1.Building safety evidence body of shuxuetong injection.
Jun-Jie JIANG ; Xing LIAO ; Yan-Ming XIE
China Journal of Chinese Materia Medica 2014;39(18):3630-3632
Evidence body is defined as an evidence complex incorporating the evidence obtained from various research methods and various resources. As one of common parenterally administered Chinese medicines, Shuxuetong's safety drew high concern from doctors. However, we only have grasped several but less systematic evidence on the safety of Shuxuetong. To build a safety evidence body of Shuxuetong injection. Review and evaluate the evidence related to the safety of Shuxuetong injection after accumulating, searching and classfying related literature. Accoeding to levels of evidence from high to low, the evidence related to the safety of Shuxuetong injection was classified as following: the evidence from a long-term, prospective, large-sample-size and intensive hospital monitoring study was the strongest; the evidence of hospital information system (HIS) data analysis; the evidence of spontaneous reporting system (SRS) data analysis; the evidence of adverse drugreactions (ADRs)/adverse drug events (ADEs) reported in systematic evaluation, ADRs case report, toxicological tests, pharmacological tests were weakest. Based on the evidence body, Shuxuetong Injection was proved to be safe, and its ADRs were mainly allergic reactions, and more often happened among the old patients.
Adverse Drug Reaction Reporting Systems
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Drugs, Chinese Herbal
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administration & dosage
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adverse effects
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Female
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Humans
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Prospective Studies
2.Value of histogram analysis of susceptible signal intensity in differentiating papillary from chromophobe renal cell carcinoma
Jie CHEN ; Liang PAN ; Jun SUN ; Jinggang ZHANG ; Wei XING
Chinese Journal of Radiology 2017;51(9):669-672
Objective To evaluate the feasibility of histogram analysis of susceptible signal intensity in differentiating papillary (pRCC) from chromophobe renal cell carcinoma(ChRCC). Methods Thirteen cases with pRCC and 9 cases with ChRCC, who underwent susceptible-weighted imaging(SWI), MR common scanning and enhancement, were assessed retrospectively. The histogram parameters of susceptible signal intensity were measured, including maximum, minimum, mean, median, skewness and kurtosis. The independent samples t test(normal distribution) and Mann-Whitney rank sum test(skewed distribution) were used to compare the differences in SWI parameters between pRCCs and ChRCCs. Receiver operating characteristic curve was used to evaluate the efficiency of the whole-tumor SWI parameters in differentiating pRCCs from ChRCCs. Results The significant differences of the minimum, mean, median and skewness between pRCCs and ChRCCs were present(P<0.05), and there was no significant differences in maximum and kurtosis between between pRCCs and ChRCCs(P>0.05). In all the histogram parameters, the area of ROC curve of mean value was largest(0.80). The sensitivity of minimum value (84.62%) was the highest and and the specificity of skewness(100.00%) was the highest. Conclusion Histogram analysis of susceptible signal intensity can help differentiate pRCCs from ChRCCs.
3.Antibacterial, antitrichomonal, antipruritic and anti-inflammatory effects of Jiefujing Lotion
Jun KANG ; Jianfen XING ; Yanqing LU ; Jie SONG ;
Chinese Traditional Patent Medicine 1992;0(11):-
Objective: To observe the antibacterial, antitrichomonal, antipruritic and anti inflammatory effects of Jiefujing Lotion(Rhizoma Coptidis, cortex Phellodendri, Fructus cnidii Fruetus Kochiae, Radix Angelicae Sinensis, etc). Methods: The methods were applied antibacterial in vivo and in vitro , vaginal trichomoniasis resistant in vitro , itch threshold of guinea pigs caused by histamine, rats and mouse inflammation caused by albumen and dimethylbenzene. Results: Jiefujing Lotion had considerable inhibitory and disinfecting activities to bacteria and fungus related to edeitis. The lotion could also kill vaginal trichomonads, increase the itch threshold value and had anti inflammatory effect. Conclusion: Jiefujing Lotion had obvious antibacterial, antitrichomonal, antipruritic and anti inflammatory effects.
