Babaodan inhibits cell proliferation and metastasis and enhances anti-tumor effects of camrelizumab by inhibiting M2 phenotype macrophages in hepatocellular carcinoma.

ETHNOPHARMACOLOGICAL RELEVANCE: Babaodan (BBD) is a unique Chinese medication utilized in traditional Chinese medicine. It can eliminate toxins, induce diuresis, and eliminate yellowish hue. In addition to treating acute and chronic viral hepatitis, cholecystitis, cholangitis, and urinary tract infections, BBD has garnered popularity as a substitution treatment for several malignant cancers, particularly hepatocellular carcinoma (HCC). AIM OF THE STUDY: To elucidate the efficacy and mechanism of BBD alone and combined with camrelizumab (CLM) for treating HCC. METHODS: We investigated the effects of BBD on the HCC tumor microenvironment in vivo. Furthermore, we evaluated its effects on tumor growth and metastasis induced by M2 macrophages in vitro. RESULTS: In a mouse model of orthotopic HCC, BBD decreased tumor growth. Furthermore, it increased the M1/M2 macrophage ratio and CD8+ T-cell abundance in mice. In addition, BBD reversed HCC cell proliferation and metastasis induced by M2 macrophages, increased the anti-HCC effect of low-dose CLM, and attenuated organ damage induced by high-dose CLM. Lastly, BBD enhanced the efficacy of CLM via the PI3K/AKT/mTOR signaling pathway. CONCLUSION: BBD increases the antitumor effect of CLM by modulating the tumor immune microenvironment and attenuating its the toxic side effects of CLM.

Babaodan Alleviates APAP-induced Acute Liver Injury in Mice by Inhibiting NLRP3/Caspase-1 Pathway / 中国实验方剂学杂志

ObjectiveTo explore the effect of Babaodan （BBD） on the NOD-like receptor pyrin domain containing 3/cysteine aspartate-specific protease-3 （NLRP3/Caspase-1） pathway proteins in mice with acetaminophen （APAP）-induced acute liver injury. MethodC57BL/6 mice were randomly grouped， and BBD （75， 150， 300 mg·kg-1， ig） was administered twice a day for three days. After 2 hours of the last administration， the mice were treated with APAP （400 mg·kg-1， ip）， and the eyeballs were removed to collect blood after 14 hours. Then they were sacrificed by cervical dislocation for sample collection. Hematoxylin-eosin （HE） staining was used to observe the morphological changes of liver tissue cells， and biochemical methods were used to detect the activities of alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， superoxide dismutase （SOD）， malondialdehyde （MDA） and myeloperoxidase （MPO） in serum of mice in each group. Real-time fluorescence quantitative polymerase chain reaction （Real-time PCR） was performed to determine the mRNA expression of tumor necrosis factor-α （TNF-α）， interleukin-1β （IL-1β） and IL-6， and Western blot was performed to determine the protein expression of cyclooxygenase-2 （COX-2）， inducible nitric oxide synthase （iNOS）， NLRP3， Caspase-1 and IL-18 in the liver of mice. ResultCompared with the conditions in normal group， the hepatic lobule structure of mice in the model group was partially destroyed， and the hepatic sinusoids were dilated. And the expression levels of ALT and AST in serum， the protein levels of NLRP3， Caspase-1， iNOS， IL-18 and COX-2 and the mRNA levels of IL-1β， IL-6 and TNF-α were increased （P<0.05， P<0.01）. Compared with the model group， the administration groups had improvement in liver cell rupture and hepatic sinusoidal compression， and a dose-dependent decrease in the levels of ALT and AST in serum as well as the protein levels of NLRP3， Caspase-1， iNOS， IL-18 and COX-2 and the the mRNA levels of IL-1β， IL-6 and TNF-α in liver tissue （P<0.05， P<0.01）. ConclusionBBD can reduce APAP-induced acute liver injury in mice. The mechanism may be related to anti-oxidative stress， inhibition of NLRP3/Caspase-1 pathway， and decreased expression levels of IL-1β， IL-18， TNF-α and IL-6.

Identification of bioactive ingredients from Babaodan using UPLC-QTOF-MS analysis combined with network pharmacology guided bioassays.

