Objective:To evaluate the clinical efficacy of pars plana vitrectomy (PPV) with internal limiting membrane peeling and gas tamponade in the management of optic disc pit maculopathy (ODP-M).Methods:A retrospective case analysis. From 2002 to 2021, 16 patients (16 eyes) diagnosed with ODP-M at Department of Ophthalmology of Peking University Third Hospital and Eye Center of Peking University People's Hospital were included in the study. All affected eyes underwent best corrected visual acuity (BCVA), intraocular pressure, color fundus photography and optical coherence tomography (OCT) examinations. BCVA assessment was conducted using a standard logarithmic visual acuity chart, and during statistics, it was converted to the logarithmic minimum angle of resolution (logMAR) visual acuity. According to the treatment methods, the affected eyes were divided into the laser treatment group and the surgical treatment group, with 2 and 14 eyes respectively. The affected eyes in the laser treatment group were only given simple laser photocoagulation treatment. All the affected eyes in the surgical treatment group underwent PPV combined with internal limiting membrane peeling and vitreous cavity filling with 16% SF 6. Among them, autologous platelet concentrate (APC) was simultaneously used in 5 eyes. The follow-up period after the operation was 13.5 (3-138) months. The differences in the absorption of subretinal fluid (SRF) and the improvement of BCVA in the macular area between the two groups of affected eyes were compared and observed. The absorption of SRF in the macular area measured by OCT was used as the criterion for judging the effectiveness of treatment. The Mann-Whitney U test was used for comparison between the two groups. Results:In the surgical treatment group, SRF in the macular area was completely absorbed in 14 eyes, and the complete absorption time was 7.0 (2-23) months. In the laser treatment group, SRF was not absorbed in both eyes. The logMAR BCVA of the surgical treatment group before and after the operation was 0.7 (0.3-2.0) and 0.4 (0.1-1.3), and the difference was statistically significant ( Z=2.809, P=0.005). The logMAR BCVA before and after the operation of the eyes with combined APC filling and those without combined APC filling were 0.6 (0.3-1.0) and 0.5 (0.1-0.7), as well as 0.7 (0.3-2.0) and 0.4 (0.2-1.3), respectively. There was no statistically significant difference in logMAR BCVA between the two after surgery ( Z=0.609, P=0.543). Conclusions:PPV combined with internal limiting membrane peeling and gas tamponade can effectively promote the absorption of SRF in the macular area of eyes with ODP-M, achieve anatomical macular restoration, and improve BCVA. Combined APC filling

Objective To investigate the labeling of dialysis-related information in the instructions of drugs for systemic use in patients with end-stage renal disease undergoing hemodialysis,and to provide reference for further standardization and im-provement of drug instructions.Methods Collected the information on pharmacokinetics and drug dose adjustment in hemodi-alysis patients with end-stage renal disease from the instructions of chemicals and biologics used systemically in XuanWu hospital's formulary from January to March 2023.Classified and compared the labeling rates of the corresponding information of the originally developed drugs and generic drugs,imported drugs and domestic drugs;Drugs eliminated by non-renal route,or with mo-lecular weight≥5 000,or binding rate of plasma protein ≥ 60％,or drug distribution volume＞360L were classified as"non-dialysis group",and other drugs were classified as"dialysis group",compared the labeling rate of corresponding information of drugs in"dialysis group"and"non-dialysis group";and compared the labeling rate and content with relevant information in Lexicomp and Micromedex.Results Among the 930 drug instructions,the labeling rates of drug dialysis clearance,drug adjustment,and ex-plicit drug adjustment plan were 16.67％,25.16％,and 24.52％.There was no significant difference in the labeling rate of dialysis-related information between original and generic drugs,and imported and domestic drugs.There was a significant difference in the labeling rate of dialysis-related information between the"dialyzable group"and the"non-dialyzable group"(P＜0.01).The differ-ence in the labeling rate of dialysis related information between the investigated drug instructions and the corresponding drugs in Lexicomp or Micromedex was statistically significant(P＜0.01).Conclusion Attention should be paid to the lack of informa-tion and unclear labeling of hemodialysis patients with end-stage renal disease in the drug instructions by relevant departments.

