Objective:To investigate the 2 years’ efficacy of intravesical instillation of domestic BCG versus epirubicin in the prevention of recurrence of intermediate-risk or high-risk non-muscular invasive bladder cancer and predictive factors of BCG instillation.Methods:From July 2015 to June 2020, 18-75 years old patients with moderate to high-risk non muscle invasive bladder cancer (NMIBC) confirmed by pathological examination were involved. The ECOG score was 0-2. Exclusion criteria included ①immune deficiency or impairment (such as AIDS), using immunosuppressive drugs or radiotherapy, suspected allergic to BCG or epirubicin or excipients of the two drugs, fever or acute infectious diseases including active tuberculosis or receiving anti tuberculosis treatment, with severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; ②combined with other urogenital system tumors or other organ tumors; ③combined with muscle invasive bladder urothelial carcinoma (≥T 2); ④undergoing chemotherapy, radiotherapy or immunotherapy within 4 weeks (immediate instillation after surgery not included); ⑤ pregnant or lactating women; ⑥ comfirmed or suspected bladder perforation; ⑦gross hematuria; ⑧cystitis with severe bladder irritation that may affect the evaluation; ⑨participat in other clinical trials within 3 months; ⑩alcohol or drug addiction; ?any risk factors that may increasing the risk of patients. Epirubicin 50 mg was irrigated immediately after the operation(TURBT or laser resection). The patients were randomly divided into BCG15 group, BCG19 group and epirubicin group by the ratio of 2∶2∶1, and the patients were maintained intravescical instillation for 1 year. The recurrence and adverse events of the three groups were compared. Univariate and multivariate analysis was performed to predict the risk factors of BCG irrigated therapy failure. Result:By June 15, 2020, the median follow-up duration was 22.1 months(12.1, 32.3), and there was no statistical difference between the groups ( P=0.9024). There were 274 patients enrolled in BCG19 group, 277 patients enrolled in BCG15 group and 130 patients enrolled in the epirubicin group. The drop-off rate was 16.6%(113 cases)and made no difference between groups( P=0.6222). There were no significant difference in age, gender, BMI, or ECOG score( P>0.05). During the follow-up, 116 cases was detected recurrence or progression. The recurrence rate of the three groups was 14.2% and 14.8% in BCG19 group and BCG15 group, and 27.7% in the epirubicin group. There was no difference in recurrence rate between BCG19 and BCG15 group( P=0.9464). The recurrence rate of BCG19 group was lower than that of the epirubicin group ( P=0.0017). The recurrence rate of BCG15 group was lower than that of the epirubicin group ( P=0.0020). There was no difference in the cumulative recurrence free survival rate between BCG19 and BCG15 group (95% CI0.57-1.46, P=0.7173). The cumulative recurrence free survival rate of BCG 19 group was better than that of the epirubicin group( HR=0.439, 95% CI0.26-0.74, P=0.0006), and the cumulative recurrence free survival rate of BCG15 group was better than that of the epirubicin group ( HR=0.448, 95% CI0.29-0.80, P=0.0021). The total incidence of adverse events in 19 BCG19, BCG15 and epirubicin group were 74.5%, 72.6% and 69.8% respectively. There was no difference in the incidence of adverse events between BCG19 and BCG15 group( P=0.6153). The incidence of adverse events in epirubicin group was lower than that of BCG19( P=0.0051) and BCG15( P=0.0167) groups.There was no significant difference in the incidence of serious adverse events (SAE) among the three groups ( P=0.5064). Log rank test univariate analysis and Cox risk regression model multivariate analysis showed that the history of bladder cancer recurrence( HR=6.397, 95% CI1.95-20.94, P=0.0001)was independent risk factor for BCG irrigation failure. Conclusions:The 2 years’ efficacy of intravesical instillation of domestic BCG is better than than of epirubicin with good tolerance and safety. There is no difference between BCG19 and BCG15 group. BCG doesn’t increase SAE compared with epirubicin. Recurrence status was an independent prognostic factor regarding recurrence-free survival.

