乙酰半胱氨酸注射液对40例慢性乙型肝炎的临床疗效观察

The clinic study of N-acetylcysteine injection in 40 patients with chronic hepatitis B

目的对乙酰半胱氨酸(NAC)注射液治疗慢性乙型肝炎重度的疗效进行评估。方法选择慢性乙型肝炎重度的住院病人40例,采用随机、双盲、平行对照的临床试验,治疗前做常规体检,B超、心电图等检查;给药方案乙酰半胱氨酸8g/d,静脉滴注,疗程45天,同时配合基础综合治疗,并于用药前、用药后15天、30天、45天分别抽血检查肝功能、凝血酶原时间、肾功生化、血常规等检查。结果揭盲后A组(治疗组)20例;B组(对照组)20例,脱落6例(A组2例,B组4例),乙酰半胱氨酸能显著降低血清TBIL、DBIL、ALT、AST,A组的凝血酶原活动度改善情况明显优于B组。结论乙酰半胱氨酸能明显减低患者血清总胆红素、转氨酶,改善凝血酶原活动度,试验过程中病人耐受性好,没有严重的不良反应,主要不良反应为恶心、呕吐等消化道症状,但坚持用药2～3天后消失,1例出现皮肤过敏反应停药后好转。

Objective:To observe the efficacy of N-acetylcysteine(NAC) injection to 40 patients with chronic hepatitis B.Methods:This is a double blind and randomized clinical trial with parallel control.All of 40 patients were randomly divided into the NAC treatment and placebo group.Each group consisted of 20 patients.The patients in NAC group were treated with NAC injection,once a day with 8 gram for 45 days.The control group was given the placebo.Hepatic function(TBil,PTa,ALT,AST) was tested at 0 day,15 th day,30 th day,45 th day,respectively.Results:Before and 45 days after NAC treatment,the total bilirubin(TBil) were 441.74±125.14 and 128.37±108.26,respectively.In placebo group,TBil were 420.77±154.34 and 181.96±194.30 respectively before and 45 days after treatment.The PTa also was increased.The value were50.00±5.68% and 73.50±21.93% respectively at the start and end of NAC treatment,the increasing rate being 48.78±45.08%.The PTa showed remarkable difference between the two groups.NAC also could decrease the level of alanine aminotransferase(ALT) and aspartic aminotransferase(AST) in serum.Conclusion:NAC can decrease the level of serum TBil,increase the PTa and reduce the time in hospital.NAC showed no adverse effect in the period of treament.It is effective and safe to patients with chronic hepatitis B.