Value of baseline IgM level in predicting the treatment response of primary biliary cholangitis / 临床肝胆病杂志

Objective To investigate the association between baseline IgM level and treatment response to ursodeoxycholic acid (UDCA) in patients with primary biliary cholangitis (PBC). Methods A retrospective analysis was performed for the clinical data of 637 PBC patients who were diagnosed and treated with UDCA for the first time in The Fifth Medical Center of Chinese PLA General Hospital from January 2010 to January 2020. The PBC patients were divided into UDCA complete response group with 436 patients and UDCA poor response group with 201 patients, and baseline clinical data were compared between the two groups. According to the optimal cut-off value of IgM determined by the area under the ROC curve (AUC) of baseline indices in predicting the risk of poor treatment response, the patients were divided into IgM ≥1.5×ULN group and IgM < 1.5×ULN group, and baseline parameters, treatment response, and prognostic model score were compared between groups. The t -test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between two groups. The Cochran-Mantel-Haenszel test was used for subgroup analysis, and forest plots were plotted for related risk values. Results Compared with the UDCA complete response group, the UDCA poor response group had significantly higher proportion of patients with liver cirrhosis, levels of total bilirubin, aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bile acid, total cholesterol (TC), IgA, and IgM, and positive rate of anti-Gp210 antibody at baseline ( χ 2 =4.596, Z =-9.932, -8.931, -8.361, -7.836, -4.694, -3.242, and -2.115, χ 2 =15.931, all P < 0.05). The UDCA poor response group had significantly higher Mayo Risk Score, Globe score, and UK-PBC risk score than the UDCA complete response group ( t =4.092, Z =-10.910 and -11.646, all P < 0.001). Compared with the normal IgM group, the elevated IgM group had significantly higher levels of AST, ALP, TC, IgA, and IgG and a significantly higher positive rate of anti-Gp210 antibody ( Z =-3.774, -5.063, -4.344, -2.051, and -6.144, χ 2 =25.180, all P < 0.05). IgM had an AUC of 0.552 in predicting poor treatment response. Compared with the IgM < 1.5×ULN group, the IgM ≥1.5×ULN group had significantly higher levels of AST, ALP, TC, and IgG, a significantly higher positive rate of anti-Gp210 antibody, and a significantly higher poor UDCA response rate ( Z =-4.193, -5.044, -3.250, and -5.465, χ 2 =25.204 and 8.948, all P < 0.05). IgM ≥1.5×ULN had an odds ratio of 1.416 (95% confidence interval [ CI ]: 1.129-1.776, P =0.003) in predicting poor response. The subgroup analysis showed that for patients without liver cirrhosis, IgM ≥1.5×ULN had an odds ratio of 1.821 (95% CI : 1.224-2.711, P =0.003) in predicting poor response. Conclusion Baseline IgM level has an important value in predicting UDCA response. IgM level should be closely monitored during treatment in PBC patients with a high baseline IgM level, and second-line drugs should be given in time if the abnormality persists.

Clinical effect and safety of pegylated interferon-α-2b injection (Y shape, 40 kD) in treatment of HBeAg-positive chronic hepatitis B patients / 中华肝脏病杂志

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.

The Evaluation and Significance of RANTES in Serum and Peritoneal Fluid in Patients with Endometriosis / 天津医药

Objective To investigate the role and clinical significance of RANTES in endometriosis (EM). Methods The serum level of RANTES was examined by ELISA in 50 patients with endometriosis (EM group), 32 patients with benign ovarian neoplasms (disease control group) and 30 normal control women (normal control group). The level of RANTES in peritoneal fluid was examined in EM group and disease control group. Results The serum level of RANTES was significantly higher in EM group (108.73±60.69) ng/L than that of disease control group (31.26±20.33) ng/L and normal control group (29.77 ± 11.58) ng/L (P＜0.05). The level of RANTES in peritoneal fluid was significantly higher in EM group (726.31 ± 259.83) ng/L than that of disease control group (116.19 ± 81.64) ng/L (P＜0.05). The levels of RANTES in serum and peritoneal fluid in EM group were positively correlated with clinical stage respectively (rs=0.501 and 0.562,P＜0.01). The level of RANTES in peritoneal fluid in EM group was positively correlated with dysmenorrhea score (rs=0.527,P＜0.01). The serum level of RANTES was positively correlated with the level of RANTES in peritoneal fluid in EM group (rs=0.363, P＜0.05). The levels of RANTES in serum and peritoneal fluid were positively correlated with inflammatory response degree in endometriotic tissues in EM group (rs=0.326 and 0.391,P＜0.05 or P＜0.01).Conclusion Detection of the serum level of RANTES by ELISA may be one of parameters for diagnosis of endometriosis.

