1.The effect of Xuebijing injection for severe acute pancreatitis:a Meta analysis
Rui ZHENG ; Li ZHANG ; Ran TIAN ; Nan LI ; Xiang LEI ; Li JING ; Si LIU ; Zhiqiao FENG ; Songtao SHOU ; Hongcai SHANG
Chinese Critical Care Medicine 2015;(8):682-686
ObjectiveTo assess the efficacy and safety of Xuebijing injection for the treatment of severe acute pancreatitis (SAP).Methods An extensive search of related literatures from the Cochrane Library, EMBASE, China Biology Medicine (CBM), CNKI, VIP and Wanfang data up to March 2014 was performed. Randomized controlled trials (RCTs) regarding Xuebijing injection for the treatment of SAP were collected regardless of languages. Jadad scale was taken for quality evaluation of the included studies by two researchers. The patients in control group were given conventional treatment, and those of the Xuebijing group were given Xuebijing injection on the top of conventional treatment. The Cochrane Collaboration RevMan 5.2 software was used for data analysis regarding the effect of Xuebijing injection on the mortality, incidence of complication, effective rate, the length of stay in hospital, and the safety of the drug in patients with SAP.Results A total of 15 published reports meeting the inclusion criteria were enrolled. The methodological quality of the trials was low. Meta analysis showed that the mortality in Xuebijing group was significantly lower [odds ratio (OR) = 0.37, 95% confidence interval (95%CI) =0.17 - 0.77,P = 0.008], and the incidence of complication was also significantly decreased (OR = 0.26, 95%CI =0.14 - 0.45,P< 0.000 01) as compared with those of control group. The effective rate in Xuebijing group was significantly higher than that of the control group [relative risk (RR) = 0.85, 95%CI = 0.80-0.91,P< 0.000 01]. The length of stay in hospital in Xuebijing group was significantly shorter than that of the control group [mean difference (MD) = -5.28, 95%CI = -6.69 to -3.86,P< 0.000 01]. Adverse reactions of Xuebijing injection were reported in 2 studies. The adverse reaction in one study was headache and nausea, which were relieved by adjusting the speed of intravenous infusion, and mild rash was reported in another case, and it disappeared after the withdrawal of Xuebijing. Conclusions The currently available evidence shows that Xuebijing injection may have some therapeutic effect on SAP. Because of the low methodological quality of the included trials, multi-center and high-quality RCTs with large sample sizes are needed to provide stronger evidence.
2.Effect of acupuncture plus medication on the pulmonary ventilation, IFN-γ level and sleep quality in allergic rhinitis patients
Hai-Yan LUO ; Qing-Lin WEI ; Yong-Ping TIAN ; Xiang-Yi LIU ; Ya-Nan WANG ; Hai ZHANG
Journal of Acupuncture and Tuina Science 2019;17(6):402-408
Objective:To observe the effect of warm-unblocking acupuncture plus fluticasone propionate nasal spray on the pulmonary ventilation, level of interferon-γ (IFN-γ) and sleep quality in patients with allergic rhinitis (AR). Methods: A total of 112 AR patients were enrolled between January 2013 and August 2018 and were divided into an observation group and a control group by the random number table method, with 56 cases in each group. Patients in the observation group received warm-unblocking acupuncture plus fluticasone propionate nasal spray, and patients in the control group only received fluticasone propionate nasal spray. The nasal symptom score, pulmonary function indexes, the levels of IFN-γ and interleukin (IL)-4 in serum, and sleep quality in the two groups were compared. Results: After treatment, the total effective rate in the observation group was higher than that in the control group (P<0.05). The nasal symptom score dropped in both groups after treatment (both P<0.05), and the score in the observation group was lower than that in the control group (P<0.05). The pulmonary ventilation indexes all increased significantly after treatment in the observation group (all P<0.05); the forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio (FEV1/FVC) and the forced expiratory flow at 50%, 75% and 25%-75% of the vital capacity (FEF50%, FEF75%, FEF25%-75%) increased after treatment in the control group (all P<0.05); the pulmonary ventilation indexes were higher in the observation group than those in the control group (all P<0.05). The level of IFN-γ increased significantly after treatment in the two groups (both P<0.05) and the level of IL-4 dropped significantly (both P<0.05); the observation group had a higher IFN-γ level (P<0.05) and a lower IL-4 level (P<0.05) compared with the control group. Regarding the Pittsburgh sleep quality index (PSQI), the scores of subjective sleep quality, habitual sleep efficiency and sleep disturbances and the general PSQI score decreased significantly after treatment in both groups (all P<0.05), and the scores in the observation group were significantly lower than those in the control group (all P<0.05). Conclusion: Warm-unblocking acupuncture plus fluticasone propionate nasal spray can effectively control the clinical symptoms and improve pulmonary function in the treatment of AR; this approach can regulate the levels of IFN-γ and IL-4 towards the normal range in AR patients; it can also improve patient’s sleep quality. This method can produce more significant efficacy than fluticasone propionate nasal spray used alone.
