Clinical efficacy of entecavir combined with Biejiajian pills and its influence on TCM syndrome scores during the treatment of chronic hepatitis B with hepatic fibrosis and blood stasis syndrome / 中华肝脏病杂志

Objective: To investigate the clinical efficacy of entecavir combined with Biejiajian pills and its influence on TCM syndrome scores during the treatment of chronic hepatitis B with hepatic fibrosis and blood stasis syndrome by prospective, randomized and controlled study. Methods: Patients with chronic hepatitis B with hepatic fibrosis and blood stasis syndrome were selected as the research subjects and randomly divided into a treatment group and a control group. Entecavir plus Biejiajian pills or entecavir plus a simulant of Biejiajian pills were given for 48 weeks. The changes in liver stiffness measurement (LSM) and TCM syndrome scores before and after treatment were compared between the two groups to analyze the correlation. The data between groups were analyzed by t-test/Wilcoxon rank sum test or χ(2) test. Pearson correlation coefficient was used to analyze the correlation between TCM syndrome scores and LSM values. Results: After 48 weeks of treatment, the LSM values of the two groups were significantly lower than those of the baseline (P < 0.001), liver fibrosis was significantly improved, and the LSM values of the treatment group were lower than those of the control group [(8.67 ± 4.60) kPa and (10.13 ± 4.43) kPa, t = -2.011, P = 0.049]. After 48 weeks of treatment, the TCM syndrome scores of the two groups were significantly reduced compared with the baseline (P < 0.001), and the clinical symptoms were significantly relieved, and the total effective rates of the improvement of the TCM syndrome scores in the two groups were 74.19% and 72.97%, respectively, but the differences between the groups were not statistically significant (χ(2) = 0.013, P = 0.910). Correlation analysis showed that there was no obvious trend between TCM syndrome scores and LSM values. There were no serious adverse reactions associated with the drug during the observation period of this study. Conclusion: Based on antiviral treatment with entecavir, regardless of whether it is combined with the Biejiajian pill, it can effectively reduce the LSM value, improve liver fibrosis, reduce TCM syndrome scores, and alleviate symptoms in patients with chronic hepatitis B with liver fibrosis and blood stasis syndrome. Compared with entecavir alone, the combined Biejia pill has greater efficacy in improving liver fibrosis and a favorable safety profile, meriting its implementation and widespread application.

Expert consensus statement on Hugan Tablets in clinical practice / 中国中药杂志

Hugan Tablets is a Chinese patent medicine,it has the function of anti-inflammation and reducing transaminase. Based on questionnaire investigation of doctors and a systematic review of research literature on Hugan Tablets,using international clinical practice guidelines' developing methods,with the best available evidence and fully combining expert experience,and following the principle of " evidence-based,consensus-based and experience-based",Expert consensus statement on Hugan Tablets in clinical practice was developed by more than 30 multidisciplinary experts from the nationwide,aimed at guiding and standardizing the rational use of Hugan Tablets by clinicians and to improve clinical efficacy and safety. The expert consensus adopts internationally recognized recommendation criteria for classification of evidence: GRADE. The formation of expert consensus adopts the nominal group technique. Six main considerations are quality of evidence,curative effect,safety,economical efficiency,patient acceptability and other factors. If there is sufficient evidence,a " recommendation" is formed,using GRADE grid voting rule. If there isn' t sufficient evidence,a " consensus opinion" is formed,using majority counting rule. Focus on the indication,usage and dosage,drug use in special population and safety of Hugan Tablets,two recommendations and eight consensus opinions were put forward. Through expert meetings and correspondence,a nationwide consultation and peer review was conducted. This consensus applies to clinicians in hospitals and grass-roots health services,to provide guidance and reference for the rational use of Hugan Tablets.

