Effect of Fuzheng Jiedu granule on immunological function and level of immune-related cytokines in immune-suppressed mice

Fuzheng Jiedu granule exhibits a number of health benefits and it is thought that the mechanisms involved in these effects are due to the modulation of immunity. In this article, we studied the effect of Fuzheng Jiedu granule on immunological function and the expression of immune-related cytokines in immune-suppressed mice. 72 mice were randomly divided into six groups, with 12 in each group. The control groups included an untreated group, a negative control group（Cyclophosphamide） and a positive control group（Astragalus polysaccharide）. There were three treated groups, which were given different doses of Fuzheng Jiedu granule： a low dose（100 mg kg^（–1））, a medium dose（400 mg kg^（–1）） and a high dose（600 mg kg^（–1））. With the exception of the untreated control animals, each group received an intraperitoneal injection of Cyclophosphamide（100 mg kg^（–1）） for 3 days to establish the immune-suppressed model. Mice were then treated for 19 consecutive days and, 24 h after the last treatment, blood was taken for the eyeballs and serum separation was performed. Analysis was made of the levels of related cytokines（IgA, IgG, IgM, IL-6, IFN-γ, C3, C4 and TNF-α）, the transformation of lymphocytes and the immune organ indexes. The results showed that Fuzheng Jiedu granule can improve the levels of cytokines, the rate of proliferation of lymphocytes and the immune organ indexes of immune-suppressed mice.

Clinical Effect of Fuzheng Jiedu Granule (扶正解毒颗粒) on Serum NO, NOS and Microelements in Patients with Coronary Heart Disease in Long-term Contact with Nickel

Objective: To study the clinical effect of Fuzheng Jiedu granule (扶正解毒颗粒,FJG) and its influence on serum nitric oxide (NO), nitric oxide synthase (NOS) and microelements in patients with coronary heart disease who are in long-term contact with nickel. Methods: Sixty patients were randomly divided into two groups, the treated group and the control group, 30 in each group. Conventional Western medicinal treatment was applied to both groups, but to the treated group, FJG was given additionally by oral intake, and the therapeutic course for both groups was 4 weeks. Besides, a health control group was set up with 15 healthy subjects selected from the same area, who had no history of contact with nickel. Clinical symptoms of the patients and changes in their electrocardiogram (ECG) and serum levels of NO, NOS and microelements were observed before and after treatment. Results: The total effective rate on clinical symptoms in the treated group was 93. 3% and that in the control group 63. 3% , comparison between the two showing significant difference (P<0.05); the total effective rate on ECG in the two groups was 90.0% and 56.7% respectively, which also showed significant difference (P<0.05). After treatment, levels of serum NO, NOS, Mg, Zn and Ca increased and those of Ni, Mn and Fe decreased significantly (P<0.05 or P<0.01) in the treated group, while in the control group, changes in these laboratory indexes were insignificant. Conclusion: FJG could lower the blood nickel level and regulate the unbalance of microelements, help restore serum NO and NOS in persons exposed to nickel and improve the clinical symptoms of patients with coronary heart disease and in long-term contact with nickel.

Efficacy and Safety of Bufei Jiedu Granules in Treating Multidrug-Resistant Pulmonary Tuberculosis:A Multi-center,Double-Blinded and Randomized Controlled Trial

Objective: To assess the efficacy and safety of Bufei Jiedu(BFJD) Granules as adjuvant therapy for patients with multidrug-resistant pulmonary tuberculosis(MDR-PTB). Methods: A large-scale, multi-center, double-blinded, and randomized controlled trial was conducted in 18 sentinel hospitals in China from December 2012 to December 2016. A total of 312 MDR-PTB patients were randomly assigned to BFJD Granules or placebo groups(1:1) using a stratified randomization method, which both received the long-course chemotherapy regimen for 18 months(6 Am-Lfx-P-Z-Pto, 12 Lfx-P-Z-Pto). Meanwhile, patients in both groups also received BFJD Granules or placebo twice a day for a total of 18 months, respectively. The primary outcome was cure rate. The secondary outcomes included time to sputum-culture conversion, changes in lung cavities and quality of life(QoL) of patients. Adverse reactions were monitored during and after the trial. Results: A total of 216 cases completed the trial, 111 in the BFJD Granules group and 105 in the placebo group. BFJD Granules, as adjuvant treatment, increased the cure rate by 13.6% at the end of treatment, compared with the placebo(58.4% vs. 44.8%, P=0.02), and accelerated the median time to sputum-culture conversion(5 months vs. 11 months). The cavity closure rate of the BFJD Granules group(50.6%, 43/85) was higher than that of the placebo group(32.1%, 26/81;P=0.02) in patients who completed the treatment. At the end of the intensive treatment, according to the 36-item Short Form, the BFJD Granules significantly improved physical functioning, general health, and vitality of patients relative to the placebo group(all P<0.01). Overall, the death rates in the two groups were not significantly different;5.1%(8/156) in the BFJD Granules group and 2.6%(4/156) in the placebo group. Conclusions: Supplementing BFJD Granules with the long-course chemotherapy regimen significantly increased the cure rate and cavity closure rate, and rapidly improved QoL of patients with MDR-PTB(Registration No. ChiCTR-TRC-12002850)

