Objective: To evaluate the bioavallability and bioequivalence of rabeprazole sodium enteric-coated pellets capsules. Methods:A randomized crossover design was performed in 32 healthy male volunteers. A single oral dose of 20 mg rabeprazole sodium enteric-coated pellets capsules ( test preparation) or enteric-coated shell capsules ( the reference capsules) was administrated under fed conditions. The wash period was 7 days. The blood samples were collected at different time points. The concentration of rabeprazole in plasma was determined by an LC-MS/MS method. The pharmacokinetic parameters were calculated by DAS 3. 0 software and the bio-equivalence was evaluated. Results:The maln pharmacokinetic parameters of the two formulations were shown as follows:T1/2 of (2. 20 ± 0. 83)h and(1. 951 ± 0. 515)h,Tmax of (3. 88 ± 1. 11)h and(4. 64 ± 1. 504)h,Cmax of (401. 06 ± 170. 75)ng·ml-1 and(394. 63 ± 215.64)ng·ml-1,AUC0→t of (918.42 ±427.39)ng·h·ml-1 and (994.49 ±520.73)ng·h·ml-1, and AUC0→∞ of(937.30 ± 445.13)ng·h·ml-1 and(1 011.69 ±534.77)ng·h·ml-1. The analysis showed that the maln pharmacokinetic parameters of the two formulations had no significant differences(P>0. 05) except for Tmax(P<0. 05). The relative bioavallability of rabeprazole sodium enteric-coated pellets capsules was (99. 80 ± 7. 20) %. Conclusion:Compared with the reference capsules, rabeprazole sodium enter-ic-coated pellets capsules show the property of higher dispersion degree, milder influence from food, more rapid release and absorption. The enteric-coated pellets capsules and the reference capsules are bioequivalence.

Objective:To optimize the clinical dosage regimen of amoxicillin and clavulanate potassium extended release ( ER) tablets based on the PK/PD parameters. Methods:Totally 30 healthy subjects ( half male and half female) were randomly divided into three groups, and orally administered the ER tablets respectively under fasting condition, before the meal and after the meal, and the optimal administration time was determined by comparing the pharmacokinetic characteristics. The subjects in the three groups were ad-ministered the ER tablets respectively at low, medium and high dosage, and the optimal dosage and dosing interval were determined based on the PK/PD parameters. Results:Under fasting condition, the AUC of amoxicillin [(32.2 ±15.0) μg·h·ml-1] was sig-nificantly lower than that before the meal [(41.7 ±1.92) μg·h·ml-1] and that after the meal [(42.6 ±17.7) μg·h·ml-1]. In contrast, the AUC of clavulanate acid after the meal [(1.89 ±0.54) μg·h·ml-1] was significantly lower than that under fasting condition [(2.55 ±0.76) μg·h·ml-1] and that before the meal [(2.58 ±0.76) μg·h·ml-1] (P<0.05). Amoxicillin and clavulanic acid displayed linear pharmacokinetics within the range of 1000-4000 mg and 62. 5-250 mg, respectively. After a single o-ral administration of amoxicillin and clavulanate potassium ER tablets at low, medium and high dose, the duration of blood concentra-tion above the minimum inhibitory concentration (MIC, 2. 0 μg·ml-1) (T> MIC) in 12 h was 5. 5, 7 and 10 h, and the percentage was 46%, 58% and 83%, respectively, and T> MIC in 12 h was 4. 5, 6 and 8 h, and the percentage was 38%, 50% and 67%, re-spectively when MIC was 4. 0μg·ml-1 . Conclusion:It is suggested that amoxicillin and clavulanate potassium ER tablets be taken at the start of a standard meal, 2 tablets per time, twice daily, which is sufficient to achieve T> MIC of 40% -50%.

The current study was designed to determine the safety, tolerability and pharmacokinetic parameters of recombinant human parathyroid hormone [rhPTH (1-84)] used for the treatment of osteoporosis. In the single-dose format pharmacokinetic study, thirty-six healthy male volunteers received three dose levels of rhPTH (1-84) subcutaneously: 1, 2, and 4 mug/kg. The blood was timing drawn and the serum concentration of rhPTH (1-84) was determined by enzyme linked immunosorbent assay (ELISA). Serum concentration-time curves of PTH (1-84) exhibited a double-peak pattern, the first peak appearing about 10 to 30 min after administration and the second peak occurring about 1.5 to2 h after administration. Serum terminal half-time of PTH (1-84) was approximately 2 h. The parameters indicated the serum levels were directly proportional to the administered dose, with the mean C(max) and AUC(0-24) ranging from approximately 543.47 to 1845 pg/mL and 2358.6 to 9232.12 pg.h.mL(-1) over the dose range. The drug was well tolerated, the clinical symptoms were generally mild and of short duration.

