1.General considerations for the design of bioequivalence studies of etomidate medium/long-chain fat emulsion injection
Na AN ; Dong LI ; Li-Li LIU ; Fang LI ; Li-Li HA ; Man-Ru REN ; Yu ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(10):1541-1544
Etomidate reversibly blocks 11-β-hydroxylated steroid dehydrogenase inhibits the synthesis of cortisol by adrenal cells.This product is a special injection.When evaluating the quality and efficacy of the generic and the reference preparations,it should be based on pharmaceutical and non-clinical consistency and adopt a step-by-step research strategy,firstly,bioequivalence(BE)was studied.In bioequivalence study,the research type,dosage and method,bioequivalence evaluation,safety monitoring and pharmacodynamics(PD)evaluation should be considered and designed reasonably.Based on the pharmacokinetics(PK)characteristics of etomidate medium-long chain fat emulsion injection and the bioequivalence study of its generic drug before its domestic market,the general design requirements and relevant considerations for the bioequivalence study of this product were systematically discussed.The purpose is to provide useful reference and guidance for domestic research and development of generic drugs.
2.Anastomosis fixation method of lifting the suborbicularis oculi fat and fixing with the orbital septum and fat to correct eyelid bags with tear trough deformity
Gaofeng LI ; Wanhong ZHANG ; Qian CHEN ; Wei DING ; Bo ZHANG ; Man FANG ; Youqi LUO ; Xiaojia LIU
Chinese Journal of Plastic Surgery 2024;40(7):709-715
Objective:To investigate the clinical effectiveness of anastomosis fixation method of lifting the suborbicularis oculi fat (SOOF) and fixing with the orbital septum and fat to correct eyelid bags with tear trough deformity.Methods:A retrospective analysis was conducted on patients treated at Hunan Provincial People’s Hospital (the First Affiliated Hospital of Hunan Normal University) from January 2019 to January 2021. The patients underwent lower eyelid blepharoplasty via a sub-lower eyelid skin approach. During the surgery, the SOOF was lifted and fixed with the orbital septum and fat, correcting the eye bags, filling the tear troughs, and lifting the midface. Postoperative observations included incision healing and complications. The correction of eye bags, tear troughs, and midface sagging was followed up. Adobe Photoshop CS6 software was used to measure the vertical distance from the nasolabial and buccal fat prominent point to the lower eyelid margin before surgery and at the last follow-up to evaluate the correction of midface sagging. Data were expressed as Mean ± SD, and pre- and post-operative comparisons were analyzed using paired t-test, with P<0.05 indicating statistical significance. Patients’ and nurses’ satisfaction evaluations of surgical outcomes were classified into three levels: satisfied, basically satisfied, and dissatisfied, requiring consensus between the two evaluators. Results:A total of 132 patients (264 eyes) were included, consisting of 23 males and 109 females, with an average age of (50.3±6.0) years. Hirmand tear trough classification included 178 type Ⅱeyes and 86 type Ⅲ eyes. Postoperative wound healing was well, with no hematoma, infection, diplopia, corneal foreign body sensation, and discomfort from external eye corner tightness. Follow-up ranged from 6-12 months, with 252 out of 264 eye bags disappeared and 12 eye bags reduced. Among the 86 type Ⅲ tear trough eyes, 10 improved to type Ⅰ, while the remaining 76 type Ⅲ and 178 type Ⅱ tear troughs disappeared postoperatively. All 264 midface sagging cases showed improvement, with the vertical distance from the nasolabial fat prominence point to the lower eyelid margin significantly shortening postoperatively [(29.23±1.58) mm vs. (34.08±3.23) mm, t=22.88, P<0.001)]. Satisfaction evaluation result showed 118 cases were satisfied (satisfaction rate of 89.4%), and 14 cases were basically satisfied. Conclusion:The anastomosis fixation method of lifting the SOOF and fixing with the orbital septum and fat effectively removes eyelid bags, smooths tear troughs, and lifts the midface, achieving a rejuvenated appearance and renders a high patient satisfaction rate.
