1.Characterization and diagnostic efficacy of Rose-Bengal plate agglutination test, standard-tube agglutination test and enzyme-linked immunosorbent assay methods in detecting brucellosis
LI Shu-jun ; ZHANG Yu-long ; MA Long ; ZHANG Jing ; ZU Jian-bing
China Tropical Medicine 2022;22(11):1078-
Abstract: Objective To study the characteristics and diagnostic efficacy of Rose-Bengal plate agglutination test (RBPT), standard-tube agglutination test (SAT) and enzyme-linked immunosorbent assay (ELISA) in the diagnosis of brucellosis. Methods A total of 489 suspected brucellosis patients with complete records, who admitted to Xing'anmeng People's Hospital from March 2020 to May 2021, were selected as the subjects. The diagnostic value of SAT, RBPT and ELISA for brucellosis was analyzed with exposure history + clinical symptoms + serological test/brucellosis isolation and culture as the gold standard. Results Of the 489 suspected patients, 183 (37.42%) were diagnosed with brucellosis, while 234 (47.85%), 148 (30.27%) and 195 (39.88%) were positive by RBPT, ELISA and SAT, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of RBPT in the diagnosis of brucellosis were 95.08%, 80.39%, 74.36%, 96.47%, and 85.89%, respectively; the values of the above parameters for ELISA were 78.69%, 98.69%, 97.30%, 88.56%, and 91.21%, respectively; those values of SAT were 98.36%, 95.10%, 92.31%, 98.98%, and 96.32%, respectively. The sensitivity of RBPT was significantly higher than ELISA, but the specificity and accuracy were significantly lower than ELISA (all P<0.05). The sensitivity and accuracy of SAT diagnosis were significantly higher than ELISA, but the specificity was significantly lower than ELISA (all P<0.05). There was no significant difference between SAT and RBPT in the sensitivity of diagnosis, but the specificity and accuracy were significantly higher than those of RBPT (P<0.05). Conclusion RBPT and SAT have high sensitivity in diagnosis of brucellosis, while ELISA has high specificity in diagnosis. RBPT with high sensitivity and convenient operation can be used for primary screening in field detection, and then the other two methods can be used for rechecking, so as to further improve the efficiency and accuracy of diagnosis of brucellosis.
2."Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations.
Shu-Xin WU ; Hong-Feng SUN ; Xiao-Hui YANG ; Hong-Zhu LONG ; Zu-Guang YE ; Shao-Liang JI ; Li ZHANG
China Journal of Chinese Materia Medica 2014;39(15):2983-2988
We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in that it enhances the pharmaceutical manufactures the ability to control enterprise risk and eliminate the negative impact on traditional Chinese medicine. With the widely used and ADR report concentrated Radix Bupleuri injection as an example, the author provide a new approach to post-marketing clinical research.
Bupleurum
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chemistry
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Drug Compounding
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Drug-Related Side Effects and Adverse Reactions
;
etiology
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Drugs, Chinese Herbal
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adverse effects
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Humans
;
Product Surveillance, Postmarketing
;
methods
;
Safety
3.Chimeric rabies glycoprotein with a transmembrane domain and cytoplasmic tail from Newcastle disease virus fusion protein incorporates into the Newcastle disease virion at reduced levels.
Gui Mei YU ; Shu Long ZU ; Wei Wei ZHOU ; Xi Jun WANG ; Lei SHUAI ; Xue Lian WANG ; Jin Ying GE ; Zhi Gao BU
Journal of Veterinary Science 2017;18(S1):351-359
Rabies remains an important worldwide health problem. Newcastle disease virus (NDV) was developed as a vaccine vector in animals by using a reverse genetics approach. Previously, our group generated a recombinant NDV (LaSota strain) expressing the complete rabies virus G protein (RVG), named rL-RVG. In this study, we constructed the variant rL-RVGTM, which expresses a chimeric rabies virus G protein (RVGTM) containing the ectodomain of RVG and the transmembrane domain (TM) and a cytoplasmic tail (CT) from the NDV fusion glycoprotein to study the function of RVG's TM and CT. The RVGTM did not detectably incorporate into NDV virions, though it was abundantly expressed at the surface of infected BHK-21 cells. Both rL-RVG and rL-RVGTM induced similar levels of NDV virus-neutralizing antibody (VNA) after initial and secondary vaccination in mice, whereas rabies VNA induction by rL-RVGTM was markedly lower than that induced by rL-RVG. Though rL-RVG could spread from cell to cell like that in rabies virus, rL-RVGTM lost this ability and spread in a manner similar to the parental NDV. Our data suggest that the TM and CT of RVG are essential for its incorporation into NDV virions and for spreading of the recombinant virus from the initially infected cells to surrounding cells.
