Motherwort Injection for Preventing Uterine Hemorrhage in Women With Induced Abortion: A Systematic Review and Meta-Analysis of Randomized Evidence.

Objective: Motherwort injection (MI) is a modern patented injection extracted from motherwort (Leonurus japonicus Hoult). Empirical studies and systematic reviews have shown the benefits of motherwort injection for preventing postpartum hemorrhage after vaginal delivery and cesarean section. This study was conducted to explore the efficacy and safety of motherwort injection for women with the prevention of post-abortion uterine hemorrhage. Methods: A comprehensive literature search was conducted to identify RCTs regarding the effect of the use of motherwort injection in women after abortion. Data from trials were pooled by meta-analysis and a random-effects model was used to calculate the summarized relative risks (RRs) and their 95% confidence intervals (CIs). The grading of recommendations assessment, development, and evaluation (GRADE) methodology was used to access the quality of the evidence. Results: Nine trials with a total of 1,675 participants were identified. Overall, motherwort injection combined with oxytocin compared to oxytocin had a significantly lower blood loss within 2 hours (MD = -50.00, 95% CI -62.92 to -37.08, very low quality); lower blood loss within 24 h (MD = -50.00, 95% CI -62.92 to -37.08, very low quality); however, there was no significant difference between motherwort injection and oxytocin (24 h: MD: 0.72, 95% CI -7.76 to 9.20; 48 h: MD: -0.01, 95% CI -11.35 to 11.33; 72 h: MD: -1.12, 95% CI -14.39 to 12.15, very low quality). Compared with oxytocin or no intervention, both motherwort injection and motherwort injection combined with oxytocin had a significantly decreased duration of blood loss (MI vs. O: MD -2.59, 95% CI -4.59 to -0.60, very low quality; MI + O vs. O: MD -2.62, 95% CI -3.02 to -2.22, very low quality; MI + O vs. No intervention: MD: -1.80, 95% CI -2.28 to -1.33, low quality). Seven of nine included trials reported adverse event outcomes. Three cases were found in the motherwort injection group, and five induced abortion syndromes were found in the motherwort injection plus oxytocin group. 29 adverse events were reported in the oxytocin group instead. The recovery time of normal menstruation after abortion was significantly earlier in the group using motherwort injection compared with oxytocin (MDs -3.77, 95% CI -6.29 to -1.25, very low quality), and the endometrial thickness in the motherwort injection group was significantly different from that in the oxytocin group (MD: 2.24, 95% CI 1.58 to 2.90, very low quality). Conclusion: The results of this meta-analysis indicate prophylactic use of motherwort injection may reduce the risk of uterine hemorrhage in women after abortion, and more high-quality research is needed to confirm the efficacy and safety of motherwort injection in preventing uterine hemorrhage after abortion. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=274153, identifier CRD42021274153.

Interpretation for Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China / 中国药房

Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China was published in the British Journal of Clinical Pharmacology in February 2022. The guideline followed the latest definition of clinical practice guideline and the methodology specification for the guideline development of WHO. The Grading of Recommendations Assessment ， Development，and Evaluation （GRADE）approach was applied to rate the quality of evidence and determine the strength of recommendations. Finally ，this guideline presents 28 recommendations covering the whole process of clinical medication of high-dose methotrexate ，involving evaluation prior to administration （liver and renal function ，pleural effusion and ascites ， comedication，genetic testing ），pre-treatment and routine dosing regimen （pretreatment of hydration and alkalization ，urine alkalization，routine dosing regimen ），therapeutic drug monitoring （necessity，method，timing，target concentration ），leucovorin rescue（rescue timing ，rescue regimen ，rescue dose optimization ），and management of toxicities （liver and kidney function monitoring，supportive treatment ，blood purification treatment ）. This article aims to summarize and interpret the recommendations of this guideline ，so as to promote the better promotion and implementation of this guideline and provide comprehensive technical support and suggestions for whole-course individualized administration of high-dose methotrexate in China.

