Chinese herbs in HBV-related acute-on-chronic liver failure

StephenW

Zhong Xi Yi Jie He Xue Bao. 2012 Feb;10(2):176-85.
[A prospective cohort study on the influence of high doses of herbs for clearing heat and resolving stasis on survival rates in patients with hepatitis B-related acute-on-chronic liver failure]. [Article in Chinese]
Hu XY, Zhang Y, Chen G, Zhong S, Fan XJ.
SourceDepartment of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan Province, China; E-mail: [email protected].

AbstractBACKGROUND: Hepatitis B-related acute-on-chronic liver failure (ACLF) is a severe clinical syndrome characterized by jaundice, coagulopathy, ascites and hepatic encephalopathy and with a high mortality rate of 65% to 93%. It involves significant ethical issues when a randomized, double-blinded, placebo-controlled clinical study is conducted to such a serious disease. Therefore, a prospective cohort study design was utilized to explore a new treatment modality of applying integrated traditional Chinese and Western medicine.
OBJECTIVE: To evaluate the efficacy, safety and recent survival rates of high-dose herbs with the function of clearing heat and resolving stasis, named Qingre Huayu, in patients with hepatitis B-related ACLF with heat toxin stagnation syndrome. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A matched, prospective cohort study was conducted. Participants who met the inclusion criteria were recruited from the Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine. Patients were assigned to either an integrated medicine group or a Western medicine group according to their own preference and received either a regime of classic Western medical treatment (control group) or a regime of classic Western medical treatment plus Qingre Huayu herbs (treatment group). The regimes were conducted for 12 weeks.
MAIN OUTCOME MEASURES: Survival rates of non-liver transplantation patients were evaluated after 12-week treatment. The levels of total bilirubin (TBiL), albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and prothrombin activity (PTA) were detected at baseline and weeks 4, 8 and 12. Scores of traditional Chinese medicine (TCM) syndrome and complications were evaluated at baseline and study completion. Adverse events were recorded.
RESULTS: All patients were followed up to the deadline for this study. There were 21 cases (31.8%) who died in the treatment group (n=66) and 19 cases (59.4%) in the control group (n=32). Significant difference (X(2)=6.775, P<0.01) was found in comparing the survival and death rates between the two groups by X(2) test. At 12 weeks, mean survival time of the two groups was 69.9 and 47.2 d respectively; cumulative survival rate of patients in the treatment group was higher than that of patients in the control group (P<0.01). Levels of TBiL, ALT, AST, ALB and PTA at weeks 4, 8 and 12 in the treatment group were superior to those in the control group with statistical significance (P<0.01 or P<0.05). In comparison of the TCM syndrome scores at week 12, the average score of the TCM syndrome of the treatment group (n=45) was 7.52±2.41, lower than 18.34±4.36 of the control group (n=13), and the difference was significant (t=8.784, P<0.01). Complication incidences after 12 weeks of treatment were statistically different between the treatment group (n=45) and the control group (n=13) by X(2) test (P<0.05 or P<0.01). Incidence rates of ascites, infection and hepatic encephalopathy accounted for 22.22%(10/45) and 69.23% (9/13), 8.89% (4/45) and 53.85% (7/13), and 11.11% (5/45) and 46.15% (6/13) in the two groups respectively. The incidence rates of adverse events in the treatment group and the control group were 0.00% and 12.50% respectively and the difference was statistically significant (X(2)=5.705, P<0.05). No drug-related adverse events were found in blood, urine and stool routine tests, renal function test and electrocardiography.
CONCLUSION: High doses of Qingre Huayu herbs can significantly improve liver function and coagulation function, reduce complications, and reduce mortality in patients with hepatitis B-related ACLF.

StephenW

中西医结合学报。 2012 02 10（2）:176-85。
[作者：高剂量的草药清热和解决血瘀与乙肝相关的急性，慢性肝功能衰竭患者生存率的影响的前瞻性队列研究]。
[文章在中国]
胡锦涛的XY，张芸，陈国，钟S，范许继。
源

传染病附属医院，成都中医大学，四川，成都610072，中国;电子邮件：[email protected]系。
抽象
背景：

B型肝炎相关的急性，慢性肝功能衰竭（ACLF）是一种严重的临床综合征，黄疸，凝血功能障碍，腹水和肝性脑病的65％至93％的高死亡率的特点。它涉及重大伦理问题时，随机，双盲，安慰剂对照的临床研究进行这样一种严重的疾病。因此，一项前瞻性队列研究设计，利用探索出一条运用中国传统和西方医学结合的新的治疗方法。
目的：

具有清热，化瘀，清热化瘀的功能来评估高剂量的草药的疗效，安全性和近期生存率，与乙型肝炎相关ACLF与热毒滞综合征患者。一个匹配的，前瞻性队列研究设计，设置，参与者和干预措施：进行。符合纳入标准的参与者谁被招募从传染病部，成都中医大学附属医院。患者被分配到中西医结合组或西药组根据自己的喜好和接受经典的西医药治疗（对照组）或经典的西医治疗加上清热化瘀中药（治疗组）的政权制度。进行了为期12周的政权。
主要观察指标：

非肝移植患者的生存率分别为12周的治疗后评估。总胆红素（TBIL），白蛋白（ALB）的水平，谷丙转氨酶（ALT），谷草转氨酶（AST），凝血酶原活动度（PTA）检测在基线和周4，8和12。在基线和研究完成后，传统的中医（中医）综合征及并发症进行评分。不良事件的记录。
结果：

所有患者随访这项研究的最后期限。有21例（31.8％）死于治疗组（N = 66）和对照组19例（59.4％）（N = 32）。由X（2）测试的生存和死亡率两组之间比较差异显着（第十（2）= 6.775，P <0.05），被发现。 12周时，平均生存时间两组分别为69.9和47.2ð;治疗组患者的累积生存率高于对照组患者（P <0.05）。 TBIL，ALT和AST，白蛋白和PTA水平在治疗组4周，8日和12均优于对照组差异有统计学意义（P <0.01或P级<0.05）。在中医证候评分的比较，在第12周，中医辨证治疗组（45例）的平均得分为7​​.52±2.41比18.34±4.36，对照组（N = 13），差异有显着性（T = 8.784，P <0.05）。统计并发症发生率分别为12周的治疗后治疗组（45例）和对照组（N = 13）的X（2）测试（P <0.05或P级<0.01）之间的不同。腹水，感染和肝性脑病的发病率占22.22％（10/45）和69.23％（9/13），8.89％（4/45）和53.85％（7/13），11.11％（5/45 ）和46.15％（6/13）分别在两组。在治疗组和对照组的不良事件的发生率分别为0.00％和12.50％，差异有统计学意义（x（2）= 5.705，P <0.01）。没有药物相关的不良事件被发现在血液，尿液和大便常规检查，肾功能和心电图。
结论：

清热化瘀药材高剂量可显着改善肝功能和凝血功能，减少并发症，降低乙型肝炎相关ACLF患者的死亡率。