Thin Layer Identification of Jiedu Shengxue Granules and Determination of Notoginsenoside R1 Content

[Objectives]To establish the quality standard of hospital preparation Jiedu Shengxue granules.[Methods]Scleromitrion diffusum and Prunella vulgaris in Jiedu Shengxue granules were qualitatively identified by thin layer chromatography(TLC).A high performance liquid chromatography(HPLC)was established to determine the content of notoginsenoside R1 in the granule.[Results]The traditional Chinese medicinal materials in Jiedu Shengxue granules could be identified by TLC,and the characteristic spots were stable and clear.Notoginsenoside R1 had a good linear relationship in the range of 10.45-104.5μg/mL,with an average recovery of 98.52%and RSD=2.36%.[Conclusions]TLC and HPLC,as the quality control methods of Jiedu Shengxue granules,have high accuracy and good repeatability,which lays a foundation for the quality control of this mixture.

Preventive Effects of Jiedu Granules(解毒颗粒) Combined with Cinobufacini Injection(华蟾素注射液) versus Transcatheter Arterial Chemoembolization in Post-Surgical Patients with Hepatocellular Carcinoma:A Case-Control Trial

Objective： To investigate the therapeutic effects of Jiedu Granules （解毒颗粒）, a Chinese medicine （CM） compound, plus Cinobufacini Injection （华蟾素注射液）, which was extracted from skin of Bufo bufo gargarizans Cantor, to prevent the recurrence of hepatocellular carcinoma （HCC） after surgical resection. Methods： In this case-control trial, a total of 120 patients who stayed in Changhai Hospital were enrolled from December 2001 to December 2006. Sixty patients were treated with Jiedu Granules plus Cinobufacini Injection to prevent tumor recurrence after operation （CM group） and 60 patients were treated with transcatheter arterial chemoembolization （TACE） after operation （TACE group）. Progression-free survival （PFS） and overall survival （OS） rates were determined to evaluate the therapeutic effects of post-operative management of patients with HCC. Results： PFS in the CM group was 18.07 months [95% confidence interval （CI）： 12.49-23.65] and the 1-, 2-, 3-, 4- and 5-year PFS rates were 61%, 39%, 26%, 22% and 12%, respectively. PFS in the TACE group was 8.03 months （95% CI： 6.63-9.44） and the 1-, 2-, 3-, 4- and 5-year PFS rates were 34%, 11%, 7%, 2% and 0%, respectively. There was significant difference in survival rate between the two groups （P〈0.01）. The mean survival time （MST） of patients in the CM group was 49.53 months versus 39.90 months of the TACE group. The 1-, 2-, 3-, 4- and 5-year survival rates were 90%, 82%, 80%, 70% and 63%, respectively, in the CM group, and 79%, 70%, 60%, 60% and 36%, respectively, in the TACE group. There was significant difference in survival time between the two groups （P=0.045）. Conclusions： Jiedu Granules plus Cinobufacini Injection, a combination that is commonly used for post-operation management of HCC, can postpone tumor recurrence and metastasis, prolong the survival time and increase the survival rate of post-surgical patients with HCC. However, these findings need to be confirmed in a prospective, randomized controlled trial.

Comparable effects of Jiedu Granule, a compound Chinese herbal medicine, and sorafenib for advanced hepatocellular carcinoma: A prospective multicenter cohort study

Objective:Sorafenib has been extensively used for the treatment of advanced hepatocellular carcinoma(HCC),and Chinese herbal medicine has also been used to manage advanced HCC.The present work evaluates the effectiveness and safety of Jiedu(JD)Granule,a compound of traditional Chinese herbal medicine,side-by-side with sorafenib for the treatment of advance HCC.Methods:Patients with advanced HCC receiving treatment with JD Granule or sorafenib were enrolled from December 2014 to March 2018.The primary endpoint was overall survival(OS).The secondary endpoints were progression-free survival(PFS)and safety.Propensity score matching(PSM)analysis was used to control for possible selection bias from the study group allocation process.Results:Of the 325 patients included,161 received JD Granule and 164 received sorafenib.No significant differences were found in OS or PFS among patients receiving JD Granule compared to sorafenib(P>0.05).Median OS of the two study groups was 6.83 months(95%confidence interval[CI]:5.83–9.47)in the group receiving JD Granule and 8 months(95%CI:6.67–9.80)in the group receiving sorafenib,with half-,1-and 2-year survival rates of 53.6%,31.2%and 13.2%vs 60.1%,35.5%and 14.2%,respectively.Even after PSM,the median survival time did not differ between the JD Granule group(9.03 months;95%CI:6.37–14.2)and the sorafenib group(7.93 months;95%CI:6.5–9.97),with comparable half-,1-and 2-year survival rates.The most common adverse events(AEs)were diarrhea(13.7%)and fatigue(5.6%)in the JD Granule group,and hand-foot skin reaction(46.3%)and diarrhea(36.6%)in the sorafenib group.The JD Granule was more cost-effective than sorafenib treatment for advanced HCC.Conclusion:Compared to sorafenib,JD Granule was more cost-effective and caused fewer AEs for the treatment of Chinese patients with advanced HCC.

