2.Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background.
Lian-xin WANG ; Yan-ming XIE ; Qing-hua AI ; Nian-bin SONG
China Journal of Chinese Materia Medica 2015;40(24):4752-4756
This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.
Drug Combinations
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Drugs, Chinese Herbal
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adverse effects
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Humans
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Injections
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Product Surveillance, Postmarketing
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Prospective Studies
3.Residue decline dynamics and safety utilization of carbendazim in cultivation of Anoectochilus roxburghii.
Qing-Song SHAO ; Hong-Bo LIU ; Yu-Yun ZHANG ; Ai-Lian ZHANG ; Ming-Yan LI
China Journal of Chinese Materia Medica 2014;39(9):1559-1563
The paper aimed to study the residue decline dynamic and standards for safety utilization of carbendazim in roots, stems, leaves of Anoectochilus roxburghii and in growth media. Samples extracted with methanol were purified by liquid-liquid extraction and analysed by HPLC. The results showed that average rate of recovery was 82.9% - 95.7% and RSD were 2.0% - 6.3% with add of carbendazim in respectively diverse concentration, which meets inspection requirement of pesticide residue. Two kinds of dosages of carbendazim were treated, varying from recommended dosage (1.0 kg x hm(-2)) to 1.5 times recommended dosage (1.5 kg x hm(-2)). Results of two years test showed that the half-life period of carbendazim were 7.01 - 8.51 d in the growth media of A. roxburghii, 3.58 - 4.27 d in stems and 3.50 - 3.91 d in leaves, 4.93 - 5.71 d in roots. Providing max recommended residue of carbendazim in the cultivation of A. roxburghii is 0.5 mg x kg(-1), sprayed 4 times a year with the dosage of 1.0 kg x hm(-2), 28 days is proposed for the safety interval of the last pesticide application's and harvest's date.
Benzimidazoles
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metabolism
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pharmacology
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Carbamates
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metabolism
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pharmacology
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Chromatography, High Pressure Liquid
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Culture Media, Conditioned
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chemistry
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Dose-Response Relationship, Drug
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Fungicides, Industrial
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metabolism
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pharmacology
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Liquid-Liquid Extraction
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Orchidaceae
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drug effects
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metabolism
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Pesticide Residues
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analysis
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metabolism
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Plant Leaves
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drug effects
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metabolism
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Plant Roots
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drug effects
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metabolism
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Plant Stems
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drug effects
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metabolism
4.Eight Cases of Caroli′s Disease in Children
hua, SONG ; shu-hong, ZHANG ; xiao-hua, XU ; ai-ming, SI-TU ; feng-lin, LIU
Journal of Applied Clinical Pediatrics 2004;0(07):-
Objective To explore the clinical characteristics and treatment of Caroli′s disease in children.Methods The clinical data,laboratory examination and radiological feature of 8 children with Caroli′s disease between Feb.1998 and Dec.2007 were analyzed retrospectively.All children underwent CT and abdominal ultrasonogram.Results Five cases of the 8 children were male and 3 cases were female.The mean age was 6.3 years old.The cases′ history were from 5 days to 4 months.The clinical symptoms showed that 3 cases had hematemesis,5 cases had hepatosplenomegaly,and 1 case had fever and turbid urine.Of the total 8 cases,5 cases were hepatic fibrosis and liver cirrhosis and hepatosplenomegaly,3 cases were portal hypertension,and 1 case had cholangitis.The other 3 cases were simple types.One case had infantile polycystic kidney disease.Laboratory analysis revealed 2 cases had dysfunction of liver and 1 dysfunction of renal.The imaging characteristics showed multiplied irregular dilatation of the intrahepatic bile ducts in enlarged liver,with central dot sign on CT scan.One case presented enlarged gastroesophageal vein.The 8 cases undertook conservative treatment,with no surgery.Conclusions The symptoms of Caroli′s disease are highly variable.Caroli′s disease should be focused especially on children with abdominal pain and hepatomegaly.CT is important for diagnosis of Caroli′s disease at earlier stage.The disease can be conservatively treated,and(or) surgically operated.