Babaodan (BBD) is a traditional Chinese medicine (TCM) prescribed for various inflammatory diseases, including viral hepatitis and acute genitourinary tract infection. Like other TCMs, BBD is a multi-component formula whose chemical composition and mode of action are largely unknown. The current study identified the bioactive ingredients of BBD using ultrahigh-performance liquid chromatography combined with quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) followed by mass spectrometry molecular networking analysis. Subsequently, network pharmacology analysis was performed to predict the potential targets and pathways regulated by BBD. Eventually, a panel of compounds was selected and examined for their anti-inflammatory effects using lipopolysaccharide-stimulated RAW264.7 cells. Eighty-six compounds, including saponins, bile acids, and fatty acids, were identified. Tumor necrosis factor-alpha was identified as a key molecule. Pathways in cancer, inflammatory bowel disease, and hepatitis were predicted to be the major regulatory pathways. The results from bioassays validated ginsenoside Rb1, ginsenoside Rd, deoxycholic acid, chenodeoxycholic acid, and taurochenodeoxycholic acid as novel bioactive ingredients in BBD with anti-inflammatory effects. In conclusion, our study explains the anti-inflammatory efficacy of BBD from both chemical and biological aspects, which provides a scientific basis for the clinical application of BBD in inflammation-related diseases.

The Chinese medicine babaodan suppresses LPS-induced sepsis by inhibiting NLRP3-mediated inflammasome activation.

ETHNOPHARMACOLOGICAL RELEVANCE: BBD is a well-known traditional Chinese medicine widely used in clinic to treat viral hepatitis, cholecystitis, angiocholitis and urinary tract infection. According to traditional medicinal theory, BBD exerts the effects of "clearing and humid heat, activating blood and removing toxicity, curing jaundice and relieving pain", the signs of which are recognized as common symptoms of inflammation during infectious diseases in modern medicine. AIM OF THE STUDY: To determine the therapeutic effect of BBD on bacterial endotoxin lipopolysaccharide (LPS) induced sepsis and to investigate the relevant pharmacological and molecular mechanisms of action whereby BBD mitigates inflammation. MATERIALS AND METHODS: In vivo, a mouse sepsis model was induced by intraperitoneally injection of LPS; the BBD were formulated as drug suspension for intragastric administration. The survival rate, secretion of pro-inflammatory cytokines of IL-1ß and TNF-α, and multiple organ injury of lung, liver and spleen were examined. In vitro, peritoneal macrophages (PMs) were stimulated with LPS plus ATP for NLRP3 inflammasome activation; polar gradient extractions of BBD from ultrapure water (sample 1) followed by 70% ethanol (sample 2) were added as interventions. In addition to detect the secretion of IL-1ß and TNF-α, the activation of NF-κB, ASC-speck formation and ASC oligomerization were examined by western blotting and immunofluorescent stainning. Eventually, the extractions of BBD were applied for UPLC-QTOF-MS analyses; refer to the identified chemicals, the bioactive compounds in BBD with anti-NLRP3 inflammasome activities were discussed. RESULTS: BBD improved the survival of sepsis mice accomplished with diminished inflammatory cytokines production and multiple organ injury. Mechanistically, BBD inhibited both the NF-κB pathway and the assembly of NLRP3 complex in PMs. There were 29 chemical compounds identified from sample 1 and 20 from sample 2. Both samples contained bile acids and saponins and sample 2 contained 2 extra chemicals in the category of bile acids. CONCLUSIONS: BBD presents therapeutic role of endotoxin induced sepsis by inhibiting NLRP3-medaited inflammasome activation, which supports its traditional use for the treatment of infectious diseases. The bile acids and saponins are most likely related to the anti-NLRP3 inflammasome activation effect of BBD.

Quantification and discovery of quality control chemical markers for Ba-Bao-Dan by UPLC-MS/MS combined with chemometrics.

