1.Progress in residual DNA in biological products
Shuqiang ZHAO ; Jingyuan GAO ; Doudou LOU ; Qinglin PANG ; Qingshui SHI ; Yihong LU
Drug Standards of China 2024;25(5):437-442
Host cell residue DNA is one of the most common impurity which can affect the safety of biological products,therefore,domestic and international regulatory agencies have required the limit for host cell residue DNA in different biological products,either at the final product qualification or the appropriate intermediate control stage.The removal effect is verified by monitoring the residue DNA of products in different production stages,which is beneficial for assuring the scientificity and stability of the production process.In order to strengthen the understanding of control strategy about host cell residual DNA,the paper reviews progress in host cell residual DNA in biological products by authors'work experience and other's research,which provides reference for future work.
2.IgA vasculitis with necrosis of the small intestine secondary to monoclonal gammopathy of renal significance: A case report.
Yan DING ; Chaoran LI ; Wensheng HUANG ; Linzhong ZHU ; Lifang WANG ; Doudou MA ; Juan ZHANG ; Lianjie SHI
Journal of Peking University(Health Sciences) 2024;56(6):1101-1105
Monoclonal gammopathy of undetermined significance combined with renal damage is named monoclonal gammopathy of renal significance. There are few reports about IgA vasculitis in patients with monoclonal gammopathy of undetermined significance. Here, we report a case of monoclonal gammopathy of renal significance, who had manifestations of IgA vasculitis, including purpura, gastrointestinal bleeding and joint pain. The patient had elevated serum creatinine levels, prompting further investigation through immunofixation electrophoresis and bone marrow aspiration biopsy. Immunofixation electrophoresis showed IgA-λ-type monoclonal immunoglobulin, while the bone marrow aspiration biopsy suggested plasmacytosis. Kidney biopsy indicated membranous hyperplastic glomerulonephritis, light and heavy chain deposition, IgA-λ. The patient was diagnosed with monoclonal gammopathy of renal significance. In light of the elevated serum creatinine, the patient was treated with chemotherapy regimen (bortezomib +cyclophosphamide +dexamethasone). After chemotherapy, there was no significant improvement in the patient's renal function. Subsequently, the patient experienced abdominal pain, skin purpura, joint pain and severe gastrointestinal bleeding. Gastroenteroscopy did not find the exact bleeding position. Angiography revealed hyperplasia of left jejunal artery. Surgical operation found that the bleeding site was located between the jejunum and ileum, where scattered hemorrhagic spots and multiple ulcers were present on the surface of the small intestine, with the deepest ulcers reaching the serosal layer. And the damaged intestine was removed during the operation. Intestinal pathology showed multiple intestinal submucosal arteritis, rusulting in intestinal wall necrosis and multiple ulcers. Considering intestinal lesions as gastrointestinal involvement of IgA vasculitis, methylprednisolone was used continually after the operation, and the patient's condition was improved. However, after half a year, the patient suffered a severe respiratory infection and experienced a recurrence of serious gastrointestinal bleeding. It was considered that the infection triggered the activity of IgA vasculitis, accompanied by gastrointestinal involvement. Finally, the patient died from gastrointestinal bleeding. The present case represented a patient with monoclonal gammopathy of renal significance and IgA vasculitis, prominently presenting with renal insufficiency and severe gastrointestinal bleeding, making the diagnosis and treatment process complex. Patients with IgA monoclonal gammopathy who presented with abdominal pain, purpura, and arthralgia should be vigilant for the possibility of concomitant IgA vasculitis. The treatment of cases with IgA vasculitis combined with monoclonal gammopathy of renal significance was rather challenging. Plasma cell targeting therapy might be an effective regimen for IgA vasculitis with monoclonal gammopathy. However, patients with poor renal response to the treatment indicated poor prognosis.
Humans
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Cyclophosphamide/administration & dosage*
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Gastrointestinal Hemorrhage/etiology*
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IgA Vasculitis/complications*
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Immunoglobulin A
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Intestine, Small/pathology*
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Kidney/pathology*
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Kidney Diseases/pathology*
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Monoclonal Gammopathy of Undetermined Significance/complications*
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Necrosis
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Paraproteinemias/complications*
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Vasculitis/etiology*
3.Successful treatment of rheumatoid arthritis complicated with myasthenia gravis with low-dose rituximab: A case report.