Objective To investigate the efficacy and safety of intravesical instillation of BCG vaccine in the prevention of early recurrence of middle and high risk non-muscle invasive bladder cancer.Methods From July 2015,patients with non-muscle invasive bladder cancer aged 18-75 years with informed consent were screened and underwent transurethral resection of bladder tumor (TURBT).Immediately intravesical instillation of epirubicin 50 mg was given postoperatively.After pathology was comfirmed,patients was enrolled in group 1 (BCG15) or group 2 (BCG 19) or the control group (epirubicin 18) randomly with SAS 9.3 software.Data of follow-up and Adverse event was collected and analyzed.Results By May 31,2019,531 patients were enrolled in the study.The drop-off rate was 20.1％.167 patients (143 males and 24 females)in group 1,172 patients (141 males and 31 females)in group2 and 84(75 males and 9 females) in the control group with follow-up data were analyzed.There were no significant differences in age,gender,BMI,ECOG score,risk stratification between the three groups (P =0.8641,P =0.2906,P =0.9384,P =0.6126).The median follow-up time makes no statistical difference between the groups (P =0.9251),12.0 (6.0,22.5) months,13.0 (6.0,22.3) months,and 13.0 (7.0,22.3) months.The median recurrence time of the three groups was 4.0 (3.0,6.0) months,4.5 (3.0,9.8) months,4.5 (3.0,8.8) months.There was no statistical difference between the three groups (P =0.2852).Risk stratification in the patients got no significant difference between the three groups (P ＞ 0.05).The 1-year recurrence-free survival rates were 80.0％ in the group 1 and 88.3％ in the group 2 and 73.7％ in the control group.The group 2 was superior to the group 1 and the control group (P =0.0281,P =0.0031).There was no significant difference between group 1 and control group (P =0.2951).There was no significant difference in the cumulative recurrence-free survival between the experimental group 1 and the experimental group 2,(95％ CI 0.80-2.43,P =0.2433).The cumulative recurrence-free survival in the group 1 and the group 2 was better than the control group (95 ％ CI 0.31-0.92,P =0.0266;95 ％ CI 0.20-0.65,P =0.0008).All the cases underwent instillation were analyzed for adverse events.The incidence of overall AE(adverse events) in group 1 was 68.5％ (152/222),the incidence of grade Ⅰ-Ⅱ AE was 53.2％ (118/222),the incidence of grade Ⅲ-Ⅳ AE was 15.3％ (32/222).The incidence of overall AE in the group 2 was 71.8％ (160/223),the incidence of grade Ⅰ-Ⅱ AE was 60.1％ (134/223),and the incidence of grade Ⅲ-Ⅳ AE was 11.7％ (26/223).The overall AE rate in the control group was 53.2％ (59/111),of which the incidence of grade Ⅰ-Ⅱ AE was 42.4％ (47/111),and the incidence of grade Ⅲ-Ⅳ AE was 10.8％ (12/111).There was no difference in the incidence of overall AE between the group 1 and the group 2 (P =0.4497).The incidence of AE in the two experimental groups was higher than that in the control group (P =0.0062,P =0.0008).There was no difference in the incidence of grade Ⅲ-Ⅳ AE between the three groups (P =0.3902).Conclusions BCG(19 instillation schedule) has a better effect on preventing recurrence after 1 year of bladder surgery,which is superior to epirubicin group.The long-term efficacy of BCG in preventing recurrence and the efficacy of different schedules need to be further followed up.The lower urinary tract symptoms,which are mainly urinary frequency,are one of the causes of case fallout and should be fouced in future.Compared with epirubicin,BCG perfusion does not increase the incidence of grade Ⅲ-Ⅳ adverse reactions,and is safe to use.

Objective To explore coronary CT three-dimensional post-processing standardized display and the construction of digital teaching platform. Methods The conventional display positions of 3D post-processing image were summarized during daily coronary CTA examination, the common place was refined. The construction mode was explored for CTA digital teaching demonstration platform. Results Coronary CTA 3D post-processing standardized display with common and individual property contributed to enhancing the display of coronary images. The CTA digital teaching demonstration platform met the teaching requirements. Conclusion The coronary CT 3D post-processing standardized display and digital teaching platform facilitate the student to master related knowledge.

Objective To explore the effects of heart rate changes after holding breath and time for recovering stable heart rate on the quality of coronary CTA.Methods Totally 700 patients undergoing coronary CTA examination in some hospital were enrolled into the study,whose data on initial heart rate at rest condition,maximal heart rate during breath holding,stable heart rate after breath holding as well as the time consumed for recovering stable heart rate were collected and analyzed.Results A heart rate trendgram was drawn to find out the rules for heart rate changes and time for recovering stable heart rate,so that proper retrospective or prospective scanning scheme could be determined.Conclusion Mastering the rules in heart rate changes and time for recovering stable heart rate contributes to guiding coronary CTA.

