1.Development of a Core Outcome Set for Clinical Evaluation of Chronic Pulmonary Heart Disease Treated with Traditional Chinese Medicine Therapy
Baihan NIU ; Mingyan ZHANG ; Zhaochen JI ; Bo PANG ; Haiyin HU ; Junhua ZHANG
Journal of Traditional Chinese Medicine 2025;66(12):1227-1232
ObjectiveTo construct an outcome set for clinical evaluation of traditional Chinese medicine (TCM) for chronic pulmonary heart disease, and to provide consensus outcomes for the evaluation of the clinical effectiveness of TCM for chronic pulmonary heart disease. MethodsWe searched randomised controlled trials of TCM for chronic pulmonary heart disease on China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform (WF), VIP Chinese Science Journals Database (VIP), Chinese Biomedical Literature Service Database (SinoMed), PubMed, Cochrane Library, and Embase. We also searched Chinese Clinical Trial Registry Platform and the U.S. Clinical Trial Registry database to obtain the outcome indicators reported in the clinical research protocols of TCM for chronic pulmonary heart disease. The outcome indicators were also collected through semi-structured interviews of clinicians and patients. Then integrated the outcome indicators collected by the above methods to construct the indicator pool. Through two rounds of Delphi surveys and a consensus conference, the core outcome set for clinical evaluation of TCM for chronic pulmonary heart disease was determined. ResultsAfter screening, there were 1313 literature meeting the criteria, and 595 outcome indicators were extracted, then combined with the outcomes from semi-structured interviews which clinicians and patients concerned, finally an indicator item pool containing 369 outcome indicators were formed. After the initial screening of indicators in the pool by the steering committee, 58 indicators were established into the initial list of indicator entries. In the first round of Delphi survey, the expert coordination coefficient for the results was 0.401, and the Cronbach coefficient was 0.989. A total of 35 indicators that did not meet the criteria [<70% of the participants rated the outcome as 7~9 (critical) and the mean of the expert ratings <7] were deleted, and 23 were retained, with 7 new indicators added that were open to supplementation by the experts, resulting in a total of 30 indicators that were included in the second round of Delphi survey. In the second round of Delphi survey, the expert coordination coefficient was 0.303, and the Cronbach coefficient was 0.974, with a total of 7 indicators that did not meet the criteria being deleted, and 21 indicators being retained for the consensus conference. After the consensus meeting, the core outcome set for clinical evaluation of chronic pulmonary heart disease in two major categories, acute exacerbation stage and stable stage, was finally determined, in which there were four indicators in acute exacerbation stage: N-terminal B-type natriuretic peptide precursor (NT-proBNP), blood qi analysis, all-cause mortality rate, and complication rate; and there were eight indicators in the stable stage: pulmonary function index, six-minute walk test distance, New York cardiac function classification, all-cause mortality rate, re-hospitalisation rate, Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score, Short Form 36 Health Survey (SF-36), and TCM syndrome score. ConclusionThe core outcome sets of TCM clinical evaluation in the acute exacerbation stage and stable stage are constructed, which is helpful to improve the practicability, comparability and transparency of TCM clinical research results in pulmonary heart disease.
2.Occurrence of neglected perforation of sterile surgical gloves and its effect on bacterial contamination during craniocerebral surgery
Ning NIU ; Ting-Ting LI ; Jing-Jing JI ; Wen-Juan HU ; Hao WU
Journal of Regional Anatomy and Operative Surgery 2024;33(12):1085-1088
Objective To investigate the incidence of neglected perforation of sterile surgical gloves used in craniocerebral surgery and its effect on bacterial contamination of the gloves.Methods A total of 996 sterile surgical gloves worn by surgical participants during craniocerebral surgery were selected as the study objects.Univariate and multivariate Logistic regression analysis were respectively performed to analyze the factors that might cause the neglected perforation of gloves,and the detection rate of bacteria on the outer surface of perforated and unperforated gloves were compared.Results Among 996 sterile surgical gloves used in craniocerebral surgery,84(8.43%)gloves were found to have neglected perforation,and 39(3.92%)gloves were found to have bacteria.The detection rate of bacteria on the outer surface of the neglected perforation group was significantly higher than that of the non-neglected perforation group(P<0.001).The results of univariate and multivariate Logistic analysis suggested that craniotomy,emergency surgery,surgery time≥150 minutes,the use of rotating equipment during surgery and the role of glove wearing personnel as the main surgeon were the risk factors for neglected perforation of sterile surgical gloves(OR>1,P<0.05),while the use of double-layer gloves during surgery was the protective factor for avoiding perforation(OR<1,P<0.05).Conclusion The occurrence of neglected perforation of sterile surgical gloves during craniocerebral surgery is not optimistic.The probability of neglected perforation of gloves is higher in craniotomy,emergency surgery,long surgery time,the use of rotating equipment during surgery,and gloves used by the main surgeon.For surgeries with a high incidence of neglected perforation,double-layer gloves can be worn during surgery to reduce bacterial contamination on the outer surface of sterile surgical gloves.
