To conduct clinical trial in China, to go or not to go.

In the last 10 years, more and more clinical trials have come to China because of potential market/easy access of patient and cost-effectiveness, but if we look back, there had been minimum changes on the regulatory requirements, and there is a possibility that China government could further strengthen the regulatory requirements for the global pharma/foreign pharma. In 2013, there was a breaking news that China government would start to investigate the corruption of GSK. So now, should the global pharma/foreign pharma go to China to conduct clinical trial? If the sponsor wants to access China market and provide unmet medical needs to China market, there are still many opportunities and there are ways to get all of these barriers resolved.

Clinical assessment of a CMC/PEO gel to inhibit postoperative epidural adhesion formation after lumbar discectomy: a randomized, control study.

PURPOSE: To evaluate effectiveness of carboxymethylcellulose/polyethylene oxide (CMC/PEO) gel in improving clinical outcomes after the first-time lumbar discectomy. METHOD: Ninety-three patients with herniated lumbar disc at L4-L5 or L5-S1 were enrolled and randomized into two groups: CMC/PEO gel treatment group and control group. All the patients underwent laminotomy and discectomy by posterior approach. The preoperative and postoperative Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) scores for lower-back pain and leg pain were analyzed and compared between two groups at 30- and 60-day time points. RESULTS: No patient presented with any clinically measurable adverse event during surgery. There were no significant differences between the treated group and the control group on the preoperative ODI and VAS scores. In general, the ODI and VAS scores decreased in both groups at all the time points. At the 30-day time point, the VAS scores for back pain and leg pain and the ODI scores in treatment group were lower by 9.9 % (P = 0.0302), 27.0 % (P = 0.0002) and 16.3 % (P = 0.0007) than those in control group. And at the 60-day time point, the ODI and VAS scores further decreased in both groups. The VAS scores for leg pain in treatment group were lower by 4.5 % than that in the control group (P = 0.0149). However, no significant difference was detected between two groups on the ODI and VAS scores for back pain. CONCLUSIONS: The results demonstrated that CMC/PEO gel is effective in reducing posterior dural adhesions in the spine with no apparent safety issues. It can improve patients' postoperative clinical outcome.

Optimal design of thread height and width on an immediately loaded cylinder implant: a finite element analysis.

In this study, we used a finite element method to evaluate the maximum Von Mises stresses in jaw bones of immediately loaded implant with different thread heights and widths, and the maximum displacements in implant-abutment complex. The implant thread height ranged from 0.20 to 0.60 mm, and the thread width ranged from 0.10 to 0.40 mm. Compared to those in standard designed implants, the maximum Von Mises stresses in cortical and cancellous bones with axially loaded implants decreased by 18.85% and 47.46%, respectively, and by 16.38% and 63.46%, respectively in buccolingually loaded implants. The maximum displacement of implant-abutment complex loaded axially and buccolingually decreased by 13.78% and 6.97%, respectively. These results indicated that thread height played more important roles in affecting bone stresses and implant-abutment complex stability than thread width. Immediately loaded cylinder implants with thread height exceeding 0.44 mm and width ranging from 0.19 to 0.23 mm caused the lowest stresses to the type B/2 bone.

Computer-aided design and rapid manufacture of an orbital prosthesis.

This clinical report presents a novel approach that integrates a new optical digitizing (scanning) technique, a three-dimensional ocular prostheses database, and the Selective Laser Sintering technique to achieve the computer-aided design and manufacture of an orbital prosthesis. An optical-structured light scanner was used to develop a color digital model of the unaffected orbital contour, which was copied and then mirrored to generate the orbital prosthesis contour data. The ocular prostheses database was applied to ascertain the size and position of the eyeball within the orbital prosthesis. Then, a Selective Laser Sintering machine directly manufactured the wax pattern of the definitive orbital prosthesis from the three-dimensional orbital data. This new approach is time and cost-effective and can be considered an alternative to traditional manual techniques of creating facial prostheses.