2.Clinical safety studies based on 30 026 post-marketing cases of Shenqi Fuzheng injection by intensive hospital monitoring nested NCCS.
Lian-xin WANG ; Yan-ming XIE ; Qing-hua AI ; Wen-fu XU
China Journal of Chinese Materia Medica 2015;40(24):4739-4745
This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction (ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1,000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety.
Case-Control Studies
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Drug Hypersensitivity
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etiology
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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.Clinical research on acupoint catgut implantation in the prevention and treatment of postpartum pain of uterine contraction with qi and blood deficiency.
Li-Ping LI ; Ai-Wen ZHUANG ; Ye-Hua BAO ; Jia-Mei CHU ; Xiao-Qing DOU
Chinese Acupuncture & Moxibustion 2014;34(1):34-36
OBJECTIVETo observe the impacts of the acupoint catgut implantation on postpartum pain of uterine contraction with qi and blood deficiency.
METHODSOne hundred and ten primiparas of natural delivery differentiated as qi and blood deficiency pattern in TCM were selected as the subjects. They were randomized into an acupoint catgut implantation group (55 cases) and a routine nursing group (55 cases). In the acupoint catgut implantation group, the catgut was implanted in Zigong (EX-CA 1), Zusanli (ST 36), Sanyinjiao (SP 6), Pishu (BL 20) and Geshu (BL 17) in 6 h after delivery; additionally, the routine post-delivery nursing was adopted. In the routine nursing group, the routine post-delivery nursing was applied simply. Visual analogue scale (VAS) and the pain relief time of uterine contraction were compared in 24 h, 48 h, 72 h and 96 h after acupoint catgut implantation between the two groups.
RESULTSVAS Scores in 24 h, 48 h, 72 h and 96 h after acupoint catgut implantation in the acupoint catgut implantation group were lower apparently than those in the routine nursing group (3.31 +/- 0.39 vs 4.31 +/- 0.29, 1.86 +/- 0.29 vs 2.66 +/- 0.25, 0.89 +/- 0.21 vs 1.59 +/- 0.24, 0.35 +/- 0.10 vs 0.69 +/- 0.13, all P < 0.05). The pain relief was achieved in (72.06 +/- 6.83) h in the acupoint catgut implantation group and was (123.42 +/- 11.12) h in the routine nursing group. The pain relief in the acupoint catgut implantation group was achieved more quickly (P < 0.01).
CONCLUSIONThe intervention of acupoint catgut implantation in 6 h after natural delivery in primiparas prevents effectively postpartum pain of uterine contraction.
Acupuncture Points ; Acupuncture Therapy ; Adolescent ; Adult ; Catgut ; utilization ; Female ; Humans ; Labor Pain ; therapy ; Pain ; prevention & control ; Postpartum Period ; physiology ; Pregnancy ; Qi ; Uterine Contraction ; Uterus ; physiopathology ; Young Adult
4.A clinical study on coadministration of Cyclosporin A and berberin hydrochloride in renal transplanted recipients
Ai-Rong YU ; Hua-Wen XIN ; Xiao-Chun WU ; Qing LI ;
Chinese Journal of Clinical Pharmacology and Therapeutics 2004;0(12):-
AIM:To study the effect of berberin hydrochloride(Ber)on the elevation of blood concentra- tion of Cyclosporin A(CsA)and liver and renal functions in renal transplanted recipients.METHODS:138 cases with renal transplantation in experimental group were treated with CsA and Ber and 150 cases with renal trans- plantation in control group received CsA only.Blood lev- els of CsA,biochemistry indexes for liver and renal func- tion were determined.RESULTS:After 1,3,6 months combined with Ber,blood concentrations of CsA in pa- tients went up by 49.8%,81.4%,36.9% and the radios of blood concentration of CsA to CsA dosage increased 88.8%,102.0%,72.5% compared with those before taking Ber(P
5.The prevention and treatment of heijingpaichitang for immune rejection following high-risk corneal transplantation in rats
Xiao-feng, XIE ; Qing-mei, TIAN ; Hong-sheng, BI ; Ying, WEN ; Shu, ZHANG ; Ai-lian, GUO
Chinese Journal of Experimental Ophthalmology 2012;(10):902-907