3.Impact of social support on posttraumatic growth in thyroid cancer patients: a chain mediating effect of positive psychological capital and general self-efficacy
Qiaomin WANG ; Binfang LING ; Dong JI ; Jinjing WANG ; Xiaoxia NIU ; Yan YANG ; Tingting ZHANG ; Yi FANG
Chinese Journal of Modern Nursing 2024;30(33):4526-4534
Objective:To construct a chain mediating model based on two mediating variables of positive psychological capital and general self-efficacy, so as to explore the impact mechanism of social support on posttraumatic growth in thyroid cancer patients.Methods:From March to December 2023, convenience sampling was used to select 270 postoperative patients with thyroid cancer from the Chinese People's Liberation Army General Hospital as participants. The patients were surveyed using the General Information Questionnaire, Post Traumatic Growth Inventory, Social Support Rating Scale, Positive Psychological Questionnaire, and General Self-efficacy Scale. Spearman correlation was used to analyze the correlation between social support, positive psychological capital, general self-efficacy, and posttraumatic growth in thyroid cancer patients. SPSS PROCESS program was used to test for the chain mediating effect.Results:A total of 270 questionnaires were distributed, and 257 questionnaires were collected. After excluding questionnaires with missing items exceeding 10% and regular responses, 246 valid questionnaires were collected, with a valid response rate of 91.11% (246/270). Spearman correlation showed that there was positive correlations between social support, positive psychological capital, general self-efficacy, and posttraumatic growth in patients ( P<0.01). Mediating effect analysis showed that social support directly and positively predicted posttraumatic growth in thyroid cancer [ β=0.403, 95% CI (0.258, 0.547) ], and also affected patients' posttraumatic growth through three indirect pathways, namely social support → positive psychological capital → posttraumatic growth, with an effect value of 0.083 [95% CI (0.002, 0.173) ], accounting for 13.63% of the total effect, and social support → general self-efficacy → posttraumatic growth, with an effect value of 0.099 [95% CI (0.040, 0.166) ], accounting for 16.26% of the total effect, and social support → positive psychological capital → general self-efficacy → posttraumatic growth, with an effect value of 0.025 [95% CI (0.005, 0.051) ], accounting for 4.11% of the total effect. The total indirect effect accounted for 33.83% of the total effect. Conclusions:Social support can not only directly affect the post-traumatic growth of thyroid cancer patients, but also indirectly affect post-traumatic growth through the mediating effect of positive psychological capital and general self-efficacy.
4.Comparison of Clinical Characteristics of JAK2,CALR and Tri-Negative Driving Mutant Type in Patients with Essential Thrombocythemia
Yu-Meng LI ; Er-Peng YANG ; Zi-Qing WANG ; De-Hao WANG ; Ji-Cong NIU ; Yu-Jin LI ; Jing MING ; Ming-Qian SUN ; Zhuo CHEN ; Wei-Yi LIU ; Yan LYU ; Xiao-Mei HU
Journal of Experimental Hematology 2024;32(1):197-201
Objective:To investigate the relationship between mutated genes and clinical features in patients with essential thrombocythemia(ET).Methods:The clinical data of 69 patients with ET from October 2018 to March 2022 were retrospectively analyzed.According to driver mutation type,patients were divided into JAK2 group,CALR group and triple-negative group.The sex,age,cardiovascular risk factors,thrombosis,splenomegaly,routine blood test and coagulation status of patients in three groups were analyzed.Results:Among 69 ET patients,46 cases were associated with JAK2 mutation,14 cases with CALR mutation,8 cases with triple-negative mutation,and one with MPL gene mutation.There were no significant differences in age and sex among the three groups(P>0.05).The