1.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
2.Discussion on reinforcing-reducing method by lifting and thrusting the needle and slow-rapid reinforcing-reducing method from the point of view of energy.
Xing ZHANG ; Xin-nian GUO ; Yan ZHANG
Chinese Acupuncture & Moxibustion 2006;26(7):525-526
OBJECTIVETo resolve the contradictory in expounding of reinforcing and reducing by lifting and thrustion the needle and slow-rapid reinforcing and reducing method.
METHODSIn a certain condition,the relationship between the external force (the joint force of both the pressing on the force pressing on the needle and the force arresting the needle's moving) and the speed of needle's moving is deduced by means of kinetic energy theorem, so, when the needle is heavily thrust or lifted, the speed of its moving will be increased.
CONCLUSIONIn the reinforcing and reducing method by lifting and thrusting the needle, "heavily"and "gently" of heavily thrustiing and gently lifting or gently thrusting and heavily lifting should be considered as differences of the amplitudes of lifting and thrusting the needle; "slow-rapid" of slow-rapid reinforcing and reducing method should be considered as difference of the speeds.
Acupuncture Therapy ; methods ; Humans
3.Comparison of contrast sensitivity after regional refraction multifocal intraocular lens implantation
Xin-Nian YAN ; Qiang FAN ; Xiao-Li PU
Journal of Regional Anatomy and Operative Surgery 2018;27(10):753-756
Objective To compare the sensitivity of regional refraction multifocal intraocular lens implantation with other methods. Methods A total of 78 patients with simple cataract treated by visual acuity in our hospital from February 2016 to June 2017 were selected as subjects.The patients were divided into SBL-3 group (26 cases),SN6AD1 group (26 cases) and ZMB00 group (26 cases) according to the different intraocular lens.The contrast sensitivity value of patients in 3 groups under clear light(85 cd/m2),dark light(3 cd/m2),clear and glare light(45 Lux),dark and glare light(28 Lux) with different spatial frequencies (3,6,12,18 c/d) by the United States CSV-1000E contrast sensitivity tester after surgery.Results In terms of sensitivity index as clear light,dark light,clear and glare light,and dark and glare,the SBL-3 group were better than those of ZMB00 group and SN6AD1 group,the difference was significant(P<0.05);there were no significant differences between ZMB00 group and SN6AD1 group of each index sensitivity(P>0.05).Conclusion The postoperative sensi-tivity of refractive multifocal intraocular lens implantation of SBL-3 is significantly better than the apodized diffractive multifocal intraocular lens implantation of SN6AD1 and alll optical diffractive multifocal intraocular lens implantation of ZMB00,which is worthy of widely use for simple cataract.
4.The expression of interferon-regulatory factor genes in patients with systemic lupus erythematosus
Jie QIAN ; Nan SHEN ; Gui-Mei GUO ; Nian-Hong WAN ; Yan LIN ; Xin-Fang HUANG ; Hui WU ; Shun-Le CHEN ;
Chinese Journal of Rheumatology 2003;0(09):-
Objective To observe whether the expression of interferon-regulatory factor genes are re- lated to systemic lupus erythematosus (SLE).Methods The clinical data of 45 SLE patients and 37 normal controls were collected.Total RNA of peripheral blood was extracted and transcripted into cDNA.Sybr green dye based real-time quantitative PCR method was used to compare the expression (indicated as-??Ct value) of IRFI,IRF4,IRF8 in patients with SLE and those in the controls.Results The levels of IRF1,IRF4 and IRF8 mRNA were-3.90?0.19,-8.04?0.25 and 3.60?0.15 respectively in normal controls.In SLE patients, IRF4 mRNA expression was -8.82?0.18,higher than that in normal (P=0.011).But IRF8 mRNA expression was 3.09?0.13,lower than that in normal (P=0.012).Conclusion Abnormal IRF mRNA expression is found in the peripheral blood of SLE patients.IRFs may play roles in the pathogenesis of SLE by affecting the differen- tiation of Th cells.
5.Effect of eating behavior intervention on infants in the urban area of Chongqing, China.
Jing WEN ; Nian-Rong WANG ; Yan ZHAO ; Xin FAN ; Ya YE
Chinese Journal of Contemporary Pediatrics 2013;15(5):361-363
OBJECTIVETo investigate how to establish good eating behavior and correct bad eating habits in infants by means of the child health care outpatient clinic and to promote the growth and development of infants.
METHODSInfants aged 0-3 months, who were randomly selected from the urban area of Chongqing, were divided into intervention and control groups. The infants in the intervention group received all intervention measures in the study, while those in the control group received conventional health care. Both groups were subjected to regular monitoring of eating behavior indices including time of introduction of foods, frequency of adding complementary foods and intake frequency of unhealthy foods to analyze the effect of intervention.
