1.Recommendations for Standardized Reporting of Systematic Reviews and Meta-Analysis of Animal Experiments
Qingyong ZHENG ; Donghua YANG ; Zhichao MA ; Ziyu ZHOU ; Yang LU ; Jingyu WANG ; Lina XING ; Yingying KANG ; Li DU ; Chunxiang ZHAO ; Baoshan DI ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(4):496-507
Animal experiments are an essential component of life sciences and medical research. However, the external validity and reliability of individual animal studies are frequently challenged by inherent limitations such as small sample sizes, high design heterogeneity, and poor reproducibility, which impede the effective translation of research findings into clinical practice. Systematic reviews and meta-analysis represent a key methodology for integrating existing evidence and enhancing the robustness of conclusions. Currently, however, the application of systematic reviews and meta-analysis in the field of animal experiments lacks standardized guidelines for their conduct and reporting, resulting in inconsistent quality and, to some extent, diminishing their evidence value. To address this issue, this paper aims to systematically delineate the reporting process for systematic reviews and meta-analysis of animal experiments and to propose a set of standardized recommendations that are both scientific and practical. The article's scope encompasses the entire process, from the preliminary preparatory phase [including formulating the population, intervention, comparison and outcome (PICO) question, assessing feasibility, and protocol pre-registration] to the key writing points for each section of the main report. In the core methods section, the paper elaborates on how to implement literature searches, establish eligibility criteria, perform data extraction, and assess the risk of bias, based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement, in conjunction with relevant guidelines and tools such as Animal Research: Reporting of in Vivo Experiments (ARRIVE) and a risk of bias assessment tool developed by the Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE). For the presentation of results, strategies are proposed for clear and transparent display using flow diagrams and tables of characteristics. The discussion section places particular emphasis on how to scientifically interpret pooled effects, thoroughly analyze sources of heterogeneity, evaluate the impact of publication bias, and cautiously discuss the validity and limitations of extrapolating findings from animal studies to clinical settings. Furthermore, this paper recommends adopting the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to comprehensively grade the quality of evidence. Through a modular analysis of the entire reporting process, this paper aims to provide researchers in the field with a clear and practical guide, thereby promoting the standardized development of systematic reviews and meta-analysis of animal experiments and enhancing their application value in scientific decision-making and translational medicine.
2.Vertebral fractures combined with prolonged activated partial prothrombin time:A case report
Xinzhu BAI ; Jinhui HE ; Songsong LU ; Chun LI ; Yilin WANG ; Jian XIONG
Journal of Peking University(Health Sciences) 2024;56(2):371-374
With the development of modern medical standards,autoimmune diseases and their associ-ated successive osteoporosis have received increasing attention in recent years.Patients with autoimmune diseases,due to the characteristics of the disease and the prolonged use of glucocorticoid hormone thera-py,may affect the bone formation and bone absorption of the patient,followed by severe successive osteo-porosis,thereby increasing the risk of osteoporotic vertebral fractures.Vertebral compression fractures of the spine are common fracture types in patients with osteoporotic fractures.Osteoporosis is a common complication after glucocorticoid therapy in patients with autoimmune diseases.Percutaneous vertebro-plasty(PVP)and percutaneous kyphoplasty(PKP)are minimally invasive operation and are commonly used surgical methods for the treatment of osteoporotic vertebral compression fractures.However,due to the operation of spinal puncture during the operation,there are serious surgical risks such as bone cement leakage,spinal epidural hemorrhage,subdural hemorrhage,and subarachnoid hemorrhage in both PVP and PKP.As a result,it is necessary to evaluate the patient's body before surgery carefully,especially in the case of blood coagulation.This article reports a case of autoimmune disease patient admitted to Peking University People's Hospital due to lumbar 4 vertebral compression fracture combined with Sj?gren's syn-drome.The patient's preoperative examination showed that the activated partial thromboplastin time(APTT)was significantly prolonged.After completing the APTT extended screening experiment and lu-pus anticoagulant factor testing,the multi-disciplinary team(MDT)of Peking University People's Hospi-tal jointly discussed the conclusion that the patient's test results were caused by an abnormal self-immuni-ty anti-copulant lupus(LAC).Based on the results of the laboratory examination,the patient was con-sidered to be diagnosed with combined antiphospholipid syndrome(APS).For such patients,compared with the patient's tendency to bleed,we should pay more attention to the risk of high blood clotting in the lower limbs of the patient,pulmonary clots and so on.With timely anti-coagulation treatment,the patient safely passed the peripheral period and was successfully discharged from the hospital.Therefore,for pa-tients with autoimmune diseases with prolonged APTT in the perioperative period,doctors need to careful-ly identify the actual cause and carry out targeted treatment in order to minimize the risk of surgical and perioperative complications and bring satisfactory treatment results to the patients.