Animals
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Antibody Formation
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Cytoplasm*
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Glycoproteins*
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GTP-Binding Proteins
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Humans
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Mice
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Newcastle disease virus*
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Newcastle Disease*
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Parents
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Rabies virus
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Rabies*
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Reverse Genetics
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Tail*
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Vaccination
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Virion*
4.An outbreak of human Streptococcus suis serotype 2 infections presenting with toxic shock syndrome in Sichuan, China.
Wei-zhong YANG ; Hong-jie YU ; Huai-qi JING ; Jian-guo XU ; Zhi-hai CHEN ; Xiao-ping ZHU ; Hua WANG ; Xue-cCheng LIU ; Shi-wen WANG ; Lun-guang LIU ; Rong-qiang ZU ; Long-ze LUO ; Ni-juan XIANG ; Hong-lu LIU ; Wen-jun ZHONG ; Li LIU ; Ling MENG ; Heng YUAN ; Yong-jun GAO ; Hua-mao DU ; Yang-bin OU ; Chang-yun YE ; Dong JIN ; Qiang LV ; Zhi-gang CUI ; Yan HUANG ; Shou-yin ZHANG ; Xiang-dong AN ; Ting HUANG ; Xing-yu ZHOU ; Liao FENG ; Qi-di PANG ; Yue-long SHU ; Yu WANG
Chinese Journal of Epidemiology 2006;27(3):185-191
OBJECTIVEIn mid-July 2005, five patients presented with septic shock to a hospital in Ziyang city in Sichuan, China, to identify the etiology of the unknown reason disease, an epidemiological, clinical, and laboratory study were conducted.
METHODSAn enhanced surveillance program were established in Sichuan, the following activities were introduced: active case finding in Sichuan of (a) laboratory diagnosed Streptococcus suis infection and (b) clinically diagnosed probable cases with exposure history; supplemented by (c) monitoring reports on meningococcal meningitis. Streptococcus suis serotype 2 infection was confirmed by culture and biochemical reactions, followed by sequencing for specific genes for serotype and virulence factors.
RESULTSFrom June 10 to August 21, 2005, 68 laboratory confirmed cases of human Streptococcus suis infections were reported. All were villagers who gave a history of direct exposure to deceased or sick pigs in their backyards where slaughtering was performed. Twenty six (38%) presented with toxic shock syndrome of which 15 (58%) died. Other presentations were septicaemia or meningitis. All isolates were tested positive for genes for tuf, species-specific 16S rRNA, cps2J, mrp, ef and sly. There were 136 clinically diagnosed probable cases with similar exposure history but incomplete laboratory investigations.
CONCLUSIONAn outbreak of human Streptococcus suis serotype 2 infections occurred in villagers after direct exposure to deceased or sick pigs in Sichuan. Prohibition of slaughtering in backyards brought the outbreak to a halt. A virulent strain of the bacteria is speculated to be in circulation, and is responsible for the unusual presentation of toxic shock syndrome with high case fatality.
Animals ; Bacteremia ; epidemiology ; microbiology ; China ; epidemiology ; Disease Outbreaks ; Humans ; Meningitis, Bacterial ; epidemiology ; microbiology ; Shock, Septic ; epidemiology ; microbiology ; Streptococcal Infections ; epidemiology ; microbiology ; veterinary ; Streptococcus suis ; isolation & purification ; Swine ; Swine Diseases ; microbiology
5.Correlations between pathologic subtypes/immunohistochemical implication and CT characteristics of lung adenocarcinoma ≤ 1 cm with ground-glass opacity.
