本文選題：拉米夫定 + 恩替卡韋�。� 參考：《華中科技大學》2013年碩士論文

【摘要】：目的：通過薈萃分析的方法對比分析恩替卡韋和拉米夫定治療HBeAg陽性的慢性乙型肝炎患者的療效及安全性。 方法：以慢性乙型肝炎、拉米夫定、恩替卡韋、隨機對照、Entecavir(ETV)、lamivudine (LAM)、 Randomized controlled trial（sRCT）、HBeAg-positive chronichepatitis B為檢索詞，檢索2005年1月到2012年6月PubMed、 MEDLINE、EMBASE、中國生物醫(yī)學文獻數(shù)據(jù)庫（CBMdisk）、中國期刊網(wǎng)全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫、維普中文科技期刊數(shù)據(jù)庫中關(guān)于拉米夫定和恩替卡韋治療HBeAg陽性慢性乙型肝炎患者的療效和安全性的隨機對照實驗（RCT），數(shù)據(jù)用Review Manager Software5.0進行分析，用相關(guān)風險系數(shù)（RR）作為效應測量方法，并報告95%置信區(qū)間（CI）。Meta分析選用固定效應模型或者隨機效應模型，根據(jù)Cochran’s異質(zhì)性Q檢驗χ2和I2顯示是否有異質(zhì)性，無異質(zhì)性時選擇固定效應模型，有異質(zhì)性時選擇隨機效應模型。由兩名評價者對檢索到的資料獨立進行資料提取和方法學質(zhì)量評價并交叉核對。本研究以丙氨酸氨基轉(zhuǎn)移酶（ALT）復常率、HBV DNA陰轉(zhuǎn)率、HBeAg陰轉(zhuǎn)率、HBeAg血清轉(zhuǎn)換率、耐藥性發(fā)生率及不良反應為主要評價指標。為減小各試驗間異質(zhì)性，我們選用亞組分析。 結(jié)果：共納入7個隨機對照試驗，，HBeAg陽性慢性乙型肝炎患者1436人，其中ETV組734人，LAM組702人，在4周、8周、12周、24周、48周、96周各個隨訪時間，ETV組HBV DNA陰轉(zhuǎn)率高于LAM組，差異有統(tǒng)計學意義（RR5.09,95%CI1.99,13.02, P=0.007; RR3.54,95%CI1.99,6.31, P 0.0001; RR1.84,95%CI1.40,2.41, P 0.0001; RR1.45,95%CI1.24,1.70, P 0.0001; RR1.46,95%CI1.27,1.67, P 0.00001; RR1.36,95%CI1.12,1.64, P=0.002）；在4周、8周、12周、24周、48周各個隨訪時間，ETV組ALT復常率高于LAM組，差異有統(tǒng)計學意義（RR1.99,95%CI1.20,3.29, P=0.008; RR2.03,95%CI1.44,2.84,P 0.0001; RR1.61,95%CI1.09,2.38, P=0.02; RR1.34,95%CI1.06,1.70, P=0.01; RR1.23,95%CI1.12,1.34, P 0.0001），但是在96周隨訪時ALT復常率差異無統(tǒng)計學意義；在12周、24周、48周、96周各個隨訪時間，HBeAg陰轉(zhuǎn)率和HBeAg血清轉(zhuǎn)換率在兩組對比的差異無統(tǒng)計學意義；耐藥性發(fā)生率LAM組高于ETV組，差異有統(tǒng)計學意義（RR0.06,95%CI0.01,0.23, P 0.0001）；不良反應未統(tǒng)一進行薈萃分析，LAM組有兩名患者在治療期間死亡。 結(jié)論：恩替卡韋較之拉米夫定能夠更快速高效地抑制HBeAg陽性的慢性乙型肝炎患者的HBV DNA復制，改善患者肝功能，耐藥性發(fā)生率低，但兩藥在HBeAg血清學轉(zhuǎn)換方面無明顯差異，恩替卡韋和拉米夫定都有良好的安全性和耐受性。
[Abstract]:Objective: to compare the efficacy and safety of entecavir and lamivudine in the treatment of HBeAg positive chronic hepatitis B patients. Methods: chronic hepatitis B, lamivudine, entecavir (ETV) lamivudine (Lam), Randomized controlled trial (sRCT) were used as the key words. To retrieve PubMede, MEDLINE EMBASE, Chinese Biomedical Literature Database (CBMdisk), CNKI, Wanfang Database from January 2005 to June 2012. A randomized controlled trial (RCT) on the efficacy and safety of lamivudine and entecavir in the treatment of HBeAg-positive patients with chronic hepatitis B was carried out in the Weip Chinese Science and Technology Journal database. The data were analyzed with Review Manager Software 5.0. Correlation risk coefficient (RR) was used as an effect measurement method, and 95% confidence interval (CI) .Meta analysis was conducted using fixed effect model or random effect model. According to Q test of Cochrans heterogeneity, 蠂 2 and I 2 showed heterogeneity. When there is no heterogeneity, the fixed effect model is chosen, and the random effect model is chosen when there is heterogeneity. Data extraction, methodological quality evaluation and cross-check were performed by two reviewers. In this study, the seroconversion rate of HBeAg, the incidence of drug resistance and the adverse reaction of HBV DNA and HBeAg seroconversion were used as the main indexes for the evaluation of alanine aminotransferase (alt) normalization rate and HBV DNA negative conversion rate and HBeAg seroconversion rate. In order to reduce the heterogeneity of each test, we selected subgroup analysis. Results: a total of 1436 patients with HBeAg-positive chronic hepatitis B were enrolled in 7 randomized controlled trials, including 734 patients in ETV group and 702 patients in Lam group. The negative rate of HBV DNA in ETV group was higher than that in Lam group at 4 weeks, 8 weeks, 12 weeks, 48 weeks and 96 weeks, and the negative rate of HBV DNA in ETV group was higher than that in Lam group. The difference was statistically significant (RR5.0995 CI1.99 / 13.02, P0.007; RR3.5495 CI1.99 6.31, P 0.0001; RR1.8495 / 95CI1.402.41, P 0.0001; RR1.4595CI1.241.70, P 0.0001; RR1.4695CI1.271.67, P 0.00001; RR1.36-95CI1.12121.64, P0.002); the rate of recovery of ALT in ETV group was higher than that in Lam group at every follow up time of 24 weeks and 48 weeks. The difference was statistically significant (RR1.99-95CI 1.203.29, P0. 008; RR2.03C1.44, 2.84, P0.0001; RR1.61C95CI1.09C1.092.38, P0.02; RR1.34C95CI1.061.70, P0.01; RR1.23c95CI1.12C1.34, P 0.0001), but there was no significant difference in the recovery rate of alt at 96 weeks. There was no significant difference in HBeAg negative conversion rate and HBeAg seroconversion rate between the two groups at 12 weeks and 24 weeks and 48 weeks and 96 weeks, but the incidence of drug resistance in Lam group was higher than that in ETV group (RR0.06 / 95 CI 0.01 鹵0.23, P 0.0001). Adverse reactions were not uniformly meta-analyzed. Two patients in the lam group died during treatment. Conclusion: compared with lamivudine, entecavir can inhibit HBV DNA replication in HBeAg-positive patients with chronic hepatitis B more quickly and efficiently, improve liver function and lower incidence of drug resistance, but there is no significant difference between the two drugs in HBeAg serological conversion. Both entecavir and lamivudine have good safety and tolerance.
【學位授予單位】：華中科技大學
【學位級別】：碩士
【學位授予年份】：2013
【分類號】：R512.62

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