3.Method for Developing Patient Decision Aid in China
Yao LU ; Qian ZHANG ; Qianji CHENG ; Jianing LIU ; Mingyao SUN ; Jinling NING ; Jiajie HUANG ; Simeng REN ; Wenzheng ZHANG ; Yajie LIU ; Xiyuan DENG ; Jinhui TIAN ; Jie LIU ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1422-1431
To systematically construct a guideline to provide a methodological guide for researchers to develop patient decision aids. Through a literature review of international methodological guidance for developing patient decision aids, sorting out the similarities and differences in the processes and methods for developing patient decision aids, and combining them with the topic discussion of the working group, the initial guideline was drafted. A total of 13 guidances was included, with the initial version containing 3 phases, 13 steps, and 48 points. We invited 19 multidisciplinary domain experts for forming consensus. The final version of the guideline contains 3 phases, 11 steps, and 24 points. The guideline has great potential to guide the development of patient decision aids in China and is expected to fill the methodological gap in the field. In the future, several rounds of pilot testing of the guideline based on specific decision issues will be conducted, and the guideline will be further revised and improved.
4.Method for Developing Patient Decision Aid in China
Yao LU ; Qian ZHANG ; Qianji CHENG ; Jianing LIU ; Mingyao SUN ; Jinling NING ; Jiajie HUANG ; Simeng REN ; Wenzheng ZHANG ; Yajie LIU ; Xiyuan DENG ; Jinhui TIAN ; Jie LIU ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1422-1431
To systematically construct a guideline to provide a methodological guide for researchers to develop patient decision aids. Through a literature review of international methodological guidance for developing patient decision aids, sorting out the similarities and differences in the processes and methods for developing patient decision aids, and combining them with the topic discussion of the working group, the initial guideline was drafted. A total of 13 guidances was included, with the initial version containing 3 phases, 13 steps, and 48 points. We invited 19 multidisciplinary domain experts for forming consensus. The final version of the guideline contains 3 phases, 11 steps, and 24 points. The guideline has great potential to guide the development of patient decision aids in China and is expected to fill the methodological gap in the field. In the future, several rounds of pilot testing of the guideline based on specific decision issues will be conducted, and the guideline will be further revised and improved.
5.Analysis of Relationship between Serum lncRNA HIF1A-AS1,CXCL9 and Disease Severity,Adverse Pregnancy Outcomes in Patients with Preeclampsia
Jinhui ZHANG ; Weiling LI ; Lu YAN
Journal of Modern Laboratory Medicine 2024;39(6):73-78,140
Objective To explore the relationship between serum long non-coding RNA hypoxia-inducible factor 1 alpha antisense RNA 1(lncRNA HIFA1-AS1),CXC chemokine ligand 9(CXCL9)and disease severity,adverse pregnancy outcome in patients with preeclampsia.Methods A total of 83 patients with preeclampsia admitted to Xi'an Gaoxin Hospital January 2021 to December 2022 were taken as preeclampsia group,According to the time of diagnosis,patients with preeclampsia were divided into early onset preeclampsia group(n=39)and late onset preeclampsia group(n=44).According to the severity of the condition,patients with preeclampsia were divided into two groups:mild preeclampsia group(n=51)and severe preeclampsia group(n=32).According to pregnancy outcomes,they were divided into a normal pregnancy outcome group(n=56)and an adverse pregnancy outcome group(n=27).At the same time,60 healthy pregnant women with pregnancy were collected as control group.Real-time fluorescence quantitative PC(qRT-PCR)was used to detect serum lncRNA HIF1A-AS1,and enzyme-linked immunosorbent assay(ELISA)was used to detect serum CXCL9.Spearman rank correlation analysis was used to analyze the association between serum lncRNA HIF1A-AS1,CXCL9 and severity of disease.Logistic regression analysis was used to analyze the factors influencing the adverse pregnancy outcome in