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The aim of the present study was to compare the effectiveness of transarterial chemoembolization (TACE), TACE combined with Jie-du granules (JD), and TACE combined with sorafenib (SOR) for treating patients with unresectable hepatocellular carcinoma (HCC). For this purpose, we conducted a retrospective analysis of data from 266 consecutive patients with unresectable HCC who underwent TACE treatment at the Shanghai Hospital and Eastern Hepatic Surgery Hospital between Jan 2009 and Dec 2010. We prospectively analyzed patient survival and progression times as well as independent predictors, within a follow-up period of 86 months. Patients were divided into TACE-JD (n = 75), TACE-SOR (n = 124) and TACE (n = 67) groups. Median overall survival (OS) times being: TACE-JD, 21.43 months; TACE-SOR, 23.23 months; TACE, 13.97 months (TACE-SOR vs TACE, P < 0.001; TACE-SOR vs TACE-JD, P = 0.852; TACE-JD vs TACE, P < 0.001). The median times to progression (TTP) were as follows: TACE-JD, 8.67 months; TACE-SOR, 5.37 months; TACE, 4.57 months (TACE-SOR vs TACE, P = 0.479; TACE-SOR vs TACE-JD, P < 0.001; TACE-JD vs TACE, P < 0.001). Independent predictors of OS were treatment allocation, Child-Pugh class large tumor, albumin and extrahepatic metastasis. These findings show that patients with unresectable HCC who were administered TACE-JD survived significantly longer compared with those administered TACE or TACE-SOR.

// L.Y. Chen 1 , X.F. Zhai 1,* , Z. Chen 1 , J.F. Zhu 2 , P.A. Qian 2 , H.T. Zhao 1 and C.Q. Ling 1 1 Department of Traditional Chinese Medicine, Changhai Hospital, Second Military Medical University, Shanghai, China 2 Department of Liver Disease, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China * These authors have contributted equally to this work Correspondence to: C.Q. Ling, email: // Keywords : hepatocellular carcinoma, Jie-du granule, best supportive treatment, retrospective cohort study Received : July 28, 2016 Accepted : October 19, 2016 Published : October 25, 2016 Abstract Objective: To compare the clinical efficacy of Jie-du granule preparation versus best supportive treatment in patients with advanced hepatocellular carcinoma. Methods: A retrospective cohort study was carried out in patients with advanced liver cancer. Patients were divided into Jie-du granule treatment (JD) and best supportive treatment (BST) groups. The main outcomes included median overall survival time. Results: A total of 177 patients with Barcelona Clinic Liver Cancer stage C receiving JD granule treatment or BST were enrolled between January 2012 and December 2014. The overall median survival time was 6.2 months (95% confidence interval [CI] 4.546-7.854) in the JD group versus 4 months (95% CI 3.471-4.529) in the BST group. Significant independent risk factors were alpha-fetoprotein ( P = 0.048), Child-Pugh class ( P = 0.005), vascular invasion ( P = 0.003), and extrahepatic metastasis ( P = 0.0018). For patients with two or fewer of these independent risk factors, the overall median survival of those treated with JD was significantly longer than that of patients receiving BST ( P < 0.05). Conclusion: Jie-du granule preparation may prolong survival of patients with advanced HCC.

Recombinant adeno-associated virus (rAAV) serotype 2, 3 and 8 vectors are the most promising liver-tropic AAV serotype vectors. Liver diseases are significant problems in China. However, to date, few studies on AAV neutralizing antibodies (Nabs) were working with the Chinese population or with the rAAV3 vectors. The present study aimed to determine the prevalence of Nabs in Chinese population against wild-type AAV2, AAV3 and AAV8 capsids as well as additional two AAV3 variants. In addition, we performed a preliminary analysis to investigate the potential influence of traditional Chinese medicine body constitutions on AAV Nabs. Our work demonstrated that the majority of healthy Chinese subjects were positive for AAV Nabs, with the order of AAV2>AAV3=AAVLK03>AAV8. There was no difference between: 1) AAV3 and its variants; 2) male and female subjects; and 3) different age cohorts (≤35, 36-50, and ≥51 years old). People in the Qi-deficiency constitution had significantly increased AAV8 Nabs than people in the Gentleness constitution. Our studies may have impact on the future clinical design of AAV-based gene therapy in the Chinese population.