Objective To investigate the labeling of dialysis-related information in the instructions of drugs for systemic use in patients with end-stage renal disease undergoing hemodialysis,and to provide reference for further standardization and im-provement of drug instructions.Methods Collected the information on pharmacokinetics and drug dose adjustment in hemodi-alysis patients with end-stage renal disease from the instructions of chemicals and biologics used systemically in XuanWu hospital's formulary from January to March 2023.Classified and compared the labeling rates of the corresponding information of the originally developed drugs and generic drugs,imported drugs and domestic drugs;Drugs eliminated by non-renal route,or with mo-lecular weight≥5 000,or binding rate of plasma protein ≥ 60％,or drug distribution volume＞360L were classified as"non-dialysis group",and other drugs were classified as"dialysis group",compared the labeling rate of corresponding information of drugs in"dialysis group"and"non-dialysis group";and compared the labeling rate and content with relevant information in Lexicomp and Micromedex.Results Among the 930 drug instructions,the labeling rates of drug dialysis clearance,drug adjustment,and ex-plicit drug adjustment plan were 16.67％,25.16％,and 24.52％.There was no significant difference in the labeling rate of dialysis-related information between original and generic drugs,and imported and domestic drugs.There was a significant difference in the labeling rate of dialysis-related information between the"dialyzable group"and the"non-dialyzable group"(P＜0.01).The differ-ence in the labeling rate of dialysis related information between the investigated drug instructions and the corresponding drugs in Lexicomp or Micromedex was statistically significant(P＜0.01).Conclusion Attention should be paid to the lack of informa-tion and unclear labeling of hemodialysis patients with end-stage renal disease in the drug instructions by relevant departments.

Objective:To evaluate the clinical efficacy of pars plana vitrectomy (PPV) with internal limiting membrane peeling and gas tamponade in the management of optic disc pit maculopathy (ODP-M).Methods:A retrospective case analysis. From 2002 to 2021, 16 patients (16 eyes) diagnosed with ODP-M at Department of Ophthalmology of Peking University Third Hospital and Eye Center of Peking University People's Hospital were included in the study. All affected eyes underwent best corrected visual acuity (BCVA), intraocular pressure, color fundus photography and optical coherence tomography (OCT) examinations. BCVA assessment was conducted using a standard logarithmic visual acuity chart, and during statistics, it was converted to the logarithmic minimum angle of resolution (logMAR) visual acuity. According to the treatment methods, the affected eyes were divided into the laser treatment group and the surgical treatment group, with 2 and 14 eyes respectively. The affected eyes in the laser treatment group were only given simple laser photocoagulation treatment. All the affected eyes in the surgical treatment group underwent PPV combined with internal limiting membrane peeling and vitreous cavity filling with 16% SF 6. Among them, autologous platelet concentrate (APC) was simultaneously used in 5 eyes. The follow-up period after the operation was 13.5 (3-138) months. The differences in the absorption of subretinal fluid (SRF) and the improvement of BCVA in the macular area between the two groups of affected eyes were compared and observed. The absorption of SRF in the macular area measured by OCT was used as the criterion for judging the effectiveness of treatment. The Mann-Whitney U test was used for comparison between the two groups. Results:In the surgical treatment group, SRF in the macular area was completely absorbed in 14 eyes, and the complete absorption time was 7.0 (2-23) months. In the laser treatment group, SRF was not absorbed in both eyes. The logMAR BCVA of the surgical treatment group before and after the operation was 0.7 (0.3-2.0) and 0.4 (0.1-1.3), and the difference was statistically significant ( Z=2.809, P=0.005). The logMAR BCVA before and after the operation of the eyes with combined APC filling and those without combined APC filling were 0.6 (0.3-1.0) and 0.5 (0.1-0.7), as well as 0.7 (0.3-2.0) and 0.4 (0.2-1.3), respectively. There was no statistically significant difference in logMAR BCVA between the two after surgery ( Z=0.609, P=0.543). Conclusions:PPV combined with internal limiting membrane peeling and gas tamponade can effectively promote the absorption of SRF in the macular area of eyes with ODP-M, achieve anatomical macular restoration, and improve BCVA. Combined APC filling