patients with preeclampsia.ROC curve was drawn to assess the predictive value of serum lncRNA HIF1A-AS1,CXCL9 for adverse pregnancy outcome.Results The relative expression of serum lncRNA HIF1A-AS1(0.73±0.26)in preeclampsia group was lower than that(1.15±0.34)in control group,and CXCL9 level(209.34±45.34 pg/ml)higher than that(116.80±37.76 pg/ml)in control group,the differences were statistically significant(t=8.379,12.903,all P<0.05).The relative expression of serum lncRNA HIF1A-AS1(0.58±0.21)in early-onset preeclampsia group was lower than that in late-onset preeclampsia group(0.86±0.27),and CXCL9 level(236.60±31.02 pg/ml)higher than that in late-onset preeclampsia group(185.18±23.63 pg/ml),the differences were statistically significant(t=5.226,8.551,all P<0.05).The relative expression of serum lncRNA HIF1A-AS1(0.52±0.21)in severe preeclampsia group was lower than that in late-onset preeclampsia group(0.97±0.34),and CXCL9 level(253.38±41.20 pg/ml)higher than that in late-onset preeclampsia group(159.65±40.79 pg/ml),the differences were statistically significant(t=6.409,10.152,all P<0.05).Serum lncRNA HIF1A-AS1 and CXCL9 were associated with condition of preeclampsia(r=-0.627,0.651,all P<0.05).CXCL9[OR(95%CI):1.581(1.098~2.276)]was independent risk factor for adverse pregnancy outcome in patients with preeclampsia(P<0.05).LncRNA HIF1A-AS1[OR(95%CI):0.806(0.673~0.965)]was a protective factor(P<0.05),and early-onset preeclampsia[OR(95%CI):1.390(1.088~1.775)]and severe preeclampsia[OR(95%CI):1.589(1.222~2.066)]were risk factors for adverse pregnancy outcome(all P<0.05).Serum lncRNA HIF1A-AS1,CXCL9 and indicators combined had predictive value for adverse pregnancy outcome in patients with preeclampsia,with AUC of 0.770,0.767 and 0.876,respectively.And the combined prediction AUC was better than single indicator,and differences were statistically significant(Z=2.455,2.398,all P<0.05).Conclusion Serum lncRNA HIF1A-AS1 expression is down-regulated and CXCL9 expression is up-regulated in patients with preeclampsia,both indicators are associated with severity of disease and adverse pregnancy outcome.Early detection of two indicators are expected to be markers for predicting adverse pregnancy outcome in patients with preeclampsia.
6.Efficacy of Jiangsha Banxia nano-paste on nausea and vomiting in end-stage patients and its effect on QOL in cancer patients
Tianhong ZHANG ; Xiufeng LIU ; Hua WANG ; Xiujuan DING ; Haimin DAI ; Ping HU ; Weifeng WANG ; Qing LU ; Feng XU ; Wanhong HE
Journal of Pharmaceutical Practice 2023;41(6):380-384
Objective To observe the clinical efficacy of Jiangshabanxia nano-paste on nausea and vomiting in end-stage patients and its effect on the quality-of-life (QOL) in cancer patients. Methods 120 end-stage patients with nausea and vomiting symptoms above grade III were randomly divided into observation group and control group. They were treated with Jiangshabanxia nano-paste and placebo paste respectively. The paste patch was changed every 24 hours and used continuously for 7 days. The nausea and vomiting symptom score, the quality-of-life measurement score and KPS score of cancer patients in the two groups were observed to evaluate the curative effect. Results After 7 days of treatment, the symptom scores of nausea and vomiting in the observation group decreased significantly, the KPS score of the observation group increased, and the effective rate was higher than that in the control group. The score of QOL measurement showed that after treatment, the score of main symptom areas and other symptom areas (except external dyspnea, diarrhea and economic difficulties) in the observation group decreased, and the score of overall health area increased. After treatment, the score of main symptom areas and other symptom areas (except external dyspnea, diarrhea and economic difficulties) in the observation group was lower than that in the control group, and the scores of overall health area in the observation group were higher than those in the control group. Conclusion Jiangshabanxia nano-paste has a good clinical efficacy nausea and vomiting in end-stage patients, it also can improve the quality of life end-stage cancer patients.