3.Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine (version 2024)
Xiao CHEN ; Hao ZHANG ; Man WANG ; Guangchao WANG ; Jin CUI ; Wencai ZHANG ; Fengjin ZHOU ; Qiang YANG ; Guohui LIU ; Zhongmin SHI ; Lili YANG ; Zhiwei WANG ; Guixin SUN ; Biao CHENG ; Ming CAI ; Haodong LIN ; Hongxing SHEN ; Hao SHEN ; Yunfei ZHANG ; Fuxin WEI ; Feng NIU ; Chao FANG ; Huiwen CHEN ; Shaojun SONG ; Yong WANG ; Jun LIN ; Yuhai MA ; Wei CHEN ; Nan CHEN ; Zhiyong HOU ; Xin WANG ; Aiyuan WANG ; Zhen GENG ; Kainan LI ; Dongliang WANG ; Fanfu FANG ; Jiacan SU
Chinese Journal of Trauma 2024;40(3):193-205
Osteoporotic proximal humeral fracture (OPHF) is one of the common osteoporotic fractures in the aged, with an incidence only lower than vertebral compression fracture, hip fracture, and distal radius fracture. OPHF, secondary to osteoporosis and characterized by poor bone quality, comminuted fracture pattern, slow healing, and severely impaired shoulder joint function, poses a big challenge to the current clinical diagnosis and treatment. In the field of diagnosis, treatment, and rehabilitation of OPHF, traditional Chinese and Western medicine have accumulated rich experience and evidence from evidence-based medicine and achieved favorable outcomes. However, there is still a lack of guidance from a relevant consensus as to how to integrate the advantages of the two medical systems and achieve the integrated diagnosis and treatment. To promote the diagnosis and treatment of OPHF with integrated traditional Chinese and Western medicine, relevant experts from Orthopedic Expert Committee of Geriatric Branch of Chinese Association of Gerontology and Geriatrics, Youth Osteoporosis Group of Orthopedic Branch of Chinese Medical Association, Osteoporosis Group of Orthopedic Surgeon Branch of Chinese Medical Doctor Association, and Osteoporosis Committee of Shanghai Association of Integrated Traditional Chinese and Western Medicine have been organized to formulate Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine ( version 2024) by searching related literatures and based on the evidences from evidence-based medicine. This consensus consists of 13 recommendations about the diagnosis, treatment and rehabilitation of OPHF with integrated traditional Chinese medicine and Western medicine, aimed at standardizing, systematizing, and personalizing the diagnosis and treatment of OPHF with integrated traditional Chinse and Western medicine to improve the patients ′ function.
4.Early experience with mechanical hemodynamic support for catheter ablation of malignant ventricular tachycardia
Mengmeng LI ; Yang YANG ; Deyong LONG ; Chenxi JIANG ; Ribo TANG ; Caihua SANG ; Wei WANG ; Xin ZHAO ; Xueyuan GUO ; Songnan LI ; Changyi LI ; Man NING ; Changqi JIA ; Li FENG ; Dan WEN ; Hui ZHU ; Yuexin JIANG ; Fang LIU ; Tong LIU ; Jianzeng DONG ; Changsheng MA
Chinese Journal of Cardiology 2024;52(7):768-776
Objective:To explore the role of mechanical hemodynamic support (MHS) in mapping and catheter ablation of patients with hemodynamically unstable ventricular tachycardia (VT), report single-center experience in a cohort of consecutive patients receiving VT ablation during MHS therapy, and provide evidence-based medical evidence for clinical practice.Methods:This was a retrospective cohort study. Patients with hemodynamically unstable VT who underwent catheter ablation with MHS at Beijing Anzhen Hospital, Capital Medical University between August 2021 and December 2023 were included. Patients were divided into rescue group and preventive group according to the purpose of treatment. Their demographic data, periprocedural details, and clinical outcomes were collected and analyzed.Results:A total of 15 patients with hemodynamically unstable VT were included (8 patients in the rescue group and 7 patients in the preventive group). The acute procedure was successful in all patients. One patient in the rescue group had surgical left ventricular assist device (LVAD) implantation, remaining 14 patients received extracorporeal membrane oxygenation (ECMO) for circulation support. ECMO decannulation was performed in 12 patients due to clinical and hemodynamic stability, of which 6 patients were decannulation immediately after surgery and the remaining patients were decannulation at 2.0 (2.5) d after surgery. Two patients in the rescue group died during the index admission due to refractory heart failure and cerebral hemorrhage. During a median follow-up of 30 d (1 d to 12 months), one patient with LVAD had one episode of ventricular fibrillation at 6 months after discharge, and no further episodes of ventricular fibrillation and/or VT occurred after treatment with antiarrhythmic drugs. No malignant ventricular arrhythmia occurred in the remaining 12 patients who were followed up.Conclusions:MHS contributes to the successful completion of mapping and catheter ablation in patients with hemodynamically unstable VT, providing desirable hemodynamic status for emergency and elective conditions.