3.Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine.
Wen-ke ZHENG ; Zhi LIU ; Xiang LEI ; Ran TIAN ; Rui ZHENG ; Nan LI ; Jing-tian REN ; Xiao-xi DU ; Hong-cai SHANG
China Journal of Chinese Materia Medica 2015;40(18):3693-3696
The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.
Clinical Trials as Topic
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Drug-Related Side Effects and Adverse Reactions
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epidemiology
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etiology
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Drugs, Chinese Herbal
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adverse effects
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chemistry
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economics
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therapeutic use
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Herbal Medicine
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economics
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legislation & jurisprudence
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Humans
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Patents as Topic
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Product Surveillance, Postmarketing
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Quality Control
4.Efficacy and Safety Profile of Combining Sorafenib with Chemotherapy in Patients with HER2-Negative Advanced Breast Cancer: A Meta-analysis.
Jie CHEN ; Chun Xiang TIAN ; Miao YU ; Qing LV ; Nan Sheng CHENG ; Zu WANG ; Xi WU
Journal of Breast Cancer 2014;17(1):61-68
PURPOSE: The aim of the study was to evaluate the efficacy and safety of combining sorafenib with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. METHODS: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, American Society for Clinical Oncology abstracts, and European Society for Medical Oncology abstracts were searched. Randomized clinical trials that compared the efficacy and safety of sorafenib plus chemotherapy in patients with HER2-negative advanced breast cancer with placebo plus chemotherapy were eligible. The endpoints were progression-free survival (PFS), overall survival (OS), time to progression (TTP), duration of response (DOR), overall response rate (ORR), clinical benefits, and adverse effects. The meta-analysis was performed using Review Manager 5.2.6 (The Nordic Cochrane Centre), and the fixed-effect model weighted by the Mantel-Haenszel method was used. When considerable heterogeneity was found (p<0.1), further analysis (subgroup analysis, sensitivity analysis, or random-effect model) was performed to identify the potential cause. The results are expressed as hazard ratios or risk ratios, with their corresponding 95% confidence intervals. RESULTS: The final analysis included four trials comprising 844 patients. The results revealed longer PFS and TTP, and higher ORR and clinical benefit rates in patients receiving sorafenib combined with chemotherapy compared to those receiving chemotherapy and placebo. OS and DOR were similar in the two groups. Meanwhile, the incidence of some adverse effects, including hand-foot skin reaction/hand-foot syndrome, diarrhea, rash, and hypertension, were significantly higher in the sorafenib arm. CONCLUSION: Sorafenib combined with chemotherapy may prolong PFS and TTP. This treatment was associated with manageable toxicities, but frequent dose interruptions and reductions were required.
Arm
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Breast Neoplasms*
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Breast*
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Diarrhea
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Disease-Free Survival
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Drug Therapy*
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Exanthema
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Humans
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Hypertension
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Incidence
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Medical Oncology
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Odds Ratio
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Population Characteristics
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Receptor, Epidermal Growth Factor
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Skin
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Treatment Outcome
5.Reconstruction of embryo using an improved nuclear transfer method.