Doudou MA ; Zhemin LU ; Qian GUO ; Sha ZHU ; Jin GU ; Yan DING ; Lianjie SHI
Journal of Peking University(Health Sciences) 2024;56(6):1110-1114
Rheumatoid arthritis (RA) and myasthenia gravis (MG) are two distinct autoimmune diseases. Compared with the general population, the incidence of RA is notably higher among patients with MG. Similarly, the rate of MG in patients diagnosed with RA is also significantly increased. In this report, we presented an elderly female patient with a history usage of long-term glucocorticoid and conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), whose RA symptoms remained inadequately controlled. She later exhibited drooping of the right eyelid and double vision, leading to a diagnosis of ocular myasthenia gravis (OMG). Then, we made a literature review and found that the RA patients with co-existing MG were relatively more common in middle-aged and elderly women, and most of them did not have thymoma. Thymoma wasn ' t found in our patient, which was consistent with the cli-nical characteristics of RA complicated with MG reported in previous reports. In addition, there was li-mited treatment experience in patients with both RA and MG. The treatment stratergies for RA or MG included glucocorticoids and immunosuppressants. Among the 18 patients we analyzed, 8 patients expe-rienced relief after csDMARDs, while other 8 patients received biologics or targeted DMARDs, including tumor necrosis factor inhibitors (TNFi) in 5 cases, JAK inhibitors in 2 cases, and B-cell depletion therapy (rituximab) in 2 cases. What called for special attention was that one RA patient was diagnosed with MG after using 23 months of methotrexate and 6 weeks of etanercept (TNFi), with rituximab 1 000 mg for the first time, followed by 500 mg every 6 months, and finally both RA and MG were well controlled. For the patient in this study, MG symptoms improved with increased dosage of prednisone. In order to tapper the dose of glucocorticoid, it was necessary for more potent immunosuppressant for both RA and MG. Given her history of cardiac conditions, JAK inhibitors were not considered, and due to the uncertain efficacy of TNFi, we chose to administer low-dose rituximab (100 mg). Subsequent follow-up revealed stable conditions for both RA and MG, allowing for discontinuance of glucocorticoid after 5 months. It reflected the potential efficacy and cost-effectiveness of low-dose, long-interval rituximab in treating RA patients combined with MG, while it also minimized infection risks. However, the duration for subsequent infusions remained uncertain and required further observation. In conclusion, RA combined with MG is rare. For patients exhibiting poor responses to csDMARDs, low-dose, long-interval rituximab might be a promising treatment option.
Humans
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Arthritis, Rheumatoid/drug therapy*
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Rituximab/administration & dosage*
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Myasthenia Gravis/drug therapy*
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Female
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Antirheumatic Agents/administration & dosage*
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Aged
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Glucocorticoids/therapeutic use*
4. Analysis of the effective components and mechanism of Yufang Fangji II for prevention of COVID-19 based on UHPLC-Q-TOF/MS and network pharmacology
Guangyang JIAO ; Doudou HUANG ; Yong CHEN ; Deduo XU ; Wansheng CHEN ; Feng ZHANG ; Tianyi YU ; Bolong WANG ; Shi QIU ; Wansheng CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(10):1127-1145
AIM: The main chemical components of Yufang Fangji II (Hubei Fang) of COVID-19 were studied systematically and combined with network pharmacology to provide a reference for the study of its effective substances. METHODS: Ultra high-performance liquid chromatography quadrupole time of flight mass spectrometry (UHPLC-Q-TOF/MS) was applied to identify the absorbed components of the prescription in rat plasma. TCMSP database and Swiss Target Prediction data platform were used to predict the target of the identified blood components, and network visualization software Cytoscape 3.7.2 was used draw the association network diagram, and GO enrichment analysis and KEGG pathway enrichment analysis were conducted for the key targets. With the help of CB-Dock online molecular docking platform, the molecular docking of key targets and blood entering compounds was carried out, and the docking combination with good affinity value was displayed by ligplot software to verify the preventive effect of Yufang Fangji II on COVID-19. RESULTS: A total of 52 chemical components identified in the prescription, in which 13 components were absorbed in the rat plasma as the prototype, and they were from Astragalus membranaceus, Atractylodes macrocephala, Saposhnikoviae Radix, Lonicerae Japonicae Flos, and Citri Reticulatae Pericarpium, respectively. These compounds were recognized to act on 17 core targets, including mapk3, TNF and other targets related to inflammation, MPO and other targets related to oxidative stress, VEGFR, KDR and other targets related to vascular endothelium. The results of molecular docking showed that the absorbed components had good binding activity with the key targets. CONCLUSION: Compounds in Yufang Fangji II are involved in regulating inflammation, oxidative stress, vascular and cellular physiological activities, which have preventive effects on COVID-19 through regulating IL-17, PI3K Akt, MAPK and other pathways.