Efficacy and safety of integrative medical program based on blood cooling and detoxification recipe in treating patients with hepatitis B virus related acute-on-chronic liver failure: a randomized controlled clinical study / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe (BCDR) in treating patients with hepatitis B virus related acute-on-chronic liver failure (HBV-ACLF) of heat-toxicity accumulation syndrome (HTAS).</p><p><b>METHODS</b>Adopting randomized controlled clinical design, a total of 105 HBV-ACLF patients of HTAS were randomly assigned to the trial group (64 cases) and the control group (41 cases). Patients in the control group were treated with comprehensive Western therapy, while those in the trial group were treated with comprehensive Western therapy plus BCDR. All were treated for 8 weeks and followed up for 40 weeks. Effect and safety of the treatment were assessed, including fatality, liver functions [total bilirubin (TBIL), albumin (ALB), alanine aminotransferase (ALT), and aspartate transaminase (AST)], and prothrombin activity (PTA) after treatment and at week 48 of follow-ups.</p><p><b>RESULTS</b>After 8-week treatment, there was statistical difference in the overall fatality rate (15.63% vs 34.15%), the fatality rate in the mid-term (25.0% vs 64.7%), TBIL at week 8 (64.54 +/- 79.75), AST [at week 2: (178.97 +/- 44.24) U/L vs (288.48 +/- 58.49) U/L; at week 4: (61.65 +/- 27.36) U/L vs (171.12 +/- 89.11) U/L] and PTA [at week 4: (58.30 +/- 15.29) vs (42.56 +/- 15.27); at week 6: (60.77 +/- 20.40) vs (43.08 +/- 12.79)] (all P < 0.05). At week 48 of the followup, the fatality rate of the trial group (21.88%) decreased by 17. 14% when compared with that of the control group (39.02%; P < 0.05). No obvious adverse event occurred in the two groups during the 8-week treatment period.</p><p><b>CONCLUSION</b>BCDR could significantly reduce the mortality of HBV-ACLF patients.</p>

Multi-centered, randomized controlled clinical study on Chinese medicine formula particles for hyperlipidaemia associated with highly active antiretroviral therapy / 中国中药杂志

<p><b>OBJECTIVE</b>To observe the effect and safety of Xiaozhi particles, integrated taohong Siwu tang and Erchen tang and Xuezhikang capsule in treating hyperlipidaemia (HLP) associated with highly active antiretroviral therapy (HAART).</p><p><b>METHOD</b>In the multi-centered, randomized controlled clinical study, 180 hyperlipidaemia associated with highly active antiretroviral therapy cases were divided into the treatment group treated by Xiaozhi particles, integrated Taohong Siwu tang and Erchen tang, and the control group treated by Xuezhikang capsule. The treatment course was 12 weeks. The total cholesterol (Tch), triglyceride (TG), low density lipoprotein (LDL) and high-density lipoprotein(HDL) were observed.</p><p><b>RESULT</b>After 12 weeks, compared with Xuezhikang capsule, the change difference of Tch, LDL, HDL in the Chinese traditional medicine formula groups of patients is significant (P < 0.05), the change of the TG has no significant difference. The effect of Tch, LDL in Xuezhikang capsule groups is better than in traditional Chinese medicine formula group,but the effect of HDL in traditional Chinese medicine formula group is better than in Xuezhikang capsule groups.</p><p><b>CONCLUSION</b>Integrated Taohong Siwu tang and Erchen tang, Xiaozhi particles and Xuezhikang capsule can be used to control the hyperlipidaemia associated with highly active antiretroviral therapy as one of the main Chinese native medicine preparation.</p>

Study of traditional Chinese medicine syndrome features of AIDS-related chronic diarrhea / 中国中药杂志

<p><b>OBJECTIVE</b>To study the AIDS-related chronic diarrhea in traditional Chinese medicine (TCM) clinical manifestations and syndrome factors, explore the characteristics of syndrome.</p><p><b>METHOD</b>A multicenter, prospective collection of 311 cases of AIDS patients with chronic diarrhea, study the characteristics of TCM syndrome by using the method of descriptive statistics and exploratory factor analysis.</p><p><b>RESULT</b>The common clinical manifestation of TCM: fatigue (229 cases, 73.63%), bowel (229 cases, 68.81%), diarrhea (194 cases, 62.38%), thin fur (201 cases, 64.63%), pink tongue (166 cases, 53.38%), greasy fur, thready pulse (126 cases, 40.51%), sink vein (64 cases, 20.58%), slippery pulse. 17 common factors were extracted, common disease syndrome factor as the spleen, stomach, liver, gallbladder and colon syndrome factors of disease, Qi, Yang deficiency, Qi stagnation, dampness and heat evil.</p><p><b>CONCLUSION</b>AIDS-related chronic diarrhea symptoms involving multiple organs, the disease belongs to deficiency and excess.</p>

Clinical feature and treatment of 69 Chinese children patients infected with influenza A (H1N1) / 中华儿科杂志

