Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.

[Objective] To investigate the characteristics of PD-1/PD-L1 expressed on T cell and bladder cancer cell and clinical significance.[Methods] 64 patients with primary bladder cancer were into experiment group and 10 normal people were into control group.Peripheral bloods were used to test the PD-1 expressed on CD8+ T lymphocytes by flow cytometry.Immunohistochemistry staining was used to detect the PD-L1 expression in tumor and normal specimen.[Results] PD-1 expressed on CD8+T lymphocytes was (2.25 ± 0.60)％ in experiment group and (0.68 ± 0.17)％ in control group,respectively (P ＜ 0.001).And the PD-1 expression on T cell in invasive bladder cancer patient was significant higher than superficial bladder cancer patients [(3.04 ± 0.46)％ vs (0.68± 0.17)％,P ＜ 0.001].The expression of PD-L1 in experiment group was higher than control group,(26/64 vs 0/15,P ＜ 0.001).But there was no different between invasive and superficial bladder cancer patients,(41.3％ vs 38.8％,P ＞ 0.01).[Conclusions] Expression of negative stimulatory molecule PD-1 in CD8+T lymphocytes of peripheral blood is significantly correlated with bladder cancer advanced.Bladder cancer cell was strongly expressed PD-L1,and this expression is not related to cancer advanced.

Objective To further improve level of severe chest trauma care in the elderly pa-tients. Methods A retrospective study was done on data of 148 elderly patients (≥65 years with se-vere chest trauma (AIS≥3 points) (elderly group) treated in Chongqing Emergency Medical Center from June 1995 to May 2005. A total of 1669 patients at age less than 65 years and with AIS≥3 points were set as control group in the same research period (control group). Results The main injury mechanism was blunt trauma, which aceouted for 83.8% (124/148) in elderly group, higher than 69.3% (1 157/ 1 669) in control group (P < 0. 01). The injury causes were mainly traffic accidents, slip and fall from a height. Traffic accidents and slip accounted for 66.2% (98/148) and 14.9% (22/148) respectively, which was significantly higher than 50.6% (845/1 669) and 3.1% (52/1 669) respectively in control group (P < 0. 01). There was no statistical difference upon ISS, RTS, GCS and prehospital time between both groups (all P value > 0.05). The fatality rate and indicence rate of complication in the elerly group were 15.5% (23/148) and 25.7% (38/148), which was significantly higher than 6.5% (108/1 669) and 10.4% (174/1 669) respectively in control group (P <0.01). The fatality rate in elderly group with complications was significantly higher than that in control group (51.7% vs 26.7%) (P < 0.01), while those without complications showed no statistical difference between two groups (6.7% :3.5%) (P >0. 05). Conclusions The patient' s age and complications are relative independent factors to es-timate the trauma care outcome. To raise risk awareness and strengthen the management of complications and supportive treatments for organ function are key to improve survival rate of the elderly patients with se-vere chest trauma.

Objective To reproduce an SD rat model of prostatic calculus by using nanobacteria (NB), and explore the role of NB in contributing to prostatitis and prostatic calculus. Methods Twenty adult male SD rats were randomized to the control group and 20 to the model group. Rat prostate infection models were reproduced by infusing 0. 2 ml (Concentration, 1 Mai unit) NB suspension transurethrally. 0.2 ml physiological saline was infused transurethrally in the rat control group. The rats were sacrificed 4 and 8 weeks later and prostatic pathology were viewed by hematoxylin and eosin (HE) staining. Lithogenesis was observed by scanning electron microscope (SEM) or Transmission electron microscopy (TEM). Re-isolation, culture and identification of nanobacteria were also done in rat prostatic tissues. Results Chronic inflammatory changes of prostates were shown in the model group at both 4 weeks and 8 weeks after infusing NB suspension. Prostatic calculi were detected by SEM and TEM at 8 weeks in the prostates of the rat model group (7/10). Neither chronic inflammatory changes nor prostatic calculus was found in the control group. NB was positive in the model group, but negative in the control group. Conclusions NB infection could cause chronic prostatitis and prostatic calculus in rats.

