OBJECTIVE:To study the classification of deviation in drug production. METHODS:From the perspective of dom-inant and hidden deviation,combining with the theory of risk management,risk of deviation was evaluated with different risk man-agement tools to define the severity of the deviation,and it was handled by different methods. RESULTS & CONCLUSIONS:Ac-cording to the identifiability of deviation in actual management,the deviation was divided into dominance and hidden deviation. The dominant deviation can be divided into deep and shallow level. Whether the causes of deviation could be cleared and the conse-quences could be estimates were judged after the shallow level classification,and the deviation was further divided into simple and complex deviation. As for deviation complex,it could be evaluated with the tools of risk management to define the deviation severi-ty. As for hidden deviation,it needed beforehand preventing with the tools of risk management directly to define deviation levels and provide reference for preventive measures. In the process of deviation management,key point is to relay on the scientific meth-od to identify and classify deviation,and divide the influence levels. Combining the theory of risk management to select and use risk tools is the effective way to solve the problem.

Objective To discuss the effective measures for skin allergy caused by hyaline mem-brane after deep venous catheterization. Methods Patients (102 eases) were divided into the control group(50 cases) and the test group(52 cases).3M hyaline membrane was patched on the skin directly to fix the catheter after successful puncture in the control group.While in the test group 3M hyaline membrane was patched on the skin after 3M painless protective membrane was sprayed on the skin. Results The incidence of skin allergy in the test group was lower than that of the control group. Conclusions Spray of 3M painless protective membrane before usage of hyaline membrane to fix the catheter could prevent the incidence of skin allergy after deep venous catheterization.

Objective To investigate audiological characteristics of patients with intact tympanic membranes and conductive or mixed hearing loss .Methods A retrospective study was carried out among 30 patients (42 ears) with intact tympanic membranes and conductive or mixed hearing loss who underwent exploratory tympanotomy . The preoperative outcomes of pure tone audiometry ,tympanometry ,resonant frequency of middle ear and temporal bone CT scan were analyzed .Results Among 42 ears ,30 ears with otosclerosis and 12 ears with ossicular chain dis-ruption were confirmed in exploratory tympanotomy ,but only 5 ears showed positive findings in CT scan .The mean thresholds of bone conduction ,air conduction and air -bone gap at frequencies of 0 .5 ,1 and 2 kHz were 27 .5 ± 1 .3 dB HL ,67 .0 ± 1 .8 dB HL ,39 .5 ± 1 .1 dB HL ,respectively .An analysis of tympanometric data of all patients re-vealed that 50% of all ears (21/42) were type A tympanograms ,42 .9% (18/42) were type As tympanograms ,and 7 .1% (3/42) were type Ad tympanograms .The mean of the resonant frequency of the middle ear in otosclerositic patients (1 079 .0 ± 67 .4 Hz) was significantly higher than ossicular chain disruption patients (633 .3 ± 43 .6 Hz) . Conclusion Otosclerosis is the most common in the patients with intact tympanic membranes and conductive or mixed hearing loss .The middle ear resonant frequency of otosclerositic patients is significantly higher than that of ossicular chain disruption patients .

Objective To study the expression of p53,p16,PCNA protein in esophageal carcinoma and its relationship to sexual distinction,the location of disease,the biological level,the depth of invasion and lymph node metastasis.Methods 118 patients with esophageal carcinoma were included in the study,all of them were treated for the first time.p53,p16 and PCNA protein in the 118 cases of esophageal carcinoma were detected by immunohistochemical assay(SP technique). Results The positive expression of p53, p16, PCNA protein in 118 patients was 80 %(92/118),42%(50/118)and 97%(115/118),respectively.The positive expression of p53,PCNA protein were irrelated to the sexual distinction,the location of disease,the biological level,the depth of invasion and the lymph node metastasis.The loss of p16 was significantly related to the depth of invasion and the lymph node metastasis(P

