Objective: To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 μg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control. Methods: This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (CI) were calculated, and non-inferiority was demonstrated if the lower limit of 95% CI was > -10%. The t-test, chi-square test, or rank sum test was used according to the types and features of data. Results: A total of 855 HBeAg-positive CHB patients were enrolled and 820 of them received treatment (538 in the trial group and 282 in the control group). The data of the full analysis set showed that HBeAg seroconversion rate at week 72 was 27.32% in the trial group and 22.70% in the control group with a rate difference of 4.63% (95% CI -1.54% to 10.80%, P = 0.1493). The data of the per-protocol set showed that HBeAg seroconversion rate at week 72 was 30.75% in the trial group and 27.14% in the control group with a rate difference of 3.61% (95% CI -3.87% to 11.09%, P = 0.3436). 95% CI met the non-inferiority criteria, and the trial group was non-inferior to the control group. The two groups had similar incidence rates of adverse events, serious adverse events, and common adverse events. Conclusion In Peg-IFN-α regimen for HBeAg-positive CHB patients, the new drug Peg-IFN-α-2b (Y shape, 40 kD) has comparable effect and safety to the control drug Peg-IFN-α-2a.

Objective To investigate the effects of different depths of sedation during combined intravenous-inhalational anesthesia on postoperative cognitive function in patients undergoing gynecological laparoscopic surgery.Methods Ninety ASA Ⅰ or Ⅱ patients,aged 20-64 yr,with a body mass index of 19-30 kg/m2,scheduled for elective gynecological laparoscopic operation,were randomly divided into 3 groups (n =30 each).Anesthesia was induced with midazolam,fentanyl,propofol and rocuronium.The patients were tracheal intubated and mechanically ventilated.Anesthesia was maintained with inhalation of sevoflurane (end-tidal concentration 1.0％-1.5 ％),iv infusion of remifentanil and intermittent iv boluses of rocuronium.The infusion rate of remifentanil was adjusted to maintain BIS value:30 ＜ BIS value ≤ 40 in group Ⅰ,40 BIS value ≤ 50 in group Ⅱ and 50 ＜ BIS value≤60 in group Ⅲ.Cognitive function was assessed using Mini-Mental State Examination (MMSE) and TrailMaking Test (TMT) at 1 d before anesthesia and 1 d after surgery.Results MMSE scores were ＞ 24 at 1 d before anesthesia and 1 d after surgery in all the three groups,and there was no significant difference within each group and among the three groups (P ＞ 0.05).Compared with the baseline value,TMT completion time was significantly prolonged at 1 d after surgery in groups Ⅰ and Ⅲ,while shortened in group Ⅱ (P ＜ 0.05).Compared with groups Ⅰ and Ⅲ,TMT completion time was significantly shortened at 1 d after surgery in group Ⅱ (P ＜0.05).Conclusion The depth of sedation,40 ＜ BIS value ≤ 50,during combined intravenous-inhalational anesthesia with sevoflurane and remifentanil has less influence on postoperative cognitive function in patients undergoing gynecological laparoscopic surgery.

Objective To evaluate the accuracy of spectral entropy including response entropy(RE)and state entropy(SE)as a new electroencephalographic measure of depth of sedation during general anesthesia.Methods Twenty ASA Ⅰ or Ⅱ patients aged 20-55 yr undergoing elective abdominal surgery were studied.Anesthesia Was induced with intravenous propofol,fentanyl and vecuronium.After tracheal intubation anesthesia was maintained with sevoflurane inhalation and intermittent iv boluses of fentanyl and vecuronium.BP,HR,SpO2,spectral entropy(Datex-Ohmeda)and BIS(Aspect Medical)were monitored during anesthesia.Loss of eyelash reflex and unresponsiveness to verbal stimulus and mild prodding and shaking were considered to be signs of loss of consciousness(LOC).The time of regaining consciousness Was defined as the time when patients started responding to verbal commands.RE,SE and BIS were recorded before anesthesia(baseline),10 min before LOC,immediately after LOC,immediately after tracbeal intubation,1 h after skin incision,10 min before regaining consciousness immediately after consciousness was regained and 10 min after extubation.Results There were sisnificant changes in RE,SE and BIS during the transition from consciousness to LOC.The RE,SE and BIS values for LOC were 76,73 and 68 with sensitivity of 94%,95%and 92%and specificity of 92%,94%and 91%respectively.The accuracy of RE.SE and BIS in predicting LOC was 93%,95%and 94%respectively.The RE,SE and BIS values for regaining consciousness were 82,75 and 70 with sensitivity of 95%,95%and 91%and specificity of 93%,96%and 93%respectively.The accuracy in predicting regaining of consciousness was 98%,96%and 97%respectively.Conclusion Entropy index Can accurately monitor level of sedation during general anesthesia.

