127例乙肝表面抗体ELISA检测与化学发光法的比较

Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.     

127例乙肝表面抗体ELISA检测与化学发光法的比较

Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.     

127例乙肝表面抗体ELISA检测与化学发光法的比较

Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.     

127例乙肝表面抗体ELISA检测与化学发光法的比较

Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.     

127例乙肝表面抗体ELISA检测与化学发光法的比较

Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.     

127例乙肝表面抗体ELISA检测与化学发光法的比较

Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.     

127例乙肝表面抗体ELISA检测与化学发光法的比较

Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.     

127例乙肝表面抗体ELISA检测与化学发光法的比较

Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.     

127例乙肝表面抗体ELISA检测与化学发光法的比较

Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.     

免疫检查点抑制剂相关肝损伤临床特征的回顾性分析CSCD

Objective To explore the clinical manifestation, treatments, and outcomes of immune checkpoint inhibitor (ICI)⁃induced immune⁃mediated liver injury (IMLI). Methods The patients with ICI⁃ related IMLI and hospitalized in the Department of Oncology, the Affiliated Hospital of Qingdao University from January 2018 to November 2022 were collected. The basic information, tumor treatments, clinical mani⁃ festation, treatments and outcomes of the patients with IMLI were retrospectively analyzed. Results A total of 29 patients were included in the study, including 17 males (58.6%) and 12 females (41.4%), with a median age of 65 years. The median treatment cycle from the use of ICI to the occurrence of liver injury was 3 cycles, and the median time was 78 days. In patients with IMLI, 48.3% (14/29) had no obvious symptoms and 51.7% (15/29) had symptoms such as decreased appetite, nausea, abdominal distension, fatigue, fever and jaundice; 44.8% (13/29) were accompanied by other immune⁃related adverse events. The clinical clas⁃ sification of IMLI was hepatocellular type in 18 patients (62.1%), cholestasis type in 4 patients (13.8%), and mixed type in 7 patients (24.1%). According to the Common Terminology Criteria for Adverse Events (CTCAE) classification, severe liver injury (≥ grade 3) accounted for 86.2% (25/29), while according to the Chinese Diagnosis and Treatment Guideline on Drug‑Induced Liver Injury (DILI guidelines) classification, severe liver injury (≥ grade 2) accounted for 34.5% (10/29). All 29 patients discontinued the treatment of ICIs after occurrence of IMLI, and 28 patients were treated with glucocorticoids, 7 of which were combined with mycophenolate mofetil and/or human immunoglobulin and artificial liver; 22 patients (75.9%) were improved. In the other 7 patients that did not recover, 4 discharged automatically, 2 died, and 1 could not be judged. ICI was rechallenged in 3 patients after liver function improvement, and IMLI did not recur. Conclusions The IMLIs often occur 2 to 3 months after the start of ICI treatment, the most common clinical type is hepatocyte type, and the severity of clinical symptoms in patients vary from mild to severe. After discontinuing ICIs and receiving glucocorticoid treatments, most patients may have a good prognosis. © 2023 The Author(s).     

33例SARS患者临床表现与治疗

OBJECTIVE: To investigate the clinical charactertistics and therapy of patients with SARS. METHODS:The cases of total 33 chinically diagnosed SARS patients admitted in Inner Mongolia Chest Hospital were analyzed retrospectively. RESULTS:The most common complaint is fever(in 100 percent of the patients). 33.3% of the cases suffered from dyspnea. The laboratory test abnormality happened in about half of cases, including leuknpenia, thrombocytopenia, elevated serum aminotrasferase, increasd cardio enzyme and glucose levels. The IgG artibody was detected in all tested 15 patients. The features of shadow in chest X-R are “soft”, “wet” and rapid change. 48.4% are severe. Corticosteroids were used in all the cases. 33.3% were treatcd by CPAP mechanical ventilation. 33.3% had basic diseases. 42% showed the inconsistency between the diagrams of temperature and pulse. The main complications are bone necrosis, pneumothorax,deterioration of tuberculosis, temporary increase of serum glucose and so on. CONCLUSION: SARS can result in damage of multi-organs. The most common symptoms are fever and respiratory system manifestations. In order to raise cure rate and lower mortality, it is important to command correctly the administration of corticosteroids and mechanical ventilation, treat carefully basic diseases and complications, provide sufficient nutrition, pay attention psychological therapy and daily life nursc.     

