In order to ensure the science and rationality of the research , ethical review has been the general principles of the international community before biomedical research . Along with the development of Chinese medicine in China , the Chinese government has paid close attention to the construction of ethical review in re-cent years . Relying on the State Clinical Research Center of Chinese Trial Program Affiliated to State Adminis-tration of Traditional Chinese Medicine of the People's Republic of China , our hospital has some experiences in the construction of ethical review platform . The academic exchanges and strengthening of personnel training can increase the ethical review level in order to provide supports and insurance for the Chinese medicine clini-cal research .

Dental Implantation, Endosseous ; Dental Implants ; Humans ; Maxilla ; Tissue Engineering

Objective To study the calculational method for the radiotherapy facilities of the medical linear accelerator' s useful beam towars its maze.Methods The shielding calculation was made under the relevant national standards for a radiotherapy treatment room and compared with the test results.Results The dose rates at the maze entrance as calculated and measured were 89 and 86 μSv/h inside the maze door,as well as 5.7 and 6.2 μSv/h outside the maze door,respectively.The calculated results were consistent with measured results.Conclusions By comparison of calculated results with measured results,the accuracy of the theoretical calculation method could be verified.

Objective To investigate the efficacy and safety of exsanguination band used in the lower extremity varicose vein operation.Methods A total of 158 cases of lower extremities varicose veins in this hospital served as the research subjects.All cases underwent the high ligation of great saphenous vein combined with punctate stripping operation.Among them,117 cases intraoperatively used the exsanguination band for blocking the lower limb blood flow (observation group),41 cases did not use the exsanguination band (control group).Then the intraoperative bleeding volume,operation time,pain degree and postoperative complications were observed in the two groups.Results Compared with the control group,the operation time,intraoperative blood loss,hematoma score,prothrombin time (PT) and fibrinogen (FIB) in the observation group were significantly decreased (P＜0.05),while activated partial thrombin time (APTT) and thrombin time (TT) were significantly increased(P＜0.05).The lower limb blood flow occlusion time in the observation group was 45-62 min with an average of (46.68-5.53) min.The sensory score and pain score at postoperative 2 weeks had no statistical difference between the two groups (P＞0.05).No arterial abnormalities and no obvious ischemic injury were found in the injured limbs of 2 groups.Conclusion Applying the exsanguination band for transiently blocking the blood flow can effectively shorten the operation time,reduces the intraoperative bleeding amount and decreases the subcutaneous hematoma formation risk with high safety.

Objective:Objectives The aim of the study is to evaluate the mechanical performance, safety and efficacy of the novel robotic-assistant flexible ureteroscopy system (Ra-fURS) under in vitro and in vivo environments.Methods:Combing with commercial flexible ureteroscopes, the novel Ra-fURS was used for the in vitro test and animal model operation in October 2020. The study included three sections. ①Basic mechanical performance assessment: including endoscope motion control (dual deflection, axial rotation and forward/backward distance), reaction time and fiber regulation. ②Simulated surgery in ex-vivo 3D-printing renal collecting system model: including completion rate and time of calyxes exploration, directional movement and laser fragmentation [gypsum models (0.5×0.5×0.5 cm) were used to stimulate kidney stones]. ③Intrarenal surgeries in animal models (two 5-month female Yorkshire white pigs). In total, 32 surgeries was performed (8 surgeons × 2 pigs × 2 kidneys/pig). In vivo assessments were carried out including: ①consuming time for Ra-fURS installation and offloading; ②completion rate and time of calyxes exploration; ③comfort score (ranging from 0-10) as compared to the manual f-URS, which was corresponding to each Ra-fURS surgery. In simulated surgery and animal surgery sections, 8 surgeons were enrolled in the study (group A 4 without flexible ureteroscopy experience; group B: 4 highly experienced), and results were compared between two groups.Results:Under the Ra-fURS control, the flexible ureteroscope movement in three degrees of freedom (forward / backward: + 11 to -11 cm, axial rotation + 225°to -225°; active duel-flection: + 270°to -270°, as well as the laser fiber regulation + 2.5 to -2.5 cm). In simulated surgery tests, both groups achieved 100% completion rate of calyxes exploration, and there were no statistical differences in the time of the calyxes exploration between group A and group B (116.0±8.0)s vs.(110.3±15.4)s( P>0.05). Time-consumption for laser fragmentation of group B was shorter than that of group A (525.8±58.5)s vs. (780.5±141.2)s( P<0.01). In animal surgery, the installation time of Ra-fURS gradually shortened within the first 7 cases was(234.0±43.0)s, and became comparable in the later 8-32 cases was(149.3±8.0)s. The average uninstall time was (43.9 ±5.9)s and was relatively stable. There were 51 renal calyxes in two pigs. It was higher for the completion rate of calyxes exploration in group B than in group A [(95.5±9.1)% vs. (59.1±9.1)%, P<0.05], and the exploration time was also statistically variant between the two groups group A and group B[(274.8±34.6)s vs.(127.3±18.2)s, P<0.05]. For all the operators, the comfort scores were favorable to the Ra-fURS as compared to the manual f-URS (8.9±0.3 vs. 5.9±1.1, P<0.05). Conclusions:This preliminary study demonstrated that the novel Ra-fURS was capable of controlling flexible ureteroscope to perform retrograde intrarenal surgery and fragmenting stones with laser. Besides, other features, including easy installation, stable performance and comfortable manipulating environment, made it easy to use in clinical application.