RESULTSIn the intervention group, foods were introduced at a reasonable time (P<0.01). Compared with those in the control group, the children aged 9 and 12 months in the intervention group had a significantly higher intake frequency of meat, vegetables and fruits (P<0.01) and a significantly lower intake frequency of sweet drinks (P<0.05), children aged 18 and 24 months in the intervention group had a significantly lower intake frequency of sweet drinks (P<0.01), and the children aged 24 months in the intervention group had a significantly lower intake frequency of ice cream (P<0.01).
CONCLUSIONSEating behavior intervention can promote the proper introduction of foods and regular addition of supplementary foods, as well as decrease the intake frequency of unhealthy foods such as sweet drinks and ice cream, thus improving the eating behavior of infants.
China ; Feeding Behavior ; Female ; Humans ; Infant ; Infant, Newborn ; Male
6.Observation of neural electrophysiology and morphology in traumatic optic neuropathy in cat model.
Yan JIANG ; Na LI ; Nian-kai ZHANG ; Pin DONG ; Lian-xin LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2007;42(7):520-525
OBJECTIVETo establish the animal model of traumatic optic neuropathy similar to clinical feature by injuring the optic nerve of the pipeline through the ethmoid and sphenoid sinus. The electrophysiology and morphology were observed.
METHODSThe optic nerve in 2 cats was anatomically observed. Thirty healthy adult cats were divided into 1 h, 1 d, 3 d, 1 w, 2 w, 4 w injury groups. The right eye was selected as the experiment eye, and the left as the control. The optic canals were damaged by the injury instrument. The changes of optic nerve were observed using light and electron microscope. The pattern reversal visual evoked potential (PR-VEP) was used to determine the succeed model and pupil was monitored. PR-VEP and neural tissue morphology were examined at intervals of 1 h, 1 d, 3 d, 1 w, 2 w, 4 w after trauma.
RESULTSEight cats had Marcus-Gunn's pupil, and 22 cats did not have after injury. Neural tissue was physaliphorous degeneration in light microscope. The neural fibers swelled gradually and fibers physaliphorous degeneration in the first day after damage. At the seventh day, the bubble enlarged to be a big flat. After two weeks, the big flat bubble came out to be a bigger bubble. Under the electronic microscope, axons were physaliphorous degeneration, crack emerged between axon membrane and myelin sheath and myelin sheath were loose in the first day. At the third day, axon swelled, physaliphorous degeneration rose and myelin sheath were loose obviously. At the seventh day, axon and myelin sheath appeared loop in half cycle and bubble-like broke up. A lot of pieces came out and axon became physaliphorous and uniform. Microtubule and microfilament disappeared. After two weeks, myelin sheath became onion-like. On fourth week, myelin sheaths enlarged and squeezed to center. Axoplasm disappeared and neural tissues collapsed.
CONCLUSIONSThis animal model was similar to clinical optic nerve decompression through ethmoid and sphenoid sinus. The change of PR-VEP and neuromorphology were distinct before and after trauma. The pathological changes of optic nerve catching vibrated injury are mainly degeneration, so earlier decompression of optic nerve may improve the visual function.
Animals ; Cats ; Disease Models, Animal ; Evoked Potentials, Visual ; Optic Nerve ; pathology ; physiopathology ; Optic Nerve Injuries ; pathology ; physiopathology
7.Application of humidified high-flow nasal cannula in neonates with meconium aspiration syndrome and pulmonary hypertension after extubation.
Xiao-Yan GAO ; Lin FENG ; Yu-Fen QIU ; Xin-Nian PAN
Chinese Journal of Contemporary Pediatrics 2017;19(4):393-397
OBJECTIVETo investigate the clinical value of humidified high-flow nasal cannula (HHFNC) as a respiratory support after extubation by comparing it with nasal continuous positive airway pressure (NCPAP) in neonates with meconium aspiration syndrome (MAS) and persistent pulmonary hypertension of the newborn (PPHN).
METHODSA total of 78 neonates with MAS and PPHN were randomly administered with HHFNC or NCPAP immediately after extubation. The following indices were compared between the two groups: blood gas parameters, duration of noninvasive ventilation, rate of extubation failure, and incidence of complications, such as nasal damage, abdominal distension, and intraventricular hemorrhage.
RESULTSThere were no significant differences in the rate of extubation failure, PaO, PCO, and PaO/FiOratio at one hour after NCPAP or HHFNC, duration of noninvasive ventilation, time to full enteral feeding, length of hospital stay, and incidence of intraventricular hemorrhage between the two groups (P>0.05). The HHFNC group had significantly lower incidence of nasal damage (5.0% vs 31.6%; P<0.05) and incidence of abdominal distension (7.5% vs 34.2%; P<0.05) than the NCPAP group.