4.The feasibility of susceptibility weighted imaging for assessing renal difference of healthy volunteers after water loading
Jiule DING ; Wei XING ; Jie CHEN ; Shengnan YU ; Jianguo QIU ; Shijun XING ; Jun SUN
Chinese Journal of Radiology 2013;(5):436-439
Objective To probe the feasibility of susceptibility weighted imaging (SWI) for evaluation of renal blood oxygenation level of healthy volunteers after water loading.Methods SWI of 11 healthy volunteers,acquired before (group 1) and after water loading (group 2),were assessed retrospectively by two radiologists with more than 10 years abdominal work experience independently.In those images of the same section plane derived from two groups,the phase values in cortex ((φ)cor) and medulla ((φ)med),difference between the same vein and surrounding tissue on phase map (△(φ)) were measured using SPIN software package,and the oxygen extraction fraction changes (△OEF) was calculated.The (φ)cor,(φ)med and △(φ) between two groups were compared by paired t test.And the intraclass correlation coefficient (ICC)was used to evaluate the consistency between two radiologists.Results For the radiologist 1,the (φ)cor,(φ)med and △(φ) were (0.046 ±0.019),(-0.014 ±0.003) and (1.3 ±0.4) rad in group 1,and were (0.047 ±0.014),(-0.012 ±0.005) and (1.1 ±0.4) rad in group 2 respectively,and no significant change was found in (φ)cor and (φ)med after water loading (t =-0.589 and-0.206,P > 0.05 in all),except of in △(φ) (t =2.400,P < 0.01).For the radiologist 2,the (φ)cor,(φ)med and △△(φ) were (0.049 ± 0.011),(-0.012 ± 0.004)and (1.5 ±0.4) rad in Group 1,and were (0.046 ±0.017),(-0.011 ±0.003) and (1.3 ±0.2) rad in group 2 respectively,there was no significant change in (φ)cor and (φ)med after water loading (t =0.590 and -0.974,P > 0.05 in all),except of in △(φ) (t =2.760,P < 0.05).Between two radiologists,the ICC of (φ)cor,(φ)med and △(φ) were 0.623,0.472 and 0.328 in group 1 and 0.599,0.442 and 0.445 in group 2 respectively.△OEF decreased about (-4.2 ± 2.3) c% and (-4.3 ± 2.8) c% measured by two radiologists respectively,and the consistency is good between two radiologists (ICC =0.784).Conclusion SWI provides a novel method to assess indirectly the oxygenation level of kidney,△OEF is an indicator with suitable reliability.
5.Correlation between apparent diffusion coefficient value and pathological grading in pT1b clear cell renal cell carcinoma
Jun SUN ; Wei XING ; Jie CHEN ; Shijun XING ; Lijun ZHANG ; Yanwen ZHANG ; Tongbing CHEN ; Yunjie CAO
Chinese Journal of Radiology 2012;46(8):682-686
Objective To evaluate the correlation of ADC values on 3.0 T MR with the pathological grades in pT1b clear cell renal cell carcinoma(CCRCC).Methods Conventional MR images,ADC values and Fuhrman pathological grading of pT1b CCRCC were performed in 30 patients.Grade Ⅰ and Ⅱ were defined as low-grade group; grade Ⅲ and IV were defined as high-grade group.The differences of ADC values among four different pathologic grades were compared with a one-way analysis of variance. The comparison of ADC values of two different grade groups was performed with t test,and the ROC curve was performed to evaluate the diagnostic efficacy of ADC value. Correlation between pathological gradings and ADC values was assessed with Spearman rank correlation analysis. Results ( 1 ) The mean ADC value of grading Ⅰ ( 10 patients ), Ⅱ ( 8 patients ),Ⅲ ( 7 patients ),IV ( 5 patients ) was ( 0.94 ± 0.11 ) ×10-3 mm2/s,(0.82 ±0.13) × 10-3 mm2/s,(0.68 ±0.09) × 10-3 mm2/s,(0.59 ±0.03) × 10-3 mm2/s,respectively.Significant differences of ADC values among the four grades were present (F =16.422,P =0.000 ).( 2 ) The mean ADC value of the low-grade group was significantly higher than that of the high-grade group(t =5.738,P =0.000).Sensitivity and specificity of diagnosing the low-grade group was 88.9% and 83.3% respectively.There was a negative correlation between pathological grading and ADC value ( r =-0.807,P < 0.05). Conclusions The ADC values of pT1b CCRCC have close correlation with pathological gradings.They can be used to predict the degree of tumor malignancy preoperatively and guide surgical planning.