OBJECTIVETo investigate the effect of propofol on brain regions at different sedation levels and the association between changes in brain region activity and loss of consciousness using blood oxygen level-dependent functional magnetic resonance imaging (BOLD-fMRI) and bispectral index (BIS) monitoring.

METHODSForty-eight participants were enrolled at Peking Union Medical College Hospital from October 2011 to March 2012 and randomly assigned to a mild or a deep sedation group using computer- generated random numbers. Preliminary tests were performed a week prior to scanning to determine target effect site concentrations based on BIS and concomitant Observer's Assessment of Alertness/Sedation scores while under propofol. Within one week of the preliminary tests where propofol dose-response was established, BOLD-fMRI was conducted to examine brain activation with the subject awake, and with propofol infusion at the sedation level.

RESULTSMild propofol sedation inhibited left inferior parietal lobe activation. Deep sedation inhibited activation of the left insula, left superior temporal gyrus, and right middle temporal gyrus. Compared with mild sedation, deep propofol sedation inhibited activation of the left thalamus, precentral gyrus, anterior cingulate, and right basal nuclei.

CONCLUSIONMild and deep propofol sedation are associated with inhibition of different brain regions, possibly explaining differences in the respective loss of consciousness processes.

Adult ; Brain ; drug effects ; Consciousness Monitors ; Deep Sedation ; Dose-Response Relationship, Drug ; Humans ; Hypnotics and Sedatives ; pharmacology ; Male ; Propofol ; pharmacology

OBJECTIVETo investigate the effect of subanaesthetic dose of ketamine on mechanical stimulus on brain regions.

METHODSTotally 13 healthy male volunteers were enrolled in this study, in whom 0 and 100 ng/ml ketamine were administrated by target controlled infusion system in pilot study. After von Frey filaments (vFFs) 300 g were used as mechanical stimuli, Visual Analogue Scale scores were evaluated. Functional magnetic resonance imaging (fMRI)was taken 1 week after pilot study at the following sequences: structure imaging + functional imaging (stimulus sequence with 300 g vFFs, ketamine sequence); stimulus sequence = 6×(20s on + 20s off), with target concentration of ketamine at 0,100 ng/ml.fMRI result was processed by SPM2 and Metlab 7.01 software package.

RESULTSPosterior cerebellum lobe and corpus callosum were inhibited at 100 ng/ml under vFFs stimulus, whereas cingulate gyrus, middle frontal gyrus, inferior parietal lobule, occipital lobe, and posterior cerebellum lobe were activated at 100 ng/ml under vFFs stimulus.

CONCLUSIONSKetamine 100 ng/ml exerts its effect on pain related brain regions. It can both activate and inhibit these brain regions, with the activating effect being the primary effect.

Adult ; Analgesics ; administration & dosage ; pharmacology ; Brain ; drug effects ; physiopathology ; Humans ; Ketamine ; administration & dosage ; pharmacology ; Magnetic Resonance Imaging ; Male ; Pain ; physiopathology ; Pilot Projects

Severe tracheal stenosis can not only cause critical medical problems such as severe shortness of breath, hypoxia, and even orthopnea, but also impose overwhelming challenges on the physicians, particularly the anesthesiologist. Life-threatening airway obstruction can make the patient's gas exchange extremely difficult.Though several options could be offered regarding the treatment of tracheal stenosis, normally, tracheal resection and following reconstruction is the first choice for severe airway stenosis. Successful surgical intervention relies on the close communication and cooperation between surgeons and anesthesiologists. In these cases, airway management is the top issue for the anesthesiologist, and the level of difficulty varies with stenosis location, severity of stenosis, and surgical technique. Extracorporeal membrane oxygenation (ECMO), or cardiopulmonary bypass (CPB), is rarely utilized for the surgery, but for those impossible airways due to nearly complete tracheal obstruction, ECMO or CPB could be the final choice for anesthesiologists. Here we report a case of successful urgent airway management for tracheal resection and reconstruction assisted by temporary CPB.
Cardiopulmonary Bypass ; Emergencies ; Female ; Humans ; Middle Aged ; Reconstructive Surgical Procedures ; methods ; Trachea ; surgery

OBJECTIVETo observe the effects of different concentrations of propofol on brain regions activated by mechanical stimuli, and then to investigate the analgesic effect of propofol.

