To introduce and analyze guideline terminology related to clinical question formulation, evidence retrieval and appraisal, and recommendation development.

OBJECTIVE To construct the drug utilization evaluation criteria for Dezocine injection， so as to provide reference for the rational drug use in medical institutions. METHODS On the basis of evidence methodology， relevant guidelines/expert consensus， systematic reviews/meta-analysis were consulted； the evaluation criteria framework for Dezocine injection was established after screening evidence. Delphi method was employed， whereby 28 clinicians and clinical pharmacists from secondary and above-level medical institutions across eight provinces， including Tianjin， Beijing and Shandong， were selected to participate in two rounds of questionnaire surveys. The final indicators were determined based on the experts’ enthusiasm coefficient， authority coefficient， and degree of coordination. RESULTS The effective recovery rate of questionnaire was 100% in the first round and 92.86% in the second round； expert authority coefficient was 0.82 in the first round and 0.81 in the second round； the coordination degree of experts in the first round was 0.29， and in the second round was 0.31 （P＜0.001）. Drug utilization evaluation standard system for Dezocine injection was formed finally， including three dimensions of medication indications， medication process and medication results， with a total of 11 first-level indicators （such as indications， usage and dosage） and 33 second-level indicators （such as labor analgesia and the management of severe pain following major or moderate surgeries combined with other analgesic drugs）. The average importance scores for each indicator ranged from 4.08 to 5.00 points， with an overall average score of 4.61 points and coefficient of variation ranging from 0 to 0.19. CONCLUSIONS The drug utilization evaluation criteria for Dezocine injection established based on evidence-based methodology and Delphi method is authoritative and scientific， which provides a reference for subsequent evaluation of the rationality of clinical medication.

BACKGROUND: Preclinical studies have indicated that Angong Niuhuang Pills (ANP) reduce cerebral infarct and edema volumes. This study aimed to investigate whether ANP safely reduces cerebral infarct and edema volumes in patients with moderate to severe acute ischemic stroke. METHODS: This randomized, double-blind, placebo-controlled pilot trial included patients with acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores ranging from 10 to 20 in 17 centers in China between April 2021 and July 2022. Patients were allocated within 36 h after onset via block randomization to receive ANP or placebo (3 g/day for 5 days). The primary outcomes were changes in cerebral infarct and edema volumes after 14 days of treatment. The primary safety outcome was severe adverse events (SAEs) for 90 days. RESULTS: There were 57 and 60 patients finally included in the ANP and placebo groups, respectively for modified intention-to-treat analysis. The median age was 66.0 years, and the median NIHSS score at baseline was 12.0. The changes in cerebral infarct volume at day 14 were 0.3 mL and 0.4 mL in the ANP and placebo groups, respectively (median difference: -7.1 mL; interquartile range [IQR]: -18.3 to 2.3 mL, P = 0.30). The changes in cerebral edema volume of the ANP and placebo groups on day 14 were 11.4 mL and 4.0 mL, respectively ( median difference: 3.0 mL, IQR: -1.3 to 9.9 mL, P = 0.15). The rates of SAE within 90 days were similar in the ANP (3/57, 5%) and placebo (7/60, 12%) groups ( P = 0.36). Changes in serum mercury and arsenic concentrations were comparable. In patients with large artery atherosclerosis, ANP reduced the cerebral infarct volume at 14 days (median difference: -12.3 mL; IQR: -27.7 to -0.3 mL, P = 0.03). CONCLUSIONS: ANP showed a similar safety profile to placebo and non-significant tendency to reduce cerebral infarct volume in patients with moderate-to-severe stroke. Further studies are warranted to assess the efficacy of ANP in reducing cerebral infarcts and improving clinical prognosis. TRAIL REGISTRATION Clinicaltrials.gov , No. NCT04475328.
Aged ; Female ; Humans ; Male ; Middle Aged ; Double-Blind Method ; Drugs, Chinese Herbal/adverse effects* ; Ischemic Stroke/drug therapy* ; Pilot Projects ; Stroke/drug therapy* ; Treatment Outcome

BACKGROUND: The STAR (Scientific, Transparent, and Applicable Rankings) working group conducts regular evaluations of Chinese guidelines and consensus statements. This study gathered insights from STAR working group members using qualitative interviews. METHODS: From March to August 2023, members of the STAR specialist committees were interviewed using semi-structured interview outline. The interviewees were selected through purpose-based sampling. Subject analysis was employed to summarize the findings. RESULTS: We conducted interviews with 37 members from 36 committees and summarized the contents into four main themes and 16 specific topics. The value of STAR in enhancing the development and selection of high-quality guidelines in China was commonly mentioned. Challenges identified included the lack of resources and suboptimal organizational structures, collaboration, and evaluation efficiency. Suggestions for the STAR tool included developing extensions for different guideline types, adjusting certain items, and better covering guideline applicability. The promotion of STAR and the consideration of an international committee for global outreach were also highlighted. CONCLUSION STAR has exerted a substantial influence on the evaluation of Chinese guidelines, and the insights gained from interviews offer valuable directions for its further enhancement.
Humans ; China ; Qualitative Research ; Practice Guidelines as Topic ; Interviews as Topic

