【摘要】：目的:運(yùn)用系統(tǒng)評(píng)價(jià)方法建立阿必魯肽(albiglutide)治療2型糖尿病臨床合理應(yīng)用評(píng)價(jià)體系,為規(guī)范說(shuō)明書(shū)用藥提供循證醫(yī)學(xué)證據(jù)。方法:電子檢索中英文數(shù)據(jù)庫(kù)EBSCO、PubMed(Medline)、OVID(包括Embase)、Cochrane library、中國(guó)知網(wǎng)(CNKI)、萬(wàn)方醫(yī)學(xué)網(wǎng)(wanfang database)、維普中文期刊全文數(shù)據(jù)庫(kù)(VIP)及中國(guó)生物醫(yī)學(xué)全文數(shù)據(jù)庫(kù)(CBM)中有關(guān)阿必魯肽治療2型糖尿病的臨床隨機(jī)對(duì)照試驗(yàn)(RCT),檢索時(shí)限為2000年1月至2016年10月,并輔以手工檢索相關(guān)雜志和網(wǎng)站。2名研究者按照納入與排除標(biāo)準(zhǔn),篩選文獻(xiàn)、數(shù)據(jù)提取和交叉核對(duì),并按文獻(xiàn)質(zhì)量評(píng)估標(biāo)準(zhǔn)予以文獻(xiàn)偏倚風(fēng)險(xiǎn)評(píng)估。采用RevMan 5.0軟件對(duì)各干預(yù)措施組中效應(yīng)指標(biāo)進(jìn)行Meta分析及發(fā)表偏倚評(píng)估。結(jié)果:納入10篇隨機(jī)對(duì)照試驗(yàn),文獻(xiàn)偏倚風(fēng)險(xiǎn)均較低,其中8篇屬于高質(zhì)量研究,涉及有效2型糖尿病患者數(shù)2360例,其中阿必魯肽組1199例,安慰劑組613例,陽(yáng)性藥西格列汀組548例。Meta分析結(jié)果顯示:治療周期末,(1)與安慰劑組患者相比,阿必魯肽組患者糖化血紅蛋白(HbA1c)水平(MD=-0.89,95%CI:-1.11~-0.66,P0.001)、空腹血漿葡萄糖(FPG)水平(MD=-1.58,95%CI:-1.90~-1.26,P0.001)、Hb A1c(7%)達(dá)標(biāo)率(RR=3.01,95%CI:2.34~3.87,P0.001)、低血糖發(fā)生率(RR=1.64,95%CI:1.09~2.48,P0.05)和注射部位反應(yīng)(ISR)發(fā)生率(RR=2.36,95%CI:1.61~3.47,P0.001)差異有統(tǒng)計(jì)學(xué)意義,hba1c、fpg水平低且波動(dòng)范圍不大,hba1c(7%)達(dá)標(biāo)率高,但低血糖、isr發(fā)生率高,而因不良事件(ae)退出率、嚴(yán)重不良反應(yīng)(sae)(致命或非致命)發(fā)生率和其他不良反應(yīng)(腹瀉、惡心、嘔吐、便秘、消化不良、頭痛、眩暈、背痛、腹痛、高血壓、鼻咽炎、上呼吸道感染、泌尿道感染和表皮剝落型皮疹)發(fā)生率差異卻無(wú)統(tǒng)計(jì)學(xué)意義(p0.05);(2)與陽(yáng)性藥西格列汀組患者相比,阿必魯肽組患者h(yuǎn)ba1c水平(md=-0.36,95%ci:-0.47~-0.25,p0.001)、fpg水平(md=-1.06,95%ci:-1.35~-0.77,p0.001)、hba1c(7%)達(dá)標(biāo)率(rr=1.40,95%ci:1.10~1.78,p0.05)、低血糖發(fā)生率(rr=1.55,95%ci:1.10~2.19,p0.05)和isr發(fā)生率(rr=2.56,95%ci:1.69~3.89,p0.001)差異有統(tǒng)計(jì)學(xué)意義,hba1c、fpg水平低且同樣波動(dòng)范圍不大,hba1c(7%)達(dá)標(biāo)率高,但低血糖、isr發(fā)生率也較高,而因ae退出率、sae(致命或非致命)發(fā)生率和其他不良反應(yīng)(腹瀉、惡心、高血壓、鼻咽炎和上呼吸道感染)發(fā)生率差異卻無(wú)統(tǒng)計(jì)學(xué)意義(p0.05)。結(jié)論:(1)就現(xiàn)有證據(jù)而言,阿必魯肽對(duì)2型糖尿病患者的hba1c水平和fpg水平有良好的控制效果,hba1c(7%)達(dá)標(biāo)率較為理想,常見(jiàn)胃腸道反應(yīng),如惡心、嘔吐、腹瀉、便秘和腹痛等癥狀患者均可耐受,未影響繼續(xù)治療,高血壓、鼻咽炎、上呼吸道感染、泌尿道感染和表皮剝落型皮疹和sae發(fā)生率低,較為少見(jiàn),但低血糖、isr與對(duì)照組相比發(fā)生率較高,可能會(huì)影響該藥對(duì)患者的長(zhǎng)期治療。(2)因隨機(jī)對(duì)照試驗(yàn)設(shè)計(jì)的局限性,如樣本量、治療周期、隨訪時(shí)間、受試患者個(gè)體差異及其他客觀環(huán)境下的不確定等因素,均可影響試驗(yàn)結(jié)果,即也可能影響二次分析結(jié)果,因此,仍需大樣本、高質(zhì)量、嚴(yán)格設(shè)計(jì)的隨機(jī)對(duì)照試驗(yàn)對(duì)阿必魯肽進(jìn)行長(zhǎng)期的療效與安全性研究加以驗(yàn)證。
[Abstract]:Objective: To establish an evaluation system for the clinical rational application of albilutide in the treatment of type 2 diabetes mellitus by using the system evaluation method. Methods: EBSCO, PubMed (Medline), OVID (including Embase), Cochrane Library, China Knowledge Network (CNKI) and Wanfang Medical Network (CNKI) were retrieved electronically. The clinical randomized controlled trial (RCT) of the full-text database (VIP) and Chinese Biomedical Full-text Database (CBM) for the treatment of type 2 diabetes mellitus (RCT) from January 2000 to October 2016, Related journals and websites were retrieved by hand, and 2 researchers conducted a literature bias risk assessment based on inclusion and exclusion criteria, screening literature, data extraction, and cross-checking, and by document quality assessment criteria. The effects of RevMan 5.0 software were analyzed and biased in each intervention group. Results: Among the 10 