Ba-Bao-Dan (BBD) is a well-known Traditional Chinese medicine (TCM) prescription in China. It was first formulated in approximately 1555 AD. As one of the National Protected TCM, it is widely used to treat jaundice, viral hepatitis, cholecystitis, acute urinary tract infection, cancer, and other diseases. It is a healthcare medicine that is used to prevent many diseases in China. In other Asian countries and in European and American countries, BBD is used as a drug to protect the liver. However, a systematic quality study on BBD chemical markers has not been carried out. This study aimed to establish an ultra-high performance liquid chromatography coupled with triple quadrupole mass spectrometry (UPLC-MS/MS) method for the quantitative determination of 43 compounds in BBD. Furthermore, the method was used to further find chemical markers for quality control through the combination with chemometrics. The modified chromatographic conditions were achieved on Waters Cortecs C18 column (2.1 × 100 mm, 1.6 µm) with a gradient elution consisting of 0.1 % formic acid in water and acetonitrile with methanol (1:1, V/V). All analytes were determined in the multiple reaction monitoring mode. The method was validated for linearity, detection limits, precision, repeatability, stability and accuracy. The method was used to analyze the 43 compounds in 11 batches of BBD samples. Hierarchical cluster analysis and principal component analysis were applied to evaluate intrinsic quality of BBD and to identify the potential chemical markers for quality control. In conclusion, the method rapidly and sensitively determined the 43 compounds, among which 10 compounds, namely, N-Gin R1, Gin Re, Gin Rg1, Gin Rb1, GCA, Gin Rd, CA, TCA, CDCA, and DCA, were considered as the potential chemical markers for BBD quality control.

Babaodan controls excessive immune responses and may represent a cytokine-targeted agent suitable for COVID-19 treatment.

It has become evident that the actions of pro-inflammatory cytokines and/or the development of a cytokine storm are responsible for the occurrence of severe COVID-19 during SARS-CoV-2 infection. Although immunomodulatory mechanisms vary among viruses, the activation of multiple TLRs that occurs primarily through the recruitment of adapter proteins such as MyD88 and TRIF contributes to the induction of a cytokine storm. Based on this, controlling the robust production of pro-inflammatory cytokines by macrophages may be applicable as a cellular approach to investigate potential cytokine-targeted therapies against COVID-19. In the current study, we utilized TLR2/MyD88 and TLR3/TRIF co-activated macrophages and evaluated the anti-cytokine storm effect of the traditional Chinese medicine (TCM) formula Babaodan (BBD). An RNA-seq-based transcriptomic approach was used to determine the molecular mode of action. Additionally, we evaluated the anti-inflammatory activity of BBD in vivo using a mouse model of post-viral bacterial infection-induced pneumonia and seven severely ill COVID-19 patients. Our study reveals the protective role of BBD against excessive immune responses in macrophages, where the underlying mechanisms involve the inhibition of the NF-κB and MAPK signaling pathways. In vivo, BBD significantly inhibited the release of IL-6, thus resulting in increased survival rates in mice. Based on limited data, we demonstrated that severely ill COVID-19 patients benefited from BBD treatment due to a reduction in the overproduction of IL-6. In conclusion, our study indicated that BBD controls excessive immune responses and may thus represent a cytokine-targeted agent that could be considered to treating COVID-19.

BabaoDan cures hepatic encephalopathy by decreasing ammonia levels and alleviating inflammation in rats.