To explore the clinical efficacy of traditional herbal medicine (THM) in the prevention of disease recurrence of small hepatocellular carcinoma after surgery, a prospective randomized controlled study was conducted between October 2006 and May 2010. The results indicated that THM prevented the recurrence of SHCC with an efficacy that was superior to that of transarterial chemoembolization (TACE) during a median follow-up of 26.61 months.The patients were followed up every 6 months, and the clinical data before October 20, 2015 were analyzed. The primary outcome measure was recurrence-free survival (RFS), and the secondary outcome measure was overall survival (OS).The 364 patients included 180 in the THM group and 184 in the TACE group. At the time of the data cutoff of October 20, 2015, a total of 205 patients demonstrated disease recurrence, including 85 patients in the THM group and 120 patients in the TACE group. The median RFS of the THM and TACE groups demonstrated a statistically significant difference (P.001). Until October 20, 2105, there were 91 deaths, including 34 in the THM group and 57 in the TACE group. The median OS demonstrated a significant difference between the 2 groups (P = .008). Multivariate analysis indicated that THM was an independent factor influencing RFS and OS.The efficacy of THM was found to be superior to that of TACE in preventing disease recurrence in patients with small hepatocellular carcinoma and prolonging OS. Cancer 2018;124:2161-8. © 2018 American Cancer Society.

Objective The aim of this study is to analyze how patients with chronic diseases from Shanghai interpret their disease, and how these interpretations influence patients' life satisfaction, intention to escape from their illness and their ability to reflect on the implications of their illness. Methods A cross-sectional study enrolling 142 patients (mean age (50 ± 16) years; 63% men, 37% women) with chronic diseases (60% cancer) was recruited in the Changhai Hospital of Traditional Chinese Medicine, Shanghai, China and surveyed using standardized questionnaires. Results Patients with chronic diseases from Shanghai interpreted their illness mostly as an Adverse Interruption of Life (55%), as a Threat/Enemy (50%), but also as a Challenge (49%), and only rarely as a Call for Help (18%) or as a Punishment (13%). Particularly fatalistic negative ( i.e. , Threat/Enemy, Adverse Interruption of Life) and strategy-associated disease interpretations ( i.e. , Relieving Break, Call for Help) were moderately associated with patients' intention to escape from illness. In contrast, positive interpretations ( i.e. , something of Value, Challenge) and also the guilt-associated negative interpretation Failure were moderately related with patients' ability to reflect on their illness. However, life satisfaction was weakly associated only with the view that illness might be a Challenge. Interestingly, 58% of those who would see their illness as an Adverse Interruption (AI+) could see it also as a Challenge (Ch+). Detailed analyses showed that AI+Ch+ patients differ from their AI+Ch– counterparts significantly with respect to their ability to reflect life and implications of illness ( F =9.1; P =0.004). Conclusion The observed interpretations of illness, particularly the negative perceptions, could be used as indicators that patients require further psychological assistance to cope with their burden. Helping AI+ patients see their illness also as a Challenge, and thus develop a higher Reflection on Life Concerns, would be greatly beneficial, and encourages further research.

OBJECTIVE To study the traditional Chinese medicine (TCM) syndrome distribution in patients with hepatitis B virus (HBV) infection in Qidong region of Jiangsu Province, China. METHODS A cross-sectional survey was performed. Subjects from Qidong of Jiangsu Province of China were screened among the locally enrolled residents by detecting hepatitis B surface antigen (HBsAg) from May 2007 to May 2011 and were assigned to HBsAg-negative cohort or HBsAg-positive cohort. Then, the subjects were diagnosed according to alanine aminotransferase, alpha-fetoprotein and B ultrasound. The syndrome of the subjects was determined using a TCM questionnaire consisting of signs and symptoms. RESULTS A total of 5 908 subjects were enrolled in this survey, among whom, 4 718 were diagnosed with HbsAg infection (positive result of HbsAg detection) and 1 147 were negative. 143 subjects were excluded for not receiving the blood examination. The final diagnoses of the subjects were non-HBV infection (n=1128), HBV carrier (n=4019), chronic hepatitis B (n=225), posthepatitic cirrhosis (n=263) or liver cancer (n=111). The TCM syndrome differentiation results showed that there were differences in syndrome distribution between HBV-infected and non-HBV-infected patients. The main syndromes of the HBV-infected patients were qi deficiency, qi stagnation, blood stasis and dampness heat, related to the Zang of liver and spleen. The distribution principles of TCM syndrome among patients of HBV carrier, chronic hepatitis B and cirrhosis were similar. Moreover, with the progression of the patients' condition, the scores of syndromes increased, and the number of accompanying syndromes increased as well. The main syndromes of patients with liver cancer were blood stasis and excess heat, which was slightly different from that of the other HBV-infected patients. CONCLUSION The TCM syndrome distribution in patients of HBV infection in Qidong region of Jiangsu Province shows regularity. The disorder is mainly due to qi stagnation and blood stasis and is also related to deficiency of healthy qi, especially deficiency of spleen qi.

