scholarly journals Effect of WSP, a Chinese Herbal Formula, on Th17/Treg Ratio and HBeAg Seroconversion in Telbivudine-Treated HBeAg-Positive Chronic Hepatitis B Patients with High Baseline ALT Levels (20–30 Times the ULN)

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Yang Zhang ◽  
Yi-Tong Wang ◽  
Jian-Xing Luo ◽  
Xiao-Yu Hu ◽  
Fang Yang ◽  
...  

Chronic hepatitis B (CHB) is a global health problem. Clinically, many patients have baseline alanine aminotransferase (ALT) levels above 20 times the upper limit of normal (ULN), but there are few reports about these patients. The prospective randomized placebo-controlled clinical study was designed to investigate the effect of WSP, a Chinese herbal formula, on telbivudine- (LDT-) treated HBeAg-positive CHB patients with high baseline ALT levels (20–30 times the ULN) and kidney-yang deficiency syndrome. Eligible patients were randomized to receive LDT 600 mg/day in combination with WSP (treatment group) or placebo granules (control group) 16.28 g/day for 52 weeks. The results showed that HBeAg seroconversion (SC) rate (44.1%) in the treatment group (n=34) was significantly superior to that (20.6%) in the control group (n=34) at 52 weeks (P < 0.05). Meanwhile, WSP could promote HBV DNA negative conversion (85.3% versus 61.8%, P < 0.05) and ALT normalization (94.1% versus 76.5%, P < 0.05) compared with the placebo. There were no drug-related serious adverse events. During the treatment, the peripheral blood Th17/Treg ratio first increased and then decreased in the treatment group and reached the peak at 12 weeks (P < 0.05). At 12, 24, 36, and 52 weeks, Th17/Treg ratio in the treatment group was better than those in the control group (all P < 0.05). In addition, the patients (n=22) with HBeAg SC had higher Th17/Treg ratio than the patients (n=46) without SC at 12 weeks (0.68±0.26 versus 0.43±0.18, P < 0.001). In conclusion, WSP could safely enhance HBeAg SC and promote HBV DNA negative conversion and ALT normalization in LDT-treated HBeAg-positive CHB patients with high baseline ALT levels (20–30 times the ULN) and kidney-yang deficiency syndrome. Th17/Treg ratio was not only related to the mechanisms of WSP but also a good predictor of 52-week HBeAg SC.

2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Jing Zhao ◽  
Wei Sun ◽  
Jihong Chen ◽  
Zhuxing Sun ◽  
Dai Chen ◽  
...  

Background. It is generally considered that traditional Chinese medicine (TCM) therapy postpones the progression of some chronic kidney diseases (CKDs). Chinese medicine herbs are widely applied in TCM therapy. We aimed to evaluate clinical efficacy and safety of Chinese herbal formula granules in patients with CKD stage 3 through a prospective randomized controlled study. Methods. A total of 343 participants with CKD stage 3 were recruited from 9 hospitals in Jiangsu Province between April 2014 and October 2016. Participants were randomly assigned to a treatment or control group. Patients in the treatment group orally took Chinese herbal formula granules twice a day, while controls received placebo granules. The duration of intervention was 24 weeks. Primary outcomes were 24-hour proteinuria, serum creatinine, and eGFR, which were measured every 4 weeks. Results. There was no statistical difference in 24-hour proteinuria between the two groups (0.97 ± 1.14 g/d vs. 0.97 ± 1.25 g/d). Patients in the treatment group had significantly lower serum creatinine level (130.78 ± 32.55 μmol/L versus 149.12 ± 41.27 μmol/L) and significantly higher eGFR level (55.74 ± 50.82 ml/min/1.73·m2 versus 44.46 ± 12.60 ml/min/1.73·m2) than those in the control group ( P  < 0.05). There was no significant difference between two groups in the incidence of adverse events. Conclusion. The treatment adopting Chinese herbal formula granules for 24 weeks improved kidney function of patients with CKD stage 3.


2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Xiao-Jun Zhu ◽  
Xue-Hua Sun ◽  
Zheng-Hua Zhou ◽  
Shun-Qing Liu ◽  
Hua Lv ◽  
...  

