Analysis on off-label use of drugs in pediatric guidelines and consensus published by Chinese authors / 中华儿科杂志

Objective: To understand the current situation regarding pediatric off-label use of drugs recommendations in Chinese clinical practice guidelines and to make recommendations for standardized reporting format regarding off-label use of drugs for children. Methods: This cross-sectional study was carried out by systematically searching the databases for Chinese guideline consensus articles published in journals between 2018 and 2020 and extracting recommendations regarding off-label use of drugs from those articles. The essential characteristics of the included guidelines, the ranking of off-label drug types, the order of drug information, the type of off-label drug use, and the percentage of citation studies on which the recommendations were based were analyzed. Results: Among 108 studies that included Chinese off-label guidelines and consensus, 364 recommendations on pediatric off-label use of drugs were included. The Chinese Medical Association published the most, 48 out of the 108 studies (44.4%), and of those 14 studies (13.0%) were on infectious and parasitic diseases. Of the 364 recommendations on off-label use of drugs, the most commonly addressed drugs were 16 recommendations (4.4%) for cyclosporine A, 11 recommendations (3.0%) for methotrexate , and 11 recommendations (3.0%) for fentanyl. The most commonly addressed drug categories were as follows: 68 recommendations (18.6%) were immune system drugs, 66 recommendations (18.1%) were anti-infectives, and 56 recommendations (15.4%) were oncology drugs. The most commonly addressed drug information accounts were as follows: 364 recommendations (100.0%) were indications, 204 recommendations (56.0%) were dosages, and 198 recommendations (54.4%) were the route of administration. Based on the instructions approved by the Chinese Food and Drug Administration, the main forms of the off-label drug were as follows: 175 recommendations (48.1%) were unapproved indications, 127 recommendations (34.9%) were unapproved populations, and 72 recommendations (19.8%) were unapproved ages. Only 129 recommendations (35.4%) were cited, mainly including clinical guidelines (48 studies, 23.4%), reviews (22 studies, 10.7%), and pediatric randomized controlled trials (22 studies, 10.7%). Conclusions: Off-label use of drugs is commonly recommended in pediatric guidelines and consensus documents written by Chinese authors. However, the reporting of the recommendations varies widely, and the quality of the supporting evidence is poor.

Associations between gene polymorphisms of signal transducer and activator of transcription 3 and the susceptibility to hepatitis B virus related liver cirrhosis / 中华预防医学杂志

To investigate the associations between gene polymorphisms of signal transducer and activator of transcription 3 (STAT3) and liver cirrhosis (LC) after hepatitis B virus (HBV) infection. A case-control study was conducted in 243 patients with hepatitis B cirrhosis (HBV-LC, case group) and 486 HBV-infected subjects without LC (non-LC, control group) collected from January 2018 to September 2020 at the Changsha Central Hospital Affiliated to Nanhua University. Three single nucleotide polymorphisms (SNPs) of STAT3 gene, including rs4796793C>G, rs2293152C>G, and rs1053004T>C were selected through literature and biological information database, and the genotypes were detected by real-time fluorescent quantitative PCR (RFQ-PCR). The distribution differences of STAT3 SNPs genotypes between the two groups were compared using Chi-square test and haplotype analysis was conducted by Shesis online. The proportion of HBV C genotype in HBV-LC patients was significantly higher than that in the control group (80.91% vs. 70.79%, χ2=7.109, P=0.008), while the logarithm of ALT was significantly lower than that of the control group (1.78±0.43 vs. 1.95±0.54, t=3.801, P=0.000). The genotypes distributions of rs4796793, rs2293152, and rs1053004 were not significantly different between HBV-LC and non-LC in overall analysis and stratified analysis by gender (χ²=2.610, 1.505, 0.586, 2.653, 2.685, 1.583, 0.351, 5.388, 0.339, respectively, P>0.05 for each). Among the subjects infected with HBV genotype C, rs1053004 CC (vs. TT) significantly increased the risk of HBV-LC [odds ratio (OR) = 1.40, 95% confidence interval (CI): 1.03-1.91]. Among the HBV-infected subjects with HBeAg negative, rs4796793 GG genotype (vs. CC) and G allele (vs. C) significantly increased the risks of HBV-LC (OR = 2.17, 95%CI: 1.11-4.23; OR = 1.45, 95%CI: 1.06-1.97, respectively). Haplotypes analysis showed that the frequency of haplotype C-G-T composed of rs4796793, rs2293152, and rs1053004 was significantly lower in HBV-LC than that in the control group (non-LC) (27.3% vs. 35.6%, χ²=9.949, P = 0.001). The correlation between STAT3 and HBV-LC is different in HBV-infected subjects with different infection status. The HBV-infected subjects carrying haplotype rs4796793C-rs2293152G-rs1053004T of STAT3 gene have significantly decreased risk of LC.

