ABSTRACT
【Objective】 To investigate the matrix effect on the determination of potency in Recombinant Human Coagulation Factor Ⅷ for Injection (rFⅧ). 【Methods】 Two different detection matrices were used to establish two methods for detecting the potency in Recombinant Human Coagulation Factor Ⅷ for Injection. And the matrix effect on the determination of potency was determined, including specificity, linearity, repeatability, accuracy and intermediate precision. 【Results】 As to the specificity, the recoveries of the two substrates at high vs low concentration level were 112% and 110% vs 104% and 109%, respectively. As to the linearity, in the range of (0.125-1.000) IU/mL, the correlation coefficient between concentration and coagulation time of standard/ sample was higher than 0.99. As to the accuracy/repeatability, the recoveries of two matrices was 104% and 102%, and RSD was 2.4% and 1.9%. As to the intermediate precision, personnel factor of two matrices was 0.72 and 0.23, date factor was 0.79 and 0.85, and RSD(for 12 times) was 4.2% and 3.0%. Comparison of two matrices was as follows: Deviation in test results of 6 batches of rFⅧ was all lower than 5%. There was no significant difference between two matrices. 【Conclusion】 The two matrices for potency detection show good performance including specificity, linearity, repeatability, accuracy, and intermediate precision. They are suitable for the determination of potency in rFⅧ products.
ABSTRACT
Objective To evaluate the method of hemodialysis patients with the diagnosis and treatment of herpes zoster.Methods Diagnosis and treatment of 27 cases of hemodialysis patients with varicella-zoster virus (VZV) infection in patients with clinical data.Results All patients in addition to continuing the line hemodialysis treatment,use the ganciclovir,topical recombinant human interferon α -1b cream,vitamin Bl,Methycobal,antibiotics to prevent bacterial infection,oral medicine,comprehensive treatment of pain.The total effective rate of treatment group is 92.59％.Conclusion VZV was a common disease in hemodialysis patients,easy diagnosis,rational drug treatment is very important,need comprehensive treatment can achieve good results.
ABSTRACT
Objective To explore effective treatment of uremic hemodialysis patients with chronic helicobacter pylori-negative erosive gastritis.Methods Fourty-eight cases of uremic hemodialysis patients with helicobacter pylori-negative chronic erosive gastritis were diagnosed by detection of helicobacter pylori and endoscopic examination.Fourty-eight patients were randomly divided into two groups,treatment group (24 patients) with oral pantoprazole 40 mg,once a day,combinding with oral Marzulene-S particles,each 0.67 g,three times a day,the control group (24 cases ) only with the dose of pantoprazole treatment.Effect of treatment was compared in these two groups after treatment for 21 days.Results Twenty-one days after treatment,the clinical symptoms of uremic hemodialysis patients with upper gastrointestinal improved in treatment group,and the performance of endoscopic and histopathological has varying degree of improvement.It shows that pantoprazole combined with Marzulene-S treatment group has a significant effect than that single treatment with pantoprazole group.In the treatment group,the total effective rate was 95.83％,however it was 83.33％ in the control group( U =2.716,P ＜ 0.01 ).Repair of mucosal lesions were significantly different between the two groups ( total effective rate 83.33％ vs 45.83％,U =2.349,P ＜ 0.05 ).Conclusion Pantoprazole combined with Marzulene-S therapy has a significant effect on uremic hemodialysis patients with chronic Helicobacter pylori-negative erosive gastritis.