Objective. To determine the efficacy and safety of Lingmao Formula combined with entecavir for HBeAg-positive chronic hepatitis B patients with mildly elevated alanine aminotransferase (ALT).Methods. 301 patients were randomly assigned to receive Lingmao Formula combined with entecavir (treatment group) or placebo combined with entecavir (control group) for 52 weeks. The outcomes of interest included the reduction of serum HBV DNA level, HBeAg loss, HBeAg seroconversion, ALT normalization, and histological improvement.Results. The mean decrease of serum HBV DNA level from baseline and the percentage of patients who had reduction in serum HBV DNA level ≥2 lg copies/mL in treatment group were significantly greater than that in control group (5.5 versus 5.4 lg copies/mL,P=0.010; 98.5% versus 92.6%,P=0.019). The percentage of HBeAg loss in treatment group was 22.8%, which was much higher than a percentage of 12.6% in control group (P=0.038). There was no significant difference between the two groups in histological improvement. Safety was similar in the two groups.Conclusions. The combination of Lingmao Formula with entecavir could result in significant decrease of serum HBV DNA and increase of HBeAg loss for HBeAg-positive chronic hepatitis B patients with mildly elevated ALT without any serious adverse events. Clinical trial registration number isChiCTR-TRC-09000594.


2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Jianyong Gao ◽  
Yi Zhao ◽  
Tinglan Sun ◽  
Weike Liu ◽  
Zhenguo Wang

Objective: To compare the therapeutic effects of acupotomy trinity lysis and traditional acupotomy on cervical spondylotic myelopathy. Methods: A total of 205 patients with cervical spondylotic myelopathy of liver and kidney deficiency syndrome were randomly divided into the experimental group (105 cases) and the control group (100 cases). The experimental group was relaxed with acupotomy in three positions: Heaven (tian), Human (ren) and Earth (di). Traditional acupotomy was used to relax Ashi acupoints of the affected vertebra in the control group. One treatment was conducted in one week, and the duration of one course of treatment was three weeks. The VAS, JOA score and NDI index were observed after treatment.  Results: Before and after treatment, the total treatment efficiency of the treatment group was 95.23%, and that of the control group was 80.00%, there was significant difference between the two groups, P<0.05; Before operation, there was no significant difference in JOA score, NDI index score, and VAS score between the treatment group and the control group (P>0.05); there was no significant difference after 1 week (P>0.05), but there were significant differences between the two groups 2 weeks and 3 weeks after operation (P<0.05). Conclusion: Acupotomy trinity lysis is a safe, effective and economical treatment for cervical spondylotic myelopathy.


2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Shaojun Liao ◽  
Zhe Zhang ◽  
Geng Li ◽  
Li Zhou ◽  
Junwen Jiang ◽  
...  

Introduction. Stable angina (SA) in coronary heart disease is a common ischemic heart disease endangering the patient’s quality of life and longevity. Clinical trials have demonstrated that the Chinese herbal formula Xuefu Zhuyu (XFZY) has benefits for SA patients. However, there remains a lack of high-quality evidence to support clinical decision-making. Therefore, we designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of XFZY for SA. Methods and Analysis. This multicenter, double-blinded RCT will be conducted in China. 152 eligible participants will be randomly assigned to either an XFZY group or a control group at a 1 : 1 ratio. Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care. The study period is 26 weeks, including a 2-week run-in period, a 12-week treatment period, and a 12-week follow-up. The primary outcome is the change in visual analogue scale score for angina pain intensity from baseline to 12 weeks. The secondary outcomes are the angina attack frequency and duration, the nitroglycerin dosage consumed, the Canadian Cardiovascular Society grading of effort angina, the Seattle Angina Questionnaire, the EuroQol-5-Dimensions-5-Level, the incidence of major adverse cardiac events, health cost evaluation, and overall assessment for study drugs. Ethics and Dissemination. The study has been approved by the ethics committee of Guangdong Provincial Hospital of Chinese Medicine (approval no. BF2019-175-01). Results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. This trial is registered with ChiCTR1900026899, registered on 26 October 2019.


2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Yang Gong ◽  
Lixing Liu ◽  
Xiaojuan He ◽  
Hongyan Zhao ◽  
Jing Yang ◽  
...  