Drug-related problems and pharmacotherapeutic advisory intervention at a medicine clinic

Objective To describe the scenario and frequency of drug-related problems (DRPs) in in-patients and to determine whether a pharmacotherapeutic advisory intervention aiming at reducing DRPs could affect rates of re-hospitalisation and/or death within 6 months.Methods This prospective, randomised, controlled advisory intervention study was carried out at the Clinic of Internal Medicine at Stockholm S?der Hospital. Three hundred patients from four wards took part in the study. Patients taking two drugs or more were included. In the intervention arm, potential drug interactions were found using a computer system. Medical symptoms were estimated by a nurse together with the patient. Creatinine clearance was calculated. Thereafter a clinical pharmacologist scrutinised the patient′s medical record for DRPs together with the nurse. DRPs judged to be clinically relevant resulted in written advice to the physician in charge of the patient. The control group received usual care.Results In the intervention group, a total of 299 DRPs were found among 71% of the patients (106/150). The number of written letters of advice to the physicians in charge was 106. Of these, 63% were accepted. After 6 months, the proportion of re-hospitalisations or death in the intervention group was 49% (73/150) compared to 46% (69/150) in the control group. The difference was not significant.Conclusions DRPs were common. Potential drug interactions and adverse drug reactions dominated. Hospital-based medication review by a clinical pharmacologist was not associated with reduced rates of re-hospitalisation and/or death. The clinical relevancy of DRPs might be overestimated as a risk for re-hospitalisation or death. It is of great importance to clarify if and how drug-related problems can be prevented. In designing such studies, one should consider choosing inclusion criteria that accumulate risk.     

英文摘要

Special Report Quality：The Eternal Theme of Clinical Trials The quality of clinical trial is not only concerned with whether new drug can be launched, but also concerned with the lives of patients. The history of clinical trial in China is shorter than that in Europe end the United States, the overall level cannot meet requirement of development of pharmaceutical industry, and the quality of clinical trial needs to be improved further.     

P27 The Establishment of a New Experiment in Clinical Pharmacology Teaching

Clinical pharmacology is a newly emerging subject which is based on basic pharmacology and clinical medicine. It＇ s very important for training valid and good doctors and pharmaceutists. Rencently many universities in China have required clinical pharmacology as a special necessary course for medical and pharmacy students. But the experimental teaching in clinical pharmacology is not so wide till now in China. We have established a new clinical experiment as ＂Determination of the pharmacokinetic parameters of Ciprofloxacin in healthy young volunteers＂. The experiment was carried out with 10 healthy young volunteers after single oral administration of lOOmg Ciprofloxacin. Urine samples were collected then centrifuged at different time after administration. UV-spectrophotometry method was used to determine the concentration of Ciprofloxacin in urine. The pharmacokinetic parameters following oral administration of tested Ciprofloxacin in healthy young volunteers can be obtained by the formula that the elimination of Ciprofloxacin is conformed to one-compartment model. This method is rapid, accurate, sensitive and the most important, very convenient, it＇ s very suitable for experimental teaching in clinical pharmacology. This new clinical experiment can be widely spread through all the medical and pharmaceutical universities.     

Clinical obser ration of interferon α-2b on the treatment of viral keratitis:476 cases study

Objective To observe the clinical effect of interferon on the treatment of virus keratitis. Meth-ods Review and analysis was made of 476 patients with virus keratitis who was treated with high concentration of an-ti-virus eyedrops and one million unit of α-2b interferon, the clinical safety and effect was evaluated. Result The total cure rate was 59. 1%, and the type from high to low is interstitial、endothelial、epithelial and the total cornea. The total recurrence rate is 23.5% ,and the type from high to low is epithelial,the total cornea,endothelial and inter-stitial. The incidence rate of the adverse effect is 10. 7%. Condusion Systemic administration of interferon has a direct anti-virus effect, and it can raise the cure rate of virus keratitis as well as decrease recurrencerate. One million unit of interferon has a high clinical safety and effect.     

Selective enrichment of hepatocytes from mouse embryonic stem cells with a culture system containing cholestatic serum