7.Association between low ambient temperature during pregnancy and adverse birth outcomes: A systematic review and meta-analysis.
Tiechao RUAN ; Yan YUE ; Wenting LU ; Ruixi ZHOU ; Tao XIONG ; Yin JIANG ; Junjie YING ; Jun TANG ; Jing SHI ; Hua WANG ; Guoguang XIAO ; Jinhui LI ; Yi QU ; Dezhi MU
Chinese Medical Journal 2023;136(19):2307-2315
BACKGROUND:
Extreme temperature events, including extreme cold, are becoming more frequent worldwide, which might be harmful to pregnant women and cause adverse birth outcomes. We aimed to investigate the association between exposure to low ambient temperature in pregnant women and adverse birth outcomes, such as preterm birth, low birth weight, and stillbirth, and to summarize the evidence herein.
METHODS:
Relevant studies were searched in PubMed, Cochrane, and Embase electronic databases until November 2021. Studies involving low ambient temperature, preterm birth, birth weight, and stillbirth were included. The guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses were followed to conduct this study risk of bias and methods for data synthesis.
RESULTS:
A total of 34 studies were included. First, pregnant women exposed to low ambient temperature had an increased risk of preterm birth (risk ratio [RR] 1.08; 95% confidence interval [CI] 1.04-1.13). Subgroup analyses revealed that exposure during late pregnancy was more likely to induce preterm birth. In addition, only pregnant women exposed to <1st percentile of the mean temperature suffered increased risk of preterm birth. Moreover, pregnant women living in medium or hot areas were more prone to have preterm births than those in cold areas when exposed to low ambient temperatures. Asians and Blacks were more susceptible to low ambient temperatures than Caucasians. Second, pregnant women exposed to low ambient temperature had an increased risk of low birth weight (RR 1.07; 95% CI 1.03-1.12). Third, pregnant women had an increased risk of stillbirth while exposed to low ambient temperature during the entire pregnancy (RR 4.63; 95% CI 3.99-5.38).
CONCLUSIONS:
Exposure to low ambient temperature during pregnancy increases the risk of adverse birth outcomes. Pregnant women should avoid exposure to extremely low ambient temperature (<1st percentile of the mean temperature), especially in their late pregnancy. This study could provide clues for preventing adverse outcomes from meteorological factors.
REGISTRATION
No. CRD42021259776 at PROSPERO ( https://www.crd.york.ac.uk/PROSPERO/ ).
Pregnancy
;
Infant, Newborn
;
Female
;
Humans
;
Pregnancy Outcome
;
Premature Birth/epidemiology*
;
Stillbirth/epidemiology*
;
Temperature
;
Pregnancy Complications
8.Analysis of phenotype and pathogenic variants in a Chinese pedigree affected with Multiple synostoses syndrome type 1.
Wenyuan ZHANG ; Lu MAO ; Jinhui ZHANG ; Hongen XU ; Bei CHEN
Chinese Journal of Medical Genetics 2023;40(9):1118-1123
OBJECTIVE:
To explore the clinical and genetic characteristics of a Chinese pedigree affected with Multiple synostoses syndrome type 1 (SYNS1).
METHODS:
Clinical data of the proband and her family members were collected. Genomic DNA was extracted from peripheral blood samples. Whole-exome sequencing (WES) and whole-genome sequencing (WGS) were carried out for the proband and her parents.
RESULTS:
The pedigree has comprised of 14 members from three generations, of whom six had manifested hearing loss, with other symptoms including proximal symphalangism, hemicylindrical nose, amblyopia, strabismus, brachydactyly, incomplete syndactyly, which fulfilled the diagnostic criteria for SYNS1. WES had detected no pathogenic single nucleotide variants and insertion-deletion (InDel) in the coding region of the NOG gene, whilst copy number variation (CNV) analysis indicated that there was a heterozygous deletion involving the NOG gene. WGS revealed a heterozygous deletion (54171786_55143998) in 17q22 of the proband. The CNV was classified as pathogenic based on the guidelines from the American College of Medical Genetics and Genomics (ACMG).
