮治療精神分裂癥的臨床隨機(jī)對照試驗(yàn)結(jié)果,采用Meta分析的方法,客觀地評價(jià)魯拉西酮治療精神分裂癥的療效及不良代謝反應(yīng),為精神分裂癥的藥物治療提供選擇依據(jù)。方法:計(jì)算機(jī)檢索PUBMED、EMBASE、Cochrane Library、Elsevier、中國知網(wǎng)(CNKI)、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(CBM)、中文科技期刊全文數(shù)據(jù)庫(VIP)、萬方數(shù)據(jù)庫等,檢索時(shí)間從建庫截至2016年12月,收集魯拉西酮治療精神分裂癥的隨機(jī)對照試驗(yàn)(randomized controlled trial,RCT)。根據(jù)制定的納入標(biāo)準(zhǔn)、排除標(biāo)準(zhǔn)對收集的文獻(xiàn)進(jìn)行嚴(yán)格篩查;采用Cochrane協(xié)作網(wǎng)的研究偏倚風(fēng)險(xiǎn)評價(jià)工具對納入的研究進(jìn)行質(zhì)量評價(jià),收集相關(guān)數(shù)據(jù)資料,使用RevMan5.2軟件進(jìn)行Meta分析,切換效應(yīng)模型進(jìn)行敏感性分析,漏斗圖法分析發(fā)表偏倚。結(jié)果:本研究共納入7項(xiàng)符合納入標(biāo)準(zhǔn)的隨機(jī)對照研究,合計(jì)樣本量2615人。在所納入魯拉西酮與安慰劑的隨機(jī)對照研究中,有5項(xiàng)提供了PANSS、CGI-S量表終點(diǎn)較基線評分變化、體重變化情況,3項(xiàng)提供了BMI終點(diǎn)較基線的變化值,1項(xiàng)提供了血糖、血脂變化情況。Meta分析結(jié)果顯示:與安慰劑比較,治療后PANSS量表評分變化[MD=-5.60,95%CI(-8.69,-2.52),p=0.0004],CGI-S量表評分變化[MD=-0.31,95%CI(-0.50,-0.12),p=0.001]差異具有統(tǒng)計(jì)學(xué)意義,體重變化[MD=0.47,95%CI(0.23,0.72),p=0.0002],BMI變化[MD=0.23,95%CI(0.10,0.35),p=0.0003]差異具有統(tǒng)計(jì)學(xué)意義。提示魯拉西酮治療精神分裂癥的療效優(yōu)于安慰劑,但較安慰劑更易引起體重、BMI升高。僅有1篇文獻(xiàn)比較了魯拉西酮與安慰劑對血糖、血脂方面的影響,不宜進(jìn)行定量Meta分析,故進(jìn)行描述性研究。魯拉西酮與其他抗精神病藥的隨機(jī)對照試驗(yàn)數(shù)量有限,故在療效及不良代謝反應(yīng)方面,均進(jìn)行描述性研究。結(jié)論:魯拉西酮治療精神分裂癥療效確切,與其他抗精神病藥相比效果相當(dāng),對體重及代謝參數(shù)的影響較其他非典型抗精神病藥更小。
[Abstract]:Objective: Lurassetron is an atypical antipsychotic drug approved by the Food and Drug Administration (FDA) in 2010 and is widely used in psychiatric clinics. However, the evidence of clinical efficacy and adverse metabolic reaction of Lurassetron was few. Based on the results of randomized controlled trials at home and abroad on the treatment of schizophrenia with Lurassetron, the method of Meta analysis was used. Objective to evaluate the efficacy and adverse metabolic reaction of roxidone in the treatment of schizophrenia. Methods: to search PUBMED EMBASE Cochrane Library Elsevier, CNKIN, CBMN, VIPA, Wanfang database, and so on, to provide the basis for the choice of drug therapy for schizophrenic patients, including PUBMED, EMBASE, Cochrane Library Elsevier, Chinese Biomedical Literature Database, Chinese Biomedical Literature Database, Chinese Journal of Science and Technology Full-text Database, etc. The retrieval time was from the establishment of the library to December 2016, and the randomized controlled trial of Lurassetron for the treatment of schizophrenia was collected. The collected literature was screened strictly according to the inclusion criteria and the exclusion criteria. The research bias risk assessment tool of Cochrane cooperation network was used to evaluate the quality of the included research, to collect relevant data, to use RevMan5.2 software for Meta analysis, and to analyze the sensitivity of the switching effect model. Results: a total of 7 randomized controlled trials with a total sample size of 2,615 subjects were included in the study. Five items provided changes in the end points of the PANSS CGI-S scale compared with the baseline scores, and three items of weight changes provided the change value of the end point of BMI compared with the baseline value. One item provided the change of blood glucose, and the results of Meta-analysis showed that compared with placebo, the change of blood lipid was higher than that of placebo. There were significant differences in PANSS score after treatment [MD-5.6095 CI-8.69C -2.52C + 0.0004] CGI-S scale score [MD-0.31J 95CI-0.50 + -0.12C], and the weight change [MD0.4795CI0.237CI0.232P0.0002] had statistical significance. It suggested that the therapeutic effect of Lurassetron on schizophrenia was better than that of placebo (MD0.2395CIX 0.100.35p0.0003). However, placebo was more likely to lead to higher BMI. Only one article compared the effects of roxidone and placebo on blood glucose and blood lipid, so it was not suitable for quantitative Meta analysis. Therefore, descriptive studies were carried out. A limited number of randomized controlled trials of roxidone and other antipsychotics were carried out. Conclusion: Lurassetron is effective in the treatment of schizophrenia because of its efficacy and adverse metabolic reactions. Compared with other antipsychotics, the effect on body weight and metabolic parameters is smaller than that on other atypical antipsychotics.
【學(xué)位授予單位】：南昌大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R749.3

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