摘要
目的观察解毒凉血方治疗乙型肝炎慢加急性肝衰竭(hepatitis B virus related acute-onchronic liver failure,HBV-ACLF)热毒瘀结证的疗效和安全性。方法采用随机对照设计方法,将105例热毒瘀结证的HBV-ACLF患者随机分为试验组与对照组,试验组64例,对照组41例。试验组在西医内科综合治疗的基础上加用解毒凉血方,对照组仅给予西医内科综合治疗,治疗8周,随访40周。比较两组治疗后及随访至48周时的病死率、肝功能[包括总胆红素(total bilirubin,TBIL)、白蛋白(albumin,ALB)、丙氨酸氨基转移酶(alanine aminotransferase,ALT)、天冬氨酸氨基转移酶(aspartate transaminase,AST)]、凝血酶原活动度(prothrombin activity,PTA)的改善及用药安全性。结果在8周的治疗期内,试验组和对照组在总体病死率(15.63%vs 34.15%)、疾病处于中期患者的病死率(25.0%vs 64.7%)、第8周TBIL、第2及4周AST、第4及6周PTA方面比较,差异均有统计学意义(P<0.05);随访至48周,试验组病死率(21.88%)较对照组病死率(39.02%)下降了17.14%,差异有统计学意义(P<0.05)。试验期间两组均无明显不良反应发生。结论解毒凉血方能够显著降低HBV-ACLF患者的病死率。
Objective To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe （BCDR） in treating patients with hepatitis B virus related acute-on-chronic liver failure （HBV-ACLF） of heat-toxicity accumulation syndrome （HTAS） . Methods A- dopting randomized controlled clinical design, a total of 105 HBV-ACLF patients of HTAS were randomly as- signed to the trial group （64 cases） and the control group （41 cases）. Patients in the control group were treated with comprehensive Western therapy, while those in the trial group were treated with comprehen- sive Western therapy plus BCDR. All were treated for 8 weeks and followed up for 40 weeks. Effect and safety of the treatment were assessed, including fatality, liver functions [total bilirubin （TBIL）, albumin （ALB）, alanine aminotransferase （ALT）, and aspartate transaminase （AST）], and prothrombin activity （PTA） after treatment and at week 48 of follow-ups. Results After 8-week treatment, there was statistical difference in the overall fatality rate （15.63% vs 34. 15%）, the fatality rate in the mid-term （25.0% vs 64.7% ）, TBIL at week 8 （64.54 ±79.75）, AST I-at week 2- （178.97 ±44.24） U/L vs （288.48 ±58.49） U/L; atweek4; （61.65 ±27.36） U/Lvs （171.12 ±89.11） U/LI and PTA Eat week 4. （58.30 ±15.29） vs（42.56 ±15. 27） ; at week 6. （60.77 ±20.40） vs （43.08 ±12.79） J （all P 〈0.05）. At week 48 of the follow- up, the fatality rate of the trial group （21.88%） decreased by 17.14% when compared with that of the control group （39.02%; P 〈0.05）. No obvious adverse event occurred in the two groups during the 8-week treatment period. Conclusion BCDR could significantly reduce the mortality of HBV-ACLF patients.
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2014年第4期412-417,共6页
Chinese Journal of Integrated Traditional and Western Medicine
基金
国家“十一五”中医药防治传染病重大专项资助项目(No.2008ZX10005-007)
北京市科技计划课题资助项目(No.Z111107056811044)
北京市中医药科技发展基金科技提升专项资助项目(No.KJTS2011-05)
关键词
解毒凉血方
中西医结合治疗
乙型肝炎慢加急性肝衰竭
随机对照临床研究
blood cooling and detoxification recipe
integrative medical treatment
hepatitis B virus related acute-on-chronic liver failure
a randomized controlled clinical study