Objective To explore the correlation between the width of lingual varix and changes of hemodynamics of portal system in patients with primary liver cancer so as to supply the data for the forecast of portal hypertension by observing lingual varix. Methods The diameter of lingual vein (Dlv) was measured by vernier caliper as dependent variable, and the diameters and indexes of hemodynamics of portal vessels were measured by Doppler as independent variables, then a multipe stepwise analysis was performed. Results The diameters of portal vein (Dpv) and splenic vein (Dsv) entered the formula Dlv (mm) = 0.185 + 0.311 Dsv (mm) + 0.236 Dpv (mm) when the entry and removal values were alpha(in)=0.10 and alpha(out)=0.15, respectively. Conclusion The width of lingual vein is closely correlated with the diameters of portal vein and splenic vein in patients with primary liver cancer.

Even in secular societies, a small portion of patients find their spirituality to help cope with illness. But for the majority of patients, psychosocial and spiritual needs are neither addressed nor even considered a relevant factor by health care professionals. To measure such specific needs, the Spiritual Needs Questionnaire (SpNQ) was developed. The aim of this study was to validate the Chinese version of the SpNQ (SpNQ-Ch) and thus to measure psychosocial and spiritual needs of Chinese patients.This was a cross-sectional study among 168 patients with chronic diseases who were recruited in the Changhai Hospital of Traditional Chinese Medicine, Shanghai, China using standardized questionnaires. We performed reliability and factor analyses, as well as analyses of variance, first order correlations and regression analyses.The 17-item SpNQ-Ch had a similar factorial structure as the original version with two main and three minor factors which accounted for 64% of variance, and internal consistency estimates (Cronbach's α) ranging from 0.51 to 0.81. Included were the 4-item scale Inner Peace Needs, the 5-item scale Giving/Generativity Needs, the 5-item scale Religious Needs (with 2 sub-constructs, Praying and Sources), and a 3-item scale Reflection/Release Needs. In Chinese patients with cancer (63%), pain affections (10%), or other chronic conditions (23%), the needs for Giving/Generativity (which refer to categories of Connectedness and Meaning) and Inner Peace Needs scored highest, while Religious Needs and the Reflection/Release Needs scored lower.The SpNQ-Ch is congruent with its primary version, and can be used in future studies with the mostly nonreligious patients from China. First findings indicate specific psychosocial and spiritual needs which should be addressed by health care professionals to support patients in their struggle with chronic illness in terms of psycho-emotional stabilization, finding hope and meaning, and thus achieving peaceful states of mind despite chronic illness.

The present study was undertaken to investigate the anti-inflammatory and analgesic activity of total flavone of branches and leaves of Cunninghamia lanceolata (TFC) to provide a scientific basis for its clinical use and resource development. TFC was evaluated for anti-inflammatory and analgesic activity in mice or rats using chemical and thermal models of nociception, including acetic acid-induced writhing test, hot plate latency test, formalin test and carrageenan induced paw oedema test. Results showed that TFC given orally can significantly attenuate acetic acid-induced writhing in mice in a dose-dependent manner. In the hot plate latency test, TFC showed common activity in prolonging duration time only at the highest dose (400 mg/kg). Each dose of TFC could not significantly inhibit the first phase but was active in the later phase of formalin-induced pain, whereas morphine showed notable activity in the two phases. In the carrageenan-induced paw oedema model, TFC could significantly and dose-dependently reduce the carrageenan-induced paw edema at the third and fifth hour, and decrease the content of PEG(2) in paw edema tissue and that of COX-2 in blood serum. It may be concluded that TFC showed both anti-inflammatory and analgesic effects, showing that it can be of importance in drug development, especially in the field of pain and inflammation.