BACKGROUND: Left ventricular hypertrophy induced by primary hyper tension is a risk factor which has a dependent effect on various cardiovas cular complications. Reversal left ventricular hypertrophy has been a keyobject for treating hypertension currently. Plasma neuropeptide Y has en dothelium-derived contracting blood vessel, and has adjusting effect on va somotor function through endothelial cell to participate in onset and main tenance of hypertension. OBJECTIVE: To investigate effect of yixin jiangya capsule on left ven tricular mass index (LVMI) and content of neuropeptide Y of primary grade2 hypertensive patiepts with left ventricular hypertrophy of hyperactivity ofyang due to yin deficiency blood stasis. DESIGN: Case analysis on the basis of patients. SETTING: Department of Traditional Chinese Medicine, General Hospitalof Jinan Military Area Command of Chinese PLA; Department of InternalMedicine, Affiliated Hospital of Shandong University of Traditional Chi nese Medicine. PARTICIPANTS: Totally 93 primary grade 2 hypertensive patients withleft ventricular hypertrophy of hyperactivity of yang due to yin deficiency blood stasis were selected from General Hospital of Jinan Military AreaCommand of Chinese PLA and Affiliated Hospital of Shandong University of Traditional Chinese Medicine from March 2003 to August 2005. All cases were divided into two groups according to random digital table. There were 62 cases in observational group including 40 males and 22 females aged from 46 to 70 years with mean age of 58.94 years and coursed from 2 to 19 years with mean course of 8.93 years. There were 31 cases in control group including 19 males and 12 females aged from 44 to 69 years with mean age of 59.27 years and coursed from 2.5 to 18 years with mean course of 9.11 years. Another 30 people were regarded as healthy group.METHODS: Patients in both groups were treated with enalaprol orally with 10 mg each time of once a day. Patients in observational group were also treated with yixin jiangya capsule (component: shengrlihuang, shengshouwu, sangjisheng, chuanniuxi, gouteng, shijueming, xiakucao, tianma,mudanpi, chishaoyao, dilong, chuanshanjia, etc. Mixed according to ratio,extracted, concentrated, made of capsule, 0.5 g/pill, 4.65 g/raw drug, provided by Shandong Jinan Hongjitang Pharmacy Limited-liability Company,batch number:. 021214), 5 pills once for 3 times every day. Courses in both groups were 24 weeks respectively. LVMI and content of neuropeptide Y were measured with ultrasonic cardiograph and radio-immunity analysis method before and after treatment. Meanwhile, indexes mentioned above were also measured in healthy group so as to regard as the controls.MAIN OUTCOME MEASURFS: LVMI, content of neuropeptide Y,changes of blood pressure, adverse events and side effects.RESULTS: Totally 93 patients entered the final analysis. ① LVMI and content of neuropeptide Y were increased both observational group and control group before treatment [(147.2±16.9), (146.7±17.2), (101.8±.22.4) g/m2;(135.4±33.2), (133.8±31.1), (78.6±24.5) ng/L.; P ＜ 0.01]. ② LVMI and content of neuropeptide Y were decreased both observational group and control group after 24-week treatment, and those in observational group were superior to those in control group [(103.9±24.6), (122.6±19.9) g/m2;(82.9±25.2), (113.7±26.2) ng/L; P ＜ 0.05-0.01]. ③ LVMI and content of neuropeptide Y in observational group were not significantly different from those in healthy group increased both in observational group and control group after treatment (P.＞ 0.05), and those in control group were higher than those in healthy group (P ＜ 0.01). ④ Descent levels of systolic pressure and diastolic pressure were not significantly different between observational group and control group [(137.4±12.8), (134.2:t:11.9) mm Hg;(80.1±8.3), (81.7±7.4) mm Hg, P ＞ 0.05]. Blood routine and liver-kidney function were not changed obviously both groups before and after treatment, and side effect was not observed during the process.CONCLUSION: LVMI and content of neuropeptide Y of primary grade 2 hypertensive patients with left ventricular hypertrophy of hyperactivity of yang due to yin deficiency blood stasis are higher than those of healthy people. Yixin jiangya capsule can deteriorate left ventricular hypertrophy and decrease the content of neuropeptide Y on the basis of application of enalaprol.