Objective: To summarize the initial experience of flexible ureteroscopy combined with thulium laser for the treatment of high-risk upper urinary tract urothelial carcinoma (UTUC) in patients with solitary kidney or renal insufficiency. Methods: A retrospective analysis was performed in 5 cases of UTUC with solitary kidney or renal insufficiency treated via flexible ureteroscopy combined with thulium laser from May 2016 to November 2018. Patients consisted of 4 cases of left side tumor, 1 case of right side tumor, with median age of 73 years old(ranging 53-87 years old). Among the 5 cases, 3 were solitary kidney with renal pelvis tumors, 2 cases were renal insufficiency accompanied with proximal ureter or renal pelvis tumor. All the patients had tumors large than 2 cm in diameter. The creatine in 3 cases with solitary kidney was 102, 128, 143μmol/L, respectively. The creatine in 2 cases with renal insufficiency was 281, 179μmol/L, respectively. Variable hydronephrosis was noticed in all paients. The cytological examination could reveal tumor cells in all cases. During the operation, part of tumor tissues were resected for pathological examination and the remaining visible tumor tissue was all ablated and vaporized. As there was no obvious residual tumor tissue, double J stent was retained. Patients were regularly reexamined after surgery. Results: Of the 5 cases, 4 patients were successfully performed, while intraoperative bleeding occurred in 1 case. The operation was suspended after indwelling double J stent. Then, the renal artery interventional embolism was performed after ineffective conservative treatment, and the bleeding was well controlled. One month later, the patient was treated with thulium laser tumor ablation and vaporizaiton under flexible ureteroscopy again. The pathology of all cases was high-grade invasive urinary epithelial carcinoma. Patients were followed up with regular imaging and endoscopic examination. The median follow-up period was 19 (4-26) months, during which 4 cases had local recurrence, one patient died of non-tumor factors. No recurrence of urothelial carcinoma occurred in the bladder during follow-up, the overall recurrence rate was 80%, and the median recurrence time was 6 (1-24) months. Patients with recurrence was treated with thulium laser tumor ablation and vaporizaiton under flexible ureteroscopy again. Conclusions Flexible ureteroscopy combined with thulium laser is an alternative treatment for high-risk upper urinary tract urothelial carcinoma in patients with solitary kidney or renal insufficiency, while with high tumor recurrence rate. Therefore, a stringent imaging and endoscopic follow-up should carry out postoperatively.