6.Imaging manifestations of mucinous tubular and spindle cell carcinoma of the kindey : a pilot study
Jun SUN ; Wei XING ; Jie CHEN ; Jiule DING ; Yunjie CAO ; Tongbing CHEN ; Shijun XING
Chinese Journal of Urology 2014;35(12):885-890
Objective To investigate the imaging characteristics of mucinous tubular and spindle cell carcinoma of the kindey (MTSCC-K).Methods Five cases of pathologically confirmed MTSCC-K were analyzed retrospectively.All patients underwent CT scanning,and 4 cases underwent conventional MR and diffusion weighted imaging (DWI) scanning.MR enhancement ratio for the tumor was calculated according to MR signal intensity of pre-and post-contrast in tumor and apparent diffusion coefficient (ADC) values of tumor and normal renal cortical.Results Two case located in the right kindey,and 3 cases located in the left kindey.The maximum diameter of lesions ranged from 3.2 cm to 7.1 cm.Five cases showed nearly round shape with clear borderline.Pseudocapsule was found in 4 cases,3 cases had necrosis and cystic,and 1 case had calcification.There were no hemorrhage,fat and invasion of adjacent tissue.Isodensity or hypodense tumors were found on plain CT.Isointense or hyperintense tumors were found on plain T1WI,while isointense or mixed-signal tumors were found on plain T2WI.Slightly homogeneous or heterogeneous enhancement was observed on dynamic enhanced CT or MR,and the solid component of tumors showed hyperintense on DWI and hypointense on ADC.The mean CT value of tumor at the plain,cortical and nephrographic phase was 32.6 HU,46.5 HU and 66.5 HU,respectively.The mean ADC value of tumor and normal renal cortical was 1.23 × 10-3 mm2/s and 2.31 × 10-3 mm2/s,respectively.The mean MR percentage of enhancement value of tumor was 32.7% and 104.9%,respectively.Conclusions The imaging characteristics of MTSCC-K include nearly round shape,pseudocapsule,clear borderline,necrosis,cystic and calcification.There is no invasion of adjacent tissue and seldom malignant appearances.Isodensity or hypodense can be observed on plain CT,isointense or hyperintense on plain T1WI,and a mild continuously enhancement on dynamic enhanced scanning.
7.Abnormal imaging manifestations of delayed graft function on susceptibility weighted imaging
Jun SUN ; Zhaoyu XING ; Shengnan YU ; Jie CHEN ; Tingting ZHA ; Min FAN ; Chao WU ; Wei XING
Chinese Journal of Radiology 2016;50(3):176-179
Objective To explore the value of abnormal imaging findings on susceptibility weighted imaging (SWI) in delayed graft function (DGF). Methods The conventional MRI and SWI images of 26 cases with DGF and 20 cases with normal renal function of transplanted kidneys were retrospectively analyzed. Patients with cysts and angiomyolipomas were excluded. Normal structures of transplanted kidney were identified. If lesions of abnormal signal intensity were found in the transplanted kidney, the location, border and signal intensity compared to renal cortex would be analyzed. The differences in signal intensity between the abnormal signal lesions and normal renal cortex in the same SWI layer of DGF were compared by using independent-sample t test. The differences in positive detection rate of discovering the abnormal signal lesions in DGF between conventional MRI and SWI were compared by using McNemar test. Results Of the 26 cases with DGF, one case was found to exhibit abnormally low signal lesions with fuzzy boundary located at junctional zone between cortex and medulla on both conventional MRI and SWI images. Ten cases were found to exhibit abnormally low signal lesions with fuzzy boundary located at junctional zone between cortex and medulla on SWI images only. Fifteen cases exhibited no abnormal signal lesions on both conventional MRI and SWI images. Twenty cases with normal renal function of transplanted kidney, no abnormal signal lesions were found on both conventional MRI and SWI images. The differences in signal intensity between the abnormally low signal lesions (130±20) and normal renal cortex (177±25) in the same SWI layer of 11 cases with DGF were statistically significant (t=-4.582,P<0.01). The differences in positive detection rate of discovering the abnormally low signal lesions in DGF between conventional MRI [3.8%(1/26)] and SWI [42.3% (11/26)] were statistically significant (χ2=8.100,P=0.002). Conclusions Abnormally low signal lesions with fuzzy boundary located at junctional zone between cortex and medulla on SWI images suggest the presence of DGF. Compared with conventional MRI, SWI appears to be superior in detecting the abnormally low signal lesions.
8.Shuxuetong injection-based on nested case-control study of blood through injection suspect allergic reaction influencing factors.