5.Anastomosis fixation method of lifting the suborbicularis oculi fat and fixing with the orbital septum and fat to correct eyelid bags with tear trough deformity
Gaofeng LI ; Wanhong ZHANG ; Qian CHEN ; Wei DING ; Bo ZHANG ; Man FANG ; Youqi LUO ; Xiaojia LIU
Chinese Journal of Plastic Surgery 2024;40(7):709-715
Objective:To investigate the clinical effectiveness of anastomosis fixation method of lifting the suborbicularis oculi fat (SOOF) and fixing with the orbital septum and fat to correct eyelid bags with tear trough deformity.Methods:A retrospective analysis was conducted on patients treated at Hunan Provincial People’s Hospital (the First Affiliated Hospital of Hunan Normal University) from January 2019 to January 2021. The patients underwent lower eyelid blepharoplasty via a sub-lower eyelid skin approach. During the surgery, the SOOF was lifted and fixed with the orbital septum and fat, correcting the eye bags, filling the tear troughs, and lifting the midface. Postoperative observations included incision healing and complications. The correction of eye bags, tear troughs, and midface sagging was followed up. Adobe Photoshop CS6 software was used to measure the vertical distance from the nasolabial and buccal fat prominent point to the lower eyelid margin before surgery and at the last follow-up to evaluate the correction of midface sagging. Data were expressed as Mean ± SD, and pre- and post-operative comparisons were analyzed using paired t-test, with P<0.05 indicating statistical significance. Patients’ and nurses’ satisfaction evaluations of surgical outcomes were classified into three levels: satisfied, basically satisfied, and dissatisfied, requiring consensus between the two evaluators. Results:A total of 132 patients (264 eyes) were included, consisting of 23 males and 109 females, with an average age of (50.3±6.0) years. Hirmand tear trough classification included 178 type Ⅱeyes and 86 type Ⅲ eyes. Postoperative wound healing was well, with no hematoma, infection, diplopia, corneal foreign body sensation, and discomfort from external eye corner tightness. Follow-up ranged from 6-12 months, with 252 out of 264 eye bags disappeared and 12 eye bags reduced. Among the 86 type Ⅲ tear trough eyes, 10 improved to type Ⅰ, while the remaining 76 type Ⅲ and 178 type Ⅱ tear troughs disappeared postoperatively. All 264 midface sagging cases showed improvement, with the vertical distance from the nasolabial fat prominence point to the lower eyelid margin significantly shortening postoperatively [(29.23±1.58) mm vs. (34.08±3.23) mm, t=22.88, P<0.001)]. Satisfaction evaluation result showed 118 cases were satisfied (satisfaction rate of 89.4%), and 14 cases were basically satisfied. Conclusion:The anastomosis fixation method of lifting the SOOF and fixing with the orbital septum and fat effectively removes eyelid bags, smooths tear troughs, and lifts the midface, achieving a rejuvenated appearance and renders a high patient satisfaction rate.