OBJECTIVE: To analyze and summarize nystagmus of patients with posterior canal benign paroxysmal positional vertigo (BPPV) in positioning test,and to improve the diagnosis and treatment of posterior canal BPPV (PSC-BPPV). METHOD: The present study was conducted on 175 patients who had unilateral BPPV of the posterior semicircular canal (PSC). Their positional nystagmus recorded by videnonystagmography in Dix-Hallpike test,roll test and roll over test were analyzed to summarize the characteristics of nystagmus on nystagmograph of PSC-BP-PV. RESULT: Of the 175 patients, lesion was located in the left PSC in 69 (39.4%) patients,the right PSC in 106 (60. 6%)patients. The nystagmus of patients with PSC-canalithiasis showed upward on the vertical phase of nystagmograph and orientated the different side on horizontal phase in the head hangging position. The horizontal phase pointed to the contralateral side in 47(26. 9%) patients, the ipsilateral contralateral side in 100(57. 1%) patients,no significant reverse ingredients in 28(16.0%) patients. When these patients returned to sit,139(79.4%) patients showed down beating positioning nystagmus, whereas 36 (20. 6%) patients with no nystagmus only had a short vertigo or dizziness. The horizontal phase of the 139 patients pointed to the contralateral side in 40(22. 9%) patients,the ipsilateral contralateral side in 68(38. 9%) patients,no significant reverse ingredients in 31(17. 7%) patients. In roll test,12 patients of the right PSC-BPPV presented an up-beating rotatory nystagmus when the head turned to right,and 5 patients of the left PSC-BPPV presented a down-beating rotatory nystagmus when the head turned to left. When the patients changed body from the left lateral position to the right lateral position in the roll over test, 74(42. 3%) patientsshowed vertical positioning nystagmus. In 30 patients who presented an up-beating nystagmus, there were 25(83. 3%) patientscame from the right PSC-BPPV. In 44 patients who presented a down-beating nystagmus, there were 36(81. 8%) patientscame from the left PSC-BPPV. The direction of the vertical nystagmus was highly correlated with the judgment about the side of the PSC-BPPV in roll over test (P<0. 01). CONCLUSION The patient with PSC-canalithiasis showed an uncertain direction in torsional nystagmus in Dix-Hallpike test,the diagnosis was mainly concern with the vertical nystagmus. When we found a rotatory nystagmus with much more up-beating nystagmus in roll test, it might be PSC-BPPV. We also can use the roll over test to diagnose the location of the otolith in which side of the PSC-BPPV.
Benign Paroxysmal Positional Vertigo ; complications ; Dizziness ; Electronystagmography ; Face ; Head ; Humans ; Nystagmus, Physiologic ; Otolithic Membrane ; Patient Positioning ; Semicircular Canals ; Vertigo ; Vestibular Function Tests

OBJECTIVE: To explore the effect of masking therapy for the early stage of the patients with noise-induced tinnitus,and imply the treatment for patients with noise-induced tinnitus. METHOD: Sixty-eight cases with tinnitus were studied. All the patients took the audiological examinations and tinnitus tests firstly, and accepted the masking therapy for 6 months. The therapeutic effiency was evaluated according to tinnitus handicap inventory (THI) and subjective visual-analogue scale (VAS). The minimum masking intensity was also evaluated. RESULT: The majority of the patients with noise-induced tinnitus (59 cases, 86. 8%) had tinnitus frequency of 4 kHz,and most of them (44 cases, 64. 7%) had positive residual inhibition tests. Tinnitus completely disappeared in 3 cases after masking therapy, and the efficiency of this treatment is 83. 8%. There was significant difference in the scores of THI and VAS before and after therapy(P<0. 01), and there was also significant difference in the minimum masking intensity (P<0. 01). CONCLUSION Masking therapy is the most important treatment for the patients in the early stage of noise-induced tinnitus. The therapeutic effiency is significant and should be promoted.
Humans ; Noise ; adverse effects ; Tinnitus ; etiology ; therapy

The relationship between tyrosine phosphorylation (TP) and protein expression of insulin receptor (InsR) and insulin resistance (IR) in patients with gestational diabetes mellitus (GDM) was investigated. The InsR expression and TP in skeleton muscle tissue were determined by Western blotting and immunoprecipitation in women with GDM (GDM group, n=22), normal pregnant women (normal pregnancy group, n=22) and normal non-pregnant women (normal non-pregnant group, n=13). Fasting plasma glucose (FPG) and fasting insulin (FINS) were measured by oxidase assay and immunoradioassay. The results showed that the levels of FPG (5.61±0.78 mmol/L), FINS (15.42±5.13 mU/L) and Homeostasis model assessment-IR (HOMA-IR) (1.21±0.52) in GDM group were significantly higher than those in normal pregnancy group (4.43±0.46 mmol/L, 10.56±3.07 mU/L and 0.80±0.31 respectively) (P<0.01). The levels of FINS and HOMA-IR in normal pregnancy group were significantly higher than those in normal non-pregnant group (7.56±2.31 mU/L and 0.47±0.26 respectively) (P<0.01). There was no significant difference in the InsR expression level among the three groups (P>0.05). TP of InsR with insulin stimulation was significantly decreased in GDM group (0.20±0.05) as compared with normal pregnancy group (0.26±0.06) (P<0.01). TP of InsR with insulin stimulation in normal pregnancy group was lower than that in normal non-pregnant group (0.31±0.06) (P<0.01). TP of InsR with insulin stimulation was negatively related with HOMA-IR in GDM group (r=-0.525, P<0.01). There was no correlation between the protein expression of InsR and HOMA-IR in GDM group (r=-0.236, P>0.05). It was suggested that there is no significant correlation between the protein expression of InsR in skeletal muscle and IR in GDM, but changes in TP of InsR are associated with IR in GDM.