The methodological framework of surgical innovation: the introduction of IDEAL framework and recommendation / 中国胸心血管外科临床杂志

@#Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.

The methodological framework of surgical innovation: The interpretation of IDEAL reporting guideline / 中国胸心血管外科临床杂志

@#Adherence to reporting guidelines contributes to report methodology and outcomes of research distinctly and transparently. There are some checklists with specific study types related to surgery on the EQUATOR Network’s website. However, the IDEAL framework focuses on stepwise evaluation of surgical innovation through all stages with some key elements, which those existing guidelines may not mention. This likely results in the inaccuracy in reporting in studies attempting to follow the IDEAL recommendations and suggests a pressing need for IDEAL reporting guidelines. Considering these limitations, the IDEAL developed the IDEAL reporting guidelines between October 2018 and May 2019. The paper aimed to provide interpretation of IDEAL reporting guideline, and promote its understanding and use among Chinese researchers.

An instrument for evaluating the clinical applicability of guidelines.

OBJECTIVE: To establish an instrument for evaluating the clinical applicability of guidelines from the guideline-users' perspective. METHODS: We established this instrument through forming a working group, forming an initial list of items based on a qualitative systematic review, establishing initial instrument via two rounds of modified Delphi surveys, and external review the initial instrument. RESULTS: The results of modified Delphi surveys establishing appraisal aspects, appraisal items, general information of the evaluator met the preset requirements. The instrument includes three parts: general information of the evaluator (12 items), evaluation of clinical applicability (12 items, including items on the availability, readability, acceptability, feasibility, and overall applicability of guideline), and scoring scheme. CONCLUSIONS: The instrument for evaluating the clinical applicability of guidelines from the guideline-users' perspective provides criteria and methods for improving the clinical applicability of guidelines during development and updating.

Study on key healthcare resources allocation in COVID-19 pandemic control: case study of Wuhan city in Hubei province / 中华医院管理杂志

Key healthcare resources are doubtlessly critical in emergency management. How to balance the supply and demand, use limited resources scientifically and rationally, and maintain a healthy public service system, have emerged an important challenge in emergency command. Based on the theory of supply-demand balance of public goods, the article took Wuhan as an example to analyze and establish a model on key healthcare resources allocation, in order to provide reference and evidence for global health governance and other similar public health emergencies.

Problems of Using Traditional Chinese Medicine Injections in Clinical Practice and the Suggestions about Making the Package Inserts / 世界科学技术-中医药现代化

In clinical practice, the application of Traditional Chinese Medicine injections (TCMIs) has several problems, for example, at some time, the components are complicated, the ingredients and pyrogen are uncontrollable, the usage, the dosage, and the drug interactions are unclear and the method of application is also ambiguous and non-standard. The factors have restricted the development of TCMIs. Based on the policies of the TCMI package inserts since 2006, this paper takes consideration of the problems and gives suggestions of making strict, normal and evidence-based TCMI package inserts.

Causality Assessment of Adverse Drug Reactions and Its Guiding Significance for Post-evaluation of Chinese Patent Medicine / 世界科学技术-中医药现代化

This study introduces 5 methods of causality assessment of adverse drug reactions (ADRs) domestic and overseas. According to the assessment of ministry of public health of China, the key points about the relevance analysis have been illuminated for the post-evaluation of Chinese patent medicine. Under the guidance of the causality assessment, we should describe the ADR reports in detail and further detect the accurate ADR warning signals. In order to supplement the ADR information, more researches concerning the ADR mechanism should be fully explored.

Progress in molecular genetic studies of retinitis pigmentosa / 中华医学遗传学杂志

Retinitis pigmentosa (RP) is a group of inherited disorders which involve photoreceptors of the retina and can lead to visual loss. The genetic and clinical phenotypes of RP feature high heterogeneity. RP can be divided into nonsyndromic and syndromic types, both may feature autosomal dominant, autosomal reccesive and X-linked inheritance. So far, many genes have been identified, most of which are expressed in the photoreceptors or retinal pigment epithelium. Sixty-three genes have been identified in nonsyndromic RP. This paper reviews recent progress in the research of the genetics of RP.

