Objective:Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:Ten articles were included to discuss how to use the RCT research protocol as a template to develop the corresponding RWS research protocol. Moreover, based on correctly estimating the efficacy-effectiveness gap, evaluate the intervention effect in the patient subgroup to confirm the subgroup that can achieve the expected benefit-risk ratio to bridge the efficacy-effectiveness gap.Conclusion:Using real-world data to simulate key features of randomized controlled clinical trial study design can improve the authenticity and effectiveness of study results and bridge the efficacy-effectiveness gap.

Objective:Randomized controlled trials (RCT) usually have strict implementation criteria. The included subjects' characteristics of the conditions for the intervention implementation are quite different from the actual clinical environment, resulting in discrepancies between the risk-benefit of interventions in actual clinical use and the risk-benefit shown in RCT. Therefore, some methods are needed to enhance the extrapolation of RCT results to evaluate the real effects of drugs in real people and clinical practice settings.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:A total of 12 articles were included. Three methods in the included literature focused on: ①improving the design of traditional RCT to increase population representation; ②combining RCT Data with real-world data (RWD) for analysis;③calibrating RCT results according to real-world patient characteristics.Conclusions:Improving the design of RCT to enhance the population representation can improve the extrapolation of the results of RCT. Combining RCT data with RWD can give full play to the advantages of data from different sources; the results of the RCT were calibrated against real-world population characteristics so that the effects of interventions in real-world patient populations can be predicted.

Objective To perform genetic analysis in a family line of a pregnant couple with autosomal reces-sive non-syndromic deafness in order to identify its possible genetic etiology and provide prenatal diagnosis.Methods Whole-exome sequencing(WES)was used to analyze the genes of the proband,and Sanger sequencing was used to verify the suspected pathogenic loci.Prenatal genetic diagnosis was performed after amniotic fluid collection at 18 weeks of pregnancy.Results Autosomal recessive deafness type 3 related gene MYO15A c.10419_10423delCAGCT/c.10294_10308delCCTTGCATCCTTGCC compound heterozygous variant was found in the wife.A compound heterozygous variant of autosomal recessive deafness type 77-related gene LOXHD1:c.6388C＞T/ex-on 33-38 del.Maternal MYO15A c.10294_10308del CCTTGCATCCTTGCC heterozygous variant were detected in the husband and paternal LOXHD1 exon 33-38 del heterozygous variant were detected in the fetus.At the same time,the paternal CDH23 c.6693delT heterozygous mutation and the maternal PCDH15 c.5048_5051dupAGAA heterozygous mutation were detected in the fetus.These two heterozygous mutations lead to the possibility of the fe-tus suffering from ID/F Usher syndrome.Conclusion The deafness of the couple is caused by two different deaf gene mutations,and the probability of the fetus having the same deafness as the couple is very low.However,the fetus has a high possibility of having deafness caused by two gene mutations.Therefore,deafness caused by two gene mutations should be paid attention to in the prenatal diagnosis of families with both deaf parents.

