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目的系统评价膦甲酸钠治疗慢性乙型肝炎的有效性和安全性。方法采用Cochrane系统评价方法,计算机检索MEDLINE、EMBASE、Cochrane图书馆临床对照试验数据库(CENTRAL)和CNKI等数据库,检索时间从1978年到2006年。纳入在治疗慢性乙型肝炎中,以膦甲酸钠为治疗组,其他药物为对照组或空白对照组的随机对照试验。由2名研究者独立评价纳入研究的的方法学质量,并采用RevMan4.2.7软件对相关数据进行Meta分析。结果共纳入包括337例患者的7个研究,其中1个研究为膦甲酸钠与干扰素对比,其余6个研究为膦甲酸钠与空白比较。根据随机方法、分配隐藏与盲法对纳入研究质量进行评价,结果均为C级。Meta分析结果显示:膦甲酸钠与干扰素在肝功能恢复、病毒学指标转阴率与副反应发生率的差异无统计学意义(尸>0.05);膦甲酸钠在病毒学指标转阴率上明显优于空白对照组[HBeAg: RR=6.20,95%CI(1.76,21.79);HBV-DNA:RR=4.13,95%CI(1.32, 12.86)];膦甲酸钠在副反应发生率上虽高于空白对照组,但差异无统计学意义;因各文献数据存在临床异质性,故无法判断膦甲酸钠在肝功能恢复上是否优于空白对照组。结论现有研究结果显示,膦甲酸钠治疗慢性乙型肝炎的疗效与安全性和干扰素无明显差别,但其证据强度很弱;与空白对照组相比,膦甲酸钠可明显提高病毒学指标转阴率和临床症状体征缓解率,其副反应发生率可能高于空白对照组;膦甲酸钠是否有助于肝功能恢复,目前尚无肯定结论。
Objective To evaluate the efficacy and safety of foscarnet in the treatment of chronic hepatitis B Methods The Cochrane systematic review method was used to search the databases of MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) and CNKI. The retrieval time was from 1978 to 2006. Included in the treatment of chronic hepatitis B, with foscarnet as the treatment group, other drugs for the control group or control group randomized controlled trials. Two investigators independently assessed the quality of the methodology included in the study and Meta-analysis of the data using RevMan 4.2.7 software. Results A total of 7 studies including 337 patients were included. One study compared foscarnet to interferon and the remaining six studies compared foscarnet to blank. According to the random method, the distribution of hidden and blind evaluation of the quality of included studies, the results are C level. The results of Meta analysis showed that there was no significant difference in the rate of side effects and the incidence of side effects between foscarnet and interferon in the recovery of liver function (P> 0.05); foscarnet on the rate of virological negative conversion (HBeAg: RR = 6.20, 95% CI (1.76, 21.79); HBV-DNA: RR = 4.13, 95% CI (1.32, 12.86)]; The incidence of side effects of foscarnet was higher than that of the blank control group, but the difference was not statistically significant. Because of the existence of clinical heterogeneity of the literature data, it is not possible to judge whether foscarnet is superior to the blank control group in liver function recovery. Conclusion The results of the existing studies show that there is no significant difference between the efficacy and safety of foscarnet in the treatment of chronic hepatitis B and interferon. However, the evidence strength is very weak. Compared with the blank control group, foscarnet can obviously improve the virological indicators negative Rate of symptom relief and clinical symptoms, the incidence of side effects may be higher than the blank control group; foscarnet is helpful in the recovery of liver function, there is no conclusive conclusion.