Alemtuzumab (Campath) was successfully injected in 21 kidney transplant patients,7 islet transplant patients and 1 simultaneous kidney and islet transplant patient for either prevention or treatment of graft rejection.Prophylactic administration was successfully completed in all patients without discontinuation.Adverse events were not observed in 11 patients (38%),but hypertension in 18 patients (62%),shivering in 3 patients (10.3%),high fever in 3 patients (10.3%),and bronchospasm in 1 patient (3%),respectively.All complications alleviated after proper therapy.During the prophylactic administration of alemtuzumab,strict,timely and proper ward-management was needed.Care for lung,perineum,skin,diet and psychological nursing were necessary.Neither graft acute rejection nor graft chronic rejection episode occurred in all patients during 6 months to 2 years follow-up.Therefore,long term effects of Alamtuzumab and consequences of lymphocytopenia need further observation.

OBJECTIVE：To provide reference for clinical empirical treatme nt of non-fermentative Gram-negative bacilli （NFGNB）infection. METHODS ：All kinds of clinical specimens were collected from Jan. 2010 to Dec. 2019 in a tertiary hospital from Hanzhong city of Shaanxi province ；the distribution and drug resistance of NFGNB were analyzed retrospectively. RESULTS ： A total of 26 386 strains of pathogenic bacteria were detected in the hospital during 2010-2019，including 4 077 strains of NFGNB （15.45％），mainly from patients ≥60 years old （1 836 strains，45.05％）. During the 10 years，the detection rate of NFGNB decreased from 20.14％ in 2010 to 15.36％ in 2019 （P＜0.001）. Acinetobacter baumannii （1 359 strains），Pseudomonas aeruginosa （1 269 strains），Stenotrophomonas maltophilia （447 strains） and Burkholderia cepacia （351 strains） were main pathogens. The detected NFGNB mainly came from hospitalized patients （4 001 strains），and most of them were found in ICU （17.05％），neurosurgery department （14.52％），respiratory department （12.41％），and respiratory tract （66.69％），secretion （7.80％）specimens. The detection rates of A. baumannii and P. aeruginosa in oncology department ，blood specimens and urine specimens showed an overall upward trend ，while the detection rates in ICU of the hospital showed a downward trend （P＜0.05）； the detection rate of P. aeruginosa in neurosurgery department showed an upward trend （P＜0.05），and that of A. baumannii in respiratory department showed an upward trend （P＜0.05）. The resistance rate of A. baumannii to carbapenems increased from about 10％ in 2010 to about 75％ in 2019，and the guyh3201@163.com resistance rate to cephalosporins exceeded 78％. The resistance rates of P. aeruginosa to imipenem and me ropenem were lower than 35％ and 30％ respectively，and the trend of drug resistance did not change significantly （P＞0.05）；the resistance rates to 12 kinds of clinically commonly used antibiotics as piperacillin and aztreonam were lower than 40％. The resistance rate of S. maltophilia to compound sulfamethoxazole showed a decreasing trend （P＜0.001），and the resistance rate to ceftazidime was high （54.70％-74.10％）. The resistance rates of B. cepacia to compound sulfamethoxazole，meropenem and ceftazidime showed a downward trend （P＜0.01），and were lower than 15％ after 2014. CONCLUSIONS：Although the detection rate of NFGNB in our hospital showed a downward trend ，the multi-drug resistance and pan-drug resistance of A. baumannii are serious ，and the resistance rate to carbapenems is increased. Sensitive drugs such as cefoperazone/sulbactam，amikacin，levofloxacin and ceftazidime should be selected for NFGNB infection according to the results of drug sensitivity tests.

Objective: To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control. Methods: A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed. Results: A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95% CI 65.00%-74.60%) in the trial group and 74.16% (95% CI 67.73%-80.59%) in the control group (P = 0.297 0). The data of the per protocol set (PPS) showed that SVR rate was 80.63% (95% CI 76.04%-85.23%) in the trial group and 81.33% (95% CI 75.10%-87.57%) in the control group (P = 0.849 8), and the 95% CI of rate difference conformed to the non-inferiority standard. The analysis of the PPS population showed that of all subjects, 47.9% achieved rapid virologic response, with a positive predictive value of 93.8%. The incidence rate of adverse events was 96.30% in the trial group and 94.94% in the control group, and the incidence rate of serious adverse events was 5.13% in the trail group and 5.06% in the control group. Conclusion In the regimen of Peg-IFN-α combined with ribavirin for the treatment of genotype 1/6 CHC, the new investigational drug Peg-IFN-α-2b(Y shape, 40 kD) has comparable clinical effect and safety to the control drug Peg-IFN-α-2a.

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.