6.Expert consensus on the rational use of psychotropic drugs related to intensive care medicine
Shenglin SHE ; Zhen SONG ; Tongwen SUN ; Jingguo ZHAI ; Yan YU ; Ningbo YANG ; Maosheng FANG ; Wenbin GUO ; Man WANG ; Guanglei XUN ; Lulu ZHANG ; Xijia XU ; Xiaoli WU ; Qinling WEI ; Fang LIU ; Huiping LI ; Xingrong SONG ; Youping WANG ; Yingjun ZHENG ; Xueqin SONG
Chinese Journal of Nervous and Mental Diseases 2024;50(9):513-524
Critical care medicine-related treatment is an interdisciplinary and multi-professional process,often leading to secondary or concomitant mental disorders in clinical practice.Currently,there is no consensus on the pharmacological treatment of related mental illnesses in China.The Chinese Society of Psychosomatic Medicine collaborated with the Critical Care Medicine expert group to form a consensus writing expert group.After a systematic review of relevant literature,summarizing published domestic and foreign literature,and extensive discussions,the consensus was developed.The consensus elaborates on the principles and processes of the standardized use of psychotropic drugs in critical care medicine,as well as the clinical indications,precautions,and specific drug selection of various psychiatric medications,providing feasible suggestions and guidance for the clinical application of psychiatric medications in the intensive care unit.
7.Clinical characteristics and risk factors analysis of dengue fever incidence in Xishuangbanna, Yunnan Province in 2023
Lei CAI ; Shize DUAN ; Wangbin XU ; Dongmei DAI ; Fang YANG ; Man YANG ; Yanhui LI ; Pinghua LIU
Chinese Critical Care Medicine 2024;36(9):917-923
Objective:To analyze the clinical characteristics of dengue fever patients, summarize the course and characteristics of the disease, and analyze the risk factors that affect the condition.Methods:Retrospective collection of general information, clinical symptoms, medical history, laboratory tests, prognosis and other clinical data of dengue fever patients that admitted to Jinghong First People's Hospital and severe dengue fever patients at People's Hospital of Xishuangbanna Dai Autonomous Prefecture from June to December 2023 was conducted using a case report form (CRF). According to the diagnostic criteria of the World Health Organization (WHO), patients were divided into dengue fever group, dengue fever with warning signs group, and severe dengue fever group. The differences in clinical data between different groups of patients were analyzed and compared. Binary multiple factor Logistic regression analysis was used to explore the risk factors affecting the severity of dengue fever in patients. Receiver operator characteristic curve (ROC curve) was drawn to analyze the predictive value of prediction models constructed for various risk factors for severe dengue fever. Subgroup analysis was performed on the prognosis of severe dengue fever patients, and the differences in clinical data between two groups of patients with different prognoses were compared. Binary multivariate Logistic regression analysis was used to explore the risk factors affecting the prognosis of severe dengue fever patients. ROC curve was drawn to analyze the predictive value of prediction models constructed for various risk factors on the prognosis of severe dengue fever patients.Results:A total of 2 264 patients were included, including 499 cases in the dengue fever group, 1 379 cases in the dengue fever with warning signs group, and 386 in the severe dengue fever group (43 deaths and 343 survivors). The most common symptom of dengue fever patients was fever (94.70%), followed by muscle soreness (70.54%), headache (63.12%), fatigue (58.92%), and chills (46.02%). Compared with the dengue fever group and the dengue fever with warning signs group, the ratio of thalassemia and the levels of cardiac troponin (cTnI, cTnT), MB isoenzyme of creatine kinase (CK-MB), and myoglobin were significantly increased in patients with severe dengue fever group, albumin (Alb) was significantly decreased in patients with severe dengue fever group. The levels of cTnT and myoglobin in patients with dengue fever with warning signs group were significantly higher than those in the dengue fever group, and the level of Alb in patients with dengue fever with warning signs group was