Objective:To systematically identify and summarizes the weaknesses of the key aspects of Investigator-Initiated Clinical Trial (IIT) quality management in China, and quantitatively assess these weaknesses with a synthesis of relevant evidence, thereby providing references for the subsequent establishment of a complete IIT quality management system in China.Methods:According to the Scoping review report checklist (PRISMA-ScR statement), we conducted a systematic literature retrieval and screening, data extraction, and result synthesis of IIT quality management issues after defining the research questions.Results:73 eligible studies were eventually included. It was found that the most frequently explored issues were a lack of guidance and support from methodological and statistical experts at the project initiation stage (60.9%), a lack of research funding or improper funding management at the project implementation stage (49.3%), mismanagement of archival materials at the project completion stage (70.0%). Meta-analysis results showed that after evidence synthesis, the incidence of irregular informed consent signing, untraceable raw data, delayed study progress, and protocol violation were all above 40%, but there was heterogeneity in the results.Conclusion:Some outstanding issues in IIT quality management need to be addressed. Future studies should conduct more practical research to obtain quantitative data, undertake demonstrative application of management protocols, further carry out pioneering exploration and research in the field of IIT quality management, and propose effective solutions and strategies to improve IIT quality.

Objective:To systematically review the application of methods for controlling time-varying confounding in pharmaco-epidemiological studies.Methods:PubMed, Embase, CNKI, and Wanfang were searched for pharmaco-epidemiological studies involving time-varying confounding on June 15 th, 2020. The basic characteristics, drug exposure and outcome, time-varying confounders and the application of methods to control these confounders were analyzed. Results:A total of 298 articles were included. An increasing trend was observed in numbers of studies dealing with time-varying confounding in pharmaco-epidemiological studies in recent years. A total of 106 (35.6%) studies involved the safety or effectiveness of medication use in HIV/AIDS patients and 92 of them involved antiretroviral drugs. The most common outcome was mortality, while the most commonly concerned time-dependent confounders were laboratory examination results (179, 60.1%), comorbidities (136, 45.6%), and co-used medications (108, 36.2%). Marginal structure model (MSM) and inverse probability of treatment weighting (IPTW) were the most commonly used methods to control time-varying confounding factors (244, 81.9%). Compared with the results after properly controlling time-varying confounding, traditional methods adjusting only baseline confounders resulted in substantial bias (median 18.2%, interquartile range, 7.4%-40.8%). As for basic assumptions needed for causal methods controlling time-varying confounding, 28.9% and 64.8% of the included studies examined or discussed the assumptions of positivity and no unmeasured confounders, respectively.Conclusions:At present, most of the fields of drug therapy for chronic diseases still pay insufficient attention to time-varying confoundings. Information collected in routine medical practice, such as laboratory tests, comorbidities, and co-used drugs, was the most commonly concerned time-varying confounder. MSM and IPTW were the most commonly applied methods for dealing with time-varying confounding.