Objective: To compare the clinical effects of endoscopic laminectomy with traditional hemilaminectomy for lumbar spinal stenosis. Methods: From January 2016 to April 2017, 61 patients with lumbar spinal stenosis were treated surgi-cally. Percutaneous endoscopic laminectomy was performed in 32 patients (minimally invasive group), including 13 males and 19 females, aged 38-76 years, with an average age of 58.47±7.51 years. Twenty-nine patients (open group) underwent hemilaminecto-my, including 11 males and 18 females, aged 38-75 years, with an average age of 57.17±9.99 years. The operation time, bleeding, incision length, bedridden time and hospitalization time were recorded. Visual analogue scale(VAS), Oswestry disability index (ODI), dural sac cross-sectional area (DSCA), ventral intervertebral space height (VH), dorsal intervertebral space height (DH) and lumbar mobility (range of motion, ROM) were compared between the two groups. Results: All of 61 patients were followed up for 14 to 27 months, with an average of 19.2±2.95 months. The operation time was 60.88±6.49 min in the minimally invasive group, and 52.07±9.45 min in the open group (t=4.277, P=0.000). The blood loss of minimally invasive group was 55.63±10.14 ml, and that of open group was 78.79±12.58 ml (t=7.952, P=0.000). The incision length of minimally invasive group was 23.31±4.56 mm, and open group 82.59±7.66 mm (t=12.047, P=0.000). Bed rest time was 21.97±6.42 h in minimally invasive group and 78.79±12.58 h in open group (t=12.047, P=0.000). The hospitalization time of the minimally invasive group was 8.53±2.75 d and the open group 11.34±3.12 d (t=3.745, P=0.000). All these parameters had statistical significance (P<0.05). At the last follow-up, the VAS score of minimally invasive group was 1.06±0.56, and the open group was 1.14±0.74 (t=0.469, P=0.634). ROM of open group was 5.66±1.12 degree, and ROM of minimally invasive group was 5.56±1.13 degree (t=0.140, P=0.710), VH of minimally invasive group was 14.75±2.81 mm, and open group was 14.44±2.89 mm (t=0.181, P=0.672). There was no significant difference between the two groups for these parameters. At the last follow-up, ODI score was 13.25%±1.08% in the minimally invasive group and 14.28%±2.10% in open group (t=5.911, P=0.018). DSCA score was 108.56±8.69 mm² in the minimally invasive group, and 117.28±11.09 mm² in open group (t=11.774, P=0.001). There were significant differences between the two groups for ODI and DS-CA. Conclusion Both endoscopic and open laminectomy have excellent clinical effects on lumbar spinal stenosis. Endoscop-ic laminectomy has the advantages of less local trauma, less damage to the stability of the lumbar spine and faster recovery. However, there's a higher technical requirement for endoscopic spine surgery.

OBJECTIVE: To study the expression and significance of TNF-alpha, MMP-9 and their relationship with the infiltration of eosinophil granulocyte in nasal polyps. METHOD: The expression of TNF-alpha and MMP-9 was determined in tissues of nasal polyps from 30 patients(nasal polyps group) and in inferior turbinate mucosa tissues from 10 patients(control group) by in situ hybridization and immunohistochemical technique, and the number of eosinophil granulocyte was counted in the same tissue by HE staining. Their correlations with each other were also analyzed in the tissue of nasal polyps. RESULT: The number of TNF-alpha and MMP-9 positive cells and TNF-alpha positive blood vessels in nasal polyps were more than that in control group (P < 0.05). The number of both TNF-alpha positive cells and blood vessels had positive relationships with the number of eosinophil granulocyte, but there was only positive relationship between the number of MMP-9 positive cells and eosinophil granulocyte (P < 0.05). At the same time there was a positive relationship between the number of TNF-alpha and MMP-9 positive cells (P < 0.05). CONCLUSION TNF-alpha and MMP-9 may play an important role in the pathological mechanism of nasal polyps. TNF-alpha may induce the expression of MMP-9 and promote the migration of eosinophil granulocyte.
Adult ; Case-Control Studies ; Eosinophils ; pathology ; Female ; Humans ; Male ; Matrix Metalloproteinase 9 ; metabolism ; Middle Aged ; Nasal Mucosa ; metabolism ; pathology ; Nasal Polyps ; metabolism ; pathology ; Tumor Necrosis Factor-alpha ; metabolism