randomized controlled trials, the risk of literature bias was low, of which 8 were high-quality studies and 2360 patients with effective type 2 diabetes, including 1199 cases, 613 cases in the placebo group and 548 in the positive group. Meta-analysis showed that (1) Compared with the placebo group, the level of glycated hemoglobin (HbA1c) (MD =-0.89, 95% CI:-1.11 ~-0.066, P0.001), fasting plasma glucose (FPG) level (MD =-1.58, 95% CI:-1.90 ~-1.26, P0.001), Hb (7%) (RR = 3.01, 95% CI: 2.34 ~ 3.87, P0.001) were observed in patients with placebo group. The incidence of hypoglycemia (RR = 1.64, 95% CI: 1.09 ~ 2.48, P0.05) and injection site reaction (ISR) (RR = 2.36, 95% CI: 1.61 ~ 3.47, P0.001) had statistical significance, hba1c, fpg level was low and the fluctuation range was not large, hba1c (7%) was high, but the incidence of hypoglycaemia and isr was high. Serious adverse reactions (sae) (fatal or non-fatal) and other adverse reactions (diarrhea, nausea, vomiting, constipation, dyspepsia, headache, dizziness, back pain, abdominal pain, hypertension, rhinitis, upper respiratory tract infection, There was no significant difference in the incidence of infection and exfoliative rash (r = 0.05); (2) Compared with the patients who were positive, the level of hba1c (md =-0.036, 95% ci:-0.47 ~-0.025, p0.01), fpg level (md =-1.06, 95% ci:-1.35 ~-0.077, 100.0. 001), hba1c (7%) (r = 1. 40, 95% ci: 1. 10 ~ 1.78, p0.05). The incidence of hypoglycaemia (rr = 1. 55, 95% ci: 1. 10 ~ 2.19, 65.05) and isr (r = 2.56, 95% ci: 1.69 ~ 3.89, 01.001) were statistically significant, hba1c, fpg were low and the same wave range was not large, hba1c (7%) had a high incidence rate, but the incidence of hypoglycaemia and isr was also high, and the ae withdrawal rate was higher. The incidence of sae (fatal or non-fatal) and other adverse reactions (diarrhea, nausea, hypertension, nasal pharyngitis, and upper respiratory tract infection) was not statistically significant (P0.05). Conclusion: (1) As far as the existing evidence is concerned, Abiu peptide has good control effect on the hba1c level and fpg level of type 2 diabetes mellitus patients, hba1c (7%) is ideal, and the common gastrointestinal reactions such as nausea, vomiting, diarrhea, constipation and abdominal pain can be tolerated. No effect on the continuation of treatment, hypertension, rhinopharyngitis, upper respiratory tract infection, urinary tract infection and epidermal exfoliation type rash and sae incidence were low, but hypoglycemia, isr were higher in comparison with the control group, which could affect the long-term treatment of the drug for the patient. (2) Due to the limitations of randomized controlled trial design, such as sample size, treatment period, follow-up time, individual difference in subject trial and uncertain factors in other objective circumstances, the test results may be affected, i.e., the results of secondary analysis may also be affected, so large samples are still required. High-quality, strictly designed randomized controlled trials have been validated for the long-term efficacy and safety study of Abiropeptide.
【學(xué)位授予單位】：西南醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：R587.1

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本文編號(hào)：2259781