To observe effects of cold- and hot-property herbs and effects of hot and cold constitutions on the tumor growth of tumor bearing rats, and to observe the effect of Cinobufacini Injection (CI) on the tumor growth of tumor bearing rats of different constitutions.Eighty healthy male Wistar rats were randomly divided into eight groups, i.e., the tumor bearing control group, the tumor bearing heat syndrome group, the tumor bearing cold syndrome group, the heat syndrome tumor bearing group, the cold syndrome tumor bearing group, the tumor bearing CI group, the heat syndrome tumor bearing CI group, and the cold syndrome tumor bearing CI group, respectively. The weight and volume of rats' subcutaneous tumor were measured 14 days after tumor inoculation.The weight and volume of tumor in the heat syndrome tumor bearing CI group [(3.55 +/- 1.12) g, (2864.44 +/- 1430.51) mm3] and the tumor bearing CI group [(4.29 +/- 1.14) g, (3397.19 +/- 1701.13) mm3] were significantly lower than those of the tumor bearing control group [(6.01 +/- 2.45) g, (6218.91 +/- 3837.64) mm3] and the cold syndrome tumor bearing CI group [(6.90 +/- 1.57) g, (6168.42 +/- 2457.03) mm3], showing statistical difference (P0.05). There was insignificant difference among other groups.CI showed better tumor inhibition effects on tumor bearing rats of heat syndrome constitution, which indicated CI was of cold property. It might be possibly used in tumor bearing rats of heat syndrome constitution.

To investigate the therapeutic effects of Jiedu granules, a Chinese medicine (CM) compound, plus cinobufacini injection, which was extracted from skin of Bufo bufo gargarizans Cantor, to prevent the recurrence of hepatocellular carcinoma (HCC) after surgical resection.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.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 (P0.01). 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).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.

Transarterial chemoembolization (TACE) is the most widely used primary treatment for unresectable hepatocellular carcinoma (HCC) due to its survival benefit, though its clinical effect is still far from satisfactory. Jiedufang (JDF) granule preparation is a commonly used Chinese herbal medicine formula for HCC. The aim of this study was to evaluate the effect of combined therapy with TACE and JDF granule preparation in treatment of unresectable HCC on survival.A retrospective study of TACE was performed in 165 patients with unresectable HCC who were admitted between January 2002 and December 2007 in Changhai Hospital, Shanghai, China. Of the 165 patients, 80 patients (study group) received combined therapy consisting of TACE and a long-term maintenance treatment with oral JDF granule preparation, and the remaining 85 patients (control group) received TACE alone. The survival rates of both groups were calculated by the Kaplan-Meier method. Factors possibly affecting survival were assessed by multivariate analysis in the Cox proportional hazard model, such as maximum tumor size, number of lesions, portal vein invasion, and etc.The median overall survival was 9.2 months (95% CI: 6.94 - 11.46) in the study group versus 5.87 months (95% CI: 4.21 - 7.52) in the control group. In the study group,survival rates of the 1-, 2- and 3-year follow-up were 41.2%, 18.4%, and 9.6%, respectively. Significant independent prognostic factors identified by the Cox regression analysis were as follows: serum hepatitis B surface antigen (HBsAg) (P = 0.014), maximum tumor size (P = 0.027), number of lesions (P0.001), portal vein invasion (P0.001), and the therapy model (P = 0.006).Combination therapy of TACE and JDF granule preparation may significantly prolong survival of patients with unresectable HCC.

OBJECTIVE To observe the effects of cinobufacini injection on serum levels of thyroid-stimulating hormone (TSH) and adrenaline (ADR) in rats, and to speculate the property (cold or heat) of the drug. METHODS Thirty-two male Wistar rats were randomly divided into normal control group, cinobufacini injection group, cold syndrome group and heat syndrome group. The rats in the four groups were administered with normal saline, cinobufacini injection, and compound of traditional Chinese drugs with heat or cold property. The weights, and the serum TSH and ADR levels of the rats were measured before and after the interventions. RESULTS The weights of the rats in heat syndrome group markedly decreased after 14-day administration when compared with the normal control group (P < 0.05). There were no significant differences among the normal control group, heat syndrome group and the cinobufacini injection group. Although no statistical difference was noted, the serum TSH levels of the cold syndrome group and cinobufacini injection group were slightly lower than that in the normal control group after 14-day administration, and the heat syndrome group showed a slightly higher serum TSH level. After administration, the serum ADR levels of the cold syndrome group and cinobufacini injection group were significantly lower than that in the normal control group (P < 0.05), and the serum ADR level in the heat syndrome group was higher than that in the normal control group (P < 0.05). CONCLUSION Cinobufacini injection seemed to be able to suppress the thyrotrophin-releasing hormone-TSH-thyroxine system and sympathetic nervous system, matching up with the characteristics of the Chinese herbs of cold property. And the study provided initial experiment evidence for the conclusion that the property of cinobufacini might be cold.