Effectiveness of Xiaoyin Jiedu granules in the treatment of psoriasis vulgaris in patients with blood-heat symptom patterns in terms of Traditional Chinese Medicine

OBJECTIVE:To evaluate the effectiveness of Xiaoyin Jiedu(XYJD)granules in the treatment of psoriasis vulgaris(PSV)in patients with a blood-heat pattern(BHP)in terms of Traditional Chinese Medicine(TCM).We also aimed to identify the possible underlying immunological mechanism.METHODS:Twenty-five PSV patients with BHP and ten normal controls were enrolled from January 1,2015 to December 31,2016.Patients were randomly assigned to either the XYJD group(15 cases)or the placebo group(10 cases),in which patients were treated with XYJD granules or a placebo,respectively.Additionally,albolene was used to relieve skin dryness in these two groups.The psoriasis area and severity indexes,dermatology life quality indexes and itching scores were assessed at the end of the 2 nd,4 th and 8 th week of treatment.The number of peripheral blood T helper(Th)9,Th17 and regulatory T cells(Tregs)and the m RNA and protein expression levels of PU.1,RAR-related orphan receptor(ROR)-γt,forkhead box protein 3(Foxp3),interleukin(IL)-9,IL-17,IL-23 and IL-10 in the control and experimental groups were compared before and after treatment.RESULTS:Psoriasis area and severity indexes and itching scores of patients in the XYJD group were significantly lower than those in the placebo group,whereas dermatology life quality indexes were significantly higher.In comparison with the placebo group,XYJD granules significantly reduced the number of Th17 cells and the m RNA and protein expression levels of Th17-related ROR-γt,IL-17,IL-22 and IL-23 in the peripheral blood and reduced the number of Th9 cells and the m RNA and protein expression levels of Th9-related PU.1 and IL-9.CONCLUSION:XYJD granules were effective against PSV in patients with BHP by reducing the number of Th9 and Th17 cells and the levels of their related cytokines.

Effect of Quyu Jiedu Granule(祛瘀解毒颗粒) on Micro-environment of Ova in Patients with Endometriosis

Objective:To observe the effect of Quyu Jiedu Granules(祛瘀解毒颗料,QJG) on the micro-environment of ova in patients with endometriosis(EM).Methods:Twenty EM patients who received in vitro fertilization and embryo transfer(IVF-ET) were randomized equally into a treated group and a control group. Further,20 patients who received IVF-ET due to oviduct factors were enrolled into a non-endometriosis group. The dosage of gonadotrophic hormone used,the number of ova attained,fertilization rate and clinical pregnancy ra...

Effectiveness of Jiedu granule(解毒颗粒) on gut microbiota in patients with advanced hepatocellular carcinoma:a randomized controlled trial

OBJECTIVE:To observe whether Jiedu granule(解毒颗粒,JDG)modulates the composition of the gut microbiota during advanced hepatocellular carcinoma(HCC).METHODS:A randomized controlled trial was conducted.Sixty-two advanced HCC participants were randomly allocated to receive JDG or placebo.The median overall survival(OS)times of patients and the variation of relative abundance of bacteria over time were used as main outcome measures.RESULTS:Patients who received JDG demonstrated significantly longer median OS times compared with the placebo group.Pyrosequencing of the V3 regions of 16S r RNA genes revealed a dose dependent deviation of gut microbiota in response to JDG treatment.Redundancy analysis identified Clostridium XI and Peptostreptococcaceae which related to the onset of liver cancer disappeared after 1-month and 2-month JDG treatment,while in control group,no significant changes of these two bacteria were found.The variation tendency of relative abundance of Bacteroides(essential in immunoblocking therapy of tumor)in JDG group was not obvious while in control group,it was decreased significantly with time.The relative abundance of Roseburia(correlated with the occurrence of liver cancer)was increased in JDG group and was decreased in control group over time.CONCLUSION:Changes in the gut microbiota may be associated with the efficiency of JDG on survival period of advanced HCC patients.Trial registration:Chinese Clinical TRIAL Registry Chi CTR-OOC-16008002.