The study aimed to clone the open reading frame of cinnamate 4-hydroxylase (C4H) from Aquilaria sinensis and analyze the bioinformatics and expression of the gene. One unique sequence containing C4H domain was discovered in our previous reported wound transcriptome dataset of A. sinensis. The open reading frame of C4H was cloned by RT-PCR strategy with the template of mixed RNA extracted from A. sinensis stem which treated by different wound time. The bioinformatic analysis of this gene and its corresponding protein was performed. C4H expression profiles in responds to MeJA (methyl jasmonate) application were analyzed by real-time PCR. The length of C4H open reading frame (ORF) was 1 515 bp, encoding 514 amino acids. The GenBank accession number is KF134783. Inducible-experiments showed that the genes were induced by mechanical wound as well as MeJA induction, and reached the highest expression level at 8 h and 20 h, respectively. The full-length cDNA of C4H and its expression patterns will provide a foundation for further research on its function in the molecular mechanisms of aromatic compounds and flavonoids biosynthesis.
Amino Acid Sequence ; Cloning, Molecular ; Models, Molecular ; Molecular Sequence Data ; Open Reading Frames ; Oxidoreductases ; chemistry ; genetics ; metabolism ; Phylogeny ; Plant Proteins ; chemistry ; genetics ; metabolism ; Thymelaeaceae ; chemistry ; enzymology ; genetics ; Trans-Cinnamate 4-Monooxygenase ; chemistry ; genetics ; metabolism

Objective To explore the determinants of Alzheimer' s disease (AD) patients with depression.Methods The degree of depression on AD patients was assessed by the geriatric depression scale.Improved cumulative logistic regression (ICLR) was used to analyze the determinants of AD patients with depression.Results 196 AD patients were investigated.Among the 196 AD patients,there were 60(30.6％ ) males and 136(69.4％ ) females,at 58-89 years of age (72.3 ± 6.0).Physical activity,diabetes,MoCA,hearing,economic sources and alcohol were related to the degree of depression of AD patients (P＜0.10 ).The difference between “normal” and “mild depression” was smaller than difference between “mild depression” and “severe depression”.Conclusion AD patients with mild depression were the target population for prevention and they were influenced by several factors listed above.

OBJECTIVETo investigate serum level and gene polymorphisms of matrix metalloproteinase 9 (MMP-9), and platelet glycoprotein VI (GPVI) in patients with acute coronary syndrome (ACS).

METHODSIn a prospective study of 179 patients with documented ACS and 164 controls, we measured baseline serum MMP-9 levels using ELISA and determined the MMP-9/C-1562T and MMP-9/G5564A genotypes using PCR-restriction fragment length polymorphism. Fib serum level was measured by Clauss assay. We also analyzed the Fib/Bbeta-148C/T and GPVI/T13254C polymorphisms.

RESULTSSerum levels of MMP-9 and Fib in ACS patients were significantly higher than in controls (P < 0.001), and serum level of Fib in the acute myocardial infarction group was higher than in patients with unstable angina (P < 0.05). No significant difference between ACS patients and controls was found in frequencies of MMP-9/C-1562T, MMP-9/G5564A, Fib/Bbeta-148C/T, and GPVI/T13254C genotypes and alleles (P > 0.05). The T allele of the Fib/Bbeta-148T polymorphism was associated with increased plasma Fib level (P < 0.05). There was a strong positive correlation between serum level of MMP-9 and Fib (r = 0.289, P < 0.01).

CONCLUSIONSerum levels of MMP-9 and Fib were independent risk factors of ACS. There was an obvious relationship between the Bbeta-148C/T mutation and high Fib level. No significant difference between controls and ACS patients was found in the frequencies of MMP-9 C-1562T and G5564A, Fib Bbeta-148C/T and GPVI T13254C genotypes and alleles (P > 0.05).

Acute Coronary Syndrome ; genetics ; Adult ; Aged ; Case-Control Studies ; Female ; Humans ; Male ; Matrix Metalloproteinase 9 ; blood ; genetics ; Middle Aged ; Platelet Membrane Glycoproteins ; genetics ; Polymorphism, Single Nucleotide