Ke-Liang WU ; Yong-Xiang SHI ; Zeng-Liang BAI ; Hai-Bin TIAN ; Nan ZHANG ; Lan-Lan LIU ; Chang-Bin LIU
Chinese Journal of Biotechnology 2007;23(1):161-165
Previous methods used for nuclear transplantation were further investigated to develop a method that was both easy to carryout and did not require any special apparatus, such as Piezoimpact or Spindle-View. Following the puncture of zona pellucida with two holes by injection pipette that contained donor nuclei or cells, the injection pipette was pulled back to the perivitelline space while the negative pressure was increased in the holding pipette until the polar body and karyoplasm were wiped off completely. Then a reconstructed embryo was completed by the direct injection of the donor nucleus or cell without pulling out the injection pipette. 200 oocytes were manipulated using this method and it cost about 40 seconds with nucleus injection and about 30 seconds with cell injection to complete a reconstructed embryo. The success rates were 62.6% and 86. 0%, respectively, and enucleation rate was about 73.3% validated by Hoechst 33342. Using this method, the nucleus was completely eliminated and another was injected using the microscope and micromanipulator. Moreover, the efficiency of nuclear transplantation and survival rate of reconstructed embryos were greatly improved. Furthermore, it is very easy to manipulate and popularize in practice.
Animals
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Cell Culture Techniques
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methods
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Cell Nucleus
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metabolism
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Cells, Cultured
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Cloning, Organism
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methods
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Embryo, Mammalian
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cytology
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metabolism
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Embryonic Development
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Female
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Male
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Mice
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Mice, Inbred C57BL
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Mice, Inbred DBA
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Mice, Inbred Strains
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Nuclear Transfer Techniques
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Oocytes
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cytology
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metabolism
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Zona Pellucida
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metabolism
6.Determination of Eight Kinds of Elements in Cuttings by Logging Special Laser-induced Breakdown Spectrometer
Nan CHEN ; Ting Yan YANG ; Di TIAN ; Xiang Yi DUAN
Chinese Journal of Analytical Chemistry 2018;46(1):74-80
It is one of the necessary work in oil and gas exploration and development to record the logging of different depth cuttings.In this study, a laser induced breakdown spectrometer ( LIBS-Trace) developed by our research group was used for the lithology logging in the field of oil and gas exploration and development.A total of 60 samples from a drilling site in the Southwest China were divided into training set and test set, and then element quantitative analysis model of eight elements of Si, Al, Ca, K, Mg, Mn, Ti and Fe was established based on support vector machine regression ( SVR).The results showed that the mean percentage prediction errors (MPE) predicted by this method were Si 5.68%, Al 7.22%, Ca 7.45%, K 9.76%, Mg 8.79%, Mn 11.9%, Ti 11.4% and Fe 10.4%, which met the requirements of logging work.In addition, according to the logging process and demand, the instrument hardware and software were modified, and the quantitative model integrated in the instrument was optimiZed.The results showed that the algorithm model combined with the instrument could quickly complete the quantitative analysis of rock debris samples, and exhibited potential application value and broad application prospect in oil and gas exploration and development.