Objective To investigate the relationship between intraoperative cerebral oxygen saturation (rSO2) and postoperative cognitive dysfunction with near-infrared cerebral oximeter (INVOS 5100) in patients operated under inhalational combined intravenous anesthesia, and to determine the critical rSO2 value below which postoperative cognitive dysfunction may occur. Methods Sixty ASAⅠ-Ⅱ patients of both sexes were selected, aged 62-80yr, weighed 58-77kg, scheduled for elective abdominal surgery or surgery on the low limb. All the patients were divided into three groups according to their educational background: in group Ⅰ were the illiterate and uneducated patients (n=20);group Ⅱ the primarily educated patients (<6yr education) (n=20), and group Ⅱ the well educated patients (>6yr education) (n=20). Each group was further divided into isoflurane and sevoflurane subgroups (n=10 in each subgroup). All patients received no pre-medication. Anesthesia was induced with intravenous atropine 0.3mg, propofol 1.0-1.5mg kg-1, fentanyl 2-3μg*kg-1 and vecuronium 0.1-0.2mg*kg-1, and maintained with isoflurane or sevoflurane inhalation(0.9-1.1 MAC) supplemented with intermittent i.v. boluses of fentanyl, and recorded after entering room (baseline) (T0), after O2 inhalation (T1), after induction of anesthesia (T2), after skin incision (T3), during operation (T4), the end of surgery (T5), and awaking (T6). Mini-Mental State Examination (MMSE) was performed before anesthesia and 1, 4, 8, 12 and 24h after surgery. BP, HR, ECG, SpO2, PETCO2 and end-tidal concentration of inhalational anesthetics were continuously monitored during anesthesia. Results In all three groups rSO2 was significantly lower during operation (T4) and at the end of surgery (T5) than baseline (T0) (P<0.05). In all patients the MMSE scores at 1h after operation were significantly lower than the baseline value (P<0.05). The MMES scores in all patients significantly declined within 1-4h after surgery, and the cognitive function recovered at 4h after surgery in 85% patients. The critical values of rSO2 below which postoperative cognition dysfunction may occur were: 45 (group Ⅰ), 47 (group Ⅱ) and 49 (group Ⅲ) for isoflurane anesthesia subgroups;47 (group Ⅰ), 48 (group Ⅱ) and 50 (group Ⅲ) for sevoflurane subgroups. Conclusion The perioperative rSO2 should be maintained up to above 50% to reduce the incidence of postoperative cognitive dysfunction under inhalational combined intravenous anesthesia.

Objective To study the relationship of implicit memory and amnesia effect of oral midazolarn premedication and toobserve its anterograde amnesia, the effect on short-term memory and the onset time and out come of retrograde amnesia. Methods60 patients with ASA I - Ⅱ status undergoing abdomen and limb operations were divided into 3 groups with 20 cases each. Group A:oral midazolam 7.5mg;Group B:oral 15mg;Group C:placebo. The patients received combined spinal-epidural anesthesia after oral midazolam. The parameterns of EEG, SEF 95 %, BISwere collected at the same time and the degree and remark of sedation were dome according to OAA/S. The amnesia and implicit memory were investigated with pictures and muddy identified hearing rate 6 hours after operation. Results (1)Twenty min following drug ad dministration the remarks of sedation of group A and B were significantly loWver than that before and that of group C, Which was not significently different between group A and B. ( 2)The amnesia rates tested six hrs after surgery were significantly higher at 30min in group A, 20min in group B than those before treatment and were kept at 70%-80% levels, which in group C was remained zero. (3)The muddy identified hearing rate was not different significantly, among the three groups. (4) The short-term memory was all 100%during the period of drug action. (5)BIS and SEF 95% Were lower 30min after the treatment and all kept at 80 Hz and 20 Hz, which were not different remarkably between group A and B. ConclnsionOral midazolam 7. 5mg has a good effect on anterograde amnesia 30min after treatment, which may not be improved with increament in dosage. It does not lead to retrograde amnesia. The long-term memory, but not short-term memory, was impaired by midazolam. It only affects the explicit memory. Oral premnedication with midazolam can not prevent the awareness during operation totally.