Objective:To explore the expression of cyclooxygenase-2(COX-2) and S-100 positive dendritic cell in laryngeal carcinoma tissue and their clinical significance.Method:Sixty-five samples of laryngeal carcinoma and thirty-four biopsies of adjacent noncancerous tissue were obtained. Immunohistochemical technique(SP method) was used to detect the expression of COX-2 and S-100 positive dendritic cell, and the relationship of their expression with clinical pathological parameters and prognosis was analyzed.Result:The rates of COX-2 expression were 63.08%(41/65)and 14.70%(5/34)in laryngeal carcinoma and control group, respectively. The difference was significant(P＜0.05).The positive expression of COX-2 was correlated with T and clinical stage in laryngeal carcinoma(all P＜0.05).The rates of S-100 positive dendritic cell expression were 61.54%(40/65)and 0 in laryngeal carcinoma and control group, respectively. The difference was significant(P＜0.05).S-100 positive dendritic cells showed significant differences between early and late clinical stage and lymph node metastasis (all P＜0.05).Kaplan-Meier survival analysis showed that patients with positive expression of COX-2 and S-100 positive dendritic cell had worse disease-free and overall survival(P＜0.05).Cox regression analysis showed that S-100 positive dendritic cell was indicated as an independent prognostic factor for survival(P＜0.05).Conclusion:COX-2 and S-100 positive dendritic cell are highly expressed in laryngeal carcinoma tissue. It suggests that the expression of COX-2 and S-100 positive dendritic cell is related to the process of carcinogenesis and may be the important indicators in laryngeal carcinoma for prognosis.

OBJECTIVE: To explore the expression of cyclooxygenase-2 (COX-2) and S-100 positive dendritic cell in laryngeal carcinoma tissue and their clinical significance. METHOD: Sixty-five samples of laryngeal carcinoma and thirty-four biopsies of adjacent noncancerous tissue were obtained. Immunohistochemical technique (SP method) was used to detect the expression of COX-2 and S-100 positive dendritic cell, and the relationship of their expression with clinical pathological parameters and prognosis was analyzed. RESULT: The rates of COX-2 expression were 63.08% (41/65)and 14.70% (5/34) in laryngeal carcinoma and control group, respectively. The difference was significant (P < 0.05). The positive expression of COX-2 was correlated with T and clinical stage in laryngeal carcinoma(all P < 0.05). The rates of S-100 positive dendritic cell expression were 61.54% (40/65)and 0 in laryngeal carcinoma and control group, respectively. The difference was significant (P < 0.05). S-100 positive dendritic cells showed significant differences between early and late clinical stage and lymph node metastasis (all P < 0.05). Kaplan-Meier survival analysis showed that patients with positive expression of COX-2 and S-100 positive dendritic cell had worse disease-free and overall survival (P < 0.05). Cox regression analysis showed that S-100 positive dendritic cell was indicated as an independent prognostic factor for survival(P < 0.05). CONCLUSION COX-2 and S-100 positive dendritic cell are highly expressed in laryngeal carcinoma tissue. It suggests that the expression of COX-2 and S-100 positive dendritic cell is related to the process of carcinogenesis and may be the important indicators in laryngeal carcinoma for prognosis.
Adult ; Aged ; Aged, 80 and over ; Carcinoma, Squamous Cell ; metabolism ; pathology ; Cyclooxygenase 2 ; metabolism ; Dendritic Cells ; metabolism ; pathology ; Female ; Humans ; Laryngeal Neoplasms ; metabolism ; pathology ; Male ; Middle Aged ; Neoplasm Staging ; S100 Proteins ; metabolism

