1.A multicenter,randomized,double-blinded and placebo-controlled study of acute brain infarction treated by human urinary kallidinogenase
De-Yun DING ; Chuan-Zhen LU ; Mei-Ping DING ; Bing-Hua SU ; Feng CHEN ;
Chinese Journal of Neurology 2000;0(05):-
Objective To evaluate the efficacy and safety of a new drug,human urinary kallidinogenase,against acute brain infarction.Method A 15-center,randomized,double-blinded and 3:1 placebo-controlled study was carried out.Acute brain infarction within 48 hours of onset in the territory of the middle cerebral artery were indicated as subjects;kallidinogenase or placebo which was dissolved in 50 ml saline,was slowly injected intraveousely within 30 minutes daily for 3 weeks.The European Stroke Scale and Barthel Index were used to evaluate the neurological deficit and the activities of daily living(ADL),followed by a follow-up at the end of the third month.Results 446 patients were enrolled,who completed ITT analysis,including 330 in kallidinogenase group and 116 in placebo group,meanwhile 421 proceeded with PP analysis(311 and 110 respectively).There were no significant differences of the baseline data between the 2 groups.At the end of treatment,the ESS scores increased by 55.1%?33.0% and 44.7%?32.8% respectively in kallidinogenase group(KG)and placebo group(PG,P=0.0022),the difference being significant.PP analysis had similar results.As for ADL,follow-up 90 days after the treatment showed 374 cases followed,280 in KG and 94 in PG;1 died in PG,while none in KG.In KG,the cases whose BI≥50 were significantly more than those in PG(P=0.0228).Adverse events possibly or definitely attributable to the drug were observed in 27 cases(7.74%),mostly were mild,such as palpitation,flush,dizziness, nausea etc,without special management needed.Only 2 died which was confirmed not correlated to kallidinogenase,and another 2 cases of sudden blood pressure drop were observed.The blood pressure drop, quickly restoring soon after the withdrawal of kallidinogenase and use of hemopiesic drugs,was considered to be caused by the combination use of anti-hypertensive drug ACEI and quick infusion speed.Conclusion Kallidinogenase is efficacious for acute brain infarction in improving the neurological deficits,which is safe in clinical use.
3.Distribution and vicissitude of drug resistance of Acinetobacter baumannii in burn intensive care unit of Wuhan City Hospital No.3 in three years.
Hong WU ; Han-mei DING ; Li LI ; Chao-li ZHAO ; De-yun WANG ; Wei-guo XIE
Chinese Journal of Burns 2010;26(4):296-299
OBJECTIVETo study the clinical distribution characteristics and vicissitude of antibiotic resistance of Acinetobacter baumannii (AB), and to look for the risk factors of AB infection in order to provide reasonable reference for the prevention and treatment of its infection.
METHODSSpecimens of blood, venous catheters, sputum, wound exudates and pharyngeal swabs from 156 patients hospitalized in our burn ICU from January 2006 to December 2008 were collected and cultured. The clinical distribution and antibiotic resistance of AB were determined and analyzed. The risk factors related to AB infection were analyzed. Drug resistance rate data were processed with WHONET 5.3 software; the other data were processed with chi-square test and Logistic regression analysis.
RESULTSNinety-two strains of AB were identified during the three years from different kinds of specimens, with 41 (44.6%) from wound exudates, 14 (15.2%) from pharyngeal swabs and sputum respectively, 13 (14.1%) from blood, and 10 (10.9%) from venous catheters. AB accounted for 23.1% (30/130), 27.5% (25/91), 28.2% (37/131) respectively among the strains detected in 2006, 2007, and 2008. During the three years, except for imipenem and cefoperazone/sulbactam, the average resistance rates of AB to other ten commonly used antibiotics were all above 50.0%. Burn area (χ(2) = 24.374, P = 0.000), mechanical ventilation (χ(2) = 8.968, P = 0.003), duration of use of antibiotics (χ(2) = 3.981, P = 0.046), and deep venous catheterization (χ(2) = 9.170, P = 0.002) were the risk factors of AB infection, and the former two were independent risk factors.
CONCLUSIONSThere is a pan-drug resistance tendency of AB in our burn ICU, and the positive culture rates are increasing in recent years. Disinfection and isolation measures, appropriate use of antibiotics, avoidance of invasive performances such as deep venous catheterization and tracheostomy, or shortening their duration are important means to prevent and control infection of AB.