Fang WU ; Zu-long CAI ; Shu-ping TIAN ; Xin JIN ; Rui JING ; Yue-qing YANG ; Ying-na LI ; Shao-hong ZHAO
Acta Academiae Medicinae Sinicae 2015;37(2):163-170
OBJECTIVETo discuss the correlation of pathologic subtypes and immunohistochemical implication with CT features of lung adenocarcinoma 1 cm or less in diameter with focal ground-glass opacity (fGGO).
METHODSCT appearances of 59 patients who underwent curative resection of lung adenocarcinoma ≤ 1 cm with fGGO were analyzed in terms of lesion location, size, density, shape (round, oval, polygonal, irregular), margin (smooth, lobular, spiculated, lobular and spiculated), bubble-like sign, air bronchogram, pleural tag, and tumor-lung interface. Histopathologic subtypes were classified according to International Association for the Study of Lung Cancer/ American Thoracic Society/European Respiratory Society classification of lung adenocarcinoma. Common molecular markers in immunohistochemical study included human epidermal growth factor receptor (HER)-1,HER-2,Ki-67, vascular endothelial growth factor (VEGF) and DNA topoisomerase 2Α.Patients' age and lesions' size and density were compared with pathologic subtypes using analysis of variance or nonparametric Wilcoxon tests. Patients' gender, lesion location, shape and margin, bubble-like sign, air bronchogram, pleural tag, and tumor-lung interface were compared with histopathologic subtypes and immunohistochemical implication using ψ² test or Fisher's exact test.
RESULTSThe patients' gender, age, lesion location, shape, air bronchogram, pleural tag, and tumor-lung interface were not significantly different among different histopathologic subtypes (P=0.194, 0.126, 0.609, 0.678, 0.091, 0.374, and 0.339, respectively), whereas the lesion size,density,bubble-like sign, and margin showed significant differences (P=0.028, 0.002, 0.003, 0.046, respectively). The expression of Ki-67 significantly differed among nodules with different shapes(P=0.015). Statistically significant difference also existed between tumor-lung interface and HER-1 expression (P=0.019) and between bubble sign and HER-2 expression (P=0.049).
CONCLUSIONSOf lung adenocarcinoma ≤ 1 cm with fGGO,bubble-like sign occurs more frequently in invasive pulmonary adenocarcinoma and less frequently in atypical adenomatous hyperplasia. In addition, preinvasive lesions (atypical adenomatous hyperplasia and adenocarcinoma in situ) more frequently demonstrates smooth margin,while invasive lesions (minimally invasive adenocarcinoma and invasive pulmonary adenocarcinoma) more frequently demonstrates lobular and spiculated margin. Some CT features are associated with immunohistochemical implication of lung adenocarcinoma ≤ 1 cm with fGGO.
Adenocarcinoma ; Humans ; Hyperplasia ; Lung ; Lung Neoplasms ; Vascular Endothelial Growth Factor A
6.Value of Baseline Clinical and CT Characteristics for Predicting the Progression of Persistent Pure Ground-glass Nodule 10 mm or Less in Diameter.
Fang WU ; Zu-Long CAI ; Shu-Ping TIAN ; Xin JIN ; Rui JING ; Yue-Qing YANG ; Mei JIN ; Shao-Hong ZHAO
Acta Academiae Medicinae Sinicae 2016;38(4):371-377
Objective To explore the risk factors of the progression of persistent pure ground-glass nodule (pGGN) and make the risk stratification for pGGN 10 mm or less in diameter. Methods From June 2008 to April 2015,100 patients (108 lesions) with persistent pGGN≤10 mm in diameter were included in this study. Patients were followed up at least 1 year using thin-section computed tomography (CT). Patients' baseline clinical data and CT characteristics of pGGN were compared between progression group (size increased or/and solid component appeared) and non-progression group. Cox regression analysis was used to assess the relationship between clinical data,CT characteristics of pGGN,and lesion progression. The risk indices of lesion progression were calculated according to the results of Cox regression analysis and the relative factors of lung adenocarcinoma in previous studies. Logistic regression analysis was used to assess the relationship between risk indices and lesion progression. The optimal cutoff value was decided on receiver operating characteristic curve of risk indices and verified for predicting lesion progression. Results Fifteen of 108 lesions showed progression. The mean follow-up duration was (1016.36±486.00) days. There were statistically significant differences of lesion size,air bronchogram,and vessel changes between progression group and non-progression group (P=0.040,P=0.003,P=0.030,respectively).Lesion density (CT value≥-542.5 HU) and air bronchogram were the risk factors of lesion progression (P=0.003,P=0.021,respectively). The optimal cutoff value of total risk indices on predicting lesion progression was 4.25,with the sensitivity of 46.7%,specificity of 89.2%,and consistency of 83.3%. Conclusions CT value ≥-542.5 HU of pGGN and air bronchogram within lesion may predict lesion progression in persistent pGGN 10 mm or less in diameter. A risk index of less than 4.25 often suggests small probability of disease progression and thus a longer follow-up interval is recommended.
