OBJECTIVE: To provide references for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level.METHODS: FDA's CGMP Warning Letters on medical products issued by the USA during 2002～2006 were analyzed statistically,and FDA's emphasis and intent on quality management system of medical products was discussed.RESULTS & CONCLUSIONS: The contents stated in FDA Warning Letters are of great importance for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level.Chinese enterprises can probe into the problems and solutions of quality management of medical products by analyzing FDA's emphasis and intent on quality management system of medical products as well as field investigation.

Objective To analyse effects of moxifloxacin solution for aerosol inhalation on inflammatory mediators and blood gas analysis index in patients with chronic obstructive pulmonary disease with respiratory failure.Methods 60 patients who were diagnosed with chronic obstructive pulmonary disease with respiratory failure in our hospital were collected.All patients were randomly divided into experimental group and control group,30 cases in each group.On the basis of conventional treatment, control group were given sulfate for inhalation shating amine alcohol solution 2mg per times, 3 times per day atomization inhalation treatment,and experimental group was given 2 mg/times, 4 times per day atomization inhalation treatment,two were treated for 2 weeks.After the treatment, the serum levels of CRP,TNF-α,IL-10,IL-18 and arterial blood PO2 ,PCO2 levels were detected in all patients.Results Compared with control group post-treatment, the serum levels of CRP, IL-18 and TNF-αwere lower in experimental group (P<0.05), and the serum level of IL-10 was higher;the arterial blood level of PO2 was higher,and the arterial blood level of PCO2was lower in experimental group (P<0.05). Conclusion Effect of moxifloxacin solution for aerosol inhalation can significantly reduce the serum CRP,TNF-αand IL-18 levels, improve serum IL-10 level in patients with chronic obstructive pulmonary disease with respiratory failure, ameliorate PO2 and PCO2 .

Objective To discover and certify the minimum required months of IQC ( Internal Quality Control ) data which were used to quantify the imprecision To identify the impact of test items , different concentrantions and years on the defective rate .Methods IQC data involving 20 analysis items ( including Albumin, Creatine kinase, Total bilirubin, Alanine aminotransferase, Aspartate aminotransferase, Lactate dehydrogenase,γ-Glutamyl transferase, Alkaline phosphatase, Calcium, Chlorine, Creatinine, Glucose, Potassium, Sodium, Phosphorus, Triglyceride, Total cholesterol, Total protein, Uric acid, Urea) and six measurement systems (including Roche, Architect, Hitachi, Dade/Behring, Beckman, Olympus) were collected from hospitals in Shanghaibetween 2009 and 2011.A total of 3 534 groups, referred to one year laboratory′s IQC data of one concentration range , were analysed to find the minimum required months in each group when the cumulative months were compared with the population by using T test.The correlation coefficient of hospital′grades, measurement levels and test items were evaluated by u test, and the percentage of groups of P>0.05 were collected.The cumulative IQC data′coefficient variation ( CV) of six months and eleven months were compared with the total CV, respectively .Imprecision higher than the professional specification was regarded as unqualified .Difference of unqualified rate among test items, concentrations and years were expolored .Results Rates of hospital′grades, measurement levels , items are 94.2%,100%, 100%respectively , 88%of groups′imprecision became stable in ten months .25%groups reach the criteria that the relative bias is ≤5% when calculated the cumulative IQC data′CV of six months, while 88%groups do when calculated the cumulative IQC data′CV of ten months.The unqualified rate is 20%and the most unqualified item is Ca , the unqualified groups of low level are larger .With increase of year , the unqualified rate showed a downtrend .Conclusions Ten months′IQC data is more reliable to quantify imprecision .Unqualified rates are different according to test items , measure levels and years , the establishment of professional specification should consider them.

Objective To investigate immune status changes in liver transplant patients suffering from early developed sepsis.Methods In this study 19 patients undergoing liver transplantation for severe hepatitis from Oct 2008 to Jul 2009 were enrolled.Immune status was compared between patients of severe hepatitis and 20 healthy volunteers.According to whether early sepsis developed or not,patients were divided into sepsis group (HSS) and non-sepsis group (HSNS).T lymphocyte subgroups of the peripheral blood were compared between post-transplant and pre-transplant in these two groups on different stages.Results Comparing to volunteers,T％ and IFN-γ/IL-4 of severe hepatitis patients significantly decreased,CD4 + CD25 + Foxp3 + Treg( ％ ),Foxp3 mRNA and IL-10 significantly increased.Early sepsis developed in 9 patients.Compared with pre-transplant levels,T％ in both groups significantly decreased on the first day post transplant.T％ in HSNS group increased to the level of pretransplant while T％ of HSS group remained at the low level.Treg％ ( t =3.265,P =0.004 ) and Foxp3 mRNA ( t =2.750,P =0.013 ) of HSNS group on day 14 decreased significantly lower than that before transplantation.Those two parameters of HSS group even increased slightly.IFN-γ/IL-4 in HSNS group increased significantly on day 3 (t =2.261,P =0.036),while there was no change in HSS group.The concentration of IL-10 in both groups significantly decreased,and the level in HSNS group remained at a low level,while that in HSS group increased on day 14.Conclusions Patients with severe hepatitis have weakened immune status.The imbalance of immune status recovers gradually since 7-14 days after transplantation in patients uncomplicated with sepsis.However,the immune status of receipients complicated with sepsis fails to improve.

