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目的 对乙酰半胱氨酸(NAC)注射液治疗慢性乙型肝炎的疗效和安全性进行评估。 方法 选择慢性乙型肝炎(重度或慢性重型肝炎早期)住院患者144例,采用随机、双盲、平行对照的临床试验,随机分为A组、B组(每组各72例),治疗前做常规体检。给药方案:NAC 8g/d,静脉滴注,疗程45d,同时配合基础综合治疗,并于用药前、用药后15、30、45d分别抽血检查肝功能、凝血酶原时间、肾功能生物化学、血常规等。 结果 入选144例患者中91例符合慢性乙型肝炎重度标准,53例符合慢性重型肝炎标准。揭盲后A组为试验组;B组为安慰剂组。脱落28例(A组11例,B组17例),进入疗效评价病例试验组61例,安慰剂组55例。试验组患者血清总胆红素、直接胆红素、丙氨酸氨基转移酶、天冬氨酸氨基转移酶显著降低,凝血酶原活动度也得到明显改善。试验组不良反应发生率为14％,安慰剂组为5％,未发生严重不良事件。 结论 NAC能明显减低患者血清总胆红素、氨基转移酶,改善凝血酶原活动度,试验过程中患者耐受性好,主要不良反应为恶心、呕吐、皮疹等,无严重的不良反应。
Objective To evaluate the efficacy and safety of acetylcysteine (NAC) injection in the treatment of chronic hepatitis B patients. Methods A total of 144 hospitalized patients with chronic hepatitis B (early severe or chronic severe hepatitis) were randomly divided into group A and group B (72 in each group), and randomized, double-blind and parallel controlled clinical trials were performed before treatment Physical examination. Dosage: NAC 8g / d, intravenous infusion, the course of treatment 45d, combined with basic treatment, and before treatment, 15,30,45 d after administration of blood were tested for liver function, prothrombin time, renal biochemistry , Blood and other. Results Of the 144 patients selected, 91 cases met the criteria of chronic hepatitis B, and 53 cases met the criteria of chronic severe hepatitis. Group A was unveiled as test group and group B as placebo group. Twenty-eight patients (11 in group A and 17 in group B) were enrolled in the study, and 61 patients in the trial group and 55 in the placebo group. The total serum bilirubin, direct bilirubin, alanine aminotransferase, aspartate aminotransferase and the activity of prothrombin in test group were also significantly improved. The incidence of adverse reactions in the trial group was 14% and in the placebo group was 5%, with no serious adverse events. Conclusion NAC can significantly reduce the serum total bilirubin and aminotransferase, and improve prothrombin activity. During the test, patients are well tolerated. The main adverse reactions are nausea, vomiting and rash. No serious adverse reactions were observed.