OBJECTIVE To provide reference for developing pharmacovigilance and constructing an active surveillance system with extensive participation of pharmaceutical enterprises in China. METHODS Retrieving the literature and data from databases such as CNKI ，PubMed，and the official website of observational medical outcomes partnership （OMOP），the mechanism of pharmaceutical enterprises ’participation and its operation mode were investigated ，while specific path and code of conduct for pharmaceutical enterprises to participate in active surveillance system were analyzed. Finally ，the corresponding suggestions were put forward according to the actual situation of China. RESULTS & CONCLUSIONS Pharmaceutical enterprises in OMOP participated in project construction and operation through public private partnership （PPP）mechanism，and played the role of project funding ，project governance and project research. Pharmaceutical enterprises participating in OMOP need to carry out activities in accordance with the code of conduct of extensive cooperation ，transparency and openness and the protection of patient privacy. In the future practice of active surveillance system in China ，it is necessary to promote the relevant legislation of active monitoring system ，emphasize the responsibility of active surveillance of pharmaceutical enterprises ，establish a PPP mechanism of industry-university-research integration ，form a good governance ecology and strengthen the protection of patients ’privacy.

OBJECTIVE: To study the characteristics of the diagnostic parameters of acute respiratory distress syndrome/multiple organ dysfunction syndrome on plateau (H-ARDS/MODS) and compare the accuracy of the three MODS scoring criteria in predicting the outcome of syndrome. METHODS: Five hundred and forty cases fulfilling the criteria of MODS were divided into four groups according to the altitude of their inhabitation area: control group (on plain, CG, n=113, altitude: <430 m), moderate high altitude group 1 (H1G, n=314, altitude: 1,517 m), moderate high altitude group 2 (H2G, n=78, altitude: 2,261 m to 2,400 m) and high altitude group (HG, n=35, altitude: 2 808 m to 3 400 m). According to the diagnostic criteria of Lushan conference and Marshall (1995) commonly used on plain, and Lanzhou criteria drafted by the authors, three data analyzing models were set up to draw the receiver operating characteristic (ROC) curves, the Yordon Index and the optimum cutoff points of the parameters were calculated and the accuracy of the three respective diagnostic criteria was evaluated in predicting the outcome of ARDS/MODS. Multiple factors affecting the outcome of MODS were analyzed using the method of stepwise forward regress model. RESULTS: Following the increase in altitude, Lanzhou criteria was clearly superior to the other two criteria in the area of ROC, the sensitivity, the specificity, and also for the optimum cutoff points of MODS. Multi-variable regression analysis showed that the impacting factor of Lanzhou criteria was the highest (P<0.05). CONCLUSION: (1)Some parameters of the current diagnostic criteria of ARDS/MODS are not suitable in moderately high or high altitude areas. It is necessary to set up the diagnostic criteria of H-ARDS/MODS. (2)Some clinical characteristics might change in areas 1,500 m altitude or higher. The pathophysiological mechanism might be attributable to peculiar biologic reactions due to hypoxia stress reaction, and it is worth further study.
Altitude ; Multiple Organ Failure/*diagnosis ; Prognosis ; ROC Curve ; Regression Analysis ; Respiratory Distress Syndrome, Adult/*diagnosis ; Severity of Illness Index

AIMTo investigate the preparation of pulsatile release tablets, the release of the drug in vitro and the pharmacokinetics in vivo.

METHODSDiltiazem hydrochloride (DIL) was used as model drug. The pulsatile release tablets were prepared by film-coated method using ethylcellulose and Eudragit L. The effect of formulation on pulsatile release of diltiazem hydrochloride was investigated under release rate test. The mechanism of pulsatile release of drug was proved by the test of water-uptake. The pharmacokinetic and bioavailability study in eight human subjects was performed by HPLC method.

RESULTSThe release of diltiazem hydrochloride effected by the formulation of the core tablets and the composition and thickness of the coating film. In vitro, the delayed-release time T10 was 4.4 h, the maximum release time Trm was 8.0 h and the pulsed-release time Trm-10 was 3.6 h. In vivo, the delayed-release time Tlag was 4.9 h, the peak time was 8.0 h and the pulsed-release time was 3.1 h. The relative bioavailability was 105%.

CONCLUSIONThe release of drug from pulsatile release tablets of diltiazem hydrochloride was shown to be in pulsed way both in vitro and in vivo.

Adult ; Antihypertensive Agents ; administration & dosage ; pharmacokinetics ; Biological Availability ; Chemistry, Pharmaceutical ; Delayed-Action Preparations ; Diltiazem ; administration & dosage ; pharmacokinetics ; Drug Delivery Systems ; Fluorocarbons ; chemistry ; Humans ; Male ; Polymethacrylic Acids ; chemistry