CONCLUSIONSBoth NCPAP and HHFNC can be used as the sequential therapy for neonates with MSA and PPHN after extubation, and they both have a definite effect. As a new strategy of respiratory support, HHFNC is better tolerated, and has fewer side effects than NCPAP.
Airway Extubation ; adverse effects ; Continuous Positive Airway Pressure ; instrumentation ; methods ; Female ; Humans ; Hypertension, Pulmonary ; therapy ; Infant, Newborn ; Male ; Meconium Aspiration Syndrome ; therapy ; Noninvasive Ventilation ; instrumentation ; methods
8.Methodological Research on Latex Enhanced Immune Turbidimetric Method for the Detection of Urine Free Hemoglobin
Hai-Bo ZHU ; Ling YIN ; Xin WANG ; Nian-Dao YAN ; Jian-Ping DENG
Journal of Modern Laboratory Medicine 2018;33(1):67-71,76
Objective To establish the test way of latex enhanced immune turbidimetric method for the concentration detection of urine free hemoglobin on the automatic biochemical analyzer,and evaluated the detection performance.Methods Prepared the detection reagents of latex enhanced immune turbidimetry method for detection of urine free hemoglobin with materials such as hemoglobin HBA0 antibody (8.5 mg/ml),80 nm carboxylic olystyrene latex microspheres (estapor,nanometer microspheres) and so on.Then,seted the project parameters on TBA120 automatic biochemical analyzer and proceeded the calibrations.Evaluated the detection performance by accuracy,precision,linear range,sensitivity,specificity and other indicators.Lastly,established the biological reference interval for urine free hemoglobin of healthy people in the region and verified it.Results To seted the project parameters on TBA120 automatic biochemical analyzer and passed the calibration.The calibration fitting curve had a smooth trend and no obvious deviation with each measuring point.In the recovery tests,added standard liquid with different concentrations of 100 mg/L and 500 mg/L to the samples with low values,the recovery rate was 95.3% and 102.7% respectively.Same to the samples with high values,the recovery rate was 104.2% and 103.5% respectively.In the precision test,samples with low and high value had a precision CV of 6.52% and 4.18% respectively.The linear range was 0 ~ 1 100 mg/L,analysis sensitivity was 2.8 mg/L.In the interference test,found that,samples had no obvious disturbance to the test with lower concentrations of free bilirubin,combined with bilirubin,vitamin C,animal hemoglobin lower than 342 μmol/L,342 μmol/L,0.03 g/L,500 mg/L respectively,while had significant interference when the concentration of chyle was higher than 870 FTU.Their study had established the biological reference interval of healthy people,male was 0~ 13.3 mg/L and female 0 ~ 17.1 mg/L,there was no significant difference between them by a t test (P>0.05).Conclusion The latex enhanced immune turbidimetric method for the detection of urine free hemoglobin has the performance of testing clinical urine specimen,which not only solved the lackage problem of specificity for occult blood in the urine dry chemistry test and realized batch automation quantitative detection.The experimental data of this study provides a theoretical basis for the application of the method in other types of clinical samples.
9.Follow-up observation of catch-up growth of preterm infants after discharge and risk factors for extrauterine growth retardation.
Xiao-Yan GAO ; Lin FENG ; Jing XU ; Xin-Nian PAN
Chinese Journal of Contemporary Pediatrics 2018;20(6):438-443
OBJECTIVETo investigate the catch-up growth of preterm infants within a corrected age of 6 months and the risk factors for extrauterine growth retardation (EUGR).
METHODSA total of 321 preterm infants who were discharged after treatment in the neonatal intensive care unit and had regular follow-up documents with complete follow-up records were enrolled. According to the Prenatal Health Care Norms in 2015, these infants were divided into low-risk group with 69 infants and high-risk group with 252 infants. The Z-score method was used to evaluate body weight, body length, and head circumference, and the catch-up growth of the preterm infants within a corrected age of 6 months was analyzed. A multivariate logistic regression analysis was performed to identify the risk factors for EUGR at the corrected age of 6 months.