ETHNOPHARMACOLOGICAL RELEVANCE: BabaoDan (BBD) is a famous traditional Chinese formula frequently used in TCM clinics to eliminate jaundice and treat infectious viral hepatitis. This paper assesses BBD's preventive and therapeutic effects on hepatic encephalopathy after liver cirrhosis (CHE) and acute liver failure (AHE) in rats and explains its possible mechanism of action. METHODS: CHE rat model was established by injection of carbon tetrachloride (CCl4) twice a week for a total of 9 weeks and then by injection of thioacetamide (TAA) to induce hepatic encephalopathy. AHE rat model was established by injection of TAA once a day for a total of 3 days. In CHE rat model, BBD was gavaged once a day at the end of the 6th week until the experiment ended. In AHE rat model,BBD was gavaged once a day 3 days before TAA injection until the experiment ended. The preventive and therapeutic effects of BBD on brain dysfunction, as well as liver injury, pathology and fibrosis were evaluated in vivo. The role of BBD in the regulation of inflammatory factors and myeloid differentiation factor 88/Toll-like receptor 4/nuclear factor kappa-B (TLR4/MyD88/NK-κ B) pathway was detected in both liver and brain in vivo. The rat bone marrow derived macrophages (BMDMs) were activated by Lipopolysaccharide (LPS), and the role of BBD in the regulation of inflammatory factors and NK-κ B pathway were detected in vitro. RESULTS: In CHE rat model: BBD significantly improved the total distance as well as the activity rate of rats. BBD also improved the learning and memory abilities of rats compared with the control group. In addition, BBD effectively decreased ammonia levels and significantly decreased the levels of alanine aminotransferase (ALT), aspartate transaminase (AST), total bilirubin (TBil) and total bile acid (TBA), as well as improved the levels of total protein (TP) and albumin (Alb). In the liver, BBD not only inhibited the gene expressions of tumor necrosis factor alpha (TNF-α), interleukini-6 (IL-6), TLR4, MyD88, and NF-κ B but also inhibited the protein expressions of TLR4, MyD88, NK-κ B and TNF-α. In the brain, BBD inhibited the gene expressions of iNOS, IL-6, TNF-α, TLR-4, MyD88, and NF-κ B, as well as inhibited the protein expressions of TLR4, MyD88, P65 TNF-α and ionized calcium binding adapter molecule 1 (Iba-1). BBD also decreased NO and TNF-α in the blood. IN AHE RAT MODEL: BBD improved neurological scores, blood ammonia levels and the brain inflammatory gene expressions of iNOS, TNF-α and IL-1ß. BBD also improved liver function biomarkers such as ALT, TBil, TBA, TP, ALB and inflammatory and apoptotic gene expressions of TNF-α, IL-1ß, IL-6, Bax, Bcl-2, caspase-9, caspase-3 and NF-κ B. In LPS-activated rat BMDMs, BBD decreased NO and TNF-α production in BMDM culture supernatant. In addition, BBD inhibited the gene expressions of TNF-α, IL-1 ß and IL-6 as well as the phosphorylation of P65. CONCLUSION: BBD can prevent and cure hepatic encephalopathy (HE) derived from both chronic and acute liver diseases. BBD can reduce hyperammonemia as well as the systematic and neurological inflammation. Inflammation is likely an important target of BBD to treat HE. The anti-inflammatory role of BBD may lie in its regulation of the TLR4/MyD88/NF-κ B pathways.

[Babaodan Capsules for viral hepatitis: systematic review of clinical efficacy and safety and Meta-analysis of randomized clinical trials].

To systemically analyze the efficacy and safety of Babaodan Capsules in treatment of viral hepatitis. Databases such as CNKI,Wan Fang Date,VIP,Sino Med,PubMed,and Cochrane Library were electronically searched for relevant randomized controlled trials about Babaodan Capsules in the treatment of viral hepatitis,from database establishment to November 11,2018. Two researchers independently screened the literature and extracted data according to the inclusion criteria. GRADE system was used to evaluate evidence quality,and we used the Cochrane Rev Man 5. 3 software for Meta-analysis. Six randomized controlled trials including 520 subjects were included. Babaodan Capsules combined with conventional treatment were used as intervention measures,and the conventional treatment was used as the control measures. The results showed Babaodan Capsules combined with conventional treatment had better efficacy on reducing the total bilirubin( MD =-16. 25,95% CI[-19. 86,-12. 63]),alanine aminotransferase( MD =-26. 62,95% CI[-41. 18,-12. 06]),total bile acid( MD=-46. 02,95%CI[-49. 18,-42. 85]) and improving clinical efficiency( RR = 1. 34,95%CI[1. 13,1. 59]) than conventional treatment alone. In addition,Babaodan Capsules combined with conventional treatment can delay the progression of liver fibrosis to some extent. Qualitative analysis showed that the combined treatment regimen was more effective in relieving clinical symptoms. There was no significant difference between the two regimens in increasing albumin and prothrombin activity. Babaodan Capsules combined with conventional treatment showed no adverse reactions. In summary,for patients with viral hepatitis,the combination of Babaodan Capsules and conventional treatment has more advantages in reducing total bilirubin,alanine aminotransferase and total bile acid and is more effective in improving clinical symptoms as compared with conventional Western medicine,with no serious adverse reactions. Its clinical application with syndrome differentiation method can be considered. However,due to the limited number and quality of the original researches,more multi-center,high-quality randomized controlled trials are needed for further verification.

