2.Construction and implementation of quality control index for clinical safety of Chinese medicine injection.
China Journal of Chinese Materia Medica 2015;40(24):4766-4769
In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference.
Humans
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Injections
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Medicine, Chinese Traditional
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adverse effects
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standards
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Quality Control
4.Influences of 1,25-(OH)_2D_3 and salvia miltiorrhiza on hematopoiesis reconstruction and T cell subsets after allogeneic bone marrow transplantation in rats
Mei YAN ; Bingzhao WEN ; Yan CAO ; Ming JIANG
Journal of Xi'an Jiaotong University(Medical Sciences) 1981;0(03):-
Objective To observe the influences of 1,25-(OH)2D3 and salvia miltiorrhiza on hematopoiesis reconstruction and T cell subsets after allogeneic bone marrow transplantation in rats.Methods Donor rats were divided randomly into four groups,namely,Group A: aGVHD group;Group B: 1,25-(OH)2D3 group;Group C: salvia miltiorrhiza group;and Group D: two-drug combination group.We observed the survival time,peripheral blood cells,clinical manifestations of aGVHD and the changes of rat T cell subsets.Results Compared with those in aGVHD group,in every drug intervention group,the time for illness attack of aGVHD was delayed,aGVHD scoring was reduced and the average survival time was obviously prolonged(P
5.Influence of 1,25-(OH)_2D_3 and salvia miltiorrhiza on T cell subsets and immune status in rats after allogeneic bone marrow transplantation
Mei YAN ; Bingzhao WEN ; Yan CAO ; Jun HU ; Ming JIANG
Journal of Third Military Medical University 2003;0(24):-
Objective To investigate the effect of 1,25-(OH)2D3 and salvia miltiorrhiza on T cell subsets and cytokines in rats after allogeneic bone marrow transplantation.Methods Female Wistar rats were used as recipients and male SD rats were used as donors.All Wistar rats were divided into aGVHD group and intervention groups at random,and the intervention groups were further divided into 1,25-(OH)2D3 group,salvia miltiorrhiza group and combination group.The changes of T cell subsets (CD4+ and CD8+) and cytokine (IL-2,IFN-?,IL-4 and IL-10) in every group were detected and measured.Results When the presentation of aGVHD was relatively conspicuous,CD4+ and CD8+ were increased,and the increase of CD4+ was predominant.Compared with the difference prior to transplantation,the difference was statistically significant (P
6.Association of subclinical hypothyroidism with dyslipidemia and non-alcoholic fatty liver
Lingding XIE ; Yan-Ming GAO ; Gui-Zhi LU ; Qiu-Ming JIANG ; Xiao-Hui GUO ; Yan GAO
Chinese Journal of Endocrinology and Metabolism 2000;0(06):-
Objective To investigate the prevalence of subclinical hypothyroidism and its relation to serum total cholesterol (TC),triglyceride (TG) levels and non-alcoholic fatty liver.Methods Serum levels of TC,TG, TSH,TT_3 and TT_4 were determined in 1 602 subjects which were divided into groups by sex and age (20-39,40- 59 and≥60 years).Fatty liver was diagnosed by type B ultrasonography.Restults ( 1 ) Prevalence of subclinical hypothyroidism was 6.6% in this population.(2) The mean levels of serum TC and TG in subclinical hypothyroidism group and normal group showed no significant difference ( both P>0.05 ).(3) On the whole,the prevalences of subclinical hypothyroidism in hypercholesterolemia group and normal cholesterolemia group showed significant difference (P<0.01 ).(4) In the three age groups of male and few.ale examinees,the prevalences of subclinical hypothyroidism in hypercholesterulemla group and normal cholesterolemia group showed no significant difference ( all P>0.05 ).In the multiple regression analysis,TSH level was not related with raised TC level.(5) In the three age groups of male,there was no significant difference between the prevalences of subclinical hypothyroidism in hypertriglyceridemla group and normal triglyceridemia group ( all P>0.05 ).In female,expect for the elderly group (>60 years old ),the prevalence of subclinical hypothyroidism was higher in hypertriglyceridemia group than that in normal triglyceridemia.However,in the multiple regression analysis, increased TSH level was positively associated with increased serum TG level ( OR = 1.072,P=0.013 and OR = 1.102,P = 0.03 ).(6) The prevalence of subclinical hypothyroidism in non-alcobolic fatty liver group and normal group showed no significant difference ( P>0.05 ).In the multiple regression analysis,TSH level was not the independent risk factor of non-alcoholic fatty liver (P>0.05 ).Conclusion Subclinical hypothyroidism is not asseciated with serum TC level but positively associated with serum TG level.Subclinical hypothyroidism does not apparently increase the prevalence of non-alcoholic fatty liver.