7. Clinical analysis of 11 patients with phytophotodermatitis caused by ingesting Chenopodium album
Nan LU ; Xiang LIU ; Lili NIU ; Xinjun SUN ; Shulan YAO ; Zhonghua TIAN ; Zhiming CHENG ; Xingyou TAN
Chinese Journal of Dermatology 2020;53(1):58-60
Objective:
To investigate clinical characteristics and treatment of phytophotodermatitis due to ingesting
8.Clinical trial of icotinib tablets in the treatment of stage ⅢA-N2 non-small cell lung cancer
Jian-Guo WANG ; Shu-Xian WANG ; Meng-Yuan TIAN ; Yan WANG ; Yu-Xiang RUAN ; Sheng-Nan HUANG
The Chinese Journal of Clinical Pharmacology 2018;34(9):1035-1038
Objective To observe the clinical efficacy and safety of icotinib tablets in the treatment of stage Ⅲ A-N2 non-small cell lung cancer (NSCLC).Methods A total of 56 patients with stage ⅢA-N2 NSCLC were randomly divided into control group and treatment group with 28 cases per group.The control group was treated with 60-75 mg · m-2 docetaxel,once a week,intravenous drip,or 500 mg · m pemetrexed,once every 3 weeks,intravenous drip,discontinuation of treatment when the disease progresses or adverse drug reactions cannot be tolerated.The treatment group was treated with icotinib tablets 125 mg,tid,orally,discontinuation of treatment when the disease progresses or adverse drug reactions cannot be tolerated.The clinical efficacy,peripheral blood dendritic cell subsets,and adverse drug reactions were compared between two groups.Results After treatment,the objective remission rates of the treatment group and the control group were 89.29% (25 cases/28 cases) and 71.43% (22 cases/28 cases),the difference was statistically significant (P < 0.05).After treatment,the number of dendritic cells (DC) in the treatment group and the control group were (15.44 ± 2.08) and (12.83 ± 1.71) × 106/L,the ratio of dendritic cells to mononuclear cells (DC/PBMC) were (0.62 ± 0.08) % and (0.57 ± 0.07) %,the differences were statistically significant (P < 0.05).The adverse drug reactions of two groups were rashes,diarrhea and mild liver dysfunction.The total incidences of adverse drug reactions in the treatment group and the control group were 46.43% and 42.86% without significant difference (P > 0.05).Conclusion The clinical efficacy of icotinib tablets in the treatment of stage ⅢA-N2 NSCLC was exact,and it did not increase the incidence of adverse drug reactions.
9.Quantitative T2 mapping evaluation for articular cartilage lesions in a rabbit model of anterior cruciate ligament transection osteoarthritis.
Zheng-mao WEI ; Xiang-ke DU ; Tian-long HUO ; Xu-bin LI ; Guang-nan QUAN ; Tian-ran LI ; Jin CHENG ; Wei-tao ZHANG
Chinese Medical Journal 2012;125(5):843-850
BACKGROUNDQuantitative T2 mapping has been a widely used method for the evaluation of pathological cartilage properties, and the histological assessment system of osteoarthritis in the rabbit has been published recently. The aim of the study was to investigate the effectiveness of quantitative T2 mapping evaluation for articular cartilage lesions of a rabbit model of anterior cruciate ligament transection (ACLT) osteoarthritis.
METHODSTwenty New Zealand White (NZW) rabbits were divided into ACLT surgical group and sham operated group equally. The anterior cruciate ligaments of the rabbits in ACLT group were transected, while the joints were closed intactly in sham operated group. Magnetic resonance (MR) examinations were performed on 3.0T MR unit at week 0, week 6, and week 12. T2 values were computed on GE ADW4.3 workstation. All rabbits were killed at week 13, and left knees were stained with Haematoxylin and Eosin. Semiquantitative histological grading was obtained according to the osteoarthritis cartilage histopathology assessment system. Computerized image analysis was performed to quantitate the immunostained collagen type II.
RESULTSThe average MR T2 value of whole left knee cartilage in ACLT surgical group ((29.05±12.01) ms) was significantly higher than that in sham operated group ((24.52±7.97) ms) (P=0.024) at week 6. The average T2 value increased to (32.18±12.79) ms in ACLT group at week 12, but remained near the baseline level ((27.66±8.08) ms) in the sham operated group (P=0.03). The cartilage lesion level of left knee in ACLT group was significantly increased at week 6 (P=0.005) and week 12 (P<0.001). T2 values had positive correlation with histological grading scores, but inverse correlation with optical densities (OD) of type II collagen.
