This article introduces the classifications of medical devices by FDA and EU and compares them with the situation in China. Towards the problems found, several reasonable advices are put forward.
China ; Durable Medical Equipment ; classification

"Treatment based on diseases identification and formulas corresponding to diseases" is one of important therapy modes of Chinese medicine. Although it originates from Huangdi Neijing, it is seldom systematically discussed. Modern Chinese medicine (CM) now faces diseases mostly with comparatively confirmed Western medical diagnoses. Most of them have specific pathophysiological changes. How to interpret these specific pathophysiological changes, play CM's advantages, and improve clinical efficacies has become an inevitable problem for modern CM in clinic. Authors expounded historic development and clinical application of "formulas corresponding to diseases", and its difference from "formulas corresponding to syndromes", put forward that we should combine "formulas corresponding to diseases" and "formulas corresponding to syndromes" in CM clinics. We should focus on the disease and summarize treatment rules, thereby improving targeted CM formulas.
Drug Compounding ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional ; Syndrome

Objective To establish a method for the determination of bacterial endotoxin in Ilex pubescens compound injection(LPCJ) .Methods According to China Pharmacopoeia (second part,2000),interference test was carried out to detect the endotoxins in LPCJ with limulus lysate agents (?was 0.25 EU/mL).Results Inhibition action was found in bacterial endotoxin test for LPCJ and in the 10-,20-,30-and 40-fold diluted liquid of LPCJ.It was proved that the maximum noninterference concentration was the 50-fold dilution.The inspection results are the same as that of rabbit pyrogen test.Conclusion The 50-fold diluted LPCJ is suitable for the determination of bacterial endotoxin and can be used as the quality control standard for its preparation.

Objective To study the influence of Dahuang granule on the level of motilin in plasma and gastrin in serum of patients with severe acute pancreatitis (SAP). Methods Sixty-four patients with SAP were divided into Dahuang granule group (32 cases) and control group (32 cases), treated with Dahuang granule and routine therapy respectively. The level of motilin in plasma and gastrin in serum of the two groups were detected by radioimmunoassay method. Results After treated for one week, the level of motilin in Dahuang granule group was significantly higher than that in the control group (P

Objective To study the CT characteristics of rare renal malignant tumors.Methods 7 cases with rare renal malignant tumors confirmed by operation and pathology were reviewed and their CT manifestations were analyzed retrospectively.In clinical, all cases had abdomen pain,6 cases had macroscopic haematuria,and 1 case had asymptomatic by chance.Results Of 7 cases,3 ca-ses were sarcomatoid carcinoma,1 case was carcinosarcoma,1 case was malignant mesenchymal tumor,1 case was lymphoma,and 1 case was neuroendocrine carcinoma.The diameter was about 4.0-12.3 cm.1 case had uniform density,6 cases uneven,and the boundary was not clear.Conclusion The rare renal malignant tumors are misdiagnosed easily.Combined clinical data with imaging performance are helpful to make comprehensive analysis,and to improve accuracy rate for diagnosis,definite diagnosis still depends on pathological examination.

Adult stem cells are the multi-potential cells, which exist in fetal and adult tissues. It can reproduce itself (undergo self-renewal) or give rise to more specialized (differentiated) cells. Under certain inducing conditions, adult stem cells can acquire the ability to differentiate into different tissue cells. Multipotent adult progenitor cells (MAPC), an alternative name of adult stem cell given by Catherine Verfaillie, existing in bone marrow, can differentiate into cells with characteristics of mesodermal, neuroectodermal, and endodermal lineages in vitro at the single-cell level. MAPC can also contribute to most cell types when injected into the blastocyst. Adult stem cell differentiation implies that different cell lineages are derived from a single initial cell; all differentiated cell types are functional in vitro and in vivo; and engraftment is robust and persistent in the physiological and pathological situations. The possible mechanisms may underlie the differentiation: various tissue-specific stem cells are present in different organs; adult stem cells would be reprogrammed when removed from their usual microenvironment and introduced into a different niche that imparts signals to activate a novel genetic program needed for the new cell fate. And true multi-potential stem cells persist in postnatal life. In the future, multi-potent adult stem cells might then be used for therapies of degenerative or genetic disorders of multiple different organs.
Adult Stem Cells ; cytology ; Cell Differentiation ; Humans ; Multipotent Stem Cells ; cytology ; Stem Cell Transplantation

