Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial / 中国结合医学杂志

<p><b>BACKGROUND</b>The domestic prevalence of chronic hepatitis B (CHB) in China is 7.18% in 2006, imposing great societal healthcare burdens. Nucleot(s)ide analogues (NUCs) anti-hepatitis B virus (HBV) therapies are widely applied despite the relatively low rate of seroconversion and high risk of drug-resistant mutation. More effective treatments for CHB deserve further explorations. Combined therapy of NUCs plus Chinese herbal medicine (CHM) is widely accepted in China, which is recognized as a prospective alternative approach. The study was primarily designed to confirm the hypothesis that Tiaogan-Yipi Granule (, TGYP) or Tiaogan-Jianpi-Jiedu Granule (, TGJPJD) plus entecavir tablet (ETV) was superior over ETV monotherapy in enhancing HBeAg loss rate.</p><p><b>METHODS</b>The study was a nationwide, large-scale, multi-center, double-blind, randomized, placebo-controlled trial with a designed duration of 108 weeks. A total of 16 hospitals and 596 eligible Chinese HBeAg positive CHB patients were enrolled from November 2012 to September 2013 and randomly allocated into 2 groups in 1:1 ratio via central randomization system: experimental group (EG) and control group (CG). Subjects in EG received CM formulae (TGYP or TGJPJD, 50 g per dose, twice daily) plus ETV tablet (or ETV placebo) 0.5 mg per day in the first 24 weeks (stage 1), and CHM granule plus ETV tablet (0.5 mg per day) from week 25 to 108 (stage 2). Subjects in CG received CHM Granule placebo plus ETV tablet (0.5 mg per day) for 108 weeks throughout the trial. The assessments of primary outcomes (HBV serum markers and HBV-DNA) were conducted by a third-party College of American Pathologists (CAP) qualified laboratory. Adverse effects were observed in the hospitals of recruitment.</p><p><b>DISCUSSION</b>The study was designed to compare the curative effect of CM plus ETV and ETV monotherapy in respect of HBeAg loss, which is recognized by the European Association for the Study of the Liver as "a valuable endpoint". We believe this trial could provide a reliable status for patients' "journey" towards durable responses after treatment discontinuation. The trial was registered before recruitment on Chinese Clinical trial registry (No. ChiCTR-TRC-12002784, Version 1.0, 2015/12/23).</p>

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>

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>