联苯双酯治疗慢性乙型肝炎的随机对照试验的系统评价

Systematic review of randomized control trials on treatment with bifendatatum for chronic hepatitis B

目的:系统评价联苯双酯治疗慢性乙型肝炎的安全性和有效性。方法:收集公开发表的近30年联苯双酯治疗慢性乙型肝炎的中文和外文文献,按纳入和排除标准选择文献,将文献中的干预措施进行亚组分析后,对肝生化指标(ALT降低量、复常率)、免疫学应答指标(HBsAg阴转率、HBeAg阴转率)、病毒学指标(HBV DNA阴转率、降低量)、肝纤维化指标[透明质酸(HA),层粘连蛋白(LN),Ⅳ型胶原(Ⅳ-C),Ⅲ型前胶原(PCⅢ)降低量]进行评价。结果:经过排除与筛选,共纳入7篇文献(1253例),均为随机设计实验,其中1篇研究注明了随机方法。结果显示:单用联苯双酯组和联苯双酯联用中药组或水飞蓟组ALT降低量均明显高于其对照组;联苯双酯+水飞蓟组HBV DNA阴转率明显高于水飞蓟组;联苯双酯滴丸+齐墩果酸片+葡醛内酯片组与齐墩果酸片+葡醛内酯片组HBV DNA降低量无明显差别;联苯双酯滴丸组HBsAg和HBeAg阴转率明显高于齐墩果酸组;联苯双酯滴丸+齐墩果酸片+葡醛内酯片组降低肝纤维化效果明显优于齐墩果酸片+葡醛内酯片组。结论:联苯双酯在降低慢性乙型肝炎ALT水平,改善其病毒学和免疫学应答指标以及肝纤维化方面疗效确切且效果显著,是一种值得进一步推广使用的药物。

Objective： To evaluate the effectiveness and safety of bifendatatum for chronic hepatitis B by systematic review.Methods： Publications on bifendatatum treatment for chronic hepatitis B were collected.Subgroup analysis was performed of interventions described in the literature;analyses were performed according to the inclusion and exclusion criteria developed over the past 30 years.Liver biochemical indices（reduction and normalization rate of alanine aminotransferase）,immunological response indicators（negative conversion rate of HBsAg and HBeAg）,virological indicators（negative conversion rate and reduction of HBV DNA） and liver fibrosis（reduction of laminin,hyaluronic acid,collagen Ⅳ and procollagen Ⅲ） were systematically evaluated.Results： A total of 7 studies involving 1253 patients met the inclusion criteria.Of these,one study reported randomization method,the results of systematic review showed： In terms of reducing ALT,a bifendate group,a bifendate plus a traditional Chinese medicine group and a silymarin group were significantly better than the control group.In terms of the rate of HBV DNA seroconversion,bifendate plus silymarin group was significantly higher than silymarin group;in terms of the reduction of HBV DNA,there was no significant differences between the group of bifendate dripping pills plus oleanic acid and glucurolactone acid tablets and the group of oleanic acid plus glucurolactone acid tablets;in terms of the rate of HBsAg and HBeAg seroconversion,bifendate group was significantly higher than oleanic acid group;in terms of reducing the index of hepatic fibrosis,bifendate dripping pills plus oleanic acid and glucurolactone acid tablets group was significantly better than the control group.Conclusion： The effect of bifendatatum on improving ALT,virological indicators,immunological response,and propensity to liver fibrosis in chronic hepatitis B is significant.Therefore,bifendatatum is really a medicine worthy of further promotion.