OBJECTIVE:To provide references for improving the quality of clinical trial of new drug (phase I-IV),guaranteeing participants' interests and enhancing the core competitive power of drug clinical trial institutions. METHODS: The advantages of both the guiding principle of Good Clinical Practice(GCP) and the quality standards of ISO/IEC17025:2005 were applied throughout the quality control process of clinical drug trial. RESULTS & CONCLUSIONS: To establish quality management and supervision system in China that is in line with the international norm and national condition by combining GCP principle with the quality standards of ISO/IEC17025 is conducive to the improvement of the quality of clinical drug trial and enhancement of the core competitive power of drug clinical trial institutions in China.

Objective: To explore the relationship between erythrocyte sedimentation rate (ESR) and myocardial infarction (MI) occurrence in patients with rheumatoid arthritis (RA) combining coronary artery disease (CAD).
Methods: A total of 106 consecutive patients with RA combining CAD were studied. There were 46 male and 60 female patients and divided into 2 groups:RA with MI group, n=46 and RA without MI group, n=60. The base line condition was compared between 2 groups, and multivariate regression analysis was conducted to explore the risk factors for MI occurrence in relevant patients.
Results: Compared with RA without MI group, RA with MI group had the lower level of cholesterol and higher levels of inlfammatory indexes of ESR, high sensitivity C-reactive protein (hs-CRP) and CRP, P<0.05. The base line condition was similar between 2 group, P>0.05. Multivariate regression analysis indicated that ESR was the independent risk factor of MI occurrence, OR=1.024, 95%CI 1.024 (1.007-1.043), P=0.007.
Conclusion: ESR was independently related to MI occurrence in patients with RA combining CAD.

Objective: To study the effect of cytochrome P-450 4F2 (CYP4F2, rs2108622) gene polymorphisms in patients with warfarin for initial doses in 7 days.
Methods: A total of 271 patients treated by warfarin were studied. The CYP4F2 gene polymorphisms were assessed by real-time PCR, the average initial warfarin doses in 7 days and the time of international normalized ratio (INR) ifrst arrived to therapeutic range were recorded. The differences of initial warfarin doses and the time of INR ifrst arrived to therapeutic range among CYP4F2 gene polymorphisms of CC, CT and TT genotypes were analyzed by statistical method.
Results: The average initial warfarin doses among CYP4F2 polymorphisms of TT and CT/TT were higher than CC, P<0.05. The times of INR first arrived to therapeutic range in TT genotype was higher than CC genotype, P<0.05. With adjusted gender, age, body height and weight, CYP2C9 and VKORC1 polymorphisms, conditions of disease and medication, the effect of CYP4F2 gene polymorphisms on initial warfarin doses in 7 days were still with the statistic meaning (regression coefifcient=0.21, P=0.003).
Conclusion: CYP4F2 polymorphisms inlfuenced the initial warfarin doses in 7 days in relevant patients.

Objective To evaluate the inhibition of urine 11-dH-TXB2 by dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin in Chinese cardiovascular patients after long-term therapy. Methods103 cardiovascular patients were treated with oral doses of dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin tablets (162 mg aspirin) daily for 24 weeks. The Urine 11-dH-TXB2 concentration were measured before and 6, 12, 24 weeks after administration. ResultsThe urine 11-dH-TXB2 concentration were （1840.41±1452.63） pg/ml, （820.01±610.55） pg/ml, （1011.19±1148.12） pg/ml, （1290.82±1425.51） pg/ml before and 6, 12, 24 weeks after administration. The urine 11-dh-TXB2 concentration was higher in 24th week than in 12th weeks and 6th week. ConclusionThe dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin can inhibit the platelet aggregation, which decreased after long-term administration.

OBJECTIVEThis study aimed to explore the differences of membrane thickness and pressure on the paranasal sinus membrane in goats and analyze their causes. The results can provide theoretical basis and guidance for the issues of the maxillary sinus floor augmentation related to the membrane.

METHODSThe membrane was cut into two sizes from every sinus membrane. The membrane was fixed in formalin to obtain tissue specimens for the membrane thickness study and pressure study. The correlation between the two parameters was then analyzed, and appropriate statistical methods and software were selected.

RESULTSThe top of maxillary sinus, the bottom of maxillary sinus and the frontal sinus membrane thickness were (410.03 ± 65.97), (461.33 ± 91.37), (216.90 ± 46.47) µm. The pressure were (260.08 ± 80.12), (306.90 ± 94.37), (121.72 ± 31.72) kPa. The mean differences of the membrane thickness between the top of the maxillary sinus and the frontal sinus, bottom and frontal, and top and bottom were statistically significant (P < 0.05). The mean differences in membrane pressure were also statistically significant (P < 0.05).

CONCLUSIONThe membrane thickness and pressure of the top and bottom of the maxillary sinus are higher than those of the frontal sinus membrane. However, the thickness and pressure of the bottom membrane are slightly higher than those of the top membrane. Pressure and membrane thickness are positively correlated in the sinus membrane.