highest thrombotic rate was 26.09%(12/46)in JAK2 group,then 12.5%(1/8)in triple-negative group,while no thrombotic events occurred in CALR group.The incidence of splenomegaly was the highest in JAK2 group(34.78%),while no splenomegaly occurred in triple-negative group.The white blood cell(WBC)count in JAK2 group was(9.00±4.86)× 109/L,which was significantly higher than(6.03±2.32)× 109/L in CALR group(P<0.05).The hemoglobin(Hb)and hematocrit(HCT)in JAK2 group were(148.42±18.79)g/L and(0.44±0.06)%,respectively,which were both significantly higher than(131.00±15.17)g/L and(0.39±0.05)%in triple-negative group(P<0.05).The platelet(PLT)in JAK2 group was(584.17±175.77)× 109/L,which was significantly lower than(703.07±225.60)× 109/L in CALR group(P<0.05).The fibrinogen(Fg)in JAK2 and triple-negative group were(2.64±0.69)g/L and(3.05±0.77)g/L,respectively,which were both significantly higher than(2.24±0.47)g/L in CALR group(P<0.05,P<0.01).The activated partial thromboplastin time(APTT)in triple-negative group was(28.61±1.99)s,which was significantly decreased compared with(31.45±3.35)s in CALR group(P<0.05).Conclusions:There are differences in blood cell count and coagulation status among ET patients with different driver gene mutations.Among ET patients,JAK2 mutation is most common.Compared with CALR group,the thrombotic rate,WBC and Fg significantly increase in JAK2 group,while PLT decrease.Compared with triple-negative group,the incidence of splenomegaly and HCT significantly increase.Compared with CALR group,Fg significantly increases but APTT decreases in triple-negative group.
5.Clinical Features and Prognosis of Patients with Primary Extranodal Diffuse Large B-Cell Lymphoma
Si YI ; Xia LI ; Huan TAO ; Hong-Bing MA ; Jie JI ; Yu WU ; Ting NIU ; Yong-Qian JIA
Journal of Experimental Hematology 2024;32(6):1711-1718
Objective:To investigate the clinical features,gene mutation profile,efficacy and prognostic factors of primary extranodal diffuse large B-cell lymphoma(EN-DLBCL).Methods:A retrospective analysis was performed for 382 patients with primary EN-DLBCL with complete clinical data who were treated in West China Hospital from January 2013 to January 2023,and their clinical characteristics,gene mutation profile,efficacy and prognostic factors were analyzed.Results:The median age of the 382 patients with EN-DLBCL was 56 (18-89 )years old.The male-to-female ratio was 1.12∶1,and the most common primary sites were gastrointestinal tract (31.7%),Wechsler ring (19. 1%)and breast gland (7.1%).A total of 51 gene mutations were fund,and the most common frequencies of gene mutations were TP53 (32.5%),MYD88 (32.5%),and CD79B (30.0%).The median follow-up was 63 months,and the 5-year progression-free survival (PFS)rate was 74.5% and the 5-year overall survival (OS)rate was 89.6%. The adverse factors on PFS were as follows:>1 extranodal sites involvement (P<0.001),P53≥50%(P<0.001),hyper double expression(hDEL)of C-myc>50%/Bcl-2>70%(P<0.001).The adverse factors affecting the OS of patients were as follows:>1 extranodal sites involvement (P<0.001),P53≥50%(P<0.001),hDEL(P<0.001). Chemotherapy combined with local radiotherapy could improve PFS (P=0.041)and OS (P=0.003),while R-CHOP+X (molecule agents as BTKi、HDACi、Lenalidomide)failed to show a significant difference in PFS (P=0.075)and OS (P=0.767 ).Among the 40 patients who underwent next-generation sequencing at high risk,there was no significant in PFS (P=0.849)and OS (P=0.500)of patients with positive MYD88 and/or CD79B mutations (MCD subtype)treated with BTKi and patients with negative MYD88 and CD79B mutations.Conclusion:Primary EN-DLBCL can involve multiple organs or tissue sites.TP53,MYD88,and CD79B are the most common gene mutations.The efficacy of BTKi in patients with positive MCD subtypes at intermediate and high risk is not inferior to that in MCD-negative control patients.