Contribution and Regulation of Forkhead Transcription Factor O1 during the Renal Fibrosis / 中国生物化学与分子生物学报

Chronic kidney disease (CKD) has become a chronic disease that cannot be ignored all over the world. Renal fibrosis is the final result and key pathological features of CKD. The whole process of renal fibrosis is associated with the repair and healing of kidney damage, and this long-term chronic stimulation promotes the renal fibrosis to the kidney failure, it is characterized by continuous activation of myofibroblasts and excessive production and deposition of extracellular matrix. Renal fibrosis is a synergistic process mediated by a variety of signaling pathways, and TGF-β / Smad and Wnt / β-catenin signaling pathways are two of the most classic ones. FoxO1 is an important transcription factor in the human body, which is expressed in a variety of cell types and plays an important role in a variety of cell life activities. Current researches have shown that FoxO1 plays an important role in renal fibrosis. FoxO1 regulates the occurrence and development of renal fibrosis through various signaling pathways such as STAT, SIRT1, Wnt / β-catenin, PI-3K / Akt. For example, FoxO1 / STAT regulates TIF and renal tubule apoptosis, SIRT1 / FoxO1 regulates oxidative stress response and lipotoxicity, FoxO1 / β-catenin inhibits the Wnt / β-catenin signaling pathway. In addition, some related studies suggest that FoxO1 / Smad may play a role in renal fibrosis. The contribution and regulation of FoxO1 in the renal fibrosis are reviewed here in order to further clarify the pathogenesis of renal fibrosis, which may bring new clues and prospects for the treatment of CKD.

Triterpenoid saponins and phenylpropanoid glycoside from the roots of Ardisia crenata and their cytotoxic activities / 中国天然药物

Two new triterpenoid saponins, ardisicrenoside R and S (1 and 2), and one new phenylpropanoid glycoside, ardicrephenin (3), along with five known compounds (4-8), were isolated from roots of Ardisia crenata. Their structures were elucidated on the basis of NMR spectroscopic data and chemical methods. Compounds 2-7 were evaluated for their cytotoxic activities against A549, MCF-7, HepG2 and MDA-MB-231 cell lines by MTT assay. Ardicrenin (6) showed significant cytotoxicity, with IC

Risk factors for 30-day unplanned reoperation after pancreatoduodenectomy: A single-center experience

Objective: The purpose of this study was to investigate the rate and reasons and also the risk factors for unplanned reoperation after pancreatoduodenectomy (PD) in a single center. Patients and Methods: This retrospective analysis included patients who underwent PD in the First Affiliated Hospital of Nanchang University between January 2010 and January 2018. The patients were divided into nonreoperation and reoperation groups according to whether they underwent unplanned reoperation following the primary PD. The incidence and reasons were examined. In addition, multivariate logistic regression analysis was performed to identify the risk factors for unplanned reoperation. Results: Of the 330 patients who underwent PD operations, 22 (6.67%) underwent unplanned reoperation. The main reasons for reoperation were postpancreaticoduodenectomy hemorrhage (PPH) (12/22 [54.5%]) and pancreaticoenteric anastomotic (PEA) leak (5/22 [22.7%]). Multivariate logistic regression analyses identified that diabetes (odds ratio [OR], 3.70; 95% confidence interval [CI], 1.06–12.90; P = 0.04), intraoperative blood loss ≥400 mL (OR, 4.06; 95% CI, 1.29–12.84; P = 0.02), occurrence of postoperative complications in the form of PPH (OR, 30.67; 95% CI, 8.85–106.31; P < 0.001), and PEA leak (OR, 11.53; 95% CI, 3.03–43.98, P < 0.001) were independent risk factors for unplanned reoperation. Conclusions: Our results suggest that diabetes, intraoperative blood loss ≥400 mL, PPH, and PEA leak were independent risk factors for unplanned reoperation after primary PD