Objective To work out a qualitative diagnostic criterion for basic syndromes of traditional Chinese medicine in patients with primary liver cancer. Methods Based on the collection and analysis of related medical literature, clinical investigation, and experts' discussion, a preliminary qualitative diagnostic criterion for basic syndromes of traditional Chinese medicine in patients with primary liver cancer was formulated. Then it was used in clinic to be verified and revised repeatedly till it was improved to be a satisfied formal criterion. Results The basic syndromes listed in the qualitative diagnostic criterion for basic syndromes in patients with primary liver cancer consisted of two parts: excessive syndromes, including the syndromes of stagnation of qi, blood stasis, excess-heat and dampness, and deficient syndromes, including the syndromes of deficiency of qi, deficiency of blood, deficiency of yin and deficiency of yang. Each of the above syndromes could be diagnosed according to specific combination of its corresponding symptoms or signs. The clinical verification results showed that the total matching ratio was 73.92% between the diagnoses made according to the criterion and the diagnoses acquired from the experts' experience. Conclusions The qualitative diagnostic criterion for basic syndromes of traditional Chinese medicine in patients with primary liver cancer is coincident with the experts' clinical practice. However, it needs to be further studied.

ObjectiveTo observe the clinical effect of cinobuf ac ini injection in treating moderate and advanced primary liver cancer (PLC). WT HZMethodsOne hundred patients with moderate and advanced PLC were rando mly divided into cino-treated group (50 patients) and control group (50 patient s). The quality of life, tumor size, some changes of laboratory tests, and survi val time were observed. ResultsThe progressive rate of cino-trea ted group (18%) was lower than that of the control group (32%). The quality of l ife of the cino-treated group (80%) was better than that of the control group ( 72%), but witbout statistical significance. The survival rate of 12 months of t he cino-treated group (30%) was higher than that of the control group (18%). Th e patients’ liver function such as serum total bilirubin and ALT decreased obvi ously in the cino-treated group while increased a lot in the control group. The level of AFP increased after treatment with statistical significance in the con trol group while there was no statistical significance in the cino-treated grou p. ConclusionCinobufacini injection can not only inhibit the proli feration of cancer, but also protect liver function, improve quality of life and prolong survival time.

Introduction Glucocorticoid (GC) therapy is the main treatment for systemic lupus erythematosus (SLE). However, some patients are resistant to these agents. Abnormalities of glucocorticoid receptor (GR) seem to be related to steroid resistance. This study evaluated GRs in T lymphocytes and monocytes of SLE patients by flow cytometry (FCM) using a monoclonal antibody (mAb) and FITC-Dex probes. Methods Thirty-five patients with SLE before treatment and 27 age- and sex-matched normal controls were studied. Disease activity scores were determined before and after treatment and used to divide the patients into steroid-resistant (SR) and steroid-sensitive (SS) groups. GRs in T lymphocytes (CD3+) and monocytes (CD14+) were examined by FCM with GR-mAb and FITC-Dex probes before treatment. Peripheral blood mononuclear cells (PBMCs) were isolated for in vitro GCs sensitivity assays. The validity of FCM analysis of intracellular staining for GR with GR-mAb and FITC-Dex probes was evaluated through comparison with western blot and radioligand binding assay (RLBA) in U937 and K562 cells in vitro. One-way ANOVA, student's t test, linear regression and spearman correlation were performed. Results A significant decrease in GR binding and the expression in K562 and U937 cells with 10-6 M dexamethasone (Dex) was found compared with those without Dex. In addition, a positive correlation was found between FCM and RLBA as well as FCM and Western blot. The expression and binding of both CD3/GR and CD14/GR in SR patients with SLE, detected by FCM, were all lower than those in SS patients with SLE, whereas there was no significant difference in SS patients and controls. In vitro corticosteroid sensitivity assay indicated that PHA-stimulated tumour necrosis factor-α (TNF-α), IL-12 and interferon-γ (IFN-γ) secretion was significantly inhibited by 10-6 M Dexamethasone in all controls and SS patients, compared with that in SR group, which confirms patient classification as SR and SS by disease activity index (SLEDAI) score. Conclusions Abnormalities of expression and binding of the GR may be involved in tissue resistance to steroids in SLE patients. Determination of GR expression and binding by FCM may be useful in predicting the response to steroid treatment of SLE patients. Trial registration Clinical trial registration number NCT00600652.