Jun-Jie JIANG ; Xing LIAO ; Yan-Ming XIE ; Hui ZHANG ; Hu YANG ; Yan ZHUANG
China Journal of Chinese Materia Medica 2014;39(18):3555-3558
OBJECTIVETo understand the real world Shuxuetong injection suspicious allergic factors.
METHODNational 18 hospitals of the hospital information system using Shuxuetong data, using design methods retrospective nested case-control, and contrast using Shuxuetong after the occurrence of allergic reactions in patients with non-allergic patients differences in age, gender, admission illness, allergies, etc.
RESULTBased on available data, indicate suspicious allergies affect Shuxuetong factors may be hospitalized illness, solvent, single dose, concomitant medications.
CONCLUSIONWhen using Shuxuetong for critically ill patients should use caution and pay attention to solvents, dose, combination therapy of choice clinically. Conclusions of this study need further study to be verified.
Case-Control Studies ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Hypersensitivity ; Injections ; Male ; Retrospective Studies
9.The effect of local mild hypothermia on the cerebral infarction volume,neurologic function and the serum concentration of neuron-specific enolase in rats
Xuzheng CAO ; Zhiqiang SU ; Jianmin XU ; Jie LAN ; Jichen XING ; Jun LIANG
Chinese Journal of Physical Medicine and Rehabilitation 2003;0(05):-
Objective To investigate the protective effect of local mild hypothermia on the ischemic cerebral tissues. Methods A model of middle cerebral artery occlusion was prepared in Wistar rats to compare the difference of the cerebral infarction volume and neurologic function and the serum concentration of neuron-specific enolase (NSE) between the local mild hypothermia group and the normal temperature group. Results It was found that the cerebral infarction volume was 84.90?11.36 and 128.95?13.42 mm 3 in the local mild hypothermia group and the normal temperature group, the neurologic function score 0.95?0.17 and 1.60?0.24, and the serum concentration of NSE 9.19?3.42 and 13.55?4.07ng/ml,respectively. The differences between the two groups were statistically significant. Conclusion The findings of this study suggest that the local mild hypothermia treatment exerted protective effect on the ischemic neurons.
10.18F-FDG PET/CT monitoring for early tumor response to cisplatin in VX2 tumor-bearing rabbits
Ling YUAN ; Ming ZHAO ; Hongyu ZHANG ; Rongrong TIAN ; Jun XING ; Jie CUI ; Hongxing JIN
Chinese Journal of Nuclear Medicine and Molecular Imaging 2015;35(3):212-216
Objective To evaluate the value of 18F-FDG PET/CT in early in vivo monitoring of tumor response to cisplatin,and analyze the relationship between 18F-FDG uptake in tumor and the corresponding pathological changes.Methods Thirty VX2 rabbits were divided into 5 groups by random number table with 6 in each group,including 4 treatment groups and 1 control group.18F-FDG PET/CT were performed before and after (6,12,24 and 36 h post-injection respectively) intravenous administration of cisplatin (7 mg/kg) in the treatment groups,respectively.The control group was injected with physiological saline followed by 18F-FDG PET/CT.The ROI was drawn and the SUVmax and T/NT ratio were calculated.The tumor necrosis rate and apoptosis index were observed by histopathologic examination.Paired t test,GamesHowell test and arcuation correlation analysis were used to analyze the data.Results Significant differences were found in SUVmax and T/NT of the control group before and after injection of physiological saline (6.58±1.67 vs 9.77±2.45,52.93±3.90 vs 29.34±3.31;t=-5.480,17.593,both P<0.05).18F-FDG uptake decreased after 6 h post-injection of cisplatin,with the mean SUVmax decrease rate of (11.83±8.89) % and the mean T/NT decrease rate of (59.00±8.22)%.In the 24 h treatment group,18F-FDG uptake decreased most,and the mean SUVmax decrease rate was (42.33±33.80)%,the mean T/NT decrease rate was (83.50± 7.69) %.The SUVmax and T/NT of those 2 groups were significantly different from those of the control group,and no difference was found between the 2 treatment groups(all P<0.05).The changes of SUVmax and T/NT were positively correlated with apoptosis index and tumor necrosis rate (r=0.750,0.794,0.804,0.874,all P<0.05).Conclusion 18F-FDG PET/CT is a sensitive method for monitoring early response to tumor chemotherapy in VX2 tumor-bearing rabbits at 24 h after treatment.