6.Analysis of Genes Related to Platelet Activation in Essential Thrombocythemia Based on Transcriptomics
Yan SUN ; Er-Peng YANG ; Yu-Meng LI ; Ji-Cong NIU ; Pei ZHAO ; Wei-Yi LIU ; Zhuo CHEN ; Ming-Jing WANG ; Teng FAN ; Xiao-Mei HU
Journal of Experimental Hematology 2024;32(6):1814-1821
Objective:To analyze the genes related to platelet activation in essential thrombocythemia (ET)based on transcriptome sequencing technology (RNA-seq ),and to explore the potential targets related to ET thrombosis. Methods:Blood samples from ET patients and healthy individuals were collected for RNA-seq,and differentially expressed lncRNAs,miRNAs,and mRNAs were selected to construct a lncRNA-miRNA-mRNA regulatory network. Differential mRNAs in the regulatory network were enriched and analyzed using Gene Ontology (GO ) and Kyoto Encyclopedia of Genes and Genomes (KEGG).The real-time PCR method was applied to validate differential mRNAs on crucial signaling pathways.Results:A total of 32 lncRNAs (3 up-regulated,29 down-regulated),16 miRNAs (8 up-regulated,8 down-regulated),and 35 mRNAs (27 up-regulated,8 down-regulated)were identified as differentially expressed.Among them,5 lncRNAs,12 miRNAs,and 19 mRNAs constituted the regulatory network.KEGG enrichment analysis showed that the differential mRNAs were related to the platelet activation signaling pathway,and there were 6 differential mRNAs related to platelet activation,namely F2R,ITGA2B,ITGB1,ITGB3,PTGS1,and GP1 BB,which were all up-regulated in their expression.RT-PCR results showed that the expression of five mRNAs including F2R,ITGA2B,ITGB1,ITGB3,and GP1BB were upregulated in ET patients compared with healthy subjects,and consistent with RNA-seq results,while PTGS1 expression was not significantly different.Conclusion:Differential mRNAs in ET patients are related to the platelet activation pathway,and F2R,ITGA2B,ITGB1,ITGB3,and GP1BB mRNAs may serve as novel targets associated with platelet activation in ET.
7.Causes of missed diagnosis of clinically significant prostate cancer by targeted biopsy
He-Song JIANG ; Shan ZHOU ; Xiao-Bing NIU ; Lu JI
National Journal of Andrology 2024;30(4):315-320
Objective:To retrospectively analyze the causes of missed diagnosis of clinically significant PCa(csPCa)by targe-ted biopsy(TB).Methods:This retrospective study included 652 males aged(71.32±16.53)years with elevated PSA and ab-normal MRI signals detected in our hospital from June 2018 to December 2020.We further examined the patients by transperineal pros-tatic TB and systematic biopsy(SB),analyzed the detection rates of PCa and csPCa by TB and SB,and investigated the causes of missed diagnosis of csPCa in TB using the fishbone diagram.Results:The total detection rate of PCa and csPCa by TB combined with SB was 45.7%(298/652),and that of csPCa was 37.4%(244/652),with 38 cases of csPCa missed in TB,including 23 cases of negative TB and 15 cases of low ISUP grade.The causes of missed diagnosis of csPCa by TB included low MRI image quality,PSA density≤0.15 ng/ml/cm3,target area<10 mm,and PI-RADS 2 score≤3.The detection rate of csPCa by TB alone was 31.6%,which was increased by 5.8%(P=0.027)when TB combined with SB.Conclusion:TB combined with SB yields a higher de-tection rate of csPCa than either used alone.Missed diagnosis of csPCa by TB is closely related to the characteristics of tumor and MR image of the target area.
8.Effect and safety of pulsatile GnRH therapy for male congenital hypogonadotropic hypogonadism
Yong-Hua NIU ; Hao XU ; Yin-Wei CHEN ; Ru-Zhu LAN ; Tao WANG ; SHAO-Gang WANG ; Ji-Hong LIU
National Journal of Andrology 2024;30(5):404-409
Objective:To investigate the efficiency and safety of the pulsatile GnRH therapy in the treatment of male congeni-tal hypogonadotropic hypogonadism(CHH).Methods:We retrospectively analyzed the clinical data on 45 CHH males treated by pulsatile GnRH therapy in our hospital from January 2013 to March 2023.We treated the patients with gonadorelin at 7-15 μg,one pulse/90 min,and followed them up every month in the first 3 months and then every 3 to 6 months after treatment,for an average of 19.1±4.3 months,during which we recorded the height,body weight,penile length,testis volume,Tanner stages,levels of FSH,LH and T,semen parameters and adverse reactions of the patients,followed by comparison of the data obtained with the baseline.Results:The levels of FSH,LH and T of the patients were dramatically elevated after treatment(P<0.01).The T level of the6 ca-ses of cryptorchidism,however,failed to reach the normal value within 18.2±8.6 months of follow-up.Significant improvement was seen in the external genitalia and secondary sexual characteristics of all the patients,and spermatogenesis was observed in the semen in 33 cases(73.3% ),with a mean sperm concentration of(18.2±6.2)106/ml,sperm progressive motility of(19.7±6.5)%,and semen volume of(1.8±0.6)ml.Eight of the cases achieved natural fertility,and another 3 achieved childbirth by assisted re-productive technology.As for adverse events,gynecomastia was observed in 8,subcutaneous induration in 6,and allergic reaction to therapeutic agent in 3 cases.Conclusion:Pulsatile GnRH therapy is an effective and safe strategy for male CHH.However,clini-cians should choose appropriate approaches to different individual cases.