Objective:To investigate the expression and clinical significance of Ang-2 and MMP-7 protein in laryngeal carcinoma tissue.Method:Immunohistochemical technique was used to detect the expression of Ang-2 and MMP-7 protein in 65 tissues of laryngeal carcinoma and 34 biopsies of adjacent non-cancerous tissue. The relationship between the expression of Ang-2 and MMP-7 and invasion, metastasis or prognosis in laryngeal carcinoma tissue was analyzed.Result:The positive rates of Ang-2 and MMP-7 were significantly higher in laryngeal carcinoma tissue than those in adjacent non-cancerous tissue(P＜0.05).The level of Ang-2 and MMP-7 expression had no significant correlations with the age and course as well as the smoking, drinking, histological differentiation of carcinoma and clinical classification (P＞0.05).While the expression of Ang-2 significantly differed between patients with different T stage and clinical stage(P＜0.05), and the expression of MMP-7 was notably correlated with the T stage,clinical stage and lymph node metastases (P＜0.05).There was a correlation between the expression of Ang-2 and MMP-7 (P＜0.05).The Kaplan-Meier survival analysis showed that patients with positive expression of Ang-2 had worse overall survival(P＜0.05).However,MMP-7 expression was not related to overall survival or disease-free survival (all P＞0.05).Cox regression analysis indicated that Ang-2 and MMP-7 expression were independent prognostic factors of laryngeal carcinoma.Conclusion:Overexpression of Ang-2 and MMP-7 was observed in laryngeal carcinoma and they might be served as an objective indicator for biological behaviour and prognosis.

OBJECTIVE: To investigate the expression and clinical significance of Ang-2 and MMP-7 protein in laryngeal carcinoma tissue. METHOD: Immunohistochemical technique was used to detect the expression of Ang-2 and MMP-7 protein in 65 tissues of laryngeal carcinoma and 34 biopsies of adjacent non- cancerous tissue. The relationship between the expression of Ang-2 and MMP-7 and invasion, metastasis or prognosis in laryngeal carcinoma tissue was analyzed. RESULT: The positive rates of Ang-2 and MMP-7 were significantly higher in laryngeal carcinoma tissue than those in adjacent non-cancerous tissue (P < 0.05). The level of Ang-2 and MMP-7 expression had no significant correlations with the age and course as well as the smoking, drinking, histological differentiation of carcinoma and clinical classification (P > 0.05). While the expression of Ang-2 significantly differed between patients with different T stage and clinical stage (P < 0.05), and the expression of MMP-7 was notably correlated with the T stage, clinical stage and lymph node metastases (P < 0.05). There was a correlation between the expression of Ang-2 and MMP-7 (P < 0.05). The Kaplan-Meier survival analysis showed that patients with positive expression of Ang-2 had worse overall survival (P < 0.05). However, MMP-7 expression was not related to overall survival or disease-free survival (all P > 0.05). Cox regression analysis indicated that Ang-2 and MMP-7 expression were independent prognostic factors of laryngeal carcinoma. CONCLUSION Overexpression of Ang-2 and MMP-7 was observed in laryngeal carcinoma and they might be served as an objective indicator for biological behaviour and prognosis.
Adult ; Aged ; Aged, 80 and over ; Angiopoietin-2 ; metabolism ; Carcinoma, Squamous Cell ; metabolism ; pathology ; Female ; Humans ; Laryngeal Neoplasms ; metabolism ; pathology ; Male ; Matrix Metalloproteinase 7 ; metabolism ; Middle Aged ; Neoplasm Staging ; Prognosis

Objective To discuss the treatment of acromioclavicular joint dislocation associated with clavicular distal end fracture and remedial means.Methods 28 cases of acromioclavicular joint dislocation associated with clavicular distal end fracture were treated with clavicular hook plate.28 patients included 4 cases of Allman's type Ⅰ,14 cases of type Ⅱ,10 cases of type Ⅲ.Classification of fracture included 9 traverse cases,14 oblique cases,3 comminuted cases,and 2 avulsion cases.There were 24 acute injury cases,4 obsolete injury cases.3 cases were open fractures.1 case was not successful by conservative management.After operation,early rehabilitation was emphasized and following-up was performed.The therapeutic effect was assessed with Karlsson standard.Results 28 patients were followed up for an average of 14.6 months(6～26 months).According to Karlsson standard:17 cases got A level,8 cases got B level,3 cases got C level.The rate of excellence was 89.3%.Conclusion Acromioclavicular joint dislocation associated with clavicular distal end fracture is not steady fracture and complicated with many ligaments avulsion often.Effective internal fixation on time and ligament repaired is necessary.