5.Effects of gestational diabetes mellitus and mid-pregnancy blood glucose levels on gestational weeks based on birth cohort study
Doudou ZHAO ; Li SHAN ; Yang MI ; Shaonong DANG ; Wenhao SHI ; Pengfei QU
Journal of Xi'an Jiaotong University(Medical Sciences) 2021;42(4):623-627
【Objective】 To explore the effects of gestational diabetes mellitus (GDM) and mid-pregnancy blood glucose levels on gestational weeks in Northwestern China. 【Methods】 For this prospective cohort study, we recruited the first-trimester pregnant women who underwent obstetrical examinations at Northwest Women’s and Children’s Hospital from July 2018 to July 2019 as the cohort. We investigated their socio-demographic characteristics and risk factors of adverse pregnancy outcomes. Additionally, we collected the OGTT test results of pregnant women in mid-pregnancy and followed up their pregnancy outcomes. The relationship of GDM and blood glucose levels with gestational weeks was analyzed by using the generalized linear model. 【Results】 A total of 2 434 subjects were included in this study. There were 668 pregnant women with GDM, with a ratio of 27.44%. GDM in pregnant women shortened the gestational weeks (β=-0.17, 95% CI: -0.28—-0.05). Fasting blood glucose, OGTT-1 h blood glucose, and OGTT-2 h blood glucose increased by 1 mmol/L; gestational weeks were shortened by 0.17 (95% CI: -0.28—-0.05), 0.05 (95% CI: -0.09—-0.02) and 0.07 (95% CI: -0.12—-0.03). Fasting blood glucose and OGTT-1 h blood glucose abnormalities shortened gestational weeks by 0.18 (95% CI: -0.31—-0.05) and 0.28 (95% CI: -0.47—-0.10) respectively. An increase by 1 mmol/L or abnormality of fasting blood glucose would increase preterm delivery risk by 1.44 (95% CI: 1.01-2.06) and 1.73 times (95% CI: 1.10-2.69), respectively. 【Conclusion】 GDM in pregnant women may shorten their gestational weeks; the abnormal and elevated fasting blood glucose, in particular, would increase the risk of preterm delivery. Therefore, we should carry out active health education to control the blood glucose and other risk factors of GDM patients and promote healthy pregnancy.
6.Association of gestational diabetes mellitus and blood glucose level during the second trimester with neonatal birth weight: A study based on birth cohort
Doudou ZHAO ; Li SHAN ; Yang MI ; Shaonong DANG ; Wenhao SHI ; Pengfei QU
Journal of Xi'an Jiaotong University(Medical Sciences) 2021;42(2):311-316
【Objective】 To explore the association of gestational diabetes mellitus (GDM) and blood glucose level with birth weight of the newborns in Northwest China. 【Methods】 Pregnant women in their first trimester who joined the birth cohort of Northwest Women and Children’s Hospital from July 2018 to July 2019 were consecutively enrolled. We collected their basic demographic characteristics, lifestyle behavior and other data. We followed up the results of the OGTT test and pregnancy outcomes. The generalized linear model was used to analyze the effects of GDM and blood glucose levels on the birth weight of newborns. 【Results】 A total of 2 422 subjects were included in this study, and 656 (27.09%) pregnant women had GDM during pregnancy. Pregnant women with GDM increased the birth weight (β=50.00, 95% CI: 17.48-82.51), Z-value (β=0.11, 95% CI: 0.03-0.19) and Z Centile value (β=3.22, 95% CI: 0.88-5.55), and increased the risk of macrosomia (OR=1.54, 95% CI: 1.04-2.28). Abnormal FPG value during the second trimester would increase the risk of macrosomia and LGA. With the increase of OGTT blood glucose value in the second trimester, the birth weight value and the incidence of macrosomia and LGA showed an upward trend. 【Conclusion】 Pregnancy in women with GDM might increase the birth weight of newborns and the risk of macrosomia, especially FPG. We should vigorously control the blood glucose level of GDM patients to promote the health of mothers and infants.