Objective: To assess the risk factors associated with nosocomial infection in patients with non-surgical basal ganglia intracranial hemorrhage (ICH) in the acute phase to provide evidence for prevention and intervention of nosocomial infections. Methods: Clinical data of 224 patients with non-surgical basal ganglia ICH from January 2014 to December 2018 in the Shenzhen People′s Hospital were analyzed. Patients were divided into 2 groups based on the presence or absence of infection. Clinical data between the two groups were compared including gender, age, past medical history, bleeding volume, hematoma growth rate, systolic blood pressure, diastolic blood pressure, GCS, NIHSS, WBC, RBC, FBI, PLT, CR, BUN, GLU, CRP, UA, CHOL, TG, LDL, HCY. Multivariate Logistic regression analysis and the area under the ROC curve were performed on meaningful variables (P<0.05) to determine the early independent predictors of risk factors for nosocomial infections. ResuIts: Nosocomial infection occurred in 47 of 224 patients, with an infection rate of 20.98%. Compared with infected group, non-infected group had a higher value of age [(63.91 ± 12.37) years vs. (58.66 ± 12.37) years, P=0.010], bleeding volume [(10.33 ± 7.94) ml vs. (7.61 ± 6.58) ml, P=0.034], hematoma growth rate [(7.34 ± 9.17) ml/h vs. (4.33 ± 6.77) ml/h, P=0.040], systolic blood pressure [(177.94 ± 25.28) mmHg (1 mmHg=0.133 kPa) vs. (164.85 ± 22.34) mmHg, P=0.001], NIHSS score [(7.89 ± 4.92) scores vs. (4.84 ± 4.59) scores, P<0.01], WBC [(9.50 ± 3.23) × 10⁹/L vs. (8.25 ± 2.28) × 10⁹/L, P=0.015], FBI [(3.44 ± 0.95) g/L vs. (3.03 ± 0.63) g/L, P=0.007], BUN [(7.01 ± 5.84) mmol/L vs. (4.95 ± 1.93) mmol/L, P=0.021], GLU [(7.27 ± 2.84) mmol/L vs. (5.96 ± 1.75), P=0.004] and CRP [(11.94 ± 21.4) mg/L vs. (4.39 ± 6.41) mg/L, P=0.021]. Multivariate Logistic regression analysis showed that systolic blood pressure (OR=1.021, 95% CI 1.005 -1.037, P=0.012), NIHSS score (OR=1.143, 95% CI 1.056 - 1.237, P=0.001), BUN (OR=1.174, 95% CI 1.025 - 1.344, P=0.020), CRP (OR=1.063, 95% CI 1.016 - 1.112, P=0.008) and age (OR=1.053, 95%CI 1.019 -1.089, P=0.002) was an independent risk factor for nosocomial infection in non-surgical basal ganglia ICH patients in the acute phase. The Area Under Curve (AUC) of the above independent risk factors was calculated, and the results showed that systolic blood pressure (AUC=0.653, 95% CI 0.564 -0.741, P=0.001), NIHSS score (AUC=0.679, 95% CI 0.592 - 0.767, P=0.000), BUN (AUC=0.617, 95% CI 0.526 - 0.708, P=0.014), CRP (AUC=0.691, 95% CI 0.614 - 0.768, P=0.000) and age (AUC=0.643, 95% CI 0.557 - 0.728, P=0.003) had an early predictive value for the occurrence of nosocomial infection in non-operative basal ganglia ICH patients in the acute stage. Conclusions The occurrence of nosocomial infections has identifiable and early predictive risk factors in patients with non-surgical basal ganglia ICH during acute phase. Therefore, controllable risk factors need to be controlled to reduce the incidence of nosocomial infections.

Objective To evaluate the correlation between serum uric acid with cognitive disorder after acute cere?bral infarction by prospective study. Methods Four hundred consecutively enrolled patients of acute cerebral infarction were divided into no cognitive impairment group and cognitive impairment group according to the assess of Montreal Cog?nitive Assessment (MoCA). Univariate analysises were conducted in the potential risk factors of cognitive impairment in?cluding age, sex, smoking, alcohol, hypertension, diabetes, dyslipidemia, level of education, infarction in key parts, atrial fibrillation, serum uric acid, blood homocysteine between two groups. The statistically significant indicators in univariate analysises were used as independent variables and the scores of MoCA were used as the dependent variable to conduct multiple linear regression analysis. The assessment on the risk of cognitive impairment after cerebral infarction were con?ducted according to serum uric acid, sex, age and TOAST classification further. Results Serum uric acid was indepen?dent risk factors of cognitive disorder after acute cerebral infarction. The risk of cognitive disorder after acute cerebral in?farction was significantly increased in patients with high level of serum uric acid than with normal level and the relative risk was 1.35,95%CI(1.098,1.660). Especially for the young, male or patients with cerebral infarction in classification of small artery occlusion, the risk increased further, and the relative risk was 1.513, 95%CI(1.092, 2.096)1.412, 95%CI (1.125, 1.771)and 1.464, 95%CI(1.128, 1.900)respectively. Conclusion Exaltation of Serum uric acid was indepen?dent risk factor of cognitive disorder after acute cerebral infarction. The risk of cognitive disorder after acute cerebral in?farction was significantly increased in patients with high level of serum uric acid than with normal level, and especially for the young, male and patients with cerebral infarction in classification of small artery occlusion, the risk increased fur?ther.