7.Multilayer amniotic membrane transplantation for the management of corneal perforation associated with ulceration
Dong-Ling, JIANG ; Ming-Chang, ZHANG ; Yan-Hua, HU
International Eye Science 2006;6(5):988-991
AIM: To investigate the efficacy, safety and localization of multilayer amniotic membrane transplantation (AMT) for the management of corneal perforation associated with ulceration.METHODS: Six eyes (6 patients) were treated with multilayer AMT for corneal perforation associated with ulceration. The perforation size was 0.5-2mm in diameter. The amniotic membrane (AM) was applied to tamp the perforation, fill the ulcer and cover the surface of ulcer. The follow-up ranged from 5-19 months.RESULTS: The anterior chamber reformed at the first postoperative day in all patients, and kept in normal depth in the follow- up time. The epithelialization of the AM grafts was observed in about 3 weeks after surgery. During the first postoperative month, the corneal thickness at the perforation site gradually increased, and the stromal inflammatory cell invasions surrounding the corneal ulcer were gradually subsided.Two months postoperatively, the ulcer healed with scar with part neovascutarization; the corneal thickness of the ulcer area was stable and recovered almost normal. The vision was not improved in all patients after operation. During-follow up,no severe complications or recurrence of ulceration was noted.CONCLUSION: Multilayer AMT is an effective and safe method for the management of small corneal perforation associated with ulceration, but the ulcer healed with scar.
8.Amniotic membrane transplantation for limbal pathological changes of vernal keratoconjunctivitis
Dong-Ling, JIANG ; Ming-Chang, ZHANG ; Yan-Hua, HU
International Eye Science 2006;6(4):762-764
AIM: To evaluate the efficacy and safety of annular bubble conjunctival excision combining with amniotic membrane transplantation(AMT) for vernal keratoconjunctivitis(VKC) with gelatinous swellings(papillae) at the limbus.METHODS: Twenty eyes(10 patients) with VKC, were characterized by gelatinous swellings(papillae) at limbus and were underwent annular bubble conjunctival excision associated with AMT. The follow up ranged 5-21months.RESULTS: After operation, the symptoms were subsided remarkably: itching,discharge and foreign body sensation were almost disappear; photophobia and tearing were obvious in the first week after surgery, but were gradually alleviated, and almost disappear after one month of postoperative.Yellow-brown or filthy red gelatinous protuberances at limbus were cleaned away by operation and did not recur during the follow up. Corneal superficial punctuate keratitis(11 eyes) and corneal ulcers(3 eyes) were healed during the first week after surgery and did not recur. Conjunctival congestion was gradually lessened after surgery, which could not be noted 1months after surgery in 19 eyes, and the conjunctiva around the limbus, where AMT was performed, was whiter than the normal. But conjunctival congestion in 1 eye lasted for about 5mon accompanying with a little of itch, and this eye was treated with eyedrops with improvement but recurrence. No severe complications had been seen during the follow up.CONCLUSION: Annular bubble conjunctival excision combining with amniotic membrane transplantation is an effective and safe method for the treatment of vernal keratoconjunctivitis with gelatinous swellings (papillae) at limbus. But the candidates must be chosen with discretion.