BabaoDan attenuates high-fat diet-induced non-alcoholic fatty liver disease via activation of AMPK signaling.

BACKGROUND: Babaodan (BBD), a traditional Chinese medicine, has been shown to have protective effects during liver injury and ameliorate liver disease progression, but little is known about its effect on non-alcoholic fatty liver disease (NAFLD). The aim of this study was to investigate the effects of BBD on obesity-induced NAFLD. METHODS: C57BL/6 J mice were fed with normal diet, high fat diet (HFD) or HFD + BBD for 8 weeks. Weights of all mice were recorded every 3 days. At the end of the experiments, the level of livers, kidneys and adipose tissues of each animal was weighed. Blood serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C) cholesterol, low density lipoprotein cholesterol (LDL-C), glucose and leptin were detected with appropriate test kits. Haematoxylin-eosin (HE), Masson trichrome and Oil Red O staining of the liver were performed. We applied immunohistochemical analysis to investigate the expression of TNF-α, IL-6 and leptin in liver tissue. The expression of genes related lipid anabolism (SREBP1-c, ACC, SCD-1, LXRα and CD36) and ß-oxidation (CPT-1 and PPARα) in liver and adipose tissues was determined by RT-PCR. The expression of AMPK and p-AMPK was determined by western blot analysis. RESULTS: We found the weight of bodies and tissues (retroperitoneal fat pads, kidneys and livers) of mice fed with HFD + BBD were significantly lower than that of HFD-fed mice. And liver injury induced by HFD was relieved in mice treated with BBD, accompanied with significant reduction were observed in serum ALT/AST activities and alleviated pathological damage. The levels of glucose, TG, TC, HDL-C and LDL-C in the liver or serum were significantly decreased on HFD + BBD group compared with HFD group. Furthermore, BBD treatment reduced the level of TNF-α and IL-6 induced by HFD. The level of leptin in the liver and serum were reduced in mice fed with HFD + BBD than that of HFD-fed mice. Several lipid synthesis genes (SREBP1-c, ACC, SCD-1, LXRα and CD36) were down-regulated and that of ß-oxidation (CPT-1 and PPARα) up-regulated in HFD + BBD group compared with HFD group. In addition, BBD increased the expression of p-AMPK compared with untreated HFD group, which suggested BBD improved the activation of AMPK pathway. CONCLUSION: In summary, our results indicate that BBD has potential applications in the prevention and treatment of NAFLD, which may be closely related to its effect on lipid metabolism via activation of AMPK signaling.

Babaodan inhibits cell growth by inducing autophagy through the PI3K/AKT/mTOR pathway and enhances antitumor effects of cisplatin in NSCLC cells.

Babaodan capsule (BBD), a traditional Chinese (TCM) formula, has been widely used as an alternative remedy for multiple types of malignancies, clinically. However, the underlying mechanisms behind the efficacy of BBD remain poorly understood, particularly in regard to lung cancer. Herein, we demonstrate that BBD induced autophagic death in A549 and A549DDP cells without apoptosis. Treatment with autophagic inhibitor 3-MA, Baf-A1 and PI3K agonist, IGF-1, fully proved our conclusion, as well as uncovered the potential downregulated signaling pathway, PI3K/AKT/mTOR. The study additionally found that BBD could downregulate the expression of MDR1 and increase the chemosensitivity of cisplatin. Collectively, our results, both in vivo and in vitro, demonstrate that BBD leads to autophagic cell death through downregulating the PI3K/AKT/mTOR signaling pathway and improved the antitumor effects of cisplatin in non-small cell lung cancer (NSCLC).