Objective To evaluate the risk of dyspepsia and anorexia due to glucagon-like peptide-1 receptor agonist(GLP-1 RA)in patients with type 2 diabetes mellitus(T2DM). Methods The electronic database of Chinese BioMedical Literature Database( CBMdisc ), Chinese Medical Current Contents( CMCC),Medline,EMbase,the Cochrane Library and web site of ClinicalTrials. gov were searched from inception to May 1st 2014. Those randomized controlled trials whose inclusion criteria including patients with T2DM as the research object,comparisons of GLP-1 RA and placebo or other conventional anti-diabetic drugs as the intervention measures,and dyspepsia and anorexia as the outcomes were collected. A traditional Meta-analysis and a Network Meta-analysis were used and relational graph and rank ordering figure of all the intervention measures were drawn. Results A total of 42 randomized controlled trials were enrolled into this study involving 20 916 patients with T2DM and 13 kinds of intervention measures comprised 7 kinds of GLP-1 RAs( exenatide,exenatide release agent,liraglutide, lixisenatide,taspoglutide, albiglutide, and dulaglutide ), 5 kinds of conventional anti-diabetic drugs ( insulin, metformin, sulfonylureas, sitagliptin, and thiazolidinediones ketones ), and placebo. The traditional Meta-analysis showed that,compared with placebo,the whole of GLP-1 RAs could increase the risks of dyspepsia[odds ratio(OR)=3. 04,95% confidence interval(CI):1. 79-5. 16]and anorexia (OR=2. 57,95%CI:1. 69-3. 91)and there were statistically significant differences(P <0. 05). The Network Meta-analysis showed that,compared with placebo,albiglutide,exenatide,exenatide release agent, liraglutide,lixisenatide,and taspoglutide could increase the risks of dyspepsia with statistically significant differences(all P<0. 05)and,of them,liraglutide was at the greatest risk and the risk was 7. 69(1/0. 13)times as high as that of the placebo. Compared with insulin,metformin,sulfonylureas,sitagliptin, and thiazolidinediones ketones,GLP-1 RAs could also increase the risks of dyspepsia in the patients with T2DM and,of them,liraglutide was at the greatest risk,which was 13. 58,4. 17(1/0. 24),3. 85(1/0. 26),5. 00(1/0. 20),and 3. 70(1/0. 27)as high as that of insulin,metformin,sulfonylureas, sitagliptin,and thiazolidinediones ketones,respectively. Compared with placebo,dulaglutide,exenatide, liraglutide,and taspoglutide could increase the risks of anorexia with statistically significant differences( all P<0. 05)and,of them,dulaglutide was at the greatest risk,5. 53 times as high as that of the placebo. Compared with insulin,sulfonylureas,thiazolidinediones ketones,and sitagliptin,GLP-1 RAs could also increase the risks of anorexia in the patients with T2DM( all OR >1. 00 except for lixisenatide versus sitagliptin )and,of them,dulaglutide was at the greatest risk,48. 91,16. 65,36. 24,and 4. 75 times as high as that of insulin,sulfonylureas,thiazolidinediones ketones,and sitagliptin,respectively. There was no statistically significant difference between two kinds of GLP-1 RAs for risks of dyspepsia and anorexia( all P>0. 05). The risks of dyspepsia and anorexia due to the 13 kinds of intervention measures were ranked by rank ordering figure and liraglutide and dulaglutide were at the greatest risks. Conclusion Both the traditional Meta-analysis and Network Meta-analysis showed that GLP-1 RAs could increase the risk of dyspepsia and anorexia in patients with T2DM.

