Application of objective performance criteria in post-marketing evaluation schemes of traditional Chinese medicine / 中国中药杂志

Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.

Therapeutic effect of ulinastatin on traumatic brain edema accompanied by seawater drowning in rats / 中华神经医学杂志

Objective To observe the therapeutic effect of ulinastatin on traumatic brain edema (TBE) accompanied by pulmonary edema due to seawater drowning in rats. Methods Thirty-two Sprague-Dawley rats were randomly divided into control group (nffi8) and ulinastatin treatment group (n=24). A rat model of moderate brain trauma was established by lateral head impact, and pulmonary edema was induced in these rats by pulmonary lavage with seawater to mimic seawater drowning. Twenty-four hours after intmperitoneal injection of ulinastatin, the changes in the cerebral and pulmonary water contents and concentrations of interleukin-1β(IL-1β) and tumor necrosis factor-α(TNF-α) in the brain, lungs and serum were measured, and the histopathological changes of the brain and lung tissues were observed. Results The cerebral and pulmonary water contents and the IL-1β and TNF-α concentrations in the serum, brain and lungs of the rats with brain trauma and pulmonary edema were markedly decreased after ulinastatin injection, which also resulted in obvious improvement of the brain and lung pathologies induced by the injuries. Conclusion Ulinastatin can alleviate traumatic brain edema in rats with pulmonary edema due to seawater drowning by inhibiting the proinflammatory cytokines.

Standard large trauma craniotomy for severe traumatic brain injury / 中华创伤杂志(英文版)

<p><b>OBJECTIVE</b>To study the effect of standard large trauma craniotomy (SLTC) on outcomes of patients with severe traumatic brain injury (TBI) (GCS<=8).</p><p><b>METHODS</b>230 patients with severe TBI were randomly divided into two groups. 115 patients underwent SLTC (10 cm x 12 cm) as an SLTC group, and other 115 patients underwent temporo-parietal or fronto-temporal craniotomy (6 cm x 8 cm) according to the position of hematomas as a routine craniotomy (RC) group. Other treatments were identical in two groups. According to Glasgow outcome scale (GOS), the prognosis of the patients was evaluated and the complications were compared between two groups.</p><p><b>RESULTS</b>27 patients got good outcome and moderate disability (23.5%), 40 severe disability and vegetative survival (34.8%), and 48 died (41.7%) in SLTC group. 21 patients got good outcome and moderate disability (18.3%), 28 severe disability and vegetative survival (24.3%), and 66 died (57.4%) in RC group. The incidence of incision hernia was lower in SLTC group than in RC group. However, the incidence of operative encephalocele, traumatic epilepsy and intracranial infection were not different in two groups.</p><p><b>CONCLUSIONS</b>Standard large trauma craniotomy significantly reduces the mortality of patients with severe TBI without serious complications, but does not improve the life quality of the patients.</p>

Purification and characterization of antifungal proteins in triticale seed / 生物工程学报

Using Trichoderma as an indicative fungus, three antifungal proteins in Triticale Zhongsi 237 seed were purified and characterized. These protein components were considered to be a new Class II chitinase and two kinds of beta-1, 3-glucanases. Chitinase molecular mass was 30.5 kD and enzyme activity was maximal at pH 6.0 and 37 degrees C. Two beta-glucanases molecular masses were 51 kD and 23 kD. N-terminal amino acid sequences of Triticale chitinase share high homology with barley chitinase. In some conditions, the chitinase and beta-glucanases all had strong antifungal activity and were able to inhibit Trichoderma growth synergistically. Moreover, the chitinase and beta-1, 3-glucanases were able to inhibit powdery mildew growth on detached susceptible wheat leaves.