Babaodan Capsules for viral hepatitis: systematic review of clinical efficacy and safety and Meta-analysis of randomized clinical trials / 中国中药杂志

To systemically analyze the efficacy and safety of Babaodan Capsules in treatment of viral hepatitis. Databases such as CNKI,Wan Fang Date,VIP,Sino Med,PubMed,and Cochrane Library were electronically searched for relevant randomized controlled trials about Babaodan Capsules in the treatment of viral hepatitis,from database establishment to November 11,2018. Two researchers independently screened the literature and extracted data according to the inclusion criteria. GRADE system was used to evaluate evidence quality,and we used the Cochrane Rev Man 5. 3 software for Meta-analysis. Six randomized controlled trials including 520 subjects were included. Babaodan Capsules combined with conventional treatment were used as intervention measures,and the conventional treatment was used as the control measures. The results showed Babaodan Capsules combined with conventional treatment had better efficacy on reducing the total bilirubin( MD =-16. 25,95% CI[-19. 86,-12. 63]),alanine aminotransferase( MD =-26. 62,95% CI[-41. 18,-12. 06]),total bile acid( MD=-46. 02,95%CI[-49. 18,-42. 85]) and improving clinical efficiency( RR = 1. 34,95%CI[1. 13,1. 59]) than conventional treatment alone. In addition,Babaodan Capsules combined with conventional treatment can delay the progression of liver fibrosis to some extent. Qualitative analysis showed that the combined treatment regimen was more effective in relieving clinical symptoms. There was no significant difference between the two regimens in increasing albumin and prothrombin activity. Babaodan Capsules combined with conventional treatment showed no adverse reactions. In summary,for patients with viral hepatitis,the combination of Babaodan Capsules and conventional treatment has more advantages in reducing total bilirubin,alanine aminotransferase and total bile acid and is more effective in improving clinical symptoms as compared with conventional Western medicine,with no serious adverse reactions. Its clinical application with syndrome differentiation method can be considered. However,due to the limited number and quality of the original researches,more multi-center,high-quality randomized controlled trials are needed for further verification.

Babaodan Capsule () combined with Qingyi Huaji Formula () in advanced pancreatic cancer-a feasibility study.

OBJECTIVE: To observe the clinical effects of Babaodan Capsule (, BBD) combined with Qingyi Huaji Formula (, QYHJ) in treating patients with advanced pancreatic cancer. METHODS: Eighty-one patients with advanced pancreatic cancer (from January 1, 2013 to December 31, 2014) were enrolled. Patients were assigned to two groups: QYHJ plus BBD group (40 cases) and QYHJ only group (41 cases), and there were no significant differences for other treatment between two groups. The survival and cancer-related symptoms were compared between two groups over two cycles of treatment. RESULTS: The cancer-related symptoms of patients such as ascites, jaundice, pain, abdominal distension, anorexia and Karnofsky performance status of QYHJ plus BBD group were significantly improved as compared with those of the QYHJ group (P<0.01). In addition, the 1-year survival rate of patients in QYHJ plus BBD group was longer than that in the QYHJ group (65% vs. 33%, respectively, P=0.0023). CONCLUSIONS: BBD with QYHJ is feasible treatment to prolong the survival of patients with advanced pancreatic cancer. However, it deserves to be further investigated in randomized clinical trials.

Clinical effect of Babaodan capsules combined with transcatheter arterial chemoembolization therapy in patients with primary hepatocellular carcinoma / 肿瘤研究与临床