Objective To evaluate the clinical efficacy and safety of retroperitoneal laparoscopy and open surgical treatment of simple renal cyst by Meta analysis.Methods Computer retrieval of MED-LINE,Cochrane Library,EMBASE,CNKI,Wanfang and VIP databases,according to the inclusion and exclusion criteria collected and screened out a randomized controlled studies on the treatment of simple renal cysts,published from January 1,2000 to August 31,2015.Two independent authors screened out randomized clinical trials (RCTs),extracted data,assessed quality of data,and then carried out Meta analysis by Revman 5.0 software with related data.Results Twenty one studies met the inclusion criteria with a total of 2 296 patients,including 1 162 patients of retroperitoneal laparoscopy and 1 134 cases of open operation group.Compared to the open operation group,retroperitoneal laparoscopy showed shorter operation time,less bleeding,shorter hospitalization time,and earlier postoperative drainage tube extraction time.No significant difference was found in the recurrence rate of the cyst for two groups.Conclusions The clinical efficacy,safety,and complication of retroperitoneal laparoscopy in the treatment of simple renal cyst is better than the open operation.

Objective To systematically review and evaluate the perioperative indicators and surgical curative effect of 980 nm diode laser vaporization of prostate and transurethral resesction of prostate (TURP) in treating benign prostatic hyperplasia (BPH). Methods Retrieved published comparative studies 980 nm diode laser vaporization of prostate versus transurethral resesction of prostate in treating benign prostatic hyperplasia, and pooled the data from eligible studies. The statistical analysis was performed using Revman 5.3 software. Results Six trials including 839 patients were eligible to the criteria (450 in 980 nm diode laser group and 389 in TURP group). The baseline of patients characteristics were comparable in all the studies. Meta analysis showed that: the operative time was not significantly different between the 980 nm diode laser group and TURP group [SMD = 0.11, 95 ~ CI (-0.52,0.74), P > 0.05]; Compared with TURP group, 980 nm diode laser group has shorter hospital stays [SMD = -1.95, 95%CI (-3.42, -0.48), P < 0.05], and shorter catheterization time [SMD = -2.64, 95%CI (-3.92, -1.36), P < 0.05]. There was no significant difference between IPSS [WMD = 0.12, 95%CI (-0.27, 0.51), P > 0.05], QOL [SMD = 0.00, 95%CI (-0.57, 0.57), P > 0.05] and Qmax [SMD = 0.06, 95%CI (-0.26, 0.37), P > 0.05]. Conclusion 980 nm diode laser vaporization of prostate is safe and effective in treating benign prostatic hyperplasia, and compared with TURP, it has advantages in shorter hospital stays and shorter catheterization time.

Objective:To investigate the association between skin advanced glycation end products (AGEs) and carotid atherosclerosis (AS) in subjects with normal glucose regulation (NGR).Methods:This was a cross-sectional study. Data from the Health Management Center of the First Affiliated Hospital of University of Science and Technology between January 2019 to June 2019 were collected. A total of 902 NGR subjects aged 40-79 were enrolled and categorized into control group (530 cases), carotid intima-media thickness (IMT) thickening group (150 cases), and carotid atherosclerosis plaque group (222 cases) based on the carotid ultrasound results. Data as follows were collected, gender, age, blood pressure, body mass index (BMI), triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), fasting blood glucose (FPG), glycosylated hemoglobin (HbA 1c) and skin AGEs. Comparison via ANOVA analysis were carried out among the 3 groups. Logistic regression analysis was used to screen the independent influencing factors of carotid atherosclerosis plaque. Spearman correlation analysis was used to evaluate the correlation between AGEs and other parameters, and receiver operating characteristic (ROC) curve was used to evaluate the efficiency of skin AGEs in predicting carotid atherosclerosis plaque in NGR subjects. Results:Among the control group, IMT thickening group and carotid atherosclerosis plaque group, gender, age, systolic blood pressure (SBP), diastolic blood pressure (DBP), TC, LDL-C, FPG, HbA 1c, AGEs were significantly different (all P<0.05). Compared with IMT thickening group, the age, SBP and AGEs of carotid atherosclerotic plaque group were higher [55 (50, 60) vs 53 (49, 56) year; 132 (122, 141) vs 126 (115, 142) mmHg(1 mmHg=0.133 kPa); 74 (67, 81) vs 72 (67, 78) AU] (all P<0.001); compared with the control group, age, LDL-C, HbA 1c and AGEs of IMT thickening group were higher [53 (49, 56) vs 48 (45, 52) year; (2.8±0.7) vs (2.7±0.7) mmol/L; 5.4% (5.2, 5.6)% vs 5.4% (5.1, 5.6)%; 72 (67, 78) vs 70 (66, 76)] (all P<0.05). Age ( OR=1.179, 95% CI: 1.107-1.255), SBP ( OR=1.045, 95% CI: 1.013-1.077), LDL-C ( OR=2.028, 95% CI: 1.036-3.969), AGEs ( OR=1.049, 95% CI: 1.000-1.100) were independent influencing factors of carotid atherosclerotic plaque in population with normal glucose regulated (all P<0.05). AGEs was positively correlated with age, HbA 1c and carotid atherosclerosis plaque ( r=0.407, 0.092, 0.172) (all P<0.01). The area under the ROC curve of skin AGEs for identifying carotid atherosclerotic plaque in NGR population was 0.650 (95% CI 0.601-0.698), the best cutoff value was 70.5, the sensitivity was 65.8%, and the specificity was 56.9%. Conclusion:Skin AGEs level is closely associated with the occurrence of carotid atherosclerosis in NGR subjects.