A new technique for clipping diaphragm defects in transsphenoidal surgery.

AIM: To deal with postoperative CSF rhinorrhea, we developed a new technique using titanium/aneurysm clips to envelope the diaphragm defect to avoid postoperative CSF rhinorrhea. MATERIAL AND METHODS: From January 2007 through December 2010, we used a new technique of clipping diaphragm defects to prevent CSF rhinorrhea in 57 of 510 patients (group 1) who underwent transsphenoidal surgery. The incidence of postoperative CSF rhinorrhea was compared with that of 245 patients who underwent transsphenoidal surgery before the usage of this clipping technique between January 2004 and December 2006 (group 2). RESULTS: Postoperative CSF rhinorrhea developed in 8 (1.57%) patients of the 510 patients in group 1 while the new technique was used, while 17 (6.94%) patients of the 245 patients in group 2 developed CSF rhinorrhea before the usage of this technique (χ2 =14.907, P < .001). No device-related complication such as optical chiasm herniation after clipping the diaphragm defect was observed. CONCLUSION: Clipping the diaphragm defect with the titanium/aneurysm clips is effective and practicable to prevent postoperative CSF rhinorrhea, it can also avoid unnecessary autologous tissue grafting and postoperative lumbar drainage.

Analysis of risk factor of acute kidney injury after craniocerebral injury / 中华肾脏病杂志

Objective To investigate the incidence and risk factors of acute kidney injury (AKI) after craniocerebral injury.Methods A single cohort of 791 patients who suffered from craniocerebral injury from January 2008 to January 2010 in the Second Hospital of Lanzhou University were prospectively analyzed.Craniocerebral injury was defined according to definite medical history of craniocerebral injury,the verification of CT and Glasgow coma scale (GCS) score.AKI was defined as a relative 50％ increase or an absolute increment of 26.4 μmol/L in Scr within 48 hours and/or urine volume ＜0.5 ml·kg-1·h-1 up to 6 h.Multivariate Logistic regression analysis was used to evaluate possible risk factors associated with post-craniocerebral injury AKI.Results Of the 791 patients,the incidence of AKI was 39.4％.In hospital mortality of AKI patients was 27.9％,which was 5.065 times of non-AKI patients (P＜0.01).The incidence of AKI in patients with lower GCS score (≤8 score,heavy group)was 69.7％,which was significantly higher as compared to moderate and mild groups (P＜0.01).Unconditional multivariate Logistic regression analysis revealed that lower GCS score (≤ 8 score),hypotension (systolic pressure＜90 mm Hg),elderly and male were the independent predictors of AKI episodes,the corresponding OR values were 2.932,2.176,1.789,1.544 respectively.Conclusions AKI is a common complication after craniocerebral injury.Lower GCS score,hypotension,elderly and male are the independent risk factors of AKI in patients after craniocerebral injury.

Analysis of risk factor on anemia in renal transplant recipients over 60 years old / 中华肾脏病杂志

Objective To investigate the characteristics and risk factors of anemia in renal transplant recipients over 60 years old.Methods Clinical data of one hundred and sixty-eight renal transplant recipients over 60 years old were retrospectively analyzed.Logistic regression analysis was used to determine the risk factors of anemia.Results In 168 cases of renal transplant recipients,the incidence of anemia was 45.2％(76/168).Forty cases were normocyte and normochromic,26 cases were microcytic hypochromic,10 cases were hemolytic anemia.In these anemic recipients,51 cases were short of erythropoietin (EPO),25 were EPO resistance.The incidence of malnutrition and cardia-cerebrovascular complication was higher in recipients with anemia than those without anemia (P＜0.01).The incidence of anemia in CsA+Aza+Pred treatment was 57.1％,which was significantly higher as compared to other three treatments (P＜0.01).Unconditional multivariate Logistic regression analysis revealed that male,creatinine level,acute reject reaction,delayed graft function (DGF) were the independent predictors of anemia,the corresponding OR values were 1.089,5.156,6.345,1.876.Conclusions Anemia is a common and serious complication in renal transplant recipients over 60 years old.Male,creatinine level,acute reject reaction,DGF are the independent risk factors of anemia in renal transplant recipients over 60 years old.