significantly lower than that in the dengue fever group, the differences were statistically significant (all P < 0.05). Binary multivariate Logistic regression analysis showed that thalassemia [odds ratio ( OR) = 6.214, 95% confidence interval (95% CI) was 2.337-16.524, P < 0.001], Alb ≤ 36 g/L ( OR = 6.297, 95% CI was 4.270-9.286, P < 0.001), and cTnT levels ( OR = 1.008, 95% CI was 1.002-1.015, P = 0.016) were risk factors for severe dengue fever. ROC curve analysis showed that the area under the ROC curve (AUC) for predicting severe dengue fever based on the prediction models constructed for the above risk factors was 0.856, with the best predictive value of 0.067, sensitivity of 67.1%, and specificity of 99.4%. In the subgroup analysis of patients with severe dengue fever, compared with the survival group, the levels of hematocrit (HCT), cTnT, and CK-MB in the death group patients were significantly increased, while the level of Alb was significantly decreased, and the differences were statistically significant. Binary multivariate Logistic regression analysis showed that Alb ( OR = 0.839, 95% CI was 0.755-0.932, P = 0.001), HCT ( OR = 1.086, 95% CI was 1.010-1.168, P = 0.025), elevated troponin level ( OR = 10.119, 95% CI was 2.596-39.440, P < 0.001), and CK-MB ( OR = 1.081, 95% CI was 1.032-1.133, P < 0.001) were risk factors for mortality in patients with severe dengue fever. ROC curve analysis showed that the AUC for predicting death in severe dengue fever patients based on the prediction models constructed for the above risk factors was 0.881, with the best predictive value of 0.113, sensitivity of 75.0%, and specificity of 88.9%. Conclusion:Thalassemia, Alb≤36 g/L, and cTnT level are risk factors for severe dengue fever, while HCT level, Alb level, CK-MB level, and elevated troponin level are risk factors for death in patients with severe dengue fever.
8.Treatment Outcomes in COVID-19 Patients with Brucellosis: Case Series in Heilongjiang and Systematic Review of Literature.
Man Li YANG ; Jing Ya WANG ; Xing Yu ZONG ; Li GUAN ; Hui Zhen LI ; Yi Bai XIONG ; Yu Qin LIU ; Ting LI ; Xin Yu JI ; Xi Yu SHANG ; Hui Fang ZHANG ; Yang GUO ; Zhao Yuan GONG ; Lei ZHANG ; Lin TONG ; Ren Bo CHEN ; Yi Pin FAN ; Jin QIN ; Fang WANG ; Gang LIN ; Nan Nan SHI ; Yan Ping WANG ; Yan MA
Biomedical and Environmental Sciences 2023;36(10):930-939
OBJECTIVE:
Clinical characteristics and outcome in COVID-19 with brucellosis patients has not been well demonstrated, we tried to analyze clinical outcome in local and literature COVID-19 cases with brucellosis before and after recovery.
METHODS:
We retrospectively collected hospitalization data of comorbid patients and prospectively followed up after discharge in Heilongjiang Infectious Disease Hospital from January 15, 2020 to April 29, 2022. Demographics, epidemiological, clinical symptoms, radiological and laboratory data, treatment medicines and outcomes, and follow up were analyzed, and findings of a systematic review were demonstrated.
RESULTS:
A total of four COVID-19 with brucellosis patients were included. One patient had active brucellosis before covid and 3 patients had nonactive brucellosis before brucellosis. The median age was 54.5 years, and all were males (100.0%). Two cases (50.0%) were moderate, and one was mild and asymptomatic, respectively. Three cases (75.0%) had at least one comorbidity (brucellosis excluded). All 4 patients were found in COVID-19 nucleic acid screening. Case C and D had only headache and fever on admission, respectively. Four cases were treated with Traditional Chinese medicine, western medicines for three cases, no adverse reaction occurred during hospitalization. All patients were cured and discharged. Moreover, one case (25.0%) had still active brucellosis without re-positive COVID-19, and other three cases (75.0%) have no symptoms of discomfort except one case fell fatigue and anxious during the follow-up period after recovery. Conducting the literature review, two similar cases have been reported in two case reports, and were both recovered, whereas, no data of follow up after recovery.
CONCLUSION
These cases indicate that COVID-19 patients with brucellosis had favorable outcome before and after recovery. More clinical studies should be conducted to confirm our findings.
