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目的对恩替卡韦分散片在慢性乙型肝炎治疗中的疗效及安全性进行分析。方法采取双盲、随机、双模拟以及阳性药物恩替卡韦片(博路定)平行对照的临床试验方法。在接受双盲治疗过程中,给予对照组29例患者恩替卡韦片及不含恩替卡韦分散片的模拟剂,温水送服1日1次,1次1片,0.5mg/片。而试验组则给予29例患者恩替卡韦分散片(润众)和不含恩替卡韦片的模拟剂,同时温水送服1日1次,1次1片,0.5mg/片。24周即可进行开放治疗,开放治疗期间,两组患者均同时服用恩替卡韦分散片,温水送服1日1次,1次1片,0.5mg/片。结果在给予患者1日0.5mg恩替卡韦分散片治疗后,对12周和24周数据进行统计,不难发现,两组患者无论是血清HBV DNA完全抑制率,HbeAg转阴率,ALT复常率,抑或HbeAg/HbeAb血清转抉率,HBV DNA下降≥2log_(10)的比例均没有明显差异。通过组内对比可以看到,24周后各项数据明显比12周时更高。开放期24周治疗后,两组患者的各项数据仍然保持较为明显的变化,且控制效果较好。结论在慢性乙型肝炎治疗中恩替卡分散片能够很好地抑制乙型肝炎病毒复制,且能够很好地控制病情发展,同时还能够保持较高的安全性,是一种值得临床推广的慢性乙型肝炎治疗药物。
Objective To analyze the efficacy and safety of entecavir dispersible tablets in the treatment of chronic hepatitis B. Methods A double-blind, randomized, double-dummy and parallel clinical trial of entecavir tablets (bhopirudin) was used. During the course of double-blind treatment, entecavir tablets and simulants without entecavir dispersible tablets were given to 29 patients in the control group. Warm water was given once a day for 1 tablet and 0.5 mg per tablet. The experimental group was given 29 patients entecavir dispersible tablets (Runzhong) and no entecavir tablets mimicking agent, while warm water delivery on the 1st 1, 1 1, 0.5mg / tablet. 24 weeks to open treatment, open treatment period, both groups of patients taking entecavir dispersible tablets at the same time, warm water delivery on the 1st 1, 1 1, 0.5mg / tablet. Results After entecavir dispersible tablets 0.5 mg once daily on the 1st day of treatment, the data of 12 weeks and 24 weeks were statistically analyzed. It is easy to find that the serum HBV DNA complete inhibition rate, HbeAg negative conversion rate, ALT normalization rate, Or HbeAg / HbeAb serum conversion rate, HBV DNA decline ≥ 2log_ (10) of the ratio were not significantly different. By comparing the group can be seen, after 24 weeks of the data was significantly higher than at 12 weeks. After 24 weeks of open treatment, the data of the two groups of patients still maintained a more obvious change, and the control effect was better. Conclusion In the treatment of chronic hepatitis B, Entecavir dispersible tablets can inhibit hepatitis B virus replication well, and can well control the progression of the disease, while maintaining high safety, which is worthy of clinical promotion Chronic Hepatitis B Therapeutics.