Objective:To evaluate the efficacy and safety of pharyngeal spraying recombinant human interfe-ron alpha 2b (rhIFNα2b) in the treatment of herpangina in children.Method:s A prospective, multicenter, rando-mized, opened and controlled study was carried out in 11 hospitals in Anhui province from August 2018 to March 2019.According to the time of admission, 180 patients diagnosed as herpangina were prospectively and randomly divided into rhIFNα2b treatment group and Ribavirin control group.On the basis of giving both groups the heat-clearing, detoxifying and anti-infection treatment, the patients in treatment group received pharyngeal spraying rhIFNα2b 9 g/L saline solution[1 million IU/mL, 0.1 million IU/(0.1 mL·press)], and the patients in control group were treated by pharyngeal spraying Ribavirin (0.5 mg RBV/press, 150 press), 3 presses per time, 4 times per day, continuous administration for 5 days for both groups.Those who recovered in advance were no longer given medication.All patients were observed to fully recover.The clinical efficacy and the disappearing time of symptoms and signs between two groups were compared, and the safety of pharyngeal spraying rhIFNα2b for patients was evaluated.Result:s All of the 180 patients completed the study, including 90 cases in the treatment group and 90 cases in the control group.There was no statistically significant difference in terms of gender, age, weight and course of illness before treatment between the two groups (all P>0.05), which had clinical comparability.The apparent efficiency of the treatment group [63.3% (57/90 cases)] was significantly higher than that in the control group [38.9% (35/90 cases)] and the difference was statistically significant( χ2=10.934, P=0.004); no significant difference in the total efficiency between the treatment group [96.7% (87/90 cases)]and the control group [92.2% (83/90 cases)]was observed ( χ2=2.924, P=0.169). The duration of fever[(32.59±20.73) h vs.(45.72±26.96) h], hyperemia[(76.48±23.12) h vs.(92.44±24.31) h], herpes[(72.99±25.77) h vs.(85.09± 26.62) h], salivation[(45.44±24.96) h vs.(54.42±31.20) h] and anorexia[(62.70±23.99) h vs.(78.71±30.54) h] in the treatment group were significantly shorter than those in the control group, and the differences were statistically significant(all P<0.05). Before treatment, the serum levels of tumor necrosis factor α(TNF-α) [(13.02±4.41) ng/L vs.(13.57±9.27) ng/L], interleukin-6(IL-6) [(26.48±11.31) ng/L vs.(30.15±15.55) ng/L] and C-reactive protein(CRP)[(19.34±14.11) mg/L vs.(19.83±14.57) mg/L]were not significantly different between the two groups (all P>0.05). After treatment, the serum levels of TNF-α and IL-6 were(7.26±1.99) ng/L and (2.42±0.73) ng/L in the treatment group, which were significantly lower than those in the control group [(12.09±6.39) ng/L and (7.32±11.51) ng/L](all P<0.05), but no significant difference in serum levels of CRP between the two groups was observed ( P>0.05). The comparison on positive rate of virus in pharyngeal swab between the treatment group [65.3% (32/49 cases) and 40.6% (13/32 cases) respectively] and the control group[66.7%(36/54 cases) and 41.0% (16/39 cases), respectively]before and after therapy showed no significant difference (all P>0.05). During the treatment, no serious adverse reactions were observed in the two groups.The incidence of adverse reactions was 1.1% (1/90 cases) in the treatment group and 5.6% (5/90 cases) in the control group.In addition, the serum hemoglobin level of children in the control group after treatment was significantly lower than that before treatment and that in the treatment group (all P<0.05). Conclusions:Compared with pharyngeal spraying ribavirin, pharyngeal spraying rhIFNα2b can greatly improve the clinical efficiency, accelerate the disappearance of clinical symptoms and signs, and shorten the total course of disease, and is more safe and worthy of clinical application.

Smoldering multiple myeloma is a kind of heterogeneous asymptomatic plasma cell disease. Some patients have a high risk of developing symptomatic multiple myeloma. However, the starting point and options of treatment for smoldering multiple myeloma patients are still unclear. This article reviews the risk stratification and treatment progress of smoldering multiple myeloma.