CONCLUSIONThis study demonstrated the reliability and practicability of quantitative T2 mapping for the cartilage injury of rabbit ACLT osteoarthritis model.
Animals ; Anterior Cruciate Ligament ; metabolism ; physiopathology ; Cartilage, Articular ; metabolism ; physiopathology ; Collagen Type II ; metabolism ; Magnetic Resonance Imaging ; Male ; Osteoarthritis ; metabolism ; physiopathology ; Rabbits
10.A preliminary investigation on the serological and epidemiological characteristics of severe acute respiratory syndrome in children.
Li CAO ; Tian-you WANG ; Hui-zhong CHEN ; Yuan QIAN ; Bo-wen CHEN ; Ping FANG ; Yan-xiang SUN ; Ru-nan ZHU ; Jie DENG ; Lin-qing ZHAO ; Jie MI ; Ting ZHANG
Chinese Journal of Pediatrics 2004;42(11):840-844
OBJECTIVEThe severe acute respiratory syndrome (SARS) is a highly contagious infection caused by a newly discovered strain of coronavirus (SARS-CoV). During the outbreak of SARS in the first half of 2003, children appeared to be less susceptible to the SARS coronavirus and pediatric patients presented with a less aggressive clinical course than adult patients did, demonstrating the traits which were rarely observed in other viral contagious disease. The present study aimed to preliminarily examine the presence of serum specific antibodies against severe acute respiratory syndrome (SARS)-associated coronavirus virus (SARS-CoV) in pediatric SARS patients and explore the possibility of subclinical infection in children/adults through close association with SARS cases.
METHODS(1) Clinicians and nurses visited families and collected general and epidemiological information about the subjects using a standard questionnaire and took serum specimens. (2) Specific antibodies against SARS-CoV were assayed with two methods, indirect immunofluorescence assay (IFA) for detecting IgG antibodies and enzyme linked immunosorbent assay (ELISA) for mixed antibodies. Serum specimens tested included those from 21 clinically confirmed pediatric SARS cases (aged from 8 months to 14 years, 11 male and 10 female) and their 23 parents who had close contact with the children, 36 adult patients in convalescence stage of SARS, 24 children (aged 1.5 to 14 years) and other 34 adults who had close contact with infected adults.
RESULTS(1) The positive rates of specific IgG and mixed antibodies against SARS-CoV were 38% (8/21) and 33% (7/21) in pediatric cases; whereas the rates were 75% (27/36) and 69% (25/36) in adult patients. (2) The proportion of the patients who had close contact to SARS patients was 7/8 among the antibody-positive group vs. 1/13 for the antibody-negative group (P < 0.05). (3) The IgG antibody emerged in one of 24 children, whose mother, a nurse, had suffered from SARS (4%). (4) Among 23 parents of children with SARS, one was positive for IgG and the mixed antibodies, whose grandson and husband suffered from SARS; The IgG antibody and the mixed antibodies were also positive in another adult who had close contact with adult SARS cases (3%).
CONCLUSIONS(1) SARS-CoV infection was confirmed by serological methods in 38.1% of clinically diagnosed pediatric SARS cases, which leads to the assumption that correct diagnosis of pediatric SARS requires more accurate and efficient ways, for example, screening for antigen or gene of SARS-CoV. (2) The proportion of the patients who had close contact to SARS patients among antibody-positive cases was higher than that in antibody-negative cases. (3) It is possible that subclinical SARS CoV infection exists in children and adults, although the rate of occurrence is low. The data of the present study did not confirm that SARS had subclinical infection among adults who had close contact to pediatric SARS cases.
Adolescent ; Adult ; Antibodies, Viral ; blood ; immunology ; Child ; Child, Preschool ; Enzyme-Linked Immunosorbent Assay ; Female ; Fluorescent Antibody Technique, Indirect ; Humans ; Immunoglobulin G ; blood ; immunology ; Infant ; Male ; SARS Virus ; immunology ; Severe Acute Respiratory Syndrome ; blood ; epidemiology ; immunology