Female
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Humans
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Male
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Middle Aged
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Brucellosis
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COVID-19
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Retrospective Studies
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SARS-CoV-2
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Treatment Outcome
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Case Reports as Topic
9.Application of plasma with same blood group as kidney donor to preconditioning of ABO incompatible kidney transplantation
Shuai DAI ; Min WANG ; Yanan JING ; Man FANG ; Xiaohong GUAN ; Zhiyong TANG ; Keru WANG ; Hongtao LIU
Chinese Journal of Organ Transplantation 2022;43(7):385-389
Objective:To explore the feasibility of applying plasma with same blood group as kidney donor to ABO incompatible kidney transplantation(ABOi-KT)preconditioning of blood group O recipients with high-titer anti-A/B preformed antibody(IgM/IgG titer ≥1∶256).Methods:A total of 15 cases of blood group O ABOi-KT recipients with high-titer anti-A/B were recruited and divided into two groups of AB( n=8)and kidney donor's blood(KD, n=7)according to plasma type for plasma exchange during preconditioning phase. Clinical data of preconditioning and post-KT were recorded. Results:They received plasmapheresis(PP)(8.1±2.5)sessions in preconditioning phase, including double plasma filtration(DFPP)(4.0±1.4)sessions and plasma exchange(PE)(4.1±2.0)sessions, PP frequency was(0.8±0.1)sessions per day. No hemolysis reaction occurred during preconditioning phase. Anti-A/B titers declined as expected and fulfilled the ABOi-KT criteria(IgM/IgG titers ≤1∶8). KT was performed successfully without antibody-mediated rejection. All of them survived with normal renal function within 90 days post-KT. Levels of serum creatinine at Day 7/30/90 post-KT were(92.9±30.4), (96.2±25.9)and(103.1±28.4)μmol/L; anti-A/B IgM titers at Day 7/30/90 post-KT 1∶1-1∶32, 1∶1-1∶64 and 1∶1-1∶32; anti-A/B IgG titers at Day 7/30/90 post-KT 1∶1-1∶64, 1∶1-1∶64 and 1∶1-1∶32 respectively. No significant differences existed in count/frequency of PP sessions, levels of serum creatinine or anti-A/B titers at each observation point between AB and KD groups( P>0.05). Conclusions:Plasma with the same blood group as kidney donor is feasible for maximizing the intensity of ABOi-KT preconditioning. Favorable outcomes may be achieved through an intensified desensitization strategy on blood group O recipients with high-titer anti-A/B preformed antibody. The potential risks and long-term outcomes should be further explored.
10.Epidemiological and etiological analysis of two infantile cases of serogroup B epidemic cerebrospinal meningitis epidemics in Shandong Province, 2021.
Yan ZHANG ; Qing Fan CAO ; Li ZHANG ; Yuan GAO ; Yuan SUN ; Gui Fang LIU ; Lei FENG ; Man Shi LI ; Ai Qiang XU
Chinese Journal of Preventive Medicine 2022;56(5):668-672
Two cases of epidemic situation of serogroup B meningitis in infants in Shandong Province in 2021 were investigated. Samples of cases and their close contacts were collected for isolation, culture and identification of Neisseria meningitides (Nm). The isolates were subjected to multi-locus sequence typing, outer membrane protein porA and fetA genotyping and drug sensitivity test. Two laboratory-confirmed outbreaks of serogroup B meningitis were reported from Yantai city and Linyi city. The indicated cases were infants aged 5 months and 2 months old respectively. They were not vaccinated with meningitis vaccine. Their epidemiological characteristics and clinical manifestations were similar and the prognosis was good. The same sequence type (ST) of serogroup B Nm strains as the indicated cases was detected in the samples of close family contacts, but without subsequent cases. Among them, Yantai strain was were identified as the type ST-8920, belonging to CC4821 clonal complex, and the genotypes of porA and fetA were p1.21-2, 23 and F3-1. Linyi strain was a new type, belonging to CC4821 clonal complex and the genotypes of porA and fetA were p1.20, 23 and F1-91. The above strains were resistant to penicillin, ciprofloxacin, levofloxacin and Chemitrim, and their sensitivity to cephalosporin decreased. Two cases of infant serogroup B epidemic were relatively rare in China, which were different from the epidemiological and pathogenic characteristics of other Nm serogroups in the past.
Epidemics
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Humans
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Infant
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Meningitis, Meningococcal/epidemiology*
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Multilocus Sequence Typing
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Neisseria meningitidis
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Serogroup

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