9.HVPG minimally invasive era: exploration based on forearm venous approach
Jitao WANG ; Lei LI ; Meng NIU ; Qingliang ZHU ; Zhongwei ZHAO ; Kohei KOTANI ; Akira YAMAMOTO ; Haijun ZHANG ; Shuangxi LI ; Dan XU ; Ning KANG ; Xiaoguo LI ; Kunpeng ZHANG ; Jun SUN ; Fazong WU ; Hailong ZHANG ; Dengxiang LIU ; Muhan LYU ; Jiansong JI ; Norifumi KAWADA ; Ke XU ; Xiaolong QI
Chinese Journal of Hepatology 2024;32(1):35-39
Objective:The transjugular or transfemoral approach is used as a common method for hepatic venous pressure gradient (HVPG) measurement in current practice. This study aims to confirm the safety and effectiveness of measuring HVPG via the forearm venous approach.Methods:Prospective recruitment was conducted for patients with cirrhosis who underwent HVPG measurement via the forearm venous approach at six hospitals in China and Japan from September 2020 to December 2020. Patients' clinical baseline information and HVPG measurement data were collected. The right median cubital vein or basilic vein approach for all enrolled patients was selected. The HVPG standard process was used to measure pressure. Research data were analyzed using SPSS 22.0 statistical software. Quantitative data were used to represent medians (interquartile ranges), while qualitative data were used to represent frequency and rates. The correlation between two sets of data was analyzed using Pearson correlation analysis.Results:A total of 43 cases were enrolled in this study. Of these, 41 (95.3%) successfully underwent HVPG measurement via the forearm venous approach. None of the patients had any serious complications. The median operation time for HVPG detection via forearm vein was 18.0 minutes (12.3~38.8 minutes). This study confirmed that HVPG was positively closely related to Child-Pugh score ( r = 0.47, P = 0.002), albumin-bilirubin score ( r = 0.37, P = 0.001), Lok index ( r = 0.36, P = 0.02), liver stiffness ( r = 0.58, P = 0.01), and spleen stiffness ( r = 0.77, P = 0.01), while negatively correlated with albumin ( r = -0.42, P = 0.006). Conclusion:The results of this multi-centre retrospective study suggest that HVPG measurement via the forearm venous approach is safe and feasible.
10.Modified silicone oil removal combined with scleral buckling for retinal detachment after silicone oil tamponade
International Eye Science 2024;24(5):826-830
AIM: To investigate the efficacy of modified silicone oil removal combined with scleral buckling in the treatment of patients with retinal detachment under silicone oil tamponade.METHODS:The retrospective study included a total of 14 patients(14 eyes)who underwent treatment for retinal detachment with silicone oil tamponade at our hospital between January 2021 and February 2023. The modified silicon oil extraction combined with scleral buckling procedure was employed. A self-made 23-gauge suction device was applied in the silicon oil extraction, which involved removing the needle from a disposable blood transfusion set, trimming it to 2.5-3.0 mm near the beveled end, and connecting the other end to a 10 mL syringe without the plunger. The opposite end of the syringe was connected to the negative pressure system of the vitreous cutter to accomplish the silicon oil removal. Scleral compression blocks in scleral buckling surgery using a homemade composite device. No additional silicon oil was injected after the procedure. Follow-up was conducted for 6 mo, assessing retinal reattachment, best-corrected visual acuity(BCVA), intraocular pressure, and complications.RESULTS: At the 6 mo follow-up, the retina was completely reset in 13 eyes, with a retinal reset rate of 93%, and an improvement in BCVA(LogMAR)compared with the preoperative period(0.95±0.18 vs 1.15±0.21, P=0.002). Transient high IOP occurred in 6 eyes at 1 d postoperatively and returned to normal after medication control. There were no intraoperative complications such as retinal hemorrhage, retinal incarceration, or iatrogenic retinal breaks, and no postoperative complications such as endophthalmitis or choroidal detachment.CONCLUSIONS:Modified silicone oil removal combined with scleral buckling can effectively treat retinal detachment in the silicone oil tamponade and induce retinal reattachment.

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