Ethical review reporting of Chinese trials records in WHO primary registries.

OBJECTIVE: To investigate the report rate of ethical review in registered Chinese trials records. METHODS: Chinese trials recorded in WHO primary registries and http://clinicaltrials.gov to 14 July 2009 were identified. The report rates of ethical review and each of the 20 items in WHO's Trial Registration Data Set were calculated. Correlation of the item's report rate with the ethical review report rate was assessed. PubMed, EMBASE, CNKI and CBM (from the establishment of each database to 14 July 2009) were also searched to collect the full texts of completed trials to calculate the report rate of ethical review in the result publications. RESULTS: A total of 1247 records were identified, and 687 (55.1%) reported ethical review. The records reporting secondary sponsor(s), contact for public queries and key secondary outcomes were more likely to report ethical review information (66.3% vs 44.3%, 38.1% vs 28.5%, 53.9% vs 51.8%). The ethical review report rate of trials sponsored by industry was lower than those sponsored by non-industry (40.9% vs 51.9%). The report rates of ethical review for self-supported trials (83.5%) and trials with unidentified sources of monetary or material support (66.7%) were lower than the average ethical review report rate for records in the Chinese Clinical Trial Registration Center (ChiCTR). The ethical review report rate was not high in the result publications (84.3% in http://clinicaltrials.gov, 50.0% in ChiCTR). CONCLUSION: Registered Chinese trials records report ethical review inadequately. Incomplete registration is correlated with not reporting ethical review. Medical journals should inspect ethical review more critically.

Epithelial-mesenchymal transition of renal tubular epithelial cells under anoxia / 中华器官移植杂志

Objective To explore whether anoxia can induce expression changes in connective tissue growth factor(CTGF)in renal tubular epithelial cells(TECs)and epithelial-mesenchymal transition of TECs.Methods Rat renal TECs(NRK-52E)anoxia models were established.NRK-52E cells were exposed to anoxia for 4 h.The real-time RT-PCR,Western blotting,immunohistochemical staining were used to detect the expression of CTGF at 6,12,24,48,and 72 h in NRK-52E cells.Morphological changes and cytoskeleton remodeling in NRK-52E cells under anoxia were examined by a laser confocal microscope and BODIPYFL staining respectively.Results Under anoxia,NRK-52E cells became round,enlarged and cytoskeleton was remodeled.The expression levels of CTGF mRNA and protein were up-regulated at 6 h,reached their peak at 48 h:the expression of CTGF mRNA protein was 29.33±0.21 and 1.30±0.02 respectively.Under anoxia,NRK-52E cells underwent an epithelial-mesenchymal transition process,including cytoskeleton remodeling,and morphological changes.Conclusion Anoxia can change the expression of CTGF and other fibrosis-associated genes in NRK-52E cells,and CTGF played an important role in fibrosis process and epithelial-mesenchymal transition development in NRK-52E cells.

Analysis of the management models of medical risk and prewarning supervision in four countries / 中华医院管理杂志

Comparison of the institutional setup, policies and adverse event report mechanism for medical risk control in the countries of UK, USA, Canada, and Australia by means of browsing information on their official websites. It is found that these countries maintain a national patient safety authority, coupled with a tiered management at national, local, medical institutions and NGOs level; the USA pattern features laws and regulations, that of UK and Australia features guidelines as policy guarantee for medical safety; these countries regulate adverse event reporting by either government leadership or cooperation with trade associations. Inspirations from this study suggest China to enhance institutional construction, complete regulations, and advocate the culture for medical safety, and to build the national-level reporting and study system for medical safety events, and improve medical risk management.