Acinetobacter Infections ; epidemiology ; Acinetobacter baumannii ; drug effects ; isolation & purification ; Adult ; Burns ; epidemiology ; microbiology ; China ; epidemiology ; Cross Infection ; microbiology ; Drug Resistance, Bacterial ; Female ; Humans ; Intensive Care Units ; statistics & numerical data ; Male ; Young Adult
4.Clinical observation of sensorineural hearing loss in patients suffering from nasopharyngeal carcinoma after radiotherapy.
Yun-kai GUO ; Xin-ming YANG ; Ding-hua XIE ; Qing-lai TANG ; Yong-de LU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2005;40(11):805-809
OBJECTIVETo study the extent and incidence of sensorineural hearing loss (SNHL) after radiotherapy (RT).
METHODSTwenty-eight patients with diagnosed nasopharyngeal carcinoma (NPC) were selected. The pure-tone audiography, auditory brain stem evoked response (ABR), impedance audiometry and evoked otoacoustic emissions (EOAE) recordings were performed before RT, 1 month, 1, 2 and 5 years after RT.
RESULTSAt 1 month after RT, there were 7.1 and 25.7 dB increased mean bone conduction (BC) thresholds at speech (0.5 - 4.0 kHz) and at high frequency (8.0 kHz), and their BC thresholds were statistically significant increase than those before RT, respectively (P < 0.001). At 1 year after RT, there were 17.6 and 28.1 dB increased respectively, and their thresholds were statistically significant increase than those at pre-irradiation (P < 0.001). There were also significant increases in thresholds than those at 1 month of post-irradiation (P <0.001 or P < 0.05). At 2 years after RT, 21 and 27.4 dB were increased at respective those two frequencies, and there was a statistically difference only at speech frequencies when compared with those at 1 year after RT (P < 0.05). At 5 years after RT, 26.7 and 35.8 dB were increased at these two frequencies, and there were significant increases in threshold than those before, 1 month, 1 and 2 years after RT, respectively (P < 0.001). From 1 month to 5 years after RT, 37. 5% to 94. 7% of ears had a BC hearing threshold of at least 15 dB losses at speech frequency, whereas the percentage at high frequency was 85.4 to 97.4%. Up to 63.2% and 73.7% of ears had 30 dB SNHL at least at speech and high frequency, respectively. Furthermore, the degree of mean threshold loss was greater at high frequency than at speech frequency. The mean value of wave I, III and V latency, and I -V interpeak latency intervals of ABR had no significant difference between at 1 month after RT and before RT (P > 0.05). The wave I , III and V latency, and I - V interpeak latency intervals at 1 year and 2 years were significantly prolonged when compared with those before and 1 month after RT (P < 0.05), but there were no significant difference between 1 year and 2 years after RT (P > 0.05). The wave I, III and V latency, and I -V interpeak latency intervals at 5 years after RT were also significantly longer than those before RT (P < 0.001). There were significant difference in wave I , III and V latency (P < 0.05), and no significant difference in wave I - V interpeak latency intervals (P > 0. 05) between 5 years after RT and 1 year or 2 years after RT. Seven of 10 ears at 1 year after RT and 4 of 7 ears at 5 years after RT had normal EOAE, but they all had abnormal ABR response.
CONCLUSIONSSNHL in NPC patients start soon after completion of RT, especially more commonly in high frequency. The incidence and the extent of hearing loss are increased with time of follow-up. The hearing impairment could occur in the cochlea and/or the retrocochlear auditory pathway, which show that the sensitivity of radiation damage may be different in different patient and anatomic site of auditory system.
Adult ; Audiometry ; Evoked Potentials, Auditory, Brain Stem ; Female ; Hearing Loss, Sensorineural ; etiology ; Humans ; Male ; Middle Aged ; Nasopharyngeal Neoplasms ; radiotherapy ; Otoacoustic Emissions, Spontaneous ; Radiotherapy ; adverse effects
5.Viral etiology of 1165 hospitalized children with acute lower respiratory tract infection.
Ni-Guang XIAO ; Bing ZHANG ; Zhao-Jun DUAN ; Zhi-Ping XIE ; Qiong-Hua ZHOU ; Li-Li ZHONG ; Han-Chun GAO ; Xiao-Fang DING ; Sai-Zhen ZENG ; Han HUANG ; Yun-De HOU
Chinese Journal of Contemporary Pediatrics 2012;14(1):28-32
OBJECTIVETo explore the viral etiology of acute low respiratory tract infection (ALRTI) among hospitalized children in Changsha of Hunan Province of China.