Objective To study the diagnostic accuracy of bedside lung ultrasound examination in chronic obstructive pulmonary disease (COPD) and cardiac pulmonary edema.Methods A prospective pilot and single-blind trial was conducted.A total of 89 patients with respiratory failure admitted to the Department of Critical Care Medicine of Anhui Provincial Hospital from September 2012 to September 2013 were enrolled.There were 32 patients with COPD,31 patients with cardiac pulmonary edema,8 patients with interstitial lung disease,12 with lung infection,and 6 patients with other diseases.Another group of 30 patients without respiratory disease were enrolled as the control group.Bedside lung ultrasound examinations were performed in all patients within 24 hours,and chest radiograph was performed at the same time.The signs to be revealed were the A lines or horizontal lines arising from the pleural line,and the comet-tail artifact (B lines) arising from the lung wall interface.Results Of 89 patients,33 patients were shown a mean of 2.94 ± 1.87 A lines per case with the bedside lung ultrasound,and 38 patients with a mean of 3.27 ± 1.72 B lines per patient.1.94 ± 0.96 A lines a case and 1.74 ± 0.82 B lines a case in control group.There were significant difference between the test group and control group (Aline:t=3.835,P=0.000; B line:t=6.540,P=0.000).Among 32 cases with COPD,28 patients had a positive result of A line with a coincidence rate of 81.2％.In the 31 patients with cardiac pulmonary edema,25 patients presented B line,with a coincidence rate of 80.6％.The A lines or horizontal lines arising from the pleural line showed a sensitivity of 81.30％ and a specificity of 87.70％ with a positive predictive value (PPV) 78.80％ and a negative predictive value (NPV) 89.30％ of in the diagnosis of COPD,and the B lines showed a sensitivity of 80.60％ and a specificity of 77.60％ with a PPV of 65.80％ and a NPV of 88.20％ in the diagnosis of cardiac pulmonary edema.However,X-ray examination showed a sensitivity of 65.50％,a specificity of 86.00％,a PPV of 72.40％ and a NPV of 81.70％ in the diagnosis of COPD,and it showed a sensitivity of 74.20％,a specificity of 69.00％,a PPV of 56.10％ and a NPV of 83.30％ in the diagnosis of cardiac pulmonary edema.Bedside ultrasound was highly consistent with X-ray in diagnosis of COPD [area under receiver operating characteristic curve (AUC):0.833 vs.0.816,P＞0.05],but Kappa value of ultrasound technology A line in the diagnosis of COPD was greater than the value of X-ray imaging techniques (0.685 vs.0.527).There was little diagnostic value of ultrasound A line in cardiac pulmonary edema (AUC was 0.305),while the B line was superior to X-ray (AUC:0.888 vs.0.747,P＜0.001),and had a higher Kappa value than the value of X-ray imaging techniques (0.553 vs.0.481) in cardiac pulmonary edema.Conclusions We conclude that bedside ultrasound is cost-effective,easy for repeated examination,and suitable for differential diagnosis of lung diseases.It might be useful in screening for COPD and cardiac pulmonary edema.

Objective To establish an analytical method for assessing acetylcysteine in human plasma and study the relative bioavailability and bioequivalence of acetylcysteine granules in Chinese healthy volunteers. Methods In the randomized crossover study, 24 healthy male volunteers received a single oral dose of 0. 6 g test acetylcysteine granules, reference acetylcysteine granules or no medication. The plasma concentration of acetylcysteine was determined by LC-MS/MS. Pharmacokinetic parameters were calculated and bioequivalence of two preparations were evaluated by DAS3. 0 software. Results The main pharmacokinetic parameters of the test and reference preparations were as follows:AUC0→t was (8 547. 64± 2 860.04) and (8 783.07±4 042. 10) μg·h·L-1, respectively; AUC0→∞ was (9 481. 64±3 444. 76) and (9 540. 51± 4 239. 30) μg·h·L-1, respectively;Cmax was (1 994. 39±726. 42) and (2 090. 27±885. 46) μg·L-1, respectively;tmax was (1.18±0. 60) and (1. 13±0. 53) h, respectively; t1/2 was (8. 60±3. 76) and (7. 75±5. 01) h, respectively. The relative bioavailability F0→t and F0→∞ was ( 107. 0 ± 43. 3 )% and ( 106. 5 ± 40. 1 )%, respectively. Conclusion The results of statistical analysis indicate that the test and reference formulations are bioequivalent.

Objective : To analyze the problems in the AIDS control strategy in key areas of Zhejiang Province, so as to provide insights into the improvement of the control strategy. Methods : The AIDS control data were collected from 10 key counties (districts) in Zhejiang Province, and the AIDS control strategy was comprehensively evaluated using a SWOT analysis. Results : The strengths of the AIDS control strategy in key counties (districts) of Zhejiang Province included distinct working objectives, well-organized leadership, and effective control measures, the weaknesses included large number of HIV-infected cases, high burden of disease, difficulty in management of AIDS transmission and insufficient AIDS control capability, and the opportunities included the AIDS control in key counties (districts) conforming to the current status of AIDS control, strong support of innovative strategies and technical support from professional teams, while the threats included insufficient working mechanisms for AIDS control, the gap between the effectiveness of AIDS control and the target goal and unverified scientific evidence of the control strategy. Supported policies should be fully used, working mechanisms need to be improved, control strategies need to be innovated, and assessments need to be implemented for AIDS control in key counties (districts). Conclusions There are both opportunities and challenges for AIDS control in key counties (districts) of Zhejiang Province. Optimization of the working mechanisms, promotion of precision interventions, and search for repeatable control strategy in other disease-affected regions are required for AIDS control.