1. The subnucleus caudalis of the spinal trigeminal nucleus of cat was injected with 30% HRP (Sigma, type Ⅵ). Well localized groups of labeled neurons were observed in the dorsolateral horn of the contralateral red nucleus. This dorsolateral horn, being present in the rostral and middle thirds of the nucleus, consisted mainly of middle-sized and small neurons.2. Injections were also made into the second and third segments of the cervical spinal cord and the caudal part of the bulbar reticular formation. The labeled neurons appearing in these experiments were diffusely distributed in the red nucleus, yet limited in the rostral third of it.3. Summarizing our findings and the data from the literature, we got the impression that the rostral two thirds of the red nucleus gave projections to the central structures rostral to the upper cervical spinal cord, and the caudal two thirds of it to those caudal to the lower cervical cord, which indicating a somatotopic organization of the red nucleus neurons giving descending projection fibers.

HRP solution was injected into the right subnucleus caudalis of the trigeminal nerve in the cat, and the labeled cells in the nucleus raphe dorsalis of six cases were examined and analyzed. The labeled cells appeared more in the middle portion and its rostral adjacent parts of the nucleus raphe dorsalis, decreased in number rostrally and caudally, and were entirely absont in the caudal end of the nucleus. In the ventral part and the ventral areas of the lateral parts of the nucleus labeled cells were more than in the other areas of the nucleus, no difference was found between the two sides. In the dorsal part and the dorsal regions of the lateral parts of the nucleus only a few labeled cells were seen. The labeled cells varied in forms, but in the ventral part and the ventral regions of the lateral parts they were mainly fusiform in shape. In addition, in nucleus raphe magnus, nucleus raphe pallidus, and nucleus raphe obscurus, small numbers of neurones were labeled as well.As the nucleus raphe magnus takes part in the inhibition of the response to noxious stimuli in the spinal dorsal horn, and as both the nucleus raphe magnus and nucleus raphe dorsalis belong to the more developed raphe nuclei and contain more 5-HT neurones, it seems that there might be somatotopic relations between the nucleus raphe dorsalis which projects mainly to subnucleus caudalis and the nucleus raphe magnus which projects mainly to the spinal dorsal horn.

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Objective:To investigate the clinical features and adjuvant chemotherapy of children with medulloblastoma(MB).Methods:Clinical data of 21 pathologically confirmed MB children admitted to the department of pediatrics of Beijing Tongren Hospital affiliated to Capital Medical University from May 2012 to November 2017 were collected to analyze the clinical efficacy and prognosis of multidisciplinary combined treatment.Results:There were 21 children enrolled in the study(15 males and 6 females; median age: 6 years and 3 months). The majority of tumors were from the fourth ventricle(66.7%, 14/21 cases). The most common type of pathological tissue was classic medulloblastoma(61.9%, 13/21 cases). Most of the molecular types was type 4(47.6%, 10/21 cases). There were 15 cases(71.4%)in the high-risk group and the remaining 6 cases(28.6%)in the low-risk group without metastasis(M0 stage). Total tumor resection was performed in 16 cases(76.2%). The patients were followed up to December 2019(median follow-up time was 29 months). After comprehensive treatment, 11 patients died and 6 patients relapsed.The 2-year survival rate was 61.5%, and the 5-year survival rate was 51.1%.Cox regression multivariate analysis showed that the survival rate of children with no tumor spread, short time interval between radiotherapy and surgery was higher( P<0.05). Conclusion:The incidence of MB in boys is higher than that in girls.Whether the tumor is disseminated or not, the time interval between radiotherapy and surgery are independent risk factor affecting the prognosis.Multidisciplinary combination therapy can effectively improve the long-term prognosis.

Objective To explore the relationship between hepatitis B virus (HBV) concentration and hepatocellular carcinoma (HCC) recurrence in HCC patients undergoing orthotopic liver transplantation (OLT). Methods 148 HCC patients associated with HBV infection undergoing OLT were enrolled in the study.Survival analysis was performed using the Kaplan-Meier method.Cox multiple regression analysis was performed to determine the parameters predicting HCC recurrence. Results Survival rates at 1,3 and 5 years were 86%,72% and 72%,respectively,and disease-free survival rate were 79%,71% and 54%,respectively.In this series 43 patients suffered from HCC recurrence.The recurrence rate was 29.1%(43/148),with the mean recurrence time being (13.16 ± 14.17) months (1 ～ 54 months).Exceeding Milan criteria (HR = 9.89; 95% CI 2.30 ～ 42.52; P = 0.002) and pretransplant HBV DNA level ＞ 5log10copies/ml (HR = 2.26; 95% CI 1.01 ～ 5.04; P = 0.047) were significant independent predictors for posttransplant HCC recurrence. Conclusion High HBV DNA load before transplantation is statistically associated with recurrence of HCC after liver transplantation.