METHODSNasopharyngeal aspirates were collected from 1165 hospitalized children with ALRTI in Changsha from September 2007 to August 2008. Respiratory syncytin virus (RSV), human rhinovirus (HRV), influenza virus A (IFVA), influenza virus B (IFVB), parainfluenza 1-3 (PIV 1-3), human metapneumovirus (hMPV), human coronaviruses NL63 (HCoV-NL63), and human coronaviruses HKU1 (HCoV-HKU1) were detected by reverse transcription polymerase chain reaction (RT-PCR). Adenovirus (ADV) and human bocavirus (HBoV) were detected by standard polymerase chain reaction (PCR). WU polyomaviruses (WUPyV) and KI polyomaviruses(KIPyV) were detected by nested PCR. The positive samples further underwent genetic sequencing.
RESULTSAmong the 1165 nasopharyngeal aspirates, viruses were detected in 871 samples (74.76%), among which RSV (27.03%) was the most common virus, followed by HRV (17.33%), PIV3 (13.73%), HBoV (8.67%) and hMPV (6.52%). The overall positive rate of viral detection showed no significant differences between males and females (X2=2.241, P=0.134), whereas the positive rates of PIV3, hMPV, and HBoV in males were higher than in females. The positive rate of viral detection showed significant differences among different age groups (X2=10.934, P=0.027), and the highest positive rate was noted in the age group of 6 months to 1 year. Furthermore, the overall positive rate of viral detection showed a significant difference in term of seasonal distribution, with a peak prevalence in winter.
CONCLUSIONSVirues predominate in the etiology of pediatric ALRTI in Changsha, and RSV, HRV and PIV3 are the main viruses for ALRTI. HBoV and hMPV have become increasingly important. Viral infection-associated ALRTI shows a prevail in the age group of 6 months to 1 year as well as in winter.
Adolescent ; Age Distribution ; Child ; Child, Hospitalized ; Child, Preschool ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Nasopharynx ; virology ; Respiratory Tract Infections ; etiology ; virology ; Seasons ; Sex Distribution ; Viruses ; isolation & purification
6.Detection and clinical study on coronavirus HKU1 with acute lower respiratory tract infections of hospitalized children in Changsha.
Ni-guang XIAO ; Zhi-ping XIE ; Qiong-hua ZHOU ; Rong-fang ZHANG ; Li-li ZHONG ; Han-chun GAO ; Xiao-fang DING ; Jia LI ; Jing-rong SONG ; Yun-de HOU ; Bing ZHANG ; Zhao-jun DUAN
Chinese Journal of Experimental and Clinical Virology 2011;25(1):2-4
OBJECTIVEIn order to understand the epidemiological and virologic characteristics of coronavirus HKU1 infection in hospitalized children with acute respiratory tract infection (ARTI) in Changsha.
METHODS1165 nasopharyngeal aspirates (NPA) specimens were collected from hospitalized children with ARTI between September 2007 and August 2008 in Changsha. Specimens were screened for pol gene of coronavirus HKU1 by polymerase chain reaction. All positive amplification products were confirmed by sequencing and compared with those in GenBank.
RESULTSCoronavirus HKU1 were detected in 12 patients (1.03%) out of the 1165 children. The patients were from 8 days to 3 years. The most common clinical diagnosis was bronchopneumonia(83.33%). Similarity of coronavirus HKU1 with those published in the GenBank at nucleotide levels was 98.18% - 100%.
CONCLUSIONCoronavirus HKU1 may be important pathogens in children with acute lower respiratory tract infection. Coronavirus HKU1 infections are common in children under 3 years old. There is no significant difference in the infectious rate between the boys and the girls. The peak of its prevalence is in spring and winter. A single genetic lineage of Coronavirus HKU1 was revealed in human subjects in Changsha.
Acute Disease ; Child, Hospitalized ; Child, Preschool ; China ; Coronavirus ; classification ; genetics ; isolation & purification ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Phylogeny ; Polymerase Chain Reaction ; Respiratory Tract Infections ; virology
7.Analysis of therapeutic effects of cannulated compression screws for the treatment of femoral neck fractures.
Hua-Ding LU ; Yun-Xu DONG ; Xiao-Yue WEN ; Kun WANG ; De-Hai SHI
China Journal of Orthopaedics and Traumatology 2011;24(4):315-318
OBJECTIVETo evaluate the therapeutic effects of cannulated compression screws for the treatment of femoral neck fractures, and to investigate the related factors influencing the avascular necrosis of femoral head after surgery.
METHODSA retrospective review was done for 96 patients with femoral neck fractures treated with cannulated compression screws from January 2003 to June 2009. Among them, there were 44 males and 52 females with 21 to 88 years old (averaged 56.3 years old). According to Garden classification, 4 patients were type I, 34 patients were type II, 37 patients were type III and 21 patients were type IV. Factors such as patients' age, gender, fracture type, duration from injury to surgery and fracture reduction quality were statistically analysed to find correlations with nonunion and avascular necrosis of femoral head.