Objective To evaluate the effect of Babaodan capsules combined with transcatheter arterial chemoembolization (TACE) therapy in patients with BCLC stage B primary hepatocellular carcinoma (HCC). Methods A total of 32 patients with BCLC B primary hepatocellular carcinoma who cannot be treated with operation in the Department of Oncology in Fujian Province Cancer Hospital from May 2010 to March 2013 were enrolled in the experimental group. According to paired design, 64 patients with BCLC B primary liver cancer who were treated with only TACE were as control. The patients of experimental group were treated with Babaodan capsules combined with TACE, and the patients of control group were treated with only TACE. Overall response rate (ORR), time to progression (TTP), overall survival (OS), liver function change 1 week after TACE, and post-embolization syndromes were analyzed. Measurement data were compared using t test, count data were compared with χ2test. Kaplan-Meier method was used for survival analysis, and Log-rank method for testing. Results The ORR 1.5 month after TACE was 75.0%in experimental group and 81.3%in control group(P=0.477). The median TTP was 8.9 months(95%CI 3.1-14.7 months) in experimental group, and 5.5 months (95%CI 4.3-6.7 months) in control group (P=0.048). The median OS time was 16 months(95%CI 8.0-24.0 months) in experimental group, and 12 months(95%CI 11.0-13.0 months) in control group (P=0.159). Compared with the experimental group, the alanine transaminase 1 week after TACE in control group increased obviously (P=0.018). The incidence rate of ≥CTCAE grade 2 pain after the first time TACE in experimental group was lower than that in control group(P=0.019). Conclusion Babaodan capsules could reduce pain of HCC patients after TACE, improve liver damage after TACE,and prolong the TTP of patients with BCLC stage B HCC.

Clinical effect of Babaodan capsules combined with transcatheter arterial chemoembolization therapy in patients with primary hepatocellular carcinoma / 肿瘤研究与临床

Objective To evaluate the effect of Babaodan capsules combined with transcatheter arterial chemoembolization (TACE) therapy in patients with BCLC stage B primary hepatocellular carcinoma (HCC). Methods A total of 32 patients with BCLC B primary hepatocellular carcinoma who cannot be treated with operation in the Department of Oncology in Fujian Province Cancer Hospital from May 2010 to March 2013 were enrolled in the experimental group. According to paired design, 64 patients with BCLC B primary liver cancer who were treated with only TACE were as control. The patients of experimental group were treated with Babaodan capsules combined with TACE, and the patients of control group were treated with only TACE. Overall response rate (ORR), time to progression (TTP), overall survival (OS), liver function change 1 week after TACE, and post-embolization syndromes were analyzed. Measurement data were compared using t test, count data were compared with χ2test. Kaplan-Meier method was used for survival analysis, and Log-rank method for testing. Results The ORR 1.5 month after TACE was 75.0%in experimental group and 81.3%in control group(P=0.477). The median TTP was 8.9 months(95%CI 3.1-14.7 months) in experimental group, and 5.5 months (95%CI 4.3-6.7 months) in control group (P=0.048). The median OS time was 16 months(95%CI 8.0-24.0 months) in experimental group, and 12 months(95%CI 11.0-13.0 months) in control group (P=0.159). Compared with the experimental group, the alanine transaminase 1 week after TACE in control group increased obviously (P=0.018). The incidence rate of ≥CTCAE grade 2 pain after the first time TACE in experimental group was lower than that in control group(P=0.019). Conclusion Babaodan capsules could reduce pain of HCC patients after TACE, improve liver damage after TACE,and prolong the TTP of patients with BCLC stage B HCC.

Babaodan Capsule () combined with Qingyi Huaji Formula () in advanced pancreatic cancer-a feasibility study / 中国结合医学杂志

<p><b>OBJECTIVE</b>To observe the clinical effects of Babaodan Capsule (, BBD) combined with Qingyi Huaji Formula (, QYHJ) in treating patients with advanced pancreatic cancer.</p><p><b>METHODS</b>Eighty-one patients with advanced pancreatic cancer (from January 1, 2013 to December 31, 2014) were enrolled. Patients were assigned to two groups: QYHJ plus BBD group (40 cases) and QYHJ only group (41 cases), and there were no significant differences for other treatment between two groups. The survival and cancer-related symptoms were compared between two groups over two cycles of treatment.</p><p><b>RESULTS</b>The cancer-related symptoms of patients such as ascites, jaundice, pain, abdominal distension, anorexia and Karnofsky performance status of QYHJ plus BBD group were significantly improved as compared with those of the QYHJ group (P<0.01). In addition, the 1-year survival rate of patients in QYHJ plus BBD group was longer than that in the QYHJ group (65% vs. 33%, respectively, P=0.0023).</p><p><b>CONCLUSIONS</b>BBD with QYHJ is feasible treatment to prolong the survival of patients with advanced pancreatic cancer. However, it deserves to be further investigated in randomized clinical trials.</p>