Objective: To compare the clinical characteristics and plasma level of N-terminal pro-brain natriuretic peptide (NT-proBNP) between the patients with hypertensive hypertrophic cardiomyopathy in elder age (HHCME) and the patients with hypertensive left ventricular hypertrophy (HTN-LVH).
Methods: Our work included 2 groups, HHCME group,n=47 and HTN-LVH group,n=44. Duplex Doppler echocardiography was performed to determine left atrial diameter (LAd), left ventricular end-diastolic dimension (LVEDd), interventricular septal thickness (IVST), left ventricular ejection fraction (LVEF), velocity of early diastolic period (VE) and velocity of end-diastolic period (VA) in mitral valve oriifce. Plasma level of NT-proBNP was measured by ELISA. The above indexes were compared between 2 groups.
Results:①Compared with HTN-LVH group, HHCME group presented decreased LVEDd and increased IVST, LVEF, allP<0.001. There were no signiifcant differences in VE/VA ratio and LAd between 2 groups, allP>0.05.②Plasma level of NT-proBNP was higher in HHCME group,P<0.01. With the adjusted age, gender, history of hypertension, LAd, IVST, left ventricular systolic and diastolic function, the level of NT-proBNP in HHCME group (1317.19 fmol/ml) was still signiifcantly higher than that in HTN-LVH group (526.19fmol/ml),P<0.01.
Conclusion: The plasma NT-proBNP level was higher in HHCME patients than that in HTN-LVH patients which indicated that HHCME patients may have worse prognosis. NT-proBNP might be helpful for differencing HHCME.

Objective: To analyze the relevant factors for combined use of low molecular weight heparin (LMWH) and statins causing transaminase elevation and to provide the reference for medication safety in clinical practice. Methods: There were 45 patients who received the combination of LMWH and statins treatment, then having ALT elevation in our ward from 2011-01 to 2012-12 were collected, by exclusion of patients with the history of high ALT at admission, interrupted treatment and incomplete record of liver function tests, a total of 32 patients were ifnally enrolled for investigation. The conditions for using LMWH and statins together, type of LMWH, timing of ALT elevation after medication and clinical outcomes were retrospectively analyzed. Results: All patients received statins including simvastatin, atorvastatin, rosuvastatin and pravastatin, and 15 patients took statins before using LMWH including enoxaparin, nadroparin and dalteparin. There were 18 patients had ALT increased below 3 times of the upper limit and 14 patients had ALT level ≥ 3 times of the upper limit, and ALT elevation occurred at the average of (3 ± 3.8) days after taking LMWH. All patients stopped using LMWH upon ALT elevation and 16 of them stopped taking statins. The ALT level gradually decreased to normal by application of hepatic-protective treatment in all patients.Conclusion: Combined using LMWH and statins could cause ALT elevation, LMWH and statins may have synergistic effect, and therefore, the enhanced monitor of liver function is necessary when using the combined medication.

OBJECTIVE:To provide references for clinicians in the choice of antihypertensive drugs.METHODS:The antihypertensive efficacy 6 classes(or 15 kinds) of antihypertensive drugs in a monotherapy in the treatment of 370 patients with essential hypertension(EH) were compared.RESULTS:The blood pressure was effectively lowered by all of the antihypertensive drugs except doxazosin,and doxazosin and torasemide showed inferior efficacy in the reduction of diastolic blood pressure(DBP).CONCLUSION:Calcium antagonists with prolonged action,angiotensin converting enzyme inhibitor(ACEI),angiotens-in receptor antagonist,and the monotherapy of Terazosin or Indapamide can all effectively bring down the blood pressure.It is suggested that low-dose doxazosin and torasemide should not be used alone in treating essential hypertension.

Objective: To describe the clinical characteristics with long-term prognosis in patients with mid-ventricular obstructive hypertrophic cardiomyopathy (MVOHCM).
Methods: A total of 66 MVOHCM patients treated in our hospital were retrospectively studied for their morbidity, clinical characteristics and mortality. The cumulative survival rate was calculated by Kaplan-Meier method; the risk factors for cardiac death and cardiovascular events were analyzed by uni- and multivariate Cox proportional hazard model.
Results: There were 66 (2.74%) patients suffering from MVOHCM among 2413 patients of hypertrophic cardiomyopathy and the average diagnostic age was (40.16 ± 14.64) years. With (7.30 ± 6.25) years of follow-up study, the cardiovascular mortality was 13.6% and unexplained syncope (HR=13.37, 95% CI: 1.65-114.46, P=0.015) was the independent predictor for cardiovascular death. There were 45.45% (30/66) patients experienced at least 1 time of cardiovascular event and the most frequent one was non-sustained ventricular tachycardia (NSVT); 19.70% (13/66) of patients combined with apical aneurysms, and they were more inclined to experience NSVT.
Conclusion: MVOHCM patients usually have unfavorable prognosis with the higher incidence of cardiovascular events, some patients may develop apical aneurysm. The early diagnosis of MVOHCM is important for appropriate treatment.

Objective To study the clinical efficacy of anus-preserving rectectomy by using telescopic anastomosis of colon and rectal mucosa for the middle and lower rectal cancer. Methods A retrospective analysis was carried out in 402 cases with middle and lower rectal cancer undergoing telescopic anastomosis for anus-preserving procedure, including 241 males and 161 females, age ranging from 21 to 99 years, averaging at 55. 7 years. The distal margins of the tumors were within 6 - 9 cm to anal verge. According to TNM staging, there were 123 cases in Stage Ⅰ , 244 cases in Stage Ⅱ , 31 cases in Stage Ⅲ,and 4 cases in Stage Ⅳ. Results 345(345/402, 85. 8% ) cases were followed up, the median time of the follow-up was 6. 1 years. Postoperative complications included 17(4.2%) cases of stomal leakage, 11(2.7% ) cases of stomal stenosis. All patients recovered normal defecating function 12-24 weeks post operation. Local recurrence rate was 6. 3% (22/345). Hepatic and lung metastasis was 13. 6% (47/345) and 2. 6% (9/345)respectively. The five year survival rate was 68. 7% (112/163). Conclusions Anuspreserving rectectomy by using telescopic anastomosis is safe and effective procedure to treat middle and lower rectal cancer, with the preservation of anal function and without the increasing rate of local recurrence.