RESULTSEighty-four patients were followed up ranging from 9 to 60 months and the mean time was 25.4 months. Postoperative complications included deep venous thrombosis of lower extremity in 2 cases, bone nonunion in 8 cases and avascular necrosis of femoral head in 11 cases. According to Harris criterion, the total postoperative Harris score was 86.20 +/- 11.00, and 40 patients got an excellent result, 32 good, 7 fair and 5 poor. The incidence of avascular necrosis of femoral head in nondisplaced fracture group and displaced fractures group were 3.22% and 18.87% respectively;and there were significant difference between the two groups (P = 0.037). The incidence of avascular necrosis of femoral head in anatomical reduction group and non-anatomical reduction group were 5.00% and 20.45% respectively; also,significant difference was existed between the two groups (P = 0.036). However, there was no statistically significant difference of the incidence of avascular necrosis of femoral head according to different age, sex, operative time.
CONCLUSIONThe therapeutic effect of cannulated compression screws for non-displaced femoral neck fractures is good. The fracture type and reduction quality are found to be main factors correlated with avascular necrosis of femoral head statistically. For young patients with a displaced femoral neck fracture,in order to avoid incidence of avascular necrosis of femoral head, anatomical reduction should be ensured. For elder patients with a severe displaced femoral neck fracture, the total hip replacement should be recommended.
Adult ; Aged ; Aged, 80 and over ; Bone Screws ; Female ; Femoral Neck Fractures ; surgery ; Fracture Fixation, Internal ; methods ; Humans ; Male ; Middle Aged ; Osteonecrosis ; etiology ; Postoperative Complications ; etiology ; Retrospective Studies
8.A field trial for evaluating the safety of recombinant human interferon alpha-2b for nasal spray.
Qing CHEN ; Li-lan ZHANG ; De-xian YU ; Zhi-ai YU ; Yi LIU ; Li-ping ZHANG ; Zhi-feng LI ; Zhao-jun DUAN ; Bin-hui WANG ; Xue-jun WEI ; Gui-fang HU ; Yu-qing LIU ; Xin-wei CHU ; Yan-hong HAN ; Min WU ; Xiao-ling JIANG ; Jian-dong LI ; Ying-chun DAI ; Jun NIE ; Jun LONG ; Li ZHU ; Su-xia SUN ; Yong-yu RUI ; Ding-kang ZHANG ; Shou-yi YU ; Yun-de HOU
Chinese Journal of Experimental and Clinical Virology 2005;19(3):211-215
OBJECTIVETo evaluate the safety of recombinant human interferon alpha-2b for nasal spray for the prevention of SARS and other upper respiratory viral infections.
METHODSField epidemiologic evaluation was conducted, the design was randomized and had a synchronously parallel control group. In the study, the drugs were given for five days and all subjects were followed up for ten days.
RESULTSDuring the period of using interferon, body temperature of the experimental group was normal compared to the control group. Experimental group had more influenza-like symptoms than the control group (P < 0.05), such as headache (4.83%-7.09%), dizziness (7.17%-11.63%), lassitude (8.55%-15.06%), muscular soreness (4.43%-7.09%), pharynx dryness (12.10%-17.85%), angina (6.25%-8.72%), abdominal pain (2.30%-5.50%) and diarrhea (2.45%-5.66%). Most of side effects reached their peak with in the first 3 days. Except for pharynx dryness, the incidences of all other side effects declined after completion of the use of the trial drug, and incidences of some symptoms in experimental group were lower than those of the control group. There were no significant differences in the symptoms of cough and expectoration between the experimental group and the control group. The incidence of exanthem in the control group was significantly higher than that in the experimental group. The side effect of bloody nasal mucus was not observed in experimental group, which had been reported by other authors in several volunteer studies.
CONCLUSIONUsing recombinant human interferon alpha-2b for nasal spray could lead to some influenza-like symptoms, however, all those symptoms were mild , reversible, and relieved after completion of the use of the trial drug. No serious side effects were found during the period of following up. The authors conclude that the drug is safe.
Abdominal Pain ; chemically induced ; Adolescent ; Adult ; Antiviral Agents ; administration & dosage ; adverse effects ; therapeutic use ; Dizziness ; chemically induced ; Female ; Follow-Up Studies ; Headache ; chemically induced ; Humans ; Interferon-alpha ; administration & dosage ; adverse effects ; therapeutic use ; Male ; Recombinant Proteins ; SARS Virus ; drug effects ; Severe Acute Respiratory Syndrome ; prevention & control ; virology ; Treatment Outcome ; Young Adult
9.Phenylhexyl isothiocyanate reducing U266 cell line methylation level of p16 gene.