7.Small/medium intracerebral hematoma in the basal ganglia: a comparison study of minimally invasive surgical treatment assisted by stereotaxis technique and conservative treatment
Xiaoqiang LIN ; Zhenyang LIU ; Jianping NIU ; Shujuan ZENG ; Doudou SHI ; Haibo TONG
Chinese Journal of Neuromedicine 2021;20(8):827-830
Objective:To investigate the influences of minimally invasive hematoma removal assisted by stereotaxis technique and conservative treatment in clinical prognoses of patients with small/medium intracerebral hematoma in the basal ganglia.Methods:Sixty-four patients with spontaneous basal ganglia cerebral hemorrhage, admitted to our hospital from March 2020 to March 2021, were enrolled in our study; these patients were randomly divided into surgical group (accepted minimally invasive hematoma removal assisted by stereotaxis technique, n=33) and conservative treatment group ( n=31). The baseline general data and 6 months follow-up data of patients from the 2 groups were compared. The Glasgow outcome scale (GOS) scores, modified Barthel index (MBI), modified Rankin scale (mRS) scores and complications were compared 7 d, 1 month and 6 months after surgery. Results:There were no significant differences in gender, age, and amount of bleeding between the 2 groups ( P>0.05). On the 7 th d of surgery, there were no significant differences in GOS scores, MBI, and mRS scores between the 2 groups ( P>0.05). One month after surgery, there were statistically significant differences in GOS scores, MBI, and mRS scores between the 2 groups ( P<0.05); the good prognosis rate in the surgical group was 78.79% (26/33), and that in the conservative treatment group was 25.81%(8/31), with significant difference ( P<0.05). Six months after surgery, there were significant differences in GOS scores, MBI, and mRS scores between the 2 groups ( P<0.05); the good prognosis rate in the surgical group was 95.7% (29/33), and that in the conservative treatment group was 32.3% (10/31), with significant difference ( P<0.05). The incidence of complications in the surgical group and conservative treatment group was 6.06% and 29.03%, respectively, with significant difference ( P<0.05). Conclusion:Minimally invasive hematoma removal assisted by stereotaxis technique is more conducive to the repair of nerve function in patients with moderate to small cerebral hemorrhage in the basal ganglia than conservative treatment.
8.Solitary fibrous tumor with endocrine manifestations as the first symptom: Two case reports
Yun SHI ; Kunyu LIU ; Doudou CHEN ; Min SHEN ; Xuqin ZHENG
Chinese Journal of Endocrinology and Metabolism 2020;36(11):966-969
Two cases of solitary fibrous tumor (SFT) with endocrine manifestations as the first symptom were investigated through comprehensively reviewing their medical history and clinical records. One case of recurrent giant solitary fibrous tumor of the thoracic cavity had repeated dizziness, palpitation and limb weakness for one month. The patient had hypoglycemia accompanied with significantly decreased serum insulin, and the ratio of insulin-like growth factor Ⅱ(IGF-Ⅱ) and insulin-like growth factor Ⅰ (IGF-Ⅰ) was greater than 10. Non-islet cell tumor hypoglycemia (NICTH) should be considered in the patient. Another case was found to have thyroid gland SFT and developed distant metastasis. The patient presented with hypoglycemia, hypokalemia and possible consumptive hypothyroidism. Clinicians should improve our understanding of the endocrine manifestations of the disease. SFT may occur in endocrine glands (such as thyroid), and may also present as NICTH and consumptive hypothyroidism.

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