Objective. To investigate the Th17/Treg immune balance in the ulcerative colitis (UC) patients with two Chinese syndrome: dampness-heat in large intestine (DHLI) and spleen and kidney Yang deficiency (SKYD).Methods. Ninety UC patients (45 were diagnosed with DHLI and 45 with SKYD syndrome) and 23 healthy people were recruited. The serumIL-17 and TGF-β1 levels of these participants were measured with ELISA; the expression of IL-17 and TGF-β1 in colonic mucosa tissue was determined with immunohistochemistry and the percentage of Th17 and Treg in peripheral blood with flow cytometry.Results. The levels of IL-17 and Th17 were significantly higher in both DHLI and SKYD groups than in healthy control group and higher in DHLI than in SKYD group (P<0.05). The levels of TGF-β1 and Treg were significantly lower in the two UC patients groups than in healthy control group; and lower in SKYD group than in DHLI group (P<0.05).Conclusions. UC with DHLI syndrome could be characterized by the elevation of Th17 and IL-17 levels, which indicated an accentuation of inflammatory reaction; UC with SKYD syndrome could be characterized by the reduction of serum Treg and TGF-β1 levels, which represented a depression of immune tolerance.


2014 ◽  
Vol 59 (No. 9) ◽  
pp. 424-432
Author(s):  
MY Geng ◽  
FZ Yuan ◽  
XD Wang ◽  
XH Zhong

Chinese herbal medicine has been used as an anti-abortive treatment in farm animals for thousands of years. To investigate the anti-abortive functions and mechanisms of Bai zhu san (BZS) on mifepristone (RU-486)-induced abortion, pregnant mice were allocated to different groups as follows: control group receiving neither RU-486 nor BZS; mice receiving RU-486 only; mice treated with both RU-486 and BZS. The results showed that the concentrations of IL-10 and IL-4 in uterine lysates were significantly higher in mice of the BZS + RU-486&nbsp;group compared with the mice of the RU-486 group. The IL-10 and IL-4 levels in serum were several folds higher than that in uterus lysates. The IFN-&gamma; concentrations in uterine lysate decreased significantly in mice of the BZS&nbsp;+ RU-486&nbsp;group vs. the RU-486 group. There were no significant differences in IL-2 concentrations between the mice of BZS + RU-486 or RU-486 groups and controls in the uterus and serum. The numbers of CD4<sup>+</sup>, CD8<sup>+</sup>T lymphocytes or macrophages in the uterus decreased in the BZS + RU-486 group compared with the RU-486&nbsp;group. These results indicate that the Chinese herbal formula Bai zhu san inhibits RU-486-induced abortion and modulates the Th1/Th2 cytokine balance at the maternal-foetal interface. &nbsp;


2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Ruixue Chen ◽  
Guijuan Zhang ◽  
Yi Ma ◽  
Fengjie Bie ◽  
Hongxia Fan ◽  
...  

Ruyan Neixiao Cream (RYNXC) is a traditional Chinese herbal formula for treating mammary precancerous disease. This study was carried out to investigate in vivo anticancer effect of RYNXC and multiple constituents. 32 virginal Sprague-Dawley rats were randomly divided into blank control group (BC), mammary precancer models group (MODEL), tamoxifen group (TAM), and Ruyan Neixiao Cream group (RYNXC). TAM was intervened by tamoxifen; RYNXC was intervened by Ruyan Neixiao Cream. The chromatographic separation was performed by high performance liquid chromatography (HPLC) coupled with mass spectrometry (MS). RYNXC showed significant improvement in erythrocyte aggregation index (EAI), hematocrit (HCT), fibrinogen (FIB), spleen coefficient, and uterus coefficient compared with MODEL. In RYNXC and TAM groups, atypical hyperplasia was observed in pathological mammary tissues; meanwhile in MODEL group, ductal carcinoma was observed in situ. Moreover, fifteen compounds were characterized according to HPLC-MS data, including organic acids, tannin, alkaloid, volatile oil, anthraquinones, and flavonoids. The study suggests that RYNXC was an effective Chinese herbal formula for mammary precancerous lesions and provides a scientific basis for the quality standard and the pharmacology of RYNXC. It will be beneficial to the future clinical application of RYNXC.


2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Shu Liang ◽  
Yupei Zhang ◽  
Yuanjun Deng ◽  
Yifang He ◽  
Yinji Liang ◽  
...  