Adenocarcinoma
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diagnostic imaging
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Disease Progression
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Humans
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Lung Neoplasms
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diagnostic imaging
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ROC Curve
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Regression Analysis
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Risk Factors
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Sensitivity and Specificity
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Tomography, X-Ray Computed
7.The association between Helicobacter pylori virulence factor genotypes and gastroduodenal diseases in children.
Jing Jing YING ; Xiao Li SHU ; Gao LONG ; Mi Zu JIANG
Chinese Journal of Pediatrics 2023;61(9):827-832
Objective: To investigate the association between Helicobacter pylori (Hp) virulence factor genotypes and the degree and activity of gastric mucosa pathological changes in pediatric gastroduodenal diseases. Methods: This retrospective cohort study was conducted from May 2020 to October 2020. The frozen strains of Hp, which were cultured with the gastric mucosa of 68 children with gastroscopy confirmed gastroduodenal diseases who visited the children's hospital of Zhejiang University School of Medicine from April 2012 to December 2014, were resuscitated. After extracting DNA from these Hp strains, PCR amplification and agarose gel electrophoresis were performed to determine the detection rate of cytotoxin-associated protein A (cagA),vacuolating cytotoxin A (vacA)(s1a、s1b/s2,m1/m2), outer inflammatory protein A (oipA),blood group antigen binding adhesin (babA),duodenal ulcer promoting protein A (dupA) genes; oipA genes were sequenced to determine the gene status. The patients were divided into different groups according to the findings of gastroscopy and gastric mucosa pathology. The detection rates of various virulence factor genotypes among different groups were compared using χ2 tests or Fisher's exact tests. Results: The 68 Hp strains all completed genetic testing. According to the diagnostic findings of gastroscopy, the 68 cases were divided into 47 cases of superficial gastritis and 21 cases of peptic ulcer. Regarding the pathological changes of gastric mucosa, 8 cases were mild, and 60 cases were moderate and severe according to the degree of inflammation; 61 cases were active and 7 cases inactive according to the activity of inflammation. The overall detection rates of cagA, vacA, vacA s1/m2, functional oipA, babA2, and dupA virulence factor genes were 100% (68/68), 100% (68/68), 94% (64/68), 99% (67/68), 82% (56/68), and 71% (48/68), respectively. In the superficial gastritis group, their detection rates were 100% (47/47), 100% (47/47), 96% (45/47), 98% (46/47), 81% (38/47), and 70% (33/47), respectively; in the peptic ulcer group, their detection rates were 100% (21/21), 100% (21/21), 90% (19/21), 100% (21/21), 86% (18/21), and 71% (15/21), respectively. There was no statistically significant difference between the two groups (all P>0.05). In the mild gastric mucosa inflammation group, the detection rates of the above six genotypes were 8/8, 8/8, 8/8, 7/8, 7/8, and 5/8, respectively; and in the moderate to severe inflammation groups, the detection rates were 100% (60/60), 100% (60/60), 93% (56/60), 100% (60/60), 82% (49/60), and 72% (43/60), respectively, with no statistically significant difference between the two groups (all P>0.05). In the active inflammation group, the detection rate of six genotypes were 100% (61/61), 100% (61/61), 93% (57/61), 98% (60/61), 82% (50/61), and 72% (44/61), respectively; and in the inactive inflammation group, they were 7/7, 7/7, 7/7, 7/7, 6/7, and 4/7, respectively. Again, there was no statistically significant difference between the two groups (all P>0.05). There was no statistically significant difference in the detection rate of combinations of 4 or 5 virulence factor genes among the different groups (all P>0.05). Conclusions: CagA, vacA, vacA s1/m2, functional oipA, babA2, and dupA genes are not associated with superficial gastritis and peptic ulcer in children, or with the degree and activity of gastric mucosa pathological inflammation. Different gene combinations of cagA, vacA, oipA, babA2, and dupA have no significant effects on predicting the clinical outcome of Hp infection in children.