Objective To compare cerebral oximetry(rSO 2 %)and somatosensory evoked potential (N 35 ) in their accuracy in monitoring cerebral perfusion during carotid endarterectomy procedure under general anesthesia. Methods Ten patients (6 males, 4 females), scheduled for selective carotid endarterectomy, were enrolled in the study. Their rSO 2 %and N 35 were also continuously monitored and recorded during perioperative periods. The patients' cognitive function was evaluated at the same time. The MAP, HR, SpO 2 were continuously monitored during operation. Results There was a significant difference in rSO 2 % between that at the period of elamping and that at the period of declamping of the carotid artery. No patients suffered from cognition dysfunction during perioperative period. Conclusion With comparison to the amplitude of N 35 it was rSO 2 % which was earlier to show alteration in cerebral perfusion in case of cerebral oxygen deficit. In monitoring cerebral perfusion, rSO 2 % was better than N 35

Objective To evaluate the effects of different anesthetic methods on myocardial function after the CABG operation and compare the hemodynamic variables under the propofol total intravenous anesthesia with high dosages fentanyl anesthesia. Methods 12 patients (ASA Ⅲ) undergoing selective CABG operation under CPB were randomly divided into two groups (with 6 in each): Group Ⅰ (large dosages of fentanyle anesthesia), and Group Ⅱ (propofol total intravenous anesthesia). The hemodynamic parameters were recorded after induction of anesthesia, after sternotomy, after CPB, and after closure of thoracostomy. Results There were no significant differences of MBP, HR, SVRI, CI, LVEF, and A/E, Tei index between the two groups. Conclusion The method of propofol total intravenous anesthesia (TIVA) was safe, effective and praticable for the CABG operations under CPB.

0.05),while the entropy index showed significant differences between the two groups(P

Objective To investigate the effects of propofol sedation on different areas of cerebral cortex and memory during operation performed under epidural anesthesia using EEG non-linear monitor and determine the critical value of approximate entropy, the EEG non-linear parameter, without implicit memory.Methods Ten ASA I or II patients of both sexes aged 42-56 yr weighing 59-73 kg undergoing elective abdominal or lower limb operation under epidural anesthesia were enrolled in the study. The patients were unpremedicated. After correct placement of epidural catheter was confirmed, a mixture of 2% lidocaine and 0.3% tetracaine 13-15 ml was injected via the catheter. Propofol was then infused i.v. at 6 mg?kg-1?h-1 for sedation. BP, HR and SpO2 were continuously monitored. The EEG non-linear monitor (ZN16E) was used. The sensors were placed on frontal (FP1 , FP2 ) , temporal (T3 , T4 ), parietal (C3 , C4 ) and occipital ( O1 , O2 ) regions. Approximate entropy and topographic map of approximate entropy were recorded before and during propofol infusion. Sedation scores (OAA/S, 1 = deep sleep, 5 = alert) were assessed during operation The patients' explicit and implicit memory scores were estimated by Process Dissociation Procedure during anesthesia sedateon Results The approximate entropy was significantly decreased during propofol sedation compared to the baseline value before sedation. OAA/S score were maintained at 1 during operation. The explicit and implicit memory scores were significantly decreased during propofol sedation compared to the baseline scores before anesthesia sedation( P

Objective To investigate the relationship of intraoperative cerebral oxygen saturation(rSO_2 )monitored with near-infrared cerebral oximeter (INNOS 5100) and postoperative cognitive dysfunction in patientsoperated upon under isoflurane or sevoflurane anesthesia and to determine the critical rSO_2 value below whichpostoperative cognitive dysfunction may occur.Methods Sixty ASA Ⅰ- Ⅱ patients of both sexes aged 62-80 yr,weighing58-77 kg schedules for elective abdominal surgery or surgery on the low limb were divided into threegroups according to their levels of education: group Ⅰthe illierate and uneducated (n = 20); group Ⅱ primaryschool education (6yr education (n = 20). Each group was furtherdivided into isoflurane and sevoflurane subgroups (n = 10 in each subgroup). The patients were unpremedicated.Anesthesia was induced with intravenous atropine 0. 3mg, propofol 1 .0-1. 5 mg?kg~(-1), fentanyl 2-3?g?kg~(-1) andvecuronium o. 1-0.2 mg?kg~(-1) and maintained with isoflurane or sevoflurane inhalation (0.9-1. 1 MAC )supplemented with intermittent i.v. boluses of fentanyl and recorded before anesthesia (baseline), after O_2inhalation(T_1), after induction of anesthesia(T_2), after skin incision (T_3), during operation (T_4)and at the end ofsurgery (T_5). Mini-Mental State Examination (MMSE) was performed before anesthesia and 1,4, 8, 12 and 24 hafter surgery. BP, HR, ECG, SpO_2, P_(ET) CO_2 and end-tidal concentration of inhalational anesthetics werecontinuously monitored during anesthesia. Results In all three groups rSO_2 was significantly lower during operation(T_4) and at the end of surgery (T_5 ) than baseline (T_0 ) (P