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement.

The Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical," to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement.

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical," to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.

Effects of different immunosuppressive agents on mesangial cell proliferation / 中华器官移植杂志

Objective To investigate the effects of different immunosuppressive agents on mesangial cell proliferation through a mesangial cell injury model in vitro. Methods Mesangial cell line (HBZY-1) in period of proliferation was cultured in vitro with cytochalasin B for 2 h, then HBZY-1 cells were divided into 5 groups: blank (control) group, cyclosporine A (CsA) group, Tacrolimus (Tac) group, mycophelonate mofetil (MMF) group and rapamycin (RAPA) group. Subsequently,the number of HBZY-1 cells at different time points was measured by using the professional image analysis software after treatment for 6, 12 and 24 h, respectively. Results Damaged HBZY-1 cells recovered in all groups. At 6 h, the number of HBZY-1 cells in Tac group was significantly more than that in control group (P＜0.05), but the difference had no significance between the other treatment groups and control group (P＞0. 05). At 12 h, there was no significant difference in of the number of HBZY-1 cells among the all groups (P＞0. 05). At 24 h, there was no significant difference in the cell number between MMF and control groups (P＞0. 05). CsA, Tac and RAPA resulted in HBZY-1 cell proliferation, and the cell number in CsA and Tac groups was significantly more than that in the other groups (P＜0. 05). As compared with the control group, the cell number in RAPA group was significantly increased (P＜0. 05). Conclusion CsA, Tac, MMF and RAPA contribute to recovery of damaged HBZY-1 cells, but CsA and Tac result in over-proliferation of HBZY-1 cells. RAPA and MMF can prevent HBZY-1 cells against over-proliferation, and MMF scarcely results in HBZY-1 cell proliferation.

B7-1 induces immunosuppression when expressed in cultured neonatal mice keratinocytes.

BACKGROUND: Chimeric (allo-auto or even xeno-auto) cultured keratinocyte grafting did not exhibit obvious acute rejection or chronic rejection. Although cultured murine keratinocytes were recognized by allogenic CD8+ T cells, they were not rejected. The precise mechanisms underlying this process were unclear. To analyze how keratinocytes attenuated the immune response, we investigated the effect of culturing on neonatal murine keratinocytes and their immunomodulatory properties. METHODS: Keratinocytes isolated and purified from BALB/c and C57BL/6 neonatal mice were cultured for 7 days. The expression of B7-1, B7-2, B7-H1 and MHC-I was examined by semi-quantitative RT polymerase chain reaction (PCR), fluorescence microscopy and flow cytometry. Cytotoxicity and mixed lymphocyte response (MLR) assays were performed to determine the effects of keratinocytes on cytotoxic T-lymphocyte (CTL) mediated cell lysis and lymphocyte proliferation. RESULTS: B7-1 was highly expressed in cultured, proliferating murine keratinocytes while no expression of B7-2 and B7-H1 was found. Keratinocytes that expressed B7-1 decreased CTL-mediated cell lysis by an interaction between B7-1 and CTLA-4. In addition, autologous keratinocytes but not allogeneic keratinocytes significantly suppressed auto-specific lymphocyte proliferation in a dose-dependent manner. The modulation was dependent on B7-1 expression and its interaction with CTLA-4. CONCLUSIONS: Cultured murine keratinocytes expressed B7-1, but not B7-2 or B7-H1. The keratinocytes attenuated CTL-mediated lysis and suppressed lymphocyte proliferation via an interaction with B7-1 and CTLA-4. Therefore, separate expression of B7-1 induced immunosuppression. Non-professional APCs (antigen presenting cells) which separately express B7-1 may possess an ability to induce immunotolerance and thus act as a regulatory APC.