| Objective:This research was designed to observe the clinical effect and safety of integrative therapy on HBV-ACLF. At the same time, the change of T lymphocyte subsets in peripheral blood in these patients and its relationship with the prognosis were investigated. Enriching the method of TCM and WM combined on liver failure and exploring the mechanisms are also important parts in this study.Method:60 inpatients were randomly divided into experimental group with 40 patients and control group with 20 patients. The control group was only treated with standard internal medications and symptomatic treatment, the experimental group was added Chinese traditional medicine. Survival analysis, effectiveness evaluation, laboratory tests including liver functions, coagulation capacity, routine blood test, BUN, SCr, symptoms and T lymphocyte subsets and NK cells in peripheral blood in patients with ACLF were compared between the two groups in 0-8weeks. Adverse reaction was monitored at the same time.Results:1. Clinical research:(1) 60 patients took part in the study; the total 8 week mortality was 15%. The mortality in the experimental group was 10%, and in the control group was 25%, the fatality rate of two groups did not show significant difference (P>0.05).(2) After 8 weeks treatment, out of the 40 cases in the experimental group,14 were fully recovered,17 showed marked progress,1 was effective,4 were inaction and 4 cases died. When it came to the control group, the data were 5,7,2,1,5, respectively. The total effective rate was 80% in the experimental group and 70% in the control group. The effective rate was markedly greater in the experimental group compared to the control group (P<0.01).(3) After 4 weeks treatment, biochemical indicators in the experimental group improved more significant than the control group, including TBIL, DBIL, AST, CHE, PT, PTA%, TG and Tch. The level of TBIL and PTA% have significant statistical differences compared with the control group (P<0.05). After 8 weeks treatment, the experimental group showed better improved in TBIL, DBIL, AST, PT, PTA%, TG and Tch. The difference of TBIL and DBIL between groups was statistically significant (P<0.05).(4) Clinical symptoms including sclera icterus, general fatigue, nausea, vomiting, loss of appetite, dark urine and abdominal distension were improved better in the experimental group compared to the control group (P<0.05).(5) No case with adverse reactions was found in each group.2. The change of T lymphocyte subsets and NK cells in peripheral blood(1) Compared with the first week, the T lymphocyte subsets and NK cells decreased in different degree in the 4th week, but there was no statistical significance (P>0.05). The level of T lymphocyte subsets and NK cells in the 8th week was higher than the 4th week, but similar with the first week, the difference in 4th and 8th week was not statistically significant (P>0.05).(2) After 8 weeks treatment, the level of T lymphocyte subsets in the experimental group was higher while the level of NK cells was lower than the control group. There was no difference in the level of T lymphocyte subsets and NK cells in peripheral blood between the experimental group and the control group before and after treatment (P>0.05).(3) There was a significant decrease in the T lymphocyte subsets of the non-survivors compared with the survivors in ACLF patients (P<0.05).(4) There was no difference of the level of T lymphocyte subsets between the ACLF patients with different type of syndrome. The NK cells in Qi Deficiency and Blood-Stasis- Yellow group decreased significantly compared with dampness-heat and Blood-Stasis-Yellow group (P<0.05).Conclusions:(1) Integrative therapy can improve the survival rate, liver function, clinical symptoms and the quality of life in treating ACLF.(2) Integrative therapy is a safe and effective method in treating ACLF, which deserves further dissemination.(3) The T lymphocyte subsets decreased a lot in ACLF patients, suggesting that cellular immune response probably serves as a factor for the pathogenesis of ACLF. The T lymphocyte subsets may relate with the progression and prognosis of this disease.It is possible that immune function of ACLF patients in Deficiency Type was lower than patients in excess type. |