METHODSTwenty healthy male volunteers were randomly divided into two groups: light anesthesia group (group L) (BIS 60-80) and deep anesthesia group (group D)(BIS 40-60). Propofol was administrated by target controlled infusion system in pilot study. The target effect site concentration (ESC) of propofol was defined as the average of the ESC from BIS 80 to 60 or BIS 60 to 40 in group L or group D respectively. Mechanical stimuli were applied using von Frey filaments at the center of the left foot, and the pain threshold and VAS scores were evaluated. fMRI examinations were taken 1 week after pilot study with the following sequences: structure imaging+ functional imaging: functional imaging=stimulus sequence+propofol sequence, in which the stimulus sequence was 6 × (20 s on + 20 s off). This sequence was repeated after propofol sequence.

RESULTSAs shown by fMRI, in group L, active brain regions of (the second stimulation-the first stimulation, P2-P1) were seen in cingulate gyrus, thalamus, and cerebellum, while active brain regions of (P1-P2) were seen in temporal lobe, frontal gyrus, and occipital lobe. In group D, the active brain region of (P2-P1) was only seen in cerebellum, while active brain regions of (P1-P2) were seen in cingulate gyrus and thalamus. Active brain regions of (deep-low) with propofol infusion in response to vFFs stimulation were observed in cerebellum.

CONCLUSIONSPropofol at different concentrations has different effect on the activation of brain regions. It may exert its analgesic effect via different mechanisms.

Adult ; Brain ; physiology ; Humans ; Magnetic Resonance Imaging ; Male ; Propofol ; pharmacology ; Stress, Mechanical ; Young Adult

OBJECTIVETo compare the efficacy of ondansetron and granisetron in the prevention of postoperative nausea and vomiting (PONV) in high-risk patients.

METHODSTotally 200 patients with three key risk factors for PONV (female, non-smoking and postoperative opioid use) were equally randomized into ondansetron group and granisetron group. Ondansetron (4 mg) or granisetron (3 mg) was intravenously administered upon the completion of surgery. The episodes of nausea and vomiting were observed for 24 hours after surgery.

RESULTSA significantly greater proportion of patients in granisetron group achieved a complete response (i.e., no PONV or rescue medication) during the first 24 hours postoperatively versus those in ondansetron group (62.6% vs. 46.9%, respectively; P=0.048). There were no significant differences in terms of postoperative nausea incidences (42.9% vs. 34.3%, respectively), postoperative vomiting incidences (25.5% vs. 20.2%, respectively) and postoperative rescue anti-emetics incidences (19.4% vs. 15.2%, respectively) (P>0.05).

CONCLUSIONGranisetron is more effective than ondansetron in preventing PONV in high-risk patients during the first 24 hours postoperatively.

Adolescent ; Adult ; Aged ; Antiemetics ; therapeutic use ; Double-Blind Method ; Female ; Granisetron ; therapeutic use ; Humans ; Male ; Middle Aged ; Ondansetron ; therapeutic use ; Postoperative Nausea and Vomiting ; prevention & control ; Treatment Outcome ; Young Adult

OBJECTIVETo evaluate the clinical efficacy of domestic sevoflurane by comparing the pharmacokinetic and pharmacodynamic characteristics of domestic sevoflurane and an imported product.

METHODSEighty patients undergoing general anesthesia for transabdominal hysterectomy were equally randomized into domestic sevoflurane group and imported sevoflurane group. The following data were recorded and compared: vital signs; change of sevoflurane concentrations in the induction period and recovery period; the time when inhaled sevoflurane concentration reached half of the pre-set concentration of the vaporizer; the time when the end-tidal sevoflurane concentration reached half of the pre-set concentration of the vaporizer; the time when the end-tidal sevoflurane concentration reached half of inhaled sevoflurane concentration; the time of the end-tidal sevoflurane concentration reached 0. 8 MAC in the induction period; the recovery time; the extubation time; and time to recovery of consciousness.

RESULTSThe general conditions of the two groups were not significantly different. The pharmacokinetic and pharmacodynamic parameters at the intra-operative time points as well as the minimal alveolar concentration, the inspired and end-tidal sevoflurane concentrations, and the time to recovery of consciousness also showed no significant differences between the two groups.

CONCLUSIONThe domestic sevoflurane has similar pharmacokinetic and pharmacodynamic characteristics as the imported products. It can serve as a cost-effective product for transabdominal hysterectomy.

Adolescent ; Adult ; Aged ; Anesthesia, Inhalation ; Anesthetics, Inhalation ; pharmacokinetics ; Double-Blind Method ; Female ; Humans ; Hysterectomy ; Methyl Ethers ; pharmacokinetics ; Middle Aged ; Young Adult