Humans ; Hyoid Bone ; pathology ; Male ; Middle Aged ; Syndrome

Objective To evaluate neurodevelopmental outcome of very preterm(gestational age ＜ 32 weeks) and very low birth weight infant (VLBWI) (weight ＜ 1 500 g) and to examine the effectiveness of an early intervention program till 12 months corrected age.Methods Seventy followed-up very preterms and VLB-WI in Jinan Maternity and Childcare Hospital were enrolled in this study from January 2012 to and were divided into two groups by birth weight.All infants received 20 items of behavioral neurological assessment at 1 to 12 months corrected age and tested mental and psychomotor development with the use of CDCC at 6,12 months corrected age.The preterms who were abnomal in the 20 items of behavioral neurological assessment would receive early intervention (including kinesitherapy, physiotherapy, cereal circulation therapeutic equipment) by physiotherapists and their parents who received an intervention program training and were strongly encouraged to participate in the intervention sessions.The intervention method was adjusted according to the neurological assessment.The SPSS statistical software package for Windows, version 15.0, was used to run Fisher's exact test and t-test on the data presented,and P value of less than 0.05 was regarded as statistically significant.Results The average gestational age of infants was (30.4 ± 1.8) weeks,and average birth weight (1 463.7 ± 307.5) g.The incidence of extrauterine growth restriction was 57.1％ at first follow-up.The incidence of neurodevelpmental impairment NDI) and cerebral palsy tendency at 6 corrected months were 14.3％ ,8.6％ respectively.At 12 months corrected age,the incidence of NDI decreased to 2.9％ and cerebral palsy to 2.9％.There was significant difference in the incidence of NDI between 6 and 12 corrected months.There was no significant difference in the incidence of psychomotor developmental index ＜ 70, mental developmental index ＜ 70, NDI and cerebral palsy between the two groups.Conclusion The early intervention program can improve VLBWI neurodevelopmental outcomes at 12 months' corrected age and reduce the incidence of cerebral palsy.

Objective To establish a method for reducing the dose to the eye lens of interventional staff,and provide the data basis for improving radiological protection measures.Methods One piece of interventional equipment coupled with conventional auxiliary protective devices and two types of common neural interventional procedures were selected to monitor 46 and 35 procedures before and after the device modification.The doses to the eye lens of staff were measured with direct-reading dosimeters for analysis of dose trends.Results After modification of the devices,the average dose to the left eye lens decreased from (9.71 ±10.86) to (3.23 ±5.59) μSv for the first operator,from (9.51 ± 12.34) to (0.68 ± 0.78) μSv for the second in cerebral angiography;whereas the dose decreased from (14.83 ± 19.13) to (4.17±4.59) for the first operator and from (14.12±21.76) to (1.23 ±1.57)μSv for the second in embolization procedure,respectively.The left eye lens doses measured before and after the modification showed significant difference (U =-2.760,-2.467,-1.967,-2.655,P ＜0.05).Conclusions The modification of the auxiliary radiological protective devices may effectively reduce the dose to the eye lens dose.This method was shown to be feasible for the improvement of radiological protection of interventional staff.

OBJECTIVE:To improve the preparation of compound menthol spray and study its stability.METHODS:The liquor compound menthol spray was changed to emulsified ones by the solubilizing action of tween80.The stability of emulsified compound menthol spray(ECMS)was observed in airtight container at room temperature(25?2)℃.RESULTS:ECMS was stable within2wks in airtight container at room temperature.CONCLUSION:ECMS is stable in property,convenient in stor?age,and accords with pharmaceutical quality standards.