Bao-An CHEN ; Bei-Ming SHOU ; Dong-Rui ZHOU ; Jia-Hua DING ; Chong GAO ; Yun-Yu SUN ; Jun WANG ; Jian CHEN ; Gang ZHAO ; Hui-Hui SONG ; Wen BAO ; De-Long LIU ; Xu-Dong MA ; Zu-Hong LU
Journal of Experimental Hematology 2008;16(5):1060-1063
This study was purposed to investigate whether phenylhexyl isothiocyanate (PHI) can reduce p16 gene methylation level or not. The myeloma U226 cell line was cultured with PHI of 0, 5, 10 micromol/L for 72 hours, then DNA was extracted. Hydrosulfite was used to treat the genome DNA of healthy adult, PCR amplification was carried out by using this DNA as template. The gene chip detecting methylation changes of 3 CpG in promoter region of p16 gene was constructed by designing a pair of probes which contain one methylated and one unmethylated probes. This pair of probes was used to detect 3 consecutive sites of CpG island in p16 gene. The standard curve was constructed by using gene chip after the methylated and unmethylated DNA were mixed at different ratio. Then treated samples of U266 cells were dotted on gene chip, obtained results were compared with standard curve to get the quantitative results. The results indicated that the probes on chip had excellent reproducible ability and precision, the methylation level of p16 gene in U266 cells treated with 0, 5 and 10 micromol/L of PHI was determined as 78.2%, 61.7% and 54.8%, respectively. It is concluded that the PHI can reduce the methylation level of p16 gene in U266 cells.
Cell Line, Tumor
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CpG Islands
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DNA Methylation
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Down-Regulation
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Genes, p16
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Humans
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Isothiocyanates
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pharmacology
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Oligonucleotide Array Sequence Analysis
10.Efficacy and safety of adjuvant post-surgical therapy with imatinib in gastrointestinal stromal tumor patients with high risk of recurrence: interim analysis from a multicenter prospective clinical trial.
Wen-hua ZHAN ; Peng-zhi WANG ; Yong-fu SHAO ; Xiao-ting WU ; Jin GU ; Rong LI ; De-sen WAN ; Ke-feng DING ; Ying-qiang SHI ; Ji-ren YU ; Hui-shan LU ; Xiao-ming ZOU ; Jian-wei BI ; Yi-hong SUN ; Yun-fei LU ; Dao-da CHEN ; Xin-hua ZHANG
Chinese Journal of Gastrointestinal Surgery 2006;9(5):383-387
OBJECTIVETo evaluate the efficacy and safety of postoperative adjuvant chemotherapy with imatinib in gastrointestinal stromal tumor(GIST) patients who had high risk of recurrence.
METHODSA prospective, open-label, multi-center trial conducted in sixteen teaching hospitals in China was carried out. The criteria of the enrolled patients included age more than 18 years old, CD117 positive GIST, tumor size more than 5 cm, pathological mitosis counts more than 5/50 HPF, and treatment beginning within 4 weeks after complete resection and with imatinib (400 mg, once a day) for at least 12 months. The 1, 3 year recurrence rates, disease free survival, overall survival rate and quality of life were evaluated.
RESULTSFrom Aug. 16th 2004 to Sep. 13th 2005, there were totally 74 patients screened and 57 patients (34 men, 23 women) enrolled in the imatinib treatment group. The primary tumors were located in the stomach in 50.9%, the small intestine in 38.6% and the colorectum in 10.5% of the cases. All the patients received radical resection. Until the cut-off date of interim analysis, there was no evidence of tumor relapse or metastasis in all patients and no death was reported either. Among the 57 enrolled patients with intention to treat(ITT), twelve patients finished the protocol (per protocol, PP). The disease free survival was (268.3 +/-120.2) d in ITT analysis, and (396.7+/-38.2) d in the PP analysis. The incidence of adverse effect was 44.4% . The score in quality of life showed no statistically significant difference between the baseline visit and the follow-up visits.
CONCLUSIONImatinib is a promising postoperative adjuvant chemotherapy in GISTs patients with high risk of recurrence, and the adverse effects are receivable.
Adult ; Aged ; Aged, 80 and over ; Benzamides ; Chemotherapy, Adjuvant ; Female ; Gastrointestinal Stromal Tumors ; drug therapy ; Humans ; Imatinib Mesylate ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Piperazines ; therapeutic use ; Postoperative Period ; Prospective Studies ; Pyrimidines ; therapeutic use ; Young Adult