Effectiveness and safety of robotic versus traditional laparoscopic gastrectomy for gastric cancer: An updated systematic review and meta-analysis

Gastrectomy is considered the gold standard treatment for gastric cancer patients. Currently, there are two minimally invasive surgical methods to choose from, robotic gastrectomy (RG) and laparoscopic gastrectomy (LG). Nevertheless, it is still unclear which is superior between the two. This meta-analysis aimed to investigate the effectiveness and safety of RG and LG for gastric cancer. A systematic literature search was performed using PubMed, Embase, and the Cochrane Library databases until September 2018 in studies that compared RG and LG in gastric cancer patients. Operative and postoperative outcomes analyzed were assessed. The quality of the evidence was rated using the Grading of Recommendations, Assessment, Development and Evaluations. Twenty-four English studies were analyzed. The meta-analysis revealed that the RG group had a significantly longer operation time, lower intraoperative blood loss, and higher perioperative costs compared to the LG group. However, there were no differences in complications, conversion rate, reoperation rate, mortality, number of lymph nodes harvested, days of first flatus, postoperative hospitalization time, and survival rate between the two groups. RG was shown to be associated with decreased intraoperative blood loss and increased perioperative cost and operation time compared to LG. Several higher-quality original studies and prospective clinical trials are required to confirm the advantages of RG

Feasibility of using bedside ultrasound to evaluate residual gastric volume in critical ill patients with enteral nutrition support / 中国实用护理杂志

Objective:To study the feasibility of using bedside ultrasound in evaluating gastric residual volume in critical ill patients with enteral nutrition support.Methods:From May 2019 to August 2019, 60 patients were selected to receive enteral nutrition via gastric tube in ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Patients were divided into the experimental group and the control group according to the odd and even number of beds, 30 patients in the experimental group with odd number of beds and 30 patients in the control group with even number of beds. Gastric residual volume was evaluated at 0, 4, 8, 12, 16, 20, 24 h of enteral nutrition. In the experimental group, the gastric residual volume was evaluated by bedside ultrasound and syringe suction at each time point. In the control group, only bedside ultrasound was used to evaluate gastric residual volume. The results of operation time, monitoring results at different time points, diarrhea and the utilization rate of gastrointestinal motility drugs target feeding time, vomiting, were compared between the two groups.Results:There was no statistical difference between the gastric residual amount monitored by ultrasound and the gastric residual amount monitored by suction ( P>0.05). The operating time of bedside ultrasound monitoring was (62.40 ± 4.00) s, the operating time of suction monitoring was (78.39 ± 12.15) s, and the operating time of bedside ultrasound monitoring was less than that of suction ( t value was 6.633, P<0.01). There was no significant difference in the rate of vomiting, diarrhea and gastrointestinal motility drugs between the two groups( P>0.05). The time to reach the target feeding amount in the control group was (3.04 ± 0.31) d, and the time to reach the target feeding amount in the experimental group was (4.19 ± 0.33) d. The time to reach the target feeding amount in the control group was less than that in the experimental group ( t value was 13.42, P<0.01). Conclusions:Bedside ultrasound can be used to evaluate the residual gastric volume of enteral nutrition support patients, guide the implementation of enteral nutrition, shorten the operation time, reduce the workload of nurses, and avoid the contamination of enteral nutrition preparation.

