Multi-stage design in phase II clinical trials for anti-cancer drug development / 肿瘤

In phase II clinical trials, multiple kinds of tumors were treated with anti-cancer drugs at different dosages and through different administration pathways to exclude the ineffective dosages and screen sensitive tumor (s) for further study. When expectant effects are not in fact observed in the experimental groups, it is essential to terminate the trials to minimize exposure of subjects to ineffective interventions. The trials are usually carried out with a multi-stage design. The present paper introduces the multi-stage design including the statistic principles and design ideas of single-stage, two-stage and three-stage design, provided the sample sizes needed in clinical trials at different stages, and estimated the value of early termination. All are illustrated with an example.

Diseño de una formulación antimicótica

Se desarrolló una formulación con nitrato de miconazol al 2 % en una crema hidrosoluble apropiada, la cual cumple con los requerimientos físicos, químicos, microbiológicos y biológicos para este tipo de forma farmacéutica. Se comprobó que el producto debe ser envasado en frascos de vidrio ámbar o en tubos de aluminio laqueado, además de presentar una estabilidad física adecuada durante 3 años. El contenido del principio activo se mantuvo dentro de los límites establecidos hasta los 16 meses. También se demostró la actividad antimicótica de la preparación y su efectividad terapéutica.

A formulation with miconazole nitrate 2 % is developed in an appropiate hydrosoluble cream, which meets all the physical, chemical, microbiologic and biologic requirements for this type of pharmaceutical form. It was proved that the product should be put into amber glass flasks or into lacquered aluminum tubes. besides having an adecuate physical stability during three years. The content of the active principle was kept within the established limits up to the 16 months. The antifungal activity of the preparation as well as its therapeutic effectiveness were also demonstrated.

Efficacy and safety of china-made remifentanil / 中华麻醉学杂志

Objective To evaluate the efficacy and safety of China-made remifentanil in a randomized, controlled and double-blinded multi-center clinical study. Methods Two hundred and one patients were randomly divided into two groups: control group received intravenous fentanyl and study group received intravenous remifentanil. In both groups anesthesia was induced with propofol 1-2 mg ?kg-1 and fentanyl 2.5?g/kg or remifentanil 2 ?g/kg. Intubation was facilitated with succinylcholine 1.0-1.5 mg?kg-1. The patients were mechanically ventilated(VT 8-10 ml?kg-1 , RR 10 bpm) . Anesthesia was maintained with fentanyl at 0.03 ?g?kg-1?min-1 or 0.2?g?kg-1?min-1 supplemented with 66% N2O and intermittent iv boluses of vecuronium. The efficacy variables recorded were the changes in blood pressure(BP) and heart rate(HR) during surgical stimulation and the quality of anesthesia. The safety variables included BP and HR, the doses of ephedrine, atropine, urapidil and naloxone required during surgery, the volume of intraoperative blood loss, changes in EGG, and the pre- and post-operative liver and kidney function, extubation time, emergence time (opening eyes when the patient's name is being called), end-tidal CO2 before extubation, admission to PACU or ICU, and the unexpected events in postoperative period. Results The anesthetic efficacy of remifentanil was similar to that of fentanyl with better analgesic effect . Remifentanil wore off faster in comparable doses. Conclusion China-made remifentanil is a good and safe anesthetic with better analgesic effect.