RESULTSThe percentage of preterm infants with Z scores of body weight, body length, and head circumference of < -2 (not reach the standard for catch-up growth) in both groups decreased gradually with increasing corrected age. At the corrected age of 6 months, the percentages of preterm infants whose body weight, body length, and head circumference did not reach the standard for catch-up growth in the low-risk group were reduced to 1.4% (1/69), 2.9% (2/69), and 1.4% (1/69) respectively, while in the high-risk group, these percentages were reduced to 1.2% (3/252), 1.6% (4/252), and 3.6% (9/252) respectively. The high-risk group had a significantly higher incidence rate of EUGR at the corrected age of 6 months than the low-risk group (28.2% vs 15.9%, P=0.039). The multivariate logistic regression analysis showed that multiple birth (OR=2.68, P=0.010), low birth weight (<1 000 g: OR=14.84, P<0.001; 1 000-1 499 g: OR=2.85, P=0.005), and intrauterine growth retardation (IUGR) (OR=11.41, P<0.001) were risk factors for EUGR at the corrected age of 6 months, while nutritional enhancement after birth (OR=0.25, P<0.001) reduced the risk of EUGR.
CONCLUSIONSMost preterm infants can achieve catch-up growth at the corrected age of 6 months. High-risk preterm infants have a high incidence rate of EUGR at the corrected age of 6 months. Multiple birth, low birth weight, and IUGR are risk factors for EUGR, while rational nutritional enhancement after birth can reduce the incidence rate of EUGR in preterm infants.
Adult ; Body Height ; Female ; Follow-Up Studies ; Humans ; Infant ; Infant, Newborn ; Infant, Newborn, Diseases ; physiopathology ; Infant, Premature ; growth & development ; Intensive Care Units, Neonatal ; Male ; Patient Discharge ; Pregnancy ; Risk Factors
10.Ahmed glaucoma valve implantation treatment of traumatic angle recession glaucoma
Qiang FAN ; Meng ZHANG ; Xin-Nian YAN
International Eye Science 2018;18(7):1298-1300
·AIM: To study the influence of Ahmed glaucoma valve implantation on eyesight, intraocular pressure and corneal endothelial cell density of patients with traumatic angle recession glaucoma. ·METHODS: Totally 33 cases (35 eyes) of patients with traumatic angle recession glaucoma admitted to our hospital since June 2014 to June 2016 were selected and treated with Ahmed glaucoma valve implantation. The clinical data of all patients were retrospectively analyzed, so as to evaluated to success rate of surgery. Non-contact tonometer was applied to surveying intraocular pressure before treatment and at 1wk, 1,3,6mo and 1a post treatment. Specular microscope was adopted to examine and calculate the corneal endothelial cell density before treatment and at 1wk, 1, 3, 6mo and 1a post treatment. All affected eyes were compared for visual acuity before surgery and in 1a after surgery, moreover, patients were followed - up, received the further consultations and the complications were recorded. ·RESULTS: As for 35 affected eyes, the absolute success rate of surgery was 54% , while the relative success rate was 40% , and the total successful rate and failure rate were 94% and 6% respectively. In terms of the number of people who had no light sensation before surgery, or who had light sensation, ≤0. 01, 0. 01-0. 10 or >0. 10-0. 20, there was no significant difference (Z=-0. 132, P=0. 362). The intraocular pressure before treatment was 43. 43 ± 3. 65mmHg, at 1wk after surgery was 13. 50 ± 2. 54mmHg, at 1mo was 15. 93 ± 2. 61mmHg, at 6mo was 16. 00 ± 2. 18mmHg and at 1a was 16. 45 ± 2. 21mmHg, and the difference among different time points had statistical significance (F= 887. 82, P<0. 01). After treatment the intraocular press decreased compared to before treatment (P<0. 05); those after treatment had no difference with each other ( P> 0. 05 ). Before treatment, the corneal endothelial cell density was 2443. 35 ± 343. 12 pieces/mm2, in 1wk after the surgery was 2231.67±334.45 pieces /mm2, in 1mo after the surgery was 2065. 47 ± 336. 45 pieces /mm2, in 3mo after surgery was 2031. 47 ± 345. 76 pieces/mm2, in 6mo was 2001. 72±337. 18 pieces /mm2and in 1a after the surgery was 1979. 65 ± 301. 32 pieces /mm2, and the difference among different time points had statistical significance ( F = 13. 49, P<0. 01 ). After treatment the corneal endothelial cell density decreased compared to before treatment (P<0. 05); those after treatment had no difference with each other (P>0. 05). After surgery, there were 4 cases (4 eyes) of ocular hypotension, 3 cases (3 eyes) of hyphema, 2 cases ( 2 eyes) of drainage tube plugging and 2 cases ( 2 eyes ) of intraocular hypertension, which were all quickly relieved after basic intervention treatment. · CONCLUSION: Treating traumatic angle recession glaucoma with Ahmed glaucoma valve implantation can dramatically optimize the state of intraocular hypertension and protect the retaining visual acuity, and visual acuity can be optimized in some cases. It causes little complication that can be relieved with basic prognosis, but postoperative corneal endothelial cell loss exists in some cases.