The present study investigates the potential therapeutic mechanism underlying the effects of the Chinese herbal formula Hongqijiangzhi Fang (HJF) on nonalcoholic fatty liver disease (NAFLD) in rats. Male Sprague Dawley (SD) rats were randomly divided into 4 groups (n=8): control group was fed a normal diet, three other groups were fed high-fat diets (HFD), and the two treatment groups were intragastrically given a compound probiotic or HJF during the molding time. After 16 w, related indices were detected. The results showed that HJF significantly reduced abdominal aorta serum cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), IL-1β, and IL-18, portal venous serum lipopolysaccharide (LPS), and liver TC and TG levels in HFD-fed rats. HJF ameliorated hepatic steatosis in the liver and improved the intestinal barrier in HFD-fed rats. Activation of the NLRP3 inflammasome was reduced by HJF in HFD-fed rats. Additionally, the abundances of A. muciniphila (Verrucomicrobiaceae), F. rappini (Helicobacteraceae), and Enterobacteriaceae bacteria significantly decreased in HJF-treated HFD-fed rats. In conclusion, these result suggested that the Chinese herbal formula HJF reduced hepatic steatosis maybe through decreasing certain gut bacteria (such as Enterobacteriaceae bacteria and F. rappini), alleviating intestinal endotoxemia and reducing NLRP3 inflammasome activation.


2013 ◽  
Vol 2013 ◽  
pp. 1-12 ◽  
Author(s):  
Jinsong He ◽  
Daqiao Zhou ◽  
Guangdong Tong ◽  
Yufeng Xing ◽  
Yingjie Chen ◽  
...  

A Chinese Herbal Formula (CHF) has acquired a certain therapeutic effect on chronic HBV infection. To assess the efficacy and safety of CHF on HBV replication in chronic HBV carriers, we performed a randomized, double-blind, and placebo-controlled trial involving patients from 16 centers. A total of 300 confirmed chronic HBV carriers were randomized at baseline in a ratio of 2 : 1 to receive either CHF or placebo for 52 weeks. The results showed that a greater proportion of CHF than placebo treated patients achieved virological response at week 52; the mean decline of serum HBsAg levels in the CHF group dropped more obviously than that in the control group at all stages of the treatment; however, the rates of HBeAg loss and seroconversion had no difference between the two groups. Meanwhile, were presented significant increases in IFN-γ; IL-2 levels and reductions in IL-4 and IL-10 levels in the treatment group compared to the control group at week 52. There were no drug-related serious adverse events. In conclusion, the treatment with 52-week CHF is safe and effective in inhibiting HBV replication in chronic HBV carriers. The ability of the compound to modulate host immune function probably contributed to this effect.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15030-e15030
Author(s):  
Tong Zhang ◽  
Wenting He ◽  
Yun Xu ◽  
Bin He ◽  
Yufei Yang

e15030 Background: To verify the efficacy of Quxie Capsule in patients with metastatic colorectal cancer (mCRC). Methods: This is a update of a randomized, double-blind, placebo-controlled trial. Between April 2014 and July 2015, 121 patients were enrolled in the study. Sixty patients were eligible and randomized to the two groups at a 1:1 ratio. Treatment group received conventional therapy and Chinese herbal medicine combined with Quxie Capsule for 3 months. Control group received conventional therapy and Chinese herbal medicine combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). As of Dec 31st 2018, one patient in the control group was still alive, and all the other patients reached the main clinical endpoint. Median follow-up time was 19.4 months. Bo Ao Tong (Beijing) Medical Technology Co. Ltd. was responsible for the protocols of blind and block randomization. Results: The median OS were 23.9 months in the treatment group [95% confidence interval (CI) 15.9–28.5] vs. 14.3 months in the control group (95% CI 11.3–21.4) (Kaplan–Meier, Log-rank P=0.032), hazard ratio (95%CI)= 0.55 (0.31, 0.95), P=0.04. In the subgroups of left-sided colon, RAS wild type, non-targeted therapy, colon cancer and ≥second-line therapy, the median OS of the treatment group and the control group were respectively: 20.9 vs 12.2m, 17.4 vs 14.4m, 20.8 vs 12.0m, 25.1 vs 18.5m, 25.1 vs 12.0m ( P=0.037, 0.019, 0.022, 0.018, 0.007). There were no significant differences between the two groups in PFS. Conclusions: Quxie Capsule showed good efficacy, can reduce the risk of death and prolong the OS of patients with mCRC. Clinical trial information: ChiCTR-IOR-16009733.


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