5.Association of Interleukin-1?-511C/T and Interleukin-1?+3953C/T Polymorphisms with Susceptibility of Pediatric Epilepsy
hai-ying, LU ; song-ming, HUANG ; ai-hua, ZHANG ; guo, ZHENG ; yan-jun, HUANG
Journal of Applied Clinical Pediatrics 2006;0(14):-
Objective To explore the relationship between IL-1?-511C/T and IL-1?+3953C/T site polymorphisms and the susceptibility of pediatric epilepsy.Methods Under the case-control study,IL-1?-511C/T and IL-1?+3953C/T site polymorphisms in 117 patients with pediatric epilepsy and 95 healthy individuals controls(healthy control group) were analyzed with polymerase chain reaction restriction and fragment length polymorphism(PCR-RFLP),the relationship between IL-1?-511C/T,IL-1?+3953 C/T site polymorphisms and the risk of pediatric epilepsy were analyzed.SAS 8.0 software was used to analyze the data.Results Multiple variate logistic regression analysis revealed that compared with healthy control group,there was no relationship between the IL-1?-511C/T site polymorphisms and the susceptibility of pediatric epilepsy individuals,carrying at least one +3953T variant allele(CT and TT genotypes) had a significantly increased risk for pediatric epilepsy(adjusted OR=2.46,95%CI 1.03-5.87),compared with the wild-type genotype(+3953CC).Furthermore,individuals with epilepsy or febrile seizures family history had a significantly higher risk(adjusted OR=4.12,95%CI 1.28-29.34),compared with those with both CC genotypes.Conclusions These findings support the hypothesis that IL-1?-511C/T site polymorphisms have no relationship with epilepsy,but the IL-1?+3953C/T polymorphism may contribute to the risk of developing pediatric epilepsy.
6.Influence of seedling grade on plant growth, yield and quality of Anoectochilus roxburghii.
Qing-Song SHAO ; Ai-Cun ZHOU ; Run-Huai HU ; Yu-Yun ZHANG ; Tang-Mei LIU ; Ming-Yan LI
China Journal of Chinese Materia Medica 2014;39(5):785-789
The morphological index of the seedlings including the plants height, the ground diameter, the leaf amounts, the fresh weight of the whole plant and the ratio of height to diameter was measured and the principal components were analyzed so as to determine the grading index, and stepwise cluster analysis was applied for clustering analysis. Pot experiments were used to measure the indicators of plant growth and development, the yield and the quality. The results showed that the height and ground diameter were determined as the quality indicators of the seedlings grading and the standard quality grading of seedlings of Anoectochilus roxburghii was initially set up, different seeding plants influenced the plants growth and the yield. The ground diameter of the class I was larger than that of the class II and III, so as the yield. The seedling grading had no obvious effect on the internal quality of medicinal materials. The results of the study provide the basis for standard cultivation of A. roxburghii.
Drugs, Chinese Herbal
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analysis
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Orchidaceae
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chemistry
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classification
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growth & development
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Quality Control
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Seedlings
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chemistry
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classification
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growth & development
7.Determination of six C-Glycoside flavones and antitumor activity of water-soluble total flavonoids from Isodon lophanthoides var. gerardianus.
Yang ZHANG ; Hai-ming TANG ; Ai LI ; Lan-fang XU ; Jian-nan CHEN ; Song HUANG ; Lian HE
China Journal of Chinese Materia Medica 2015;40(8):1543-1547
This research established an HPLC method for determination of six C-Glycoside flavones of warer-soluble total flavonoids from Isodon lophanthoides var. gerardianus (Benth.) H. Hara, and studied the antitumor activity of the warer-soluble total flavonoids. The HPLC system consisted of Kromasil 100-5 C18 (4.6 mm x 250 mm, 5 microm) column and a solution system of methanol, acetonitrile and 0.5% formic acid gradient elution at a flow rate of 0. 8 mL x min(-1) and the wavelength of detector was at 334 nm. The column temperature was 25 degrees C. The antitumor activity of water-soluble flavonoids was assayed using HepG2 cell as the tested cell. The linear ranges of vicenin II, vicenin III, isoschaftoside, schaftoside, vitexin, 6, 8-di-C-a-L-arabinosylapigenin were 0.25-2.53, 0.12-1.20, 0.37-3.69, 0.16-1.63, 0.19-1.92, 0.14-1.42 microg, respectively. The average recoveries (n = 6) were 99.6% (RSD 0.87%), 100.2% (RSD 2.0%), 99.6% (RSD 1.8%), 97.9% (RSD 1.5%), 98.8% (RSD 1.2%), 98.6% (RSD 1.2%), respectively. After exposure in 24, 48, 72 h, the total flavonoids showed inhibitory effect on the proliferation of HepG2 cells with IC50 as the evaluation index, the IC50 values of 1.89, 1.71, 1.51 g x L(-1), respectively. The method is quick, simple and accurate with good re- producibility, and can be used for determination of vicenin II, vicenin III, isoschaftoside, schaftoside, vitexin, 6, 8-di-C-a-L-arabino- sylapigenin in the warer-soluble total flavonoids from L lophanthoides var. gerardianus. The warer-soluble total flavonoids from L lophanthoides have inhibitory effect on the proliferation of HepG2 cells.