Humans
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Child
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Helicobacter pylori/genetics*
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Retrospective Studies
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Genotype
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Inflammation
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Gastritis
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Cytotoxins
8.The relationship between genetic polymorphism of CYP2C19 and the efficacy of Helicobacter pylori eradication therapy in children.
Ling Ling LUO ; Bo CHEN ; Xiao Li SHU ; Wei ZHENG ; Gao LONG ; Mi Zu JIANG
Chinese Journal of Pediatrics 2023;61(7):600-605
Objective: To investigate the relationship between genetic polymorphisms of cytochrome P450 2C19 (CYP2C19) and the efficacy of Helicobacter pylori (Hp) eradication therapy in children. Methods: The retrospective cohort study was conducted on 125 children with gastroscopy and positive rapid urease test (RUT) from September 2016 to December 2018 who presented to the Children's Hospital of Zhejiang University School of Medicine due to gastrointestinal symptoms including nausea, vomiting, abdominal pain, bloating, acid reflux, heartburn, chest pain, vomiting blood and melena. Hp culture and drug susceptibility test were carried out with gastric antrum mucosa before treatment. All the patients completed 2 weeks of standardized Hp eradication therapy and had 13C urea breath test 1 month after that, which was used to evaluate the curative effect. The DNA of gastric mucosa after RUT was analyzed and CYP2C19 gene polymorphism was detected. Children were grouped according to metabolic type. Combined with the results of Hp culture and drug susceptibility, the relationship between CYP2C19 gene polymorphism and the efficacy of Hp eradicative treatment was analyzed in children. Chi square test was used for row and column variables, and Fisher exact test was used for comparison between groups. Results: One hundred and twenty five children were enrolled in the study, of whom 76 were males and 49 females. The genetic polymorphism of CYP2C19 in these children found poor metabolizer (PM) of 30.4% (38/125), intermediate metabolizer (IM) of 20.8% (26/125), normal metabolizer (NM) of 47.2% (59/125), rapid metabolizer (RM) of 1.6% (2/125), and ultrarapid metabolizer (UM) of 0. There were statistically significant in positive rate of Hp culture among these groups (χ2=124.00, P<0.001). In addition, the successful rates of Hp eradication in PM, IM, NM and RM genotypes were 84.2% (32/38), 53.8% (14/26), 67.8% (40/59), and 0, respectively, with significant differences (χ2=11.35, P=0.010); those in IM genotype was significantly lower than that in PM genotype (P=0.011). With the same standard triple Hp eradicative regimen, the successful rate of Hp eradication for IM type was 8/19, which was lower than that of PM (80.0%, 24/30) and NM type (77.3%, 34/44) (P=0.007 and 0.007, respectively). There was a significant difference in the efficacy of Hp eradication treatment among different genotypes (χ2=9.72, P=0.008). According to the clarithromycin susceptibility result, the successful rate of Hp eradication treatment for IM genotype was 4/15 in the sensitive group and 4/4 in the drug-resistant group (χ2=6.97, P=0.018). Conclusions: The genetic polymorphism of CYP2C19 in children is closely related to the efficacy of Hp eradication treatment. PM has a higher successful rate of eradication treatment than the other genotypes.
Female
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Male
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Humans
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Child
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Cytochrome P-450 CYP2C19/genetics*
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Helicobacter pylori
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Retrospective Studies
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Genotype
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Abdominal Pain