9.Amniotic membrane transplantation for the managenment of earlier Mooren's ulcer
Dong-Ling, JIANG ; Ming-Chang, ZHANG ; Yan-Hua, HU
International Eye Science 2006;6(1):9-12
AIM: To investigate the efficacy and safety of annular conjunctival excision combined with amniotic membrane transplantation for the management of earlier Mooren's ulcer.METHODS: Thirty eyes (24 patients) with earlier Mooren's ulcer were treated with this method, followed-up for 5-30mo. The characteristic of these patients was localized periphery corneal ulcer: the ulcer involved 30-120° corneal limbus with depth of 1/3-1/2 cornealthickness and width of 2-5mm.RESULTS: After surgery, symptoms subsided remarkably and immediately in all patients,and almost disappeared after stitches were removed. Corneal melts were controlled. At postoperative 2-3mo, the corneal thickness of the ulcer area became almost stable, which in some patients recovered normal and in others were still thinner than normal, and the average increase was about 1/3 of the corneal thickness. Corneal transparence and vision were improved. During follow-up, no severe complications or recurrence were noted.CONCLUSION: Conjunctival peritomy combined with amniotic membrane transplantation is an effective and safe method for the treatment of earlier Mooren's ulcer.
10.Association between vascular endothelial growth factor + 936C/T gene polymorphism and age-related macular degeneration
Yan-ming, JIANG ; Ge, LIANG ; Lin, WEI ; Chun-mei, CAI
Chinese Journal of Experimental Ophthalmology 2013;31(9):859-862
Background Vascular endothelial growth factor(VEGF) has been shown to be associated with the pathogenesis of age-related macular degeneration (AMD),therefore VEGF is a target for the treatment of wet AMD.However,the mechanism of VEGF in the pathogenesis of AMD is not clearly understood.Studying the correlation between VEGF gene polymorphism and AMD is becoming a new research hotspot,but relevant studies on Han Chinese have not been performed.Objective This study was to investigate the association between the VEGF +936C/T gene polymorphism and AMD in the Chinese population.Methods A pilot prospective and nonrandomized controlled trial was designed.This protocol complied with Declaration of Helsinki and was approved by the Ethic Committee of Chinese PLA Second Artillery General Hospital.Written informed consent was obtained from each subject prior to entering the study.Two hundred AMD patients and 200 age-and gender-matched normal controls were enrolled in this study.The genomic DNA was extracted from the peripheral blood samples of the subjects,and analysis of the VEGF polymorphisms at the +936 position in the promoter and 3'-untranslated regions was performed by the restriction fragment length polymorphism method.Frequencies of the VEGF+936C/T genotype were compared between the two groups,and the risk of the VEGF+936C/T gene polymorphism in pre-disposing AMD was evaluated.Results No significant differences were seen in the incidence rates of smoking(P = 0.76),hypertension(P = 0.84),hyperlipidemia (P=0.71),diabetes mellitus (P=0.86) and cardiovascular disease(P=0.89) between the AMD group and the normal control group,and BMI was matched between the two groups (P =0.18).The prevalence of the TT genotype was 9.0% (18/200)in the AMD group,but that in the normal control was 3.5% (7/200),showing a significant difference between the two groups (P =0.03).The odds ratio (OR) was 2.73 with a 95% confidence interval(CI) of 1.11 to 6.68 for AMD in this genotype.The CC and CT genotypes were not significantly different between the two groups (P =0.52,P =0.57).The genotype frequency and allele frequency conformed to HardyWeinberg equilibrium law.There were no significant differences found in the CC,CT,TT genotype frequencies among the early AMD,geographic atrophy AMD and choroidal neovascular AMD (all at P>0.05).Conclusions The VEGF+936TT genotype is associated with AMD in Han Chinese population.