Summary Background Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant ...hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial. Methods Healthy adults aged 16–65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 μg of purified recombinant hepatitis E antigen adsorbed to 0·8 mg aluminium hydroxide suspended in 0·5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov , number NCT01014845. Findings 11 165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56 302) or placebo (n=56 302). 48 693 (86%) participants in the vaccine group and 48 663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100·0% (95% CI 72·1–100·0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted. Interpretation HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16–65 years. Funding Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars.
Abstract Background and aim The open abdomen (OA) is associated with significant morbidity and mortality, and its management poses a formidable challenge. Inability to achieve primary closure of the ...abdominal wall is one of the most severe complications of this technique. Factors influencing primary fascial closure, however, are unknown. This study aims to explore the influence of fluid volume overload on the application of vacuum-assisted and mesh-mediated fascial traction (VAWCM) in OA treatment. Methods A review of patients undergoing OA management using VAWCM technique from January 2006 to November 2011 was performed. Patients with aged <18 y OA treatment for fewer than 5 d and abdominal wall hernia before OA treatment were excluded. Results Average age was 45 ± 10.1 y and average OA treatment time was 31 ± 6.8 d. The complete fascial closure rate was 60%. The overall mean bodyweight-based fluid overload was 7.2 kg (range: −8.0 to +21.6 kg), representing a mean percent weight gain of 11.5% (range: −9.5% to +27%). Patients with fluid-related weight gain ≥10% had a lower primary facial closure rate than those with <10% (39% versus 77%). And primary facial closure rate seems to further decrease with fluid-related weight gain ≥20%, suggesting a dose-response effect of progressive fluid accumulation. Conclusions The VAWCM method provided a high primary fascial closure rate after long-term treatment of OA. Fluid volume overload negatively influences delayed primary facial closure. Judicious intravenous fluid resuscitation should be advocated in the therapy of critically ill patients.
To explore the clinical value of uterine artery embolization (UAE) combined with methotrexate in the treatment of cesarean scar pregnancy (CSP) before and after uterine curettage.
From August 2009 to ...April 2012, 15 patients with CSP treated with UAE (before or after uterine curettage) were analyzed retrospectively. Eleven subjects with a definite diagnosis of CSP were offered preventive UAE combined with methotrexate before uterine curettage. The other four patients, who were misdiagnosed as having an intrauterine pregnancy, were treated with emergency UAE for uncontrollable massive hemorrhage after uterine curettage. Clinical data, treatment sequence, and outcome were analyzed, and a brief review of the published literature summarizing UAE in the treatment of CSP was performed.
Eleven patients with definite CSP received preventive UAE combined with methotrexate followed by uterine curettage, and CSP was resolved successfully without hysterectomy. In the four misdiagnosed patients, three were treated successfully with emergency UAE. The other patient underwent uterine curettage and emergency UAE followed by repeat curettage, but hysterectomy was performed because of continued severe hemorrhage.
Based on a small number of patients, it appears that UAE may be an effective means of treating CSP, including treatment in an emergency setting. Further study is required before the safety and effectiveness of UAE can be confirmed.
Background:
Traditional Chinese medicine (TCM) is widely integrated into cancer care in China. An overview in 2011 identified 2384 randomized and non-randomized controlled trials (RCTs, non-RCTs) on ...TCM for cancer published in the Chinese literature. This article summarizes updated evidence of RCTs on TCM for cancer care.
Methods:
We searched 4 main Chinese databases: China National Knowledge Infrastructure, Chinese Scientific Journal Database, SinoMed, and Wanfang. RCTs on TCM used in cancer care were analyzed in this bibliometric study.
Results:
Of 5834 RCTs (477 157 cancer patients), only 62 RCTs were indexed in MEDLINE. The top 3 cancers treated were lung, stomach, and breast cancer. About 4752 RCTs (81.45%) tested TCM combined with conventional treatment, and 1082 RCTs (18.55%) used TCM alone for treating symptoms and side-effects. Herbal medicine was the most frequently used TCM modality (5087 RCTs; 87.20%). The most frequently reported outcome was symptom improvement (3712 RCTs; 63.63%) followed by quality of life (2725 RCTs; 46.71%), and biomarkers (2384 RCTs; 40.86%). The majority of RCTs (4051; 69.44%) concluded there were beneficial effects using either TCM alone or TCM plus conventional treatment compared with conventional treatment.
Conclusion:
Substantial randomized trials demonstrated different types/stages of cancer were treated by various TCM modalities, alone or in combination with conventional medicine. Further evaluation on the effects and safety of TCM modalities focusing on outcomes such as quality of life is required.
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