Antineoplastic Agents, Phytogenic
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analysis
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pharmacology
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Cell Line, Tumor
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Cell Proliferation
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drug effects
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Chromatography, High Pressure Liquid
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Drugs, Chinese Herbal
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analysis
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pharmacology
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Flavones
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analysis
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pharmacology
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Humans
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Isodon
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chemistry
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Monosaccharides
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analysis
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pharmacology
8.Effects of different transplanting conditions on survival rate and growing status of Anoictochilus roxburghii plantlets.
Qing-Song SHAO ; Ai-Cun ZHOU ; Yu-Qiu HUANG ; Ying-Lei DONG ; Bing-Kang HU ; Ming-Yan LI
China Journal of Chinese Materia Medica 2014;39(6):955-958
The growing status of Anoectochilus roxburghii seedling was observed and the survival rate of seedlings, height, stem diameter and plant fresh weight under the conditions of different transplanting substrate compositions, planting density, shading rate were measured. The results showed that the effects of different transplanting substrates, planting densities, shading rates and nutrient solutions on the growing status of A. roxburghii plantlets varied greatly. A. roxburghii plantlets demonstrated a high survival rate and better growing status under the Following conditions: the ratio of peat and river sand as 2: 1, the planting density as 3 cm x 3 cm, the shading rate as 70%, and the nutrient solution as 1/4MS. The findings of the study provide a solid technical solution for the artificial cultivation of A. roxburghii plantlets.
Breeding
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methods
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Culture Media
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chemistry
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pharmacology
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Orchidaceae
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drug effects
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growth & development
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Seedlings
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drug effects
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growth & development
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Survival Analysis
9.Operational state of drinking water defluorination project and situation of fluorosis in children aged 8 to 12 in Dagang district of Tianjin in 2009
Guang-xin, SONG ; Shu-qing, HAN ; Ming-sheng, LIU ; Ai-min, YUAN ; Gui-qin, DOU ; Wen-feng, KAN
Chinese Journal of Endemiology 2011;30(1):68-71
Objective To investigate the state of drinking water defluorination project in Dagang district and study urinary fluoride levels and detect dental fluorosis of children aged 8 to 12, and to provide scientific basis for prevention and control of fluorosis. Methods Five defluorination projects in rural streets (towns) with highfluoride water and 2 urban water supply projects were choosen to investigate the running status in Dagang district Tianjin in 2009. Five rural and 2 urban schools were choosen to select 100 children aged 8 to 12 (for gender, age matched) in each primary school to study urinary fluoride levels and detection of dental fluorosis. Results A total of 66 defluorination projects in 73 villages were surveyed, among which 61 projects actually worked normally with using rate 92.4%(61/66). Water qualification of all projects could not be ensured due to direct project managers'lack of necessary expertise. In 2009, water qualification rate were 39.3%(24/61 )among the project normally used,with highlighted problem of biological pollution. A total of 490 children aged 8 - 12 in 5 rural towns were surveyed,dental fluorosis rate were 90%(441/490), and dental fluorosis index were 1.82. A total of 207 children aged 8 - 12in 2 urban areas were surveyed, the detection rate of dental fluorosis was 49.8%(103/207), and dental fluorosis index were 0.86. The urinary fluoride level of 230 children aged 8 - 12 in the 5 villages were surveyed. The Range of geometric mean of urinary fluoride were 1.82 - 2.70 mg/L. The urinary fluoride of 102 children aged 8 - 12 in the 2 urban area were surveyed. The Range of geometric mean of urinary fluoride were 1.53 - 1.72 mg/L. Conclusions There was phenomenon of high coverage, low utilization rate and less water consumption in the villages of Dagang district, Tianjin drinking water defluoridation projects, thus the health effects of the projects was minimum.Significant health effects is found in the defluorination projects in the urban areas with high coverage and high utilization rate. Studying new water improvment methods and new forms of water supply system is urgent for solving the problems met in the ineffective water defluorination project.