Persistence of rabies antibody 3 years after postexposure prophylaxis with 2-1-1 regimen of Vero-cell rabies vaccine for human use and antibody response to two booster doses / 中华疾病控制杂志

Objective To evaluate the antibody persistence following rabies postexposure prophylaxis (PEP) with 2-1-1 regimen and antibody response to two booster doses. Methods A total of 314 healthy volunteers at year 1, year 2, year 3 who had received a complete rabies PEP using 2-1-1 regimen were recruited. Two booster doses of rabies vaccine were inoculated, and blood samples were obtained before and 14 days after two booster doses. Human rabies virus IgG antibody was evaluated by ELISA, and the antibody levels and antibody positive rates were analyzed. Results The antibody GMC of 303 people at year 1, year 2, year 3 after a complete immunization was 1.33 IU/mL, 1.04 IU/mL and 0.72 IU/mL, with an antibody positive rate of 77.78%, 66.67% and 55.56%, respectively. Among 282 people who received 2 doses for booster immunization, the antibody GMC at day 14 of 1 year, 2 year and 3 year immunization group was 16.83 IU/mL, 19.37 IU/mL and 21.05 IU/mL respectively, which was higher than that before booster immunization (t=16.54, P<0.001; t=13.85, P<0.001; t=16.02, P<0.001). The antibody positive rate was 100.00%, 99.00% and 100.00%, respectively. Conclusions The immune persistence of rabies antibody after PEP with antirabies vaccine using the 2-1-1 regimen is good so as to the immune response after 2 doses of booster immunization in 3 years is effective.

Comparison of laparoscopic and open surgery in treatment of rectal cancer patients / 中国内镜杂志

Objective To compare the effect of laparoscopic and open surgery in treatment of rectal cancer. Methods 80 cases of patients with rectal cancer from May 2008 to May 2013 were selected, they were randomly divided into laparoscopy surgery group (n = 40) and open surgery group (n = 40), the operation time, intraoperative blood loss, length of incision, lymph node dissection, number for the first time, ventilation time, ambulation time, hospitalization time, cost of hospitalization, postoperative complications, treatment satisfaction of the two groups were statistically analyzed. Results The operation time of the laparoscopic surgery group was significantly longer (P < 0.05), the amount of bleeding was significantly less (P < 0.05), the incision length was significantly shorter (P < 0.05), the first time, ventilation time, ambulation time, hospitalization time were significantly shorter (P < 0.05), the hospitalization cost was significantly higher (P < 0.05), the rate of postoperative complications 15.0% (6/40) was significantly lower than the open surgery group 35.0% (14/40) (P < 0.05) 97.5% (39/40), the treatment satisfaction was significantly higher than the open surgery group 67.5% (27/40)(P < 0.05). Conclusion The effect of laparoscopic and open surgery in treatment of rectal cancer is better than open surgery.

Effect of micro-fracture and comminution of fat pad on meniscal tear healing under arthroscopy / 中国内镜杂志

Objective To analyze the curative effect of fossa intercondyloidea of micro-fracture and comminution of subcutaneous fat pad on meniscal tear healing under arthroscopy. Methods During the clinical operation, the samples of the micro-fracture and fat pad comminution were attracted to the outside of the joint. The source and properties of cells were identified based on preclinical medicine experiment in vitro. In clinical research, 75 cases of the simple meniscus injury were selected from January 2014 to January 2016 and divided into three groups refer to treatment: Group A, B and C. Different treatments were used in the three groups. Group A - micro-fracture group; Group B - fat pad group; Group C - blank group. All patients' conditions were assessed with Lysholm, VAS score and adverse event (Swelling, anterior knee pain). Results In the preclinical medicine experiment, cells released by micro fracture were fibroblast-like cells which tend to grow more rapidly in vortex shape. Cells released by comminution of fat pad contained a small amount of impurities and necrotic cells and are mostly similar to fibroblast in long spindle shape. Besides, the Human MSC Analysis Kit was used to authenticate two cells which were considered to be as BMSCs and IPFPSCs. In clinical research, all patients received an average of 10 (8 ～ 11) months follow-up visit. No severe complication, such as blood-vessel and nerve injury, infection occurred after operations in the patients followed. Before receiving the treatment, difference in Lysholm, VAS score and general condition of joint of Group A and B, C showed no statistical difference (P > 0.05). Compared with those before operation and after operation in both of four groups, the Lysholm and VAS score were improved (P < 0.05). Besides, there had significantly difference between group A and C, B and C after post treatment in Lysholm and VAS score (P < 0.05), however, group A and B did not. Compared group A and C, the early prevalence of adverse event of group B was higher, but last follow-up show no difference between three groups. Conclusion Combined with basic experimental and clinical studies, our research suggest that micro-fracture and comminution of fat pad have good effect on the repair of meniscus injuries. Nevertheless, it should be concerned that early prevalence of increased swelling amd anterior knee pain of comminution of fat pad.