CONCLUSION
The heterozygous deletion in 17p22 involving the NOG gene probably underlay the pathogenesis of SYNS1 in this pedigree. Above finding has enriched the mutational spectrum of NOG. CNV should be considered when conventional sequencing has failed to detect any pathogenic variants in such patients.
Female
;
Humans
;
DNA Copy Number Variations
;
East Asian People
;
Pedigree
;
Synostosis
;
Phenotype
9.Risk factors of substandard drug blood concentration of meropenem in patients with hospital -acquired pneumonia
Lu SHI ; Fang CHEN ; Guangxian LU ; Lufen DUAN ; Jian LU ; Zhiwei ZHUANG ; Jinhui XU ; Hongtao XU ; Chao WU ; Qin ZHOU ; Lian TANG
China Pharmacy 2022;33(19):2388-2392
OBJECTIVE To analyze the risk factors of substandard drug blood concentration of meropenem in patients with hospital acquired pneumonia (HAP). METHODS Totally 130 HAP patients who were admitted to the intensive care unit of Suzhou Hospital Affiliated to Nanjing Medical University from January 2020 to June 2021 and received steady -state blood concentration test of meropenem were selected as the study subjects . The patient ’s age ,sex,body mass and other medical history were recorded . The steady-state blood trough concentration of meropenem was determined and its target was determined . Univariate and multivariate Logistic regression analysis were used to screen the risk factors for the substandard steady -state blood trough concentration of meropenem. The receiver operating characteristic (ROC)curve was drawn to screen the warning value of the risk factors and evaluate the predictive value of the risk factors . RESULTS The steady -state blood trough concentrations of 85 cases were ≥2 mg/L, and those of 45 cases were <2 mg/L. Multivariate Logistic regression analysis showed that age ,negative balance and brain injury were independent risk factors for the substandard steady-state blood trough concentration of meropenem (P< 0.05).ROC curve showed that when the patient was 58 years old,the area under the ROC curve was the largest (0.744), the sensitivity was 0.882,the specificity was 0.556,and the Youden index was 0.438;when the negative balance was 520.5 mL/24 h,the area under the ROC curve reached the maximum (0.827),the sensitivity was 0.722,the specificity was 0.905,and th e Youden index was 0.628. The creatinine clearance rate in the brain injury group was significantly higher than that in the non -brain injury group ,and the steady -state blood trough concentration of meropenem in the brain injury group was significantly lower than that in the non -brain injury group (P<0.001). CONCLUSIONS When the HAP patient ’s age is less than 58 years old ,the brain injury and the negative balance is more than 520.5 mL/24 h,the risk of substandard steady -state blood trough concentration of meropenem will increase .
10.QUADAS-C—A tool for assessing risk of bias regarding Quality Assessment of Diagnostic Accuracy Studies-Comparative
Qiuyu YANG ; Yao LU ; Xinling XIE ; Honghao LAI ; Chen TIAN ; Meng NIU ; Jinhui TIAN ; Ni LI ; Jiang LI ; Long GE
Chinese Journal of Epidemiology 2022;43(6):938-944
This paper introduced the Quality Assessment of Diagnostic Accuracy Studies-Comparative (QUADAS-C), illustrated the comparison with the QUADAS-2, and using QUADAS-C together with QUADAS-2 to present QUADAS-C results through systematic reviews. Like the domain for QUADAS-2, QUADAS-C retained four domains, including patient selection, index test, reference standard, flow, and timing, and comprised additional questions for each QUADAS-2 part. Unlike the QUADAS-2 tool, the starting question of each domain for QUADAS-C was designed to summarize the risk of biased information captured by QUADAS-2. QUADAS-C only dealt with the risk of bias but did not include the part of concerns regarding applicability. The answers to signaling questions for each domain of QUADAS-C would lead to a 'low''high' or 'unclear' risk of biased judgment for the original study.

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