The rate of corneal graft rejection is still high for high-risk keratoplasty although immune suppression drug is routinely used.The role of traditional Chinese medicine in corneal transplantation is concerned gradually.Heijingpaichitang on the prevention and treatment of rats with high-risk corneal allograft rejection needs further study.Objective This study was to investigate the inhibitory effect of heijingpaichitang on high-risk corneal transplantation immune rejection in rats.Methods Sixteen female SD rats were used as the donors and 32female Wistar rats were served as recipients.The high-risk corneal trasplantation models were established by corneal suture in 32 Wistar rats,and then homogeneity variant SD-Wistar corneal transplantation was performed.The recipients were randomized into model control group,cyclosporinc A (CsA)group,heijingpaichitang group and CsA +heijingpaichitang group.CsA,heijingpaichitang and CsA + heijingpaichitang was orally administered 4 days after operation once per day for 15 days,and normal saline solution was used at the same way in the model control group.Ocular anterior segment reaction was examined under the slit lamp and corneal opacification,edema and neovasculation were scored based on Larkin' s criteria.Rejection index of the corneal graft was recorded and the graft survival time was calculated.The pathological examination of the corneal graft was carried out in all rats,and the inflammatory cells in the corneas and CD4+ cells in the periphery blood were assayed using flow cytometry.The use of the animals complied with ARVO Statement.Results Corneal graft rejection occurred in 10 days after operation in the model control group,12-13 days in the CsA group and heijingpaichitang group and 22 days in the CsA +heijingpaichitang group.Compared with model control group,the scores of the corneal opacification,corneal edema and neovascularization were significantly lower in the CsA group,heijingpaichitang group and CsA+heijingpaichitang group (P<0.05),and all the scores were declined in the CsA+ heijingpaichitang group compared with CsA group and heijingpaichitang group(P<0.01),but no significant differences were seen in the scores between the CsA group and heijingpaichitang group(P>0.05).The mean survival time of grafts was (10.38 ±1.69)days in the model control group,(22.50 ± 3.07) days in the CsA + heijingpaichitang group,with the significant difference (t =-9.790,P =0.000).The pathological examination of graft showed that the lymphocytes and new blood vessels were less in the CsA+heijingpaichitang group compared with CsA group and heijingpaichitang group 15 days after operation.Flow cytometry verified that the number of lymphocytes in graft,CD4+cells and CD4+/CD8+ in periphery blood were significantly lower in the heijingpaichitang group,CsA group and CsA+heijingpaichitang group compared with model control group (P<0.05).Conclusions Heijingpaichitang can inhibit immune rejection to certain extent in high-risk corneal transplantation rat and has a similar effect to 0.1% CsA.Heijingpaichitang and 0.1% CsA have a synergistic effect.
6.Genotyping 238 HBV strains using type-specific primer PCR combined with type-specific nucleotide analysis.
Ai-Zhong ZENG ; Ai-Long HUANG ; Jin-Jun GUO ; Xiao-Yan DENG ; Qing-Ling LI ; Wen-Xiang HUANG
Chinese Journal of Hepatology 2008;16(2):84-87
OBJECTIVETo establish a set of suitable and reliable methods for HBV genotyping and to study the distribution of HBV genotypes.
METHODSType-specific nucleotides were searched through alignment of S genes (more than 1000 sequences) listed in GenBank. Then, type-specific primers were designed and type-specific primer PCR was used to genotype the 238 HBV strains. S genes of the untyped strains were further amplified and sequenced to find out their genotypes with type-specific nucleotide analysis.
RESULTSAll the 238 HBV strains were genotyped. 159 (66.8%) cases were genotype B, 69 (28.9%) were genotype C, 6 (2.5%) were mixtures of genotypes B and C and 4 (1.6%) were mixtures of genotypes B and D. No genotypes of A, E, F, G, and H were found.
CONCLUSIONGenotypes B and C are the most common types for HBV strains. Mixtures of genotypes B and C or genotypes B and D coinfection rarely existed. There is no relationship between the gender of the patients and HBV genotypes (X2 = 0.794, P more than 0.05).