Treatment of severe viral hepatitis with artificial liver support system / 中华实验和临床病毒学杂志

<p><b>BACKGROUND</b>To investigate the method and therapeutic efficacy of artificial liver support system (ALSS) in treatment of severe viral hepatitis.</p><p><b>METHODS</b>A total of 83 patients including 66 with severe viral hepatitis were treated with ALSS using Baxter-550 artificial kidney and Biologic-DT system.</p><p><b>RESULTS</b>The levels of mean bilirubin, ALT, AST, BUN, Cr and endotoxin was significantly decreased after the treatment. Of the 66 patients?with severe viral hepatitis, 31(47.0%) had improvement in symptoms and 35 (53.0%) died or left hospital. In the control group,50(27.6%) out of the 181 had improvement in symptoms and 131(72.4%) died or left hospital.</p><p><b>CONCLUSIONS</b>ALSS could exert certain therapeutic effects on severe viral hepatitis.</p>

Single factor study of prognosis from 520 cases with chronic severe hepatitis / 中华实验和临床病毒学杂志

<p><b>OBJECTIVE</b>To further understand chronic severe hepatitis (CSH) and to improve the level of diagnosis and treatment and to explore the methods to reduce the fatality rate of CSH through analysing the factors related to prognosis of CSH.</p><p><b>METHODS</b>The factors related to prognosis from 520 cases with CSH were analyzed by SPASS and STATA software.</p><p><b>RESULTS</b>1. The fatality rate in cases with age > or = 40 years was higher than that in cases with age <40 years (P<0.001), there was no significant difference (P>0.05) in sex and pathogenic basis of CSH; 2. The fatality rate rose in cases with WBC > or = 10.0 x 10(9) per liter or platelet <100 x 10(9) per liter; 3. The fatality rate increased gradually with the ratio of aspartic aminotransferase to alanine aminotransferase (AST/ALT) and serum total bilirubin (TBil), appearance of deviation of TBil and ALT, decrease in prothrombin activity (PTA), total cholesterol (TC), cholinesterase and albumin (Alb) (P<0.001). 4. The fatality rate increased with appearance of complications such as ascites, electrolyte disturbance, spontaneous peritonitis and so on (P<0.001).</p><p><b>CONCLUSIONS</b>The important factors related to prognosis were age, > or = 40 years, WBC 10.0 x 10(9) per liter or platelet <100 x 10(9) per liter; the ratio of AST/ALT, TBil, Tc, cholinesterase, Alb and complication, to monitor dynamically laboratory indexes such as TBil, PTA, Tc, cholinesterase and so on and to prevent and cure various complications are important measures to reduce the fatality rate of CSH.</p>

Features of onset of chronic severe hepatitis in 520 cases / 中华实验和临床病毒学杂志

<p><b>OBJECTIVE</b>To discuss features of onset of chronic severe viral hepatitis (CSH).</p><p><b>METHODS</b>The patterns of onset of 520 cases of CSH were analyzed by SPASS and STATA software.</p><p><b>RESULTS</b>1. Within less than 10 days, less than 2 weeks, 2 to 4 weeks, 4 weeks to 6 months, 10.4%, 18.1%, 17.1% and 64.8% of 520 cases deteriorated into severe hepatitis respectively. 2. There were no definite predisposing factors in more than 40% cases. There were 1 to 3 or more predisposing factors in more than 30% cases. The incidence of concurrent infection was the highest (P<0.01). 3. The pathogenic basis in more than 50% cases was cirrhosis. 4. Hepatic encephalopathy did not occur in more than 50% of the cases. Ascites occurred in more than 75% of cases. Hepatic encephalopathy first occurred in less than 5% cases and ascites in more than 10% of cases. 5. The latest time for occurrence of hepatic encephalopathy was later than the time of deteriorating into severe hepatitis.</p><p><b>CONCLUSIONS</b>1. Gradual deterioration into CSH was found in all the 520 cases. 2. The predisposing factors, pathogenic bases, incidence and occurring time of hepatic encephalopathy, firstly occurring complication and so on in CSH are not the same as those in acute and subacute severe hepatitis. Therefore, CSH should be independently named and the study of CSH should be strengthened.</p>

CLINICAL ANALYSIS OF SEVERE ACUTE RESPIRATORY SYNDROME / 解放军医学杂志

Objective To explore the clinical features of severe acute respiratory syndrome (SARS). Methods Clinical data of 70 patients with SARS were retrospectively analyzed. Results The age of the patients ranged from 10 to 74 years old (mean age 33.81?12.73 years). Severe type of SARS was diagnosed in 38 patients and 32 as common type of SARS. The most common symptoms included fever(98.57%), malaise(80.00%), cough(74.28%), shortness of breath (55.71%), headache(38.57%). The fever lasted for 7.20?4.57d. Based on the symptoms and chest X-ray examination, the disease was classified into early stage, progressive stage, and recovery stage with a mean duration of 3.19?2.32d, 8.18?4.36d, and 8.82?7.01d, respectively. It was found that the incidence of severe type of SARS was higher with the increase of age. Compared with common type of SARS, the fever in patients with severe type of SARS was more difficult to control (the mean highest fever 38.74?0.97℃, 38.02?0.14℃, respectively). The duration of fever after treatment (4.12?3.19d, 2.37?1.75d, respectively) was longer in the illness course (27.78?9.99d, 14.93?5.80d, respectively). The ALT, LDH and HBDH in patients with severe type of SARS were higher than those in patients with common type of SARS (ALT:78.95%,50.00%, respectively; LDH, HBDH:42.11%, 18.75%, respectively). Advanced age, pre-existing chronic disease, and elevation of LDH and HBDH were the factors of poor prognosis. Combination therapy was the first choice for the treatment of SARS. Empirical use of glucocorticoid was useful in preventing progression of the disease. Conclusion Although severe type of SARS had a high mortality, combination therapy could be very effective in the treatment of the majority of patients.