Objective： To investigate the efficacy and safety of the Fuzheng Huayu Tablet （扶正化瘀片, FZHYT）, which is used to reinforce qi and resolve stasis in patients with posthepatitic cirrhosis （PHC）. Methods： A multicenter, randomized, controlled clinical trial was conducted in 180 patients with PHC. The patients were randomly assigned using random numbers to a treatment group treated with FZHYT and a placebo group; the treatment course was 6 months for both groups. Overall response, adverse events （AEs）, and the 2-year survival rate were assessed after treatment. Evaluations were made on changes in liver function, liver fibrosis, coagulation, hemodynamics, degrees of esophagogastric varices, ascites, quality of life （QOL）, and scores of main symptoms. Results： The overall response was significantly higher in the treatment group than the placebo group （86.7% vs. 62.2%, P〈0.01）. Patients in both groups had significant improvements in liver function [total bilirubin （TBIL）, albumin （ALB）], liver fibrosis [hyaluronic acid （HA）, type 1V collagen （CIV）], coagulation [prothrombin time （PT）, activated partial thromboplastin time （APTT）, fibrinogen （FIB）, and thrombin time （TT）], hemodynamics portal venous flow （PVF）, and splenic vein flow （SVF） after treatment. Between-group comparisons showed that compared with the placebo group patients in the treatment group achieved significantly greater improvements in TBIL, ALB, HA, C IV, PT, AP＇I-r, PVF, SVF, time to ascites resolution, 2-year survival, QOL, and symptom scores （P〈0.05 or P〈0.01）. There were no significant AEs during the treatment. Conclusion： FZHYT is effective and safe for the treatment of hepatic cirrhosis as it is associated with improved liver function, liver fibrosis, coagulation, portal hypertension state, QOL, 2-year survival rate, and fewer AEs.
OBJECTIVE:To investigate the clinical effects of Weining Granules on gastric precancerous lesions(GPLs).METHODS:120 patients with GPLs were randomly assigned in a 1:1 ratio to receive Weining Granules(trial group) or the comparator Weifuchun tablets(control group) for 6 months.Outcomes were compared between the two groups including:overall response;gastroscopically-determined response;pathologically-confirmed response;eradication of Helicobacter pylori(HP);microvessel density(MVD) in the gastric mucosa;expression of vascular endothelial growth factor(VEGF);interleukin 2(IL-2);interleukin 6(IL-6);T lymphocyte subsets;immunoglobulins;symptom scores;quality of life(QOL);and adverse reactions.RESULTS:Patients in the trial group had a significantly higher(P<0.05) overall response rate(81.7%) as compared with those in the control group(63.3%).Relative to treatment with Weifuchun tablets treatment with Weining Granules resulted in a significant improvement(P<0.05) in the scores for gastric pain,distension and stuffiness in the hypochondrium,and anorexia.As compared with the tablets the Granules were associated with a significantly higher overall gastroscopically-determined response rate(78.3%;P<0.05).Pathological examination of tissue samples indicated that 61.7% of patients receiving the granules were cured with an overall response rate of 75.5%;these rates were significantly higher than in the control group(P<0.05).In comparison with patients receiving the tablets,those given the granules were significantly more likely to have their HP eradicated(75.0% vs.51.4%;P<0.05).Improvements in MVD,VEGF,CD4+,CD4+/CD8+,IL-2,IL-6 and IgG were significantly greater with the Weining Granules than with the Weifuchun tablets(P<0.05 or P<0.01).After follow-up of 1 year,17.5% of patients in the trial group relapsed as compared with 39.5% in the control group(P<0.05).Relative to the control group,the trial group showed significantly greater improvements in physical,psychological and social relationships,and in environmental domains(P<0.