DNA Primers ; DNA, Viral ; blood ; genetics ; Female ; Genotype ; Hepatitis B virus ; genetics ; Hepatitis B, Chronic ; virology ; Humans ; Male ; Nucleotides ; genetics ; Polymerase Chain Reaction ; methods ; Sequence Analysis, DNA
7.A study on quality of life in patients with coronary artery bypass grafting surgery
Ai-Ping LI ; Yun-Qing MEI ; Wen-Lin MA ; Xu ZHANG ; Xisheng WANG ; Wengen GAO ; Dayi HU ;
Chinese Journal of Thoracic and Cardiovascular Surgery 2003;0(04):-
Objective To assess the perioperative change in Quality of Life(QoL)in patients who underwent CABG surgery. Methods The Chinese version of the SF-36 and SAQ were sent to participants at baseline and three and six months after CABG sur- gery.Results Angina stability score,one of the five SAQ domains,was lowest and postoperative SAQ domains scores were with sig- nificant improvement from baseline.Many of the dimensions of the SF-36 in postoperative patients were better than baseline.The SF- 36 was also used to evaluate in groups ONCAB and OPCAB,but no difference of the SF-36 subscale scores between the two groups was observed.Conclusion SAQ domains scores were significantly improved in three months and increased further in six months.Many of the dimensions of the SF-36 in postoperative patients were improved than baseline.No difference of the SF-36 subscale scores between the groups of ONCAB and OPCAB was observed postoperatively.
8.The effect of partial body-weight supported treadmill training on hemiplegia patients caused by with cerebral infarction
Cui-Huan PAN ; Ai-Hua LUO ; En XU ; Wen-Wei WANG ; Qing-Chun GAO ; Tong YE ; Yi HUANG ;
Chinese Journal of Physical Medicine and Rehabilitation 2003;0(10):-
Objective To investigate the effect of partial body-weight supported treadmill training ( PBW- STT) on function of lower limbs, walk function, ADL performance and quality of life of hemiplegic patient induced by cerebral infarction. Methods A total of 132 cerebral infarction patients were divided into a control group (n = 69) and a training group( n = 63) randomly. Both groups accepted routine rehabilitation therapy, and the training group accepted PBWSTT at the same time in addition. Both groups were evaluated with regard to their walking ability, func- tion of lower limbs, ADL performance and their quality of life by using Functional Ambulation Category (FAC) , Fugl-Meyer assessment (FMA) , Barthel index (BI) and SF-36 before and after rehabilitation treatment. Results The function of lower limb, walking ability, ADL performance and the quality of life of both groups were improved significantly after treatment, and those in the training group were improved to a significantly greater extent than those in the control group ( P
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.
10.Role of β-endorphin in conA-induced spleen cell proliferation in rats with traumatic hemorrhagic shock
Ai-Qing WEN ; Liang-Ming LIU ; De-Yao HU
Journal of Third Military Medical University 2001;23(4):404-406
Objective To investigate the role of β-endorphin (β-EP) in conA-induced spleen cell proliferation after traumatic hemorrhagic shock. Methods ①Wistar rats with traumatic hemorrhagic shock were used and killed 0, 1, 3, 6,12 and 24 h after traumatic hemorrhagic shock. Plasma specimens were collected and β-EP levels in plasma were detected. Rats with sham-operation served as the control. ②Spleen cells isolated from normal rats were cultured in shock plasma (group Ⅰ), inactivated shock plasma (group Ⅱ) and shock plasma+β-EP antiserum (group Ⅲ) respectively. Con A-induced spleen cell proliferation was observed. Results ①The plasma β-EP level was elevated significantly immediately after shock, and reached the peak 1 h later, then showed a deceasing tendency and restored to the level as before shock at 24 h. ②Shock plasma remarkedly suppressed spleen cell response to the mitogen conA (P<0.01) compared with control; ConA-induced spleen cell proliferative function in group Ⅱ was significantly increased than that in group Ⅰ (P<0.01), so did in group Ⅲ, which still lower than in control. Conclusion The significantly elevated β-EP in the plasma after hemorrhagic shock might play an important role in inhibiting the proliferation of spleen cells.