Based on non-enzymatic protein glycated reaction, the sodium periodate-oxidated low molecular weight heparin-antithrombin covalent complex (SPLMWATH) was produced. By using polyethyleneimine-glutaraldehyde bonding technique, polyvinyl chloride (PVC) tubings were coated with SPLMWATH, heparin and low molecular weight heparin (LMWH). Spectrophotometry and dynamic clotting time experiment were used to determine the synthetic ratio of SPLMWATH, graft density, coating leaching ratio and to evaluate the antithrombogenicity of different coating on the PVC tubings. The results showed that the synthetic ratio of SPLMWATH was approximately 55%, and compared with heparin coating and LMWH coating, the graft density of SPLMWATH coating on the PVC tubing was smaller, but its coating stability and antithrombogenicity were significantly better than that of heparin coating and LMWH coating on the PVC tubings.
Anticoagulants ; chemical synthesis ; pharmacology ; Coated Materials, Biocompatible ; chemical synthesis ; pharmacology ; Extracorporeal Circulation ; instrumentation ; Heparin, Low-Molecular-Weight ; chemistry ; pharmacology ; Humans ; Polyvinyl Chloride ; chemistry ; Surface Properties

h. The parameters indicated the serum levels were directly proportional to the administered dose, with the mean Cmax and AUC0-24 ranging from approximately 543.47 to 1845 pg/mL and 2358.6 to 9232.12 mild and of short duration.

Objective: To describe the clinicopathological features of synchronous mucinous metaplasia and neoplasia of the female genital tract (SMMN-FGT). Methods: The sample consisted of 7 cases of SMMN-FGT recorded from November 2014 to September 2017 at Obstetrics and Gynecology Hospital, Fudan University.PAP method was used in immunohistochemistry.Clinical histories were retrieved and pathological slides were reviewed. Results: The patients were 37 to 70 years old(mean 54 years old). All patients showed endometrial mucinous lesions associated with cervical lesions. Three cases were an admixture of minimal deviation adenocarcinoma(MDA) and gastrictype adenocarcinoma(GAS). Three cases were an admixture of lobular endocervical glandular hyperplasia (LEGH), atypical LEGH and focal gastrictype adenocarcinoma in situ, one of which had early invasive gastrictype adenocarcinoma.Endometrium showed a structure of LEGH in one patient with focal simple gastric mucinous metaplasia in her cervix. Gastric mucinous differentiation was found in unilateral fallopian tube in 6 patients. Ovarian mucinous lesions were found in 3 patients. p16 was negative staining in 6 cases and positive in 1 case. CK7 was diffusely positive in all lesions. CK20 and CDX2 were negative or only focally positive.The expression of MUC6 was strongly positive staining or focal staining. p53 in GAS and GAS in situ had mutant expression, but wild expression in MDA region. Patients were followed up for 2 to 34 months and no recurrence was found. Conclusions SMMN-FGT is a series of rare mucinous lesions involving multiple areas of the female genital tract, including benign or malignant lesions with gastric differentiation. It is not related to infection with high-risk human papilloma virus. When cervical gastrictype lesions are found, SMMN-FGT should be considered and should be differentiated from metastatic mucinous adenocarcinoma.

Objective: To study oral sexual behavior and related factors among male students. Methods: The male students from college graduation in Hangzhou were selected as the study objects, and the inclusion criteria were having had sex and informed the type of behavior. A total of 490 subjects were finally included. Results: Among 490 male students, the 20-22 years old, 23 years old and 24-27 years old age groups accounted for 38.8% (n=190), 37.8% (n=185) and 23.3% (n=114), respectively. A total of 99 (20.2%) cases had oral sexual behavior, of which only 14 (2.9%) cases used condom. After adjusting for unplanned pregnancy, stage of sexual behavior, sexually transmitted diseases infection possibility, sexual orientation factors, normal/unnormal family relationship, more than 2 sexual partners, casual sexual partners, sexual partners from other college, sexual partners from society, sexual behavior in past 1 year were positively associated with oral sexual behavior. The corresponding OR (95%CI) values were 2.77 (1.40-5.50), 2.29 (1.27-4.15), 2.68 (1.23-5.88), 2.45 (1.34-4.48), 2.47 (1.15-5.33) and 2.04 (1.05-3.96), respectively. Use of condoms was negatively associated with oral sexual behavior, the OR (95%CI) value was 0.20 (0.09-0.42). Conclusion Normal/unnormal family relationship, more than two sexual partners, casual sexual partners, sexual partners from other college, sexual partners from society, sexual behavior in last one year and condom use in each vaginal sexual behavior were associated with oral sexual behavior.