Objective:To explore the value of conventional ultrasonography combined with cervical compression in the diagnosis of orbital venous malformation (OVM).Methods:A total of 43 patients with suspected OVM were admitted in sequentially from January 2019 to July 2022 in the Third Medical Center of PLA General Hospital. All patients were examined by ultrasonography combined with cervical compression and demonstrated by operation or digital subtraction angiography (DSA). The conventional ultrasound features of OVM were summarized, and the value of conventional ultrasonography combined with cervical compression in the diagnosis of OVM was discussed.Results:The features of the conventional ultrasound combined with cervical compression for diagnosis of OVM were as follows: the interior of lesion was mainly tubular structure, and the compression test was positive. After cervical compression, the lesion enlarged and the inner diameter of the internal tubular structure widened. Doppler flow imaging showed that the interior of lesion was mainly venous blood flow. Compared with the results of postoperative pathology or DSA, the sensitivity, specificity, accuracy and positive predictive value of ultrasonography combined with cervical compression were 0.952, 1.000, 95.3% and 100%, respectively. The results of Fisher exact diagnosis showed that there was no significant difference between ultrasonography and operation or DSA of OVM( P>0.05). Conclusions:Conventional ultrasound combined with cervical compression can be used as an effective method for the diagnosis of OVM.

Objective To investigate the safety and efficacy of wide local excision surgery combined with 5-aminolaevulinic acid(ALA)-photodynamic therapy(PDT)in treating Paget's disease of the scrotum in elderly people.Methods Patients with an average age of 68.4 ± 4.7 years undergoing wide local excision surgery combined with ALA-PDT for Paget's disease of the scrotum from June 2014 to February 2018 were followed up.All patients underwent wide local excision surgical treatment first and were then enrolled in ALA-PDT study after the diagnosis of Paget's disease of the scrotum was confirmed.Four cases were eliminated as a result of two patients refusing photodynamictherapy for various reasons and two patients lost during follow-up after ALA-PDT.A total of 16 patients were included in the study,of whom 6 cases were in Ray stage A1,7 cases in stage A2 and 3 cases in stage B.Patients underwent 3 courses of ALA-PDT after operation.Then the efficacy,shortand medium-term complications were followed up.Results The duration of disease among the 16 patients ranged from 4 to 76 months before diagnosis,with an average of 35.7 months.Surgery was performed immediately after diagnosis.Ten patients underwent resection and suture and 6 patients were treated with skin flap transfers.Of the patients treated with surgery,3 patients received suspicious lymph node dissection and 1 patient underwent reoperation due to skin flap necrosis.Patients were followed up for 3 months to 3 years and 6 months after ALA-PDT.Recurrence and distant metastasis occurred in 2 cases,with 1 case of brain metastasis and 1 case of systemic metastasis,and the overall recurrence rate was 12.5％.During the follow-up,there were no other serious complications except for 1 case(6.3 ％)with lower limb movement disorders.Conclusions Wide local excision surgery combined ALA-PDT has good clinical outcomes,low recurrence rates and few complications for the treatment of Paget's disease of the scrotum in elderly people.