Fumigation treatment of Four Yellow Qing Ling Water with artificial tears for dry eyes / 国际眼科杂志(Guoji Yanke Zazhi)

·AIM: To observe the clinical efficacy of fumigation treatment of traditional Chinese medicine(Four Yellow Qing Ling Water) for dry eye, and to provide the reference for clinical treatment of dry eye. · METHODS: Totally 82 patients (164 eyes) were randomly divided into two groups from June 2016 to December 2016 in Ophthalmology Department of our hospital. The patients in control group were given artificial tears;the patients in the observation group were given artificial tears and fumigation treatment of traditional Chinese(Four Yellow Qing Ling Water) once a day. After treatment for 14d, the SchirmerⅠtest (SⅠt), break-up time (BUT), cornea fluorescein staining (FL) and clinical efficacy of two groups were compared. ·RESULTS:The efficiency rate of observation group was significantly better than the control group (87. 8% vs 70.7%,P<0.5). The SⅠt and BUT in the observation group were significantly higher than those in the control group (8.43 ± 2.51mm/5min vs 6.38 ± 2.52mm/5min, P<0.05;8.60±2.47s vs 6.35±2.29s, P<0.05); the FL in the observation group (0.84 ± 0.75 vs 1.26 ± 0.84, P<0.05) significantly lower than those in the control group. ·CONCLUSION: The fumigation treatment of traditional Chinese medicine (Four Yellow Qing Ling Water) combined with artificial tears for dry eyes can improve the clinical symptoms of dry eye syndrome.

Mesenchymal stem cells homing to rat lung emphysema followed by differentiation into pulmonary vascular endothelial cells / 中国组织工程研究

BACKGROUND:Mesenchymal stem cells have unique homing,immunoregulation and anti-inflammatory properties.After intravenous injection,mesenchymal stem cells can home to the damaged target organs and tissues,and function to repair damaged tissues.OBJECTIVE:To observe the pathological changes of lung tissues in rats with emphysema after mesenchymal stem cells transplantation.METHODS:Twenty-four female Wistar rats were randomly divided into experimental group,control group and healthy control group.In the first two groups,the model of pulmonary emphysema was established by the method of dropping porcine pancreatic elastase.BrdU-labeled mesenchymal stem cells were injected into the tail vein of the rats in the experimental group,and PBS was injected in the control group.After 14 days,the pathological changes of lung tissues were observed.Tumor necrosis factor-α level,alveolar wall apoptotic index,anti-CD34 and anti-BrdU immunohistochemical changes in the bronchoalveolar lavage fluid were detected.RESULTS AND CONCLUSION:Compared with the healthy control group,the tumor necrosis factor-α level and apoptotic index of alveolar wall cells increased (P ＜ 0.01),and the relative areas of anti-Brdu and anti-CD34 decreased (P ＜ 0.01) in the control group.Compared with the control group,the level of tumor necrosis factor-α and apoptotic index of alveolar wall cells decreased (P ＜ 0.01),and the relative area of anti-Brdu and anti-CD34 increased (P ＜ 0.01) in the experimental group.The histopathological findings showed that both the control group and the experimental group showed emphysema-like changes,but these changes were milder in the experimental group than the control group.To conclude,mesenchymal stem cells can inhibit inflammatory response and apoptosis in experimental emphysema,improve the pathological changes of the lung,and moreover,bone marrow mesenchymal stem cells can differentiate into lung vascular endothelial cells.