Background/Aims: Acute-on-chronic liver failure (ACLF) is a catastrophic illness. Few studies investigated the prognostic value of vitamin D-binding protein (VDBP) for hepatitis B virus (HBV)-related ACLF (HBV-ACLF) resulted in conflicting results. Methods: Two prospective HBV-ACLF cohorts (n=287 and n=119) were enrolled to assess and validate the prognostic performance of VDBP. Results: VDBP levels in the non-survivors were significantly lower than in the survivors (P<0.001). Multivariate Cox regression demonstrated that VDBP was an independent prognostic factor for HBV-ACLF. The VDBP level at admission gradually decreased as the number of failed organs increased (P<0.001), and it was closely related to coagulation failure. The areas under the receiver operating characteristic curve (AUCs) of the Child-Pugh-VDBP and chronic liver failuresequential organ failure assessment (CLIF–SOFA)-VDBP scores were significantly higher than those of Child-Pugh (P<0.001) and CLIF-SOFA (P=0.0013). The AUCs of model for end-stage liver disease (MELD)-VDBP were significantly higher than those of MELD (P= 0.0384) only in the case of cirrhotic HBV-ACLF patients. Similar results were validated using an external multicenter HBV-ACLF cohort. By longitudinal observation, the VDBP levels gradually increased in survivors (P=0.026) and gradually decreased in non-survivors (P<0.001). Additionally, the VDBP levels were found to be significantly decreased in the deterioration group (P=0.012) and tended to be decreased in the fluctuation group (P=0.055). In contrast, they showed a significant increase in the improvement group (P=0.036). Conclusions The VDBP was a promising prognostic biomarker for HBV-ACLF. Sequential measurement of circulating VDBP shows value for the monitoring of ACLF progression.

Objective To study the effect of diffusion-weighted magnetic resonance imaging (DW-MRI) in the differential diagnosis of hydronephrosis and pyonephrosis.Methods From March 2015 to October 2017,50 patients with renal stone and highly suspected infectious hydronephrosis underwent renal DW-MRI,and clinical materials were collected and analyzed retrospectively.Seventeen male and 33 female patients were enrolled with a mean age of (49.40 ±-10.51) years.The median maximum diameter of renal stone was 30.30 (17.38,56.01) mm and hydronephrosis was 46.39 (34.33,56.55) mm.No pyonephrosis was diagnosed by preoperative ultrasound or CT,while 29 cases of hydronephrosis and 21 cases of pyonephrosis were reported by preoperative DW-MRI.Final diagnoses of hydronephrosis and pyonephrosis were made according to whether the pelvic urine drainage was purulent or not during the surgery.DW-MRI reports and characteristics of DW images were analyzed retrospectively.Apparent diffusion coefficient (ADC) was calculated and ADC map constructed,which was compared between the two groups.Receiver operating characteristic curve (ROC) was drawn to analyze the area under curve (AUC) and the optimal cutoff of ADC value,with sensitivity and specificity.Results Thirty-three patients of hydronephrosis and 17 pyonephrosis were confirmed intraoperatively.The overall accuracy of diagnosis using DW-MRI was 84.00％ (42/50),with sensitivity of 88.24％ (15/17) and specificity of 81.82％ (27/33).Among 30 patients who underwent CT scan in our hospital,mean CT value of 18 hydronephrosis was (7.03 ± 3.26)HU and that of 12 pyonephrosis was (8.67 ± 3.52) HU,with no statistical significance (P ＞ 0.05).On DW image,when b ≥ 500 s/mm2,hydronephrosis signal intensity was lowered apparently,whereas pyonephrosis signal intensity was intensified.On ADC map,hydronephrosis appeared as hyperintensity,whereas pyonephrosis appeared as hypointensity.The mean ADC value of pyonephrosis group was lower than hydronephrosis group [(1.53 ±0.58) × 10-3 mm2/s vs.(2.86 ±0.56) × 10-3 mm2/s,p ＜0.01].ROC analysis revealed that AUC =0.92 (95％ CI 0.80-0.98),and the cut-off value of ADC for pyonephrosis diagnosis was 1.39 × 10-3 mm2/s,of which the sensitivity and specificity was 94.12％ and 84.85％ respectively.Conclusions Signal of pyonephrosis was enhanced on DW image,while decreased on ADC image.The ADC value of pyonephrosis was much lower than that of hydronephrosis,with which the differential diagnosis between pyonephrosis and hydronephrosis could be made efficiently.