Aim： There is increasing evidence indicating that embryonic stem （ES） cells are capable of differentiating into hepatocyte-like cells in vitro. However, it is neces- sary to improve the differentiation efficiency so as to promote the clinical application. Here, we report an efficient culture system to support hepatocyte differentiation from ES cells by utilizing cholestatic serum. Methods： One week after the induction of El4 mouse ES cells into hepatocytes with sodium butyrate, cholestatic serum was added into the culture system at various concentrations and hepatocyte-like cells were induced to proliferate. The morphological and phenotypic markers of hepatocytes were characterized using light microscopy, immunocytochemistry, and RT-PCR, respectively. The function of glycogen stor- age of the differentiated cells was detected by Periodic acid-Schiff （PAS） reaction, and the ratio of hepatic differentiation was determined by counting the albumin and PAS-positive cells. Results： In the presence of conditional selective medium containing cholestatic serum, numerous epithelial cells resembling hepatocytes were observed. The RT-PCR analysis showed that undifferentiated ES cells did not express any hepatic-specific markers; however, in the presence of sodium butyrate and conditional selective medium containing cholestatic serum, hepatic differentiation markers were detected. Immunofluorescence staining showed that those ES-derived hepatocytes were αfetoprotein, albumin, and cytokeratin 18 positive, with the ability of storing glycogen. Further determination of the hepatic differentiation ratio showed that the application of cholestatic serum efficiently enriched ES-derived hepatocyte-like cells by inducing lineage differentiation and enhancing lineage proliferation. Conclusion： The conditional selective medium containing cholestatic serum is optimal to selectively enrich hepatocyte-like cells from mixed differentiated ES cells, which may provide a novel method to improve the hepatic differentiation ratio of ES cells.     

Toxicokinetics in Japan

The word ‘toxicokinetics’ is a comparatively new word,but it was being generally practiced in Japanese pharmaceutical industry over 6 years ago.Note for guidance on toxicokinetics(ICH S3A):the assessment of systemic exposure in toxicity studies was harmonized internationally and was essential as the data package for the NDA of a new drug in Japan since 1996.Toxicokinetics is a combination of toxicology and pharmacokinetics.It was to develop a tool which could be most helpful in the interpretation of toxicity data.Using “exposure” as indicated by AUC and/or cmax for parent drug or major metabolite in laboratory animals and man,one can calculate a human safety margin.This human safety margin is the ratio of the AUC of the “no effect dose” in animals in the toxicology studies to the AUC to the therapeutic dose in man.I would like to introduce the actual practice of toxicolinetics in Japan.     

Management of NSAID-related gastrointestinal mucosal injury

The three therapeutic goals in patients with NSAID-induced gastroduodenopathy are treatment of dyspeptic symptoms, management of NSAID-related ulcers and their complications, and prophylaxis against recurrent gastrointestinal toxicity. Both H₂-receptor antagonists and proton pump inhibitors (PPIs) appear to be helpful in relieving the symptoms associated with NSAID use, while treatment of NSAID-induced gastroduodenal ulcers, whether the NSAID is continued or not, is best achieved by the use of PPIs. However, because symptoms do not often predict the presence of gastroduodenal ulcers, the goal of prevention has become paramount in the treatment of patients with an increased likelihood of gastrointestinal toxicity. The best prophylaxis against NSAID-related toxicity is the use of an alternative agent such as salsalate or paracetamol (acetaminophen). However, if an NSAID is to be used, prophylaxis is best accomplished with a PPI or misoprostol, a prostaglandin E1 analogue. The use of misoprostol is limited by its frequent dosing, at least 200 μg three times a day, and its own gastrointestinal side effects. Future therapy will include NSAIDs that maintain their antiinflammatory effects, while possessing superior safety profiles, and include preferential and highly selective COX-2 inhibitors and nitric oxide releasing compounds.     

浅析脑溢血术后家庭整体医疗干预

Hypertensive cerebral hemon‘hage is a kind of hemorrhagic disease commonly seen with high mortality rate. Basides intersifing monitoring effectively controlling of blood pressure and reducing intraeranial pressure in case of another hemorrhage,attenfion also should he paid to progress of disease (improved or worsen) .There is close relationship between the results of the series of measures and medical intervention in patient‘s family. In this article, the clinical practise and observation proves that the medical intervention in family is significant in promoting the recovery of patient and reducing deformity and mortality rates.     

Huntingtin processing in pathogenesis of Huntington disease

Huntington‘s disease (HD) is caused by an expansion of the polyglutamine tract in the protein named huntingtin. The expansion of polyglutamine tract induces selective degeneration of striatal projection neurons and cortical pyramidal neurons. The bio-hallmark of HD is the formation of intranuclear inclusions and cytoplasmic aggregates in association with other cellular proteins in vulnerable neurons. Accumulation of N-terminal mutant huntingtin in HD brains is prominent. These pathological features are related to protein misfolding and impairments in protein processing and degradation in neurons. This review focused on the role of proteases in huntingtin cleavage and degradation and the contribution of altered processing of mutant huntingtin to HD pathogenesis.