Objective To explore the standardized management mode of the Ethics Committee for organ donation after citizen’s death in hospitals. Methods The situations of ethical review before and after the standardized adjustment of the Ethics Committee of human organ donation in the First Affiliated Hospital of Chongqing Medical University were retrospectively analyzed. Baseline data of donors before and after standardized adjustment of the Ethics Committee of human organ donation were compared. The influence of standardized adjustment of the Ethics Committee on the attendance rate of committee members and duration of ethical review were analyzed. Results No significant differences were observed in donors' ethical review data, such as gender, age and death determination, before and after standardized adjustment of Ethics Committee structure (all P>0.05). Significant difference was noted regarding the cause of death in ethical review (P<0.05). Univariate analysis showed that there were significant differences in the impact of Ethics Committee standardization adjustment and cause of death on the attendance rate of committee members (both P<0.05). Multivariate analysis revealed that gender, cause of death and standardized adjustment of the Ethics Committee were the influencing factors of the attendance rate of committee members, and the attendance rate of committee members after standardized adjustment was higher than that before adjustment (P<0.05). Univariate analysis showed that there were statistically significant differences in the effects of Ethics Committee standardized adjustment, attendance rate of committee members and cause of death on the duration of ethical review (all P<0.05). Multivariate analysis indicated that standardized adjustment of the ethics committee was the influencing factor of the duration of ethical review, and the duration of ethics review after standardized adjustment was shorter than that before adjustment (P<0.05). Conclusions Appropriate arrangement of the total number of ethics committee members and standardizing the review process may improve the efficiency of ethical review. Scientific evaluation mechanism for ethical committee members should be established by dynamically adjusting the ethical committee members, clarifying the responsibilities and tasks of members and secretaries, aiming to further improve standardized management level of ethical review for organ donation after citizen’s death.

Objective To observe the expression of triggering receptor-1 on myeloid cells (TREM-1) of mice with acute lung injury (ALI) in oder to find out its regularity and significance in inflammatory response of or-ganisms. Method Thirty BALB/C mice were randomly(random number) divided into normal control group (n =6) and ALl group (n = 24). The models of ALI were made with intraperitonal injection of lipopolysaccharide (LPS) in dose of 10 mg/kg. Specimens from peripheral blood and lung tissue were collected 6 h, 12 h, 24 h and 48 h after LPS injected. The fluorescent real-time quantitative reverse transcriptiun-polymerase chain (RT-PCR) was used to detect TREM-1 mRNA, and ELISA was employed for detection of TREM-1 protein and TNF-α protein, and HE staining was made doe the pathological Smith lung score under light microscope. Analysis of variance was used for comparison of TREM-1 mRNA, TNF-α and Smith lung injury score between two groups. Spearman corre-lation analysis was made to find out the relationship among these three variables. Results The expressions of TREM-1 mRNA in lung tissue of ALI mice 6 h, 12 h, 24 h, and 48 hours after injection of LPS were 6.61±0.08,34.71±0.83, 61.85±14.05 and 56.46±8.89, respectively which were higher than that in control group (1.00±0.00, P = 0.017, 0.009, 0.002 and 0.003, respectively). The expressions of TREM-1 mRNA in blood were 14.01±3.24, 47.07±0.98, 8.18±0.43 and 8.06±0.05, respectively which were higher than that in normal control group (1.00±0.00, P = 0.010, 0.004, 0.011 and 0.011, respectively). The expression of TREM-1 rnRNA in tissue began to increase 6 hours after modeling and reached its peak 24 hours later, and expres-sion of TREM-1 mRNA in blood reached its peak after 12 hours. The levels of TREM-1 protein in lung tissue of ALl mice 6 h,12 h,24 h and 48 hours after LPS injected were 997.8±114.62, 1579.70±45.92, 1123.9±108.2 and 429.8±89.96 pg/mL, respectively which were higher than that of mice in control group (279.22±4.62 pg/mL, P = 0.024, 0.007, 0.011 and 0.04, respectively). The level of TREM- 1 protein reached the peak 12 hours after LPS injected, but it had no significant correlation with the expression of TREM-1 mRNA (P =0.14). The levels of TNF-α protein in lung tissue of ALI mice 6 h, 12 h, 24 h and 48 hours after LPS injection were 313.16±39.50, 491.91±96.65, 388.48±29.84 and 282.5±52.76 pg/mL, respectively which were sig-nificantly higher than that of mice in control group (256.6±28.31 pg,/mL, P = 0.037, 0.019, 0.032 and 0.043, respectively). The TNF-α concentration was positively correlated with TREM-1 levels in lung tissue and with Smith pathological score (r = 0.795, P = 0.001: r = 0.499, P = 0.034), but not with the expression of TREM-1 mRNA (P = 0.176). Conclusions The expression of TREM-1 mRNA in lung tissue of mice with ALI is elevated, and the expression of TREM-1 mRNA is related to the level of TNF-α and the severity of the ALI in in-flammatory responses in lung. The expressions of TREM- 1 gene are not consistent with the levels of TREM- 1 pro-tein, suggesting another new functional proteins involved in immune regulation.