Objective To evaluate the risk of dyspepsia and anorexia due to glucagon-like peptide-1 receptor agonist(GLP-1 RA)in patients with type 2 diabetes mellitus(T2DM). Methods The electronic database of Chinese BioMedical Literature Database( CBMdisc ), Chinese Medical Current Contents( CMCC),Medline,EMbase,the Cochrane Library and web site of ClinicalTrials. gov were searched from inception to May 1st 2014. Those randomized controlled trials whose inclusion criteria including patients with T2DM as the research object,comparisons of GLP-1 RA and placebo or other conventional anti-diabetic drugs as the intervention measures,and dyspepsia and anorexia as the outcomes were collected. A traditional Meta-analysis and a Network Meta-analysis were used and relational graph and rank ordering figure of all the intervention measures were drawn. Results A total of 42 randomized controlled trials were enrolled into this study involving 20 916 patients with T2DM and 13 kinds of intervention measures comprised 7 kinds of GLP-1 RAs( exenatide,exenatide release agent,liraglutide, lixisenatide,taspoglutide, albiglutide, and dulaglutide ), 5 kinds of conventional anti-diabetic drugs ( insulin, metformin, sulfonylureas, sitagliptin, and thiazolidinediones ketones ), and placebo. The traditional Meta-analysis showed that,compared with placebo,the whole of GLP-1 RAs could increase the risks of dyspepsia[odds ratio(OR)=3. 04,95% confidence interval(CI):1. 79-5. 16]and anorexia (OR=2. 57,95%CI:1. 69-3. 91)and there were statistically significant differences(P <0. 05). The Network Meta-analysis showed that,compared with placebo,albiglutide,exenatide,exenatide release agent, liraglutide,lixisenatide,and taspoglutide could increase the risks of dyspepsia with statistically significant differences(all P<0. 05)and,of them,liraglutide was at the greatest risk and the risk was 7. 69(1/0. 13)times as high as that of the placebo. Compared with insulin,metformin,sulfonylureas,sitagliptin, and thiazolidinediones ketones,GLP-1 RAs could also increase the risks of dyspepsia in the patients with T2DM and,of them,liraglutide was at the greatest risk,which was 13. 58,4. 17(1/0. 24),3. 85(1/0. 26),5. 00(1/0. 20),and 3. 70(1/0. 27)as high as that of insulin,metformin,sulfonylureas, sitagliptin,and thiazolidinediones ketones,respectively. Compared with placebo,dulaglutide,exenatide, liraglutide,and taspoglutide could increase the risks of anorexia with statistically significant differences( all P<0. 05)and,of them,dulaglutide was at the greatest risk,5. 53 times as high as that of the placebo. Compared with insulin,sulfonylureas,thiazolidinediones ketones,and sitagliptin,GLP-1 RAs could also increase the risks of anorexia in the patients with T2DM( all OR >1. 00 except for lixisenatide versus sitagliptin )and,of them,dulaglutide was at the greatest risk,48. 91,16. 65,36. 24,and 4. 75 times as high as that of insulin,sulfonylureas,thiazolidinediones ketones,and sitagliptin,respectively. There was no statistically significant difference between two kinds of GLP-1 RAs for risks of dyspepsia and anorexia( all P>0. 05). The risks of dyspepsia and anorexia due to the 13 kinds of intervention measures were ranked by rank ordering figure and liraglutide and dulaglutide were at the greatest risks. Conclusion Both the traditional Meta-analysis and Network Meta-analysis showed that GLP-1 RAs could increase the risk of dyspepsia and anorexia in patients with T2DM.