Donador exógeno de óxido nítrico en la respuesta inflamatoria hepática y hemodinámica después de choque hemorrágico / Exogenous nitric oxide donor in the liver inflammatory and hemodynamic response after hemorrhagic shock

BACKGROUND: Hemorrhagic shock (HS) results in oxidative stress to cells and in the induction of the inflammatory response, with an increased expression of a number of proinflammatory mediators and cytokines. We tested the ability of the nitric oxide (NO) donor sodium nitroprusside (NP) to reduce tissue injury in a rodent model of uncontrolled hemorrhagic shock. METHODS: Seventy two Sprague Dawley rats weighing 250-300 g were subjected to a model of uncontrolled hemorrhagic shock. Four groups of animals were included (n = 18 per group): sham/saline, sham/NP, shock/saline, shock/NP. Experimental design consisted of the development of hemorrhagic shock (3 ml/100 g) in a 15-min period, tail amputation (75%) and drug administration at 30 min, fluid resuscitation (FR) with Ringer's lactate (RL) solution to reach a mean arterial pressure (MAP) of 40 mmHg, a hospital phase of 60 min with hemostasis and FR with LR solution to reach a MAP of 70 mmHg, and a 3-day observation phase. Treatment at the beginning of resuscitation included either normal saline (groups 1, 3) or NP (0.5 mg/kg) (groups 2, 4). The following parameters were evaluated: fluid requirements for resuscitation, liver injury tests, liver tissue myeloperoxidase (MPO), liver histology, and 3-day survival. RESULTS: NP significantly reduced fluid requirements for resuscitation (p = 0.0001). We also observed an improved statistically significant difference in tests demonstrating hepatic injury (p = 0.0001), neutrophil infiltration as evidences by liver MPO (p <0.05), and histology studies (p = 0.001). Survival was also increased from 40% in controls to 60% with NP treatment. CONCLUSIONS: These data suggest that excess NO mediates hemorrhage-induced liver injury, and that the suppression of NO with NP may reduce the pathological consequences of severe hemorrhage, possibly by scavenging superoxide (O(2)(-)), thus limiting the production of more aggressive radicals.

Contrast sensitivity of aspheric and standard spherical intraocular lens after phacoemulsification / 国际眼科杂志(Guoji Yanke Zazhi)

AIM:To compare the contrast sensitivity obtained through anterior surface modified prolate intraocular lens with the contrast sensitivity obtained through standard spherical intraocular Iens.METHODS:Patients presenting for cataract surgery in one eye were randomized to receive either the Acrysef IQ intraocular lens(AIcon)or the AR40e intraocular lens(AMO).50 eyes after phacoemulsification with IOL implantation were included,23 eyes received Acrysof IQ,and 27 eyes received AP40e intraocular lens (AMO).Contrast sensitivity testing under photopic conditions (85cd/m2)served as the prindpal outcome measure.The contrast sensitivity function was measured with CSV-1000E Vision Testing Instrument(provided by VECTOR ⅥSION COMPANY) at 30 days after surgery.RESULTS:The Acrysof IQ intraocular lens provided statistically significantly better contrast sensitivity at 6,12 and 18 cydes per degree under photopic conditions.CONCLUSION:The use of anterior surface modified prolate intraocular lens for cataract surgery has the potential to improve functional vision.

Eye model for inspecting the functional vision of IOLs / 国际眼科杂志(Guoji Yanke Zazhi)

· AIM: To inspect and compare the functional vision of an aspheric intraocular lens (Tecnis) with those of conventional monofocal silicone and acrylic intraocular lens and multifocal intraocular lens (Array).· METHODS: The IOLs were tested in the eye model, which was designed to be optically equivalent to the theoretical eye model. The eye model is a combination of a spherical photographic lens with 35mm focal length ( IOL put in a water cell)and a charge coupled device (CCD) camera. The images constructed by the lenses are observed on a monitor of personal computer and the contrasts of the images are analyzed by using commercial image processing software.· RESULTS: The modulation transfer function of the eye model equals the scale produced by the theoretical eye model. The images constructed by changing the diameter of aperture stop and IOL.· CONCLUSION: The proposed eye model is useful for testing functional vision and for inspecting differences of intraocular lens.