Efficacy and safety of N-acetylcysteine in treatment of severe alcoholic hepatitis
Objective To investigate the efficacy and safety of N-acetylcysteine(NAC)in the treatment of severe alcoholic hepatitis(SAH),and to provide a basis for clinical medication for SAH.Methods A prospective randomized controlled trial was conducted among 172 SAH patients with a Maddrey discriminant function score of>32 points who were recruited by The Fifth Medical Center of Chinese PLA General Hospital from June 2015 to June 2018,and these patients were divided into NAC group with 84 patients and control group with 86 patients.NAC(8 g/day,28 days)was assessed in terms of its safety in SAH patients,its impact on 28-day biochemical parameters,and its role in improving 28-and 180-day survival rates.A further analysis was performed to investigate the effect of NAC on the 28-and 180-day survival rates of SAH patients with acute-on-chronic liver failure(ACLF-SAH patients)and those without acute-on-chronic liver failure(non-ACLF-SAH patients).The independent-samples t test was used for comparison of normally distributed continuous data between two groups,and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups.The Kaplan-Meier method was used to plot survival curves,and the Log-rank test was used for comparison of survival curves.Univariate and multivariate Cox proportional-hazards regression model analyses were used to investigate independent influencing factors.Results No serious adverse events were observed during NAC treatment,suggesting that NAC had a good safety profile.Compared with the control group,NAC did not significantly improve the 28-day biochemical parameters(all P>0.05)and survival rate of SAH patients(P=0.081),but it could improve the 180-day survival rate of SAH patients(67.4%vs 81.0%,χ2=4.280,P=0.039).NAC did not improve the 28-and 180-day survival rates of ACLF-SAH patients(both P>0.05);NAC did not improve the 28-day survival rate of non-ACLF-SAH patients(P>0.05),but it could improve the 180-day survival rate of these patients(68.4%vs 88.9%,χ2=4.883,P=0.027).The multivariate Cox regression survival analysis showed that NAC treatment(hazard ratio[HR]=2.530,95%confidence interval[CI]:1.334-4.796,P=0.004,),Maddrey discriminant function score(HR=3.852,95%CI:2.032-7.304,P<0.001),and serum sodium level(HR=1.948,95%CI:1.079-3.517,P=0.027)were independent influencing factors for 180-day survival rate in SAH patients.Conclusion NAC has a good safety profile in the treatment of SAH and can improve the 180-day survival rate of SAH patients,and in particular,non-ACLF-SAH patients can benefit from NAC treatment in terms of middle-and long-term survival rates.
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