天晴复欣针剂、胶囊序贯治疗慢性乙型肝炎多中心疗效观察

Matrine for injection and capsule in sequential treatment of chronic hepatitis B

目的评价天晴复欣针剂、胶囊序贯治疗慢性乙型肝炎的疗效和安全性。方法174例选自各中心按统一标准入组的患者均采用天晴复欣注射剂与胶囊序贯治疗6个月,停药随访6个月。监测肝功能(ALT、AST、TBil)及HBV-M、HBVDNA。结果治疗6个月后患者的ALT、AST复常率分别为54.23%、56.91%,TBil的复常为54.17%;停药随访6个月分别为69.91%、61.22%和80.56%。天晴复欣治疗3个月、6个月时HBeAg阴转率分别为22.58%、36.94%,其中发生HBeAg/HBeAb转换分别为12.90%、17.12%;治疗3个月、6个月后HBVDNA下降≥2log10分别为20.12%、28.17%。治疗3个月、6个月后完全应答率分别为3.05%、5.63%,部分应答率为19.51%、35.21%。停药后随访6个月时5.31%的患者仍可维持完全应答疗效。结论天晴复欣有一定的抗病毒作用,且随治疗时间的延长其疗效增高。

Objective To evaluate the efficacy and safety of Matrine for injection and capsule in sequential treatment of chronic hepatitis B .Methods Totally 174 patients with chronic hepatitis B were enrolled. During the 6-month treatment, all patients received Matrine for injection and capsule treatment sequentially. The patients were then followed up for 6 months without treatment. The serum ALT, AST, TB, HBV-marker and HBV DNA level were measured during treatment and follow-up phase. Results Serum ALT levels had normalized at month 6 in 12.90% patient and AST levels in 17.12% patients. Serum TB levels of 54.17% patients normalized after 6-month treatment. Serum HBeAg became undetectable in 22.58% patients at month 3, and 36.94% patients at month 6. Among the HBeAg disappeared patients, eAg/eAb seroconversion rate was 12.90% and 17.12% respectively at month 3 and month 6. Serum HBV DNA levels were reduced by ≥ 2 lg in 20.12% patients at month 3 and 28.17% patients at month 6. The complete response rate was 3.05% at month 3 and 5.63% at month 6. The partial response rate was 19.51% and 35.21% respectively at month 3 and month 6. At the end of 6-month follow-up phase, 5.31% patients maintained complete response. Conclusions Matrine treatment could result in virologic and biochemical improvement with good safety.