<p><b>OBJECTIVE</b>During the 2009 influenza A (H1N1) epidemic in China, children are the main group among people infected with influenza A (H1N1) virus, but few reports about children are available. The present study aimed to observe the clinical, laboratory features and to analyze therapeutic result.</p><p><b>METHOD</b>The research subject were 93 children infected with influenza A (H1N1), 59 male and 34 female who were treated in Beijing Ditan Hospital from 15 May 2009 to 10 September 2009. The patients' data on symptoms, signs, chest X-ray, blood routine test, erythrocyte sedimentation rate (ESR), C reactive protein (CRP), liver function, renal function, helper T lymphocyte were collected and analyzed. The patients were treated with Oseltamivir, traditional Chinese medicine and symptomatic treatment.</p><p><b>RESULT</b>The main symptoms of children infected with influenza A (H1N1) are fever (84 cases, 90.3%), cough (62 cases, 66.7%), pharyngodynia (36 cases, 38.7%) and expectoration (19 cases, 20.4%) at onset, and fever (59 cases, 63.4%), cough (52 cases, 55.9%), pharyngodynia (23 cases, 24.7%) and expectoration (9 cases, 9.7%) were the mojor symptoms and signs while the patients visited our hospital. The main signs were fervescence, pharyngeal congestion (53 cases, 57.0%), tonsilar swelling (21 cases, 22.6%), and abnormal white blood count (WBC) was found in 32 cases, abnormal ESR in 10 cases, abnormal CRP in 10 cases, abnormal CD4 T lymphocyte count in 19 cases, abnormal liver function and renal function were found in very few patients. After treatment, the febrile duration and time to virus negative in patients treated with oseltamivir alone, traditional Chinese medicine alone, combined oseltamivir and traditional Chinese medicine as well as those who were neither treated with oseltamivir nor traditional Chinese medicine were respectively 1 - 6 days (median 1 day), 3 - 13 days (median 7 days), 1 - 6 days (median 1.5 days), 4 - 11 days (median 8 days), 1 - 5 days (median 1 days), 5 - 14 days (median 8 days), 1 - 5 days (median 2 days), 4 - 13 days (median 8 days).</p><p><b>CONCLUSION</b>Clinical manifestations of 93 children cases were the same as those of adults. The traditional Chinese medicine could improve symptoms of children infected with influenza A (H1N1), but other clinical therapeutic effects need further study.</p>

Exploration on relationship between TCM syndrome type and expression of human leucocyte antigen locus-DRB1 in patients with chronic hepatitis B / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study the relationship between TCM syndrome type and expression of human leucocyte antigen-DRB1 (HLA-DRB1) in patients with chronic hepatitis B.</p><p><b>METHODS</b>Using PCR method to amplify the related segments of DNA extracted from peripheral leucocytes by the routine methods, and gene array analysis was performed to detect the expression of HLA-DRB1.</p><p><b>RESULTS</b>HLA-DRB1 * 13 was expressed in healthy person in the control group, but was not expressed in chronic hepatitis B patients, showing significant difference between the two groups. In the patients with five different syndrome types, i.e. the dampness blocking middle-jiao type (A), the Gan-stagnancy with Pi-deficiency type (B), the blood stasis blocking collaterals type (C), the Gan-Shen yin-deficiency type (D) and the Pi-Shen yang-deficiency type (E), the former three belonged to the excessive syndrome and the latter two were deficient syndrome. Most of the CHB patients were differentiated as excessive syndrome.</p><p><b>CONCLUSION</b>Difference of HLA-DR expression exists between chronic hepatitis B patients and healthy persons, the action of the difference is remained for further confirmation. HLA-DR expression in patients with different syndrome types, excessive or deficient, might be different, too.</p>

An analysis of the relationship between HBV DNA and HBeAg expression and mortality in 799 severe hepatitis patients / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To evaluate the relationship between mortality and HBVDNA and HBeAg expression of severe hepatitis B patients.</p><p><b>METHODS</b>The mortality rates of different types of severe hepatitis patients in our hospital during the last five years were analysed. HBV DNA was detected using the fluorescence quantitative PCR method and the HBeAg expression of severe hepatitis B was studied using a microparticle method.</p><p><b>RESULTS</b>(1) Hepatitis B morbidity was 83.5% in each type of severe hepatitis, and severe chronic hepatitis B morbidity was 96.77% in each type of severe chronic hepatitis. (2) The mortality rate of those with HBV DNA more than 1 x 10(5) copies/ml was 53.25% and the mortality of those with HBV DNA less than 1 x 10(5) copies/ml was 34.50% (P less than 0.01). The HBeAg expression had no influence on the death rate. (3) The death rate descended to 30.38% from 54.64% (HBV DNA more than 1 x 10(5) copies/ml) when treated with Lamivudine (P less than 0.01).</p><p><b>CONCLUSION</b>In severe hepatitis the quantity of virus carried in the patient is one of the key factors of mortality; antivirus treatment can lower mortality.</p>