Drug combination is extensive in the clinical real world,which is an important part and the inherent requirements of the post-marketing evaluation of traditional Chinese medicine (TCM). The key issues and technology include multi-domain and multi-disciplinary such as the rationality, efficacy and safety evaluation of combination drug starting from clinical real world, study on component in vivo and mechanism of combination drug, the risk/benefit assessment and cost-benefit evaluation of combination drug and so on. The topic has been studied as clinical demonstration on combination therapy of variety of diseases such as coronary heart disease, stroke, insomnia, depression, hepatitis, herpes zoster, psoriasis and ectopic pregnancy. Meanwhile, multi-disciplinary dynamic innovation alliance of clinical drug combination has been presented, which can promote the academic development and improving service ability and level of TCM.
Drug Combinations ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; methods

To improve 3-ketosteroid-△1-dehydrogenase(KSDH) activity and the transformation level for androst-4-ene-3,17-dione, 3-ketosteroid-△1-dehydrogenase gene(ksdD) from Arthrobacter simplex was cloned into plasmid pWB980 and expressed in B. subtilis WB600 under the control of promoter P43. The molecular weight of expressed enzyme was about 55kDa by SDS-PAGE analysis. The activitities assayed by spectrophotometrical method of intracellular and extracellular soluble enzyme were 110?0.5mU and 15?0.6mU per milligram of protein respectively. The transformation rate of androst-4-ene-3,17-dione by the B. subtilis recombinant cells was 45.3%. Compared with Arthrobacter simplex, the enzyme activity of KSDH expressed in B. subtilis was improved about 30 fold, and the transformation level of androst-4-ene-3,17-dione by the B. subtilis recombinant cells was improved about 10 fold. The recombinant B. subtilis cells used in biotransformation of steroids provided a new way for steroid medicines production.

The paper is focused on the clinical applications of Tanreqing injection after listing, detecting and analyzing the related blood indicators of patients with allergic reactions based on prospective, multi-center, large sample, registration-type clinical safety monitoring nested case-control study (NCCS) to explore the possible mechanisms of allergic reaction of Tanreqing injection, 3 006 patients cases used with Tanreqing injection were monitored, including 3 cases of adverse reactions and 2 cases of allergic reactions. Each patient of allergic reactions, according to the ratio of 1:4 matches four cases of not adverse reactions as a control group of patients, while 5 healthy and 5 cases of volunteers into the healthy group. We examined the correlation detection of cases of allergic reactions among groups such as T-IgE, IgA, IgG, C3, C4, IFN-g, IL-2, IL-4, IL-6, IL-10. Allergic reactions of Tanreqing injection may be mediated by IgE as type I based on existing research data. This results and conclusions will promote the justifiability and safety of clinical applications.
Adolescent ; Adult ; Case-Control Studies ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Hypersensitivity ; diagnosis ; metabolism ; Interleukin-10 ; metabolism ; Interleukin-2 ; metabolism ; Interleukin-4 ; metabolism ; Interleukin-6 ; metabolism ; Male ; Prospective Studies ; Young Adult

PURPOSE: This study was undertaken to examine the impact of screening and race on breast cancer outcomes in Singapore. METHODS: An institutional database was reviewed, and invasive ductal carcinoma (IDC) and ductal carcinoma in situ (DCIS) data were analyzed separately. Overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS) were assessed. RESULTS: The study included 6,180 IDC and 1,031 DCIS patients. The median follow-up time was 4.1 years. Among IDC patients, Malay women were the youngest when first diagnosed, and were more likely to present with advanced stage disease. Malay women also had the highest proportion of T3 and T4 tumors at 14.2%, compared with Chinese women at 8.7% and Indian women at 9.6% (p<0.001). Malay women had a higher incidence of node-positive disease at 58.3% compared with Chinese women at 46.4% and Indian women at 54.9% (p<0.001). Malay subjects also had higher-grade tumors; 61.8% had grade 3 tumors compared with 45.8% of Chinese women and 52% of Indian women (p<0.001). Furthermore, tumors in Malay subjects were less endocrine-sensitive and more human epidermal growth factor receptor 2 enriched. Malay women had the lowest 5- and 10-year OS, DFS, and CSS rates (p<0.001). After separating clinically and screen-detected tumors, multivariate analysis showed that race was still significant for outcomes. For screen-detected tumors, the OS hazard ratio (HR) for Malay women compared to Chinese women was 5.78 (95% confidence interval [CI], 2.64–12.64), the DFS HR was 2.18 (95% CI, 1.19–3.99), and the CSS HR was 5.93 (95% CI, 2.15–16.39). For DCIS, there were no statistically significant differences in the tumor size, grade, histology subtypes, or hormone sensitivity. CONCLUSION: Malay race is a poor prognostic factor in both clinically and screen-detected IDC. Special attention should be given to the detection and follow-up of breast cancer in this group.
Asian Continental Ancestry Group ; Breast Neoplasms* ; Breast* ; Carcinoma, Ductal ; Carcinoma, Intraductal, Noninfiltrating ; Continental Population Groups ; Disease-Free Survival ; Early Detection of Cancer ; Ethnic Groups ; Female ; Follow-Up Studies ; Humans ; Incidence ; Mass Screening* ; Multivariate Analysis ; Prognosis ; Receptor, Epidermal Growth Factor ; Singapore

The selective side-chain cleavage of phytosterol to 4-androstene-3,17-dione(4-AD)and 1,4-androstadiene-3,17-dione(ADD)by Mycobacterium sp.was described.Because of the similarity in chemical structure between 4-AD and ADD,it is difficult to separate them from the fermentation broth.So far,it has been verified that the ADD can be produced by dehydrogenation of 4-AD.In this reaction,3-Ketosteriod-1-Dehydrogenase(ksdD)plays an important role.The gene knocking out method was used to solve the problem.Partial sequence of ksdD was obtained by PCR which was 631bp in length.Then,a targeting vector pUC19-MK was constructed,which was electroporate into the original strain Mycobacterium neoauru.The method of homologous recombination was used to knock out ksdD gene located in the chromosome of Mycobacterium neoauru.In this way,ksdD would lose its enzyme activity.In the result,5 transformants were screened.The experiments of steroid transformation by the transformants were carried out.The productivity of 4-AD reached 17.52% after 144h,which is 192% higher than the original strain.Meanwhile,the productivity of ADD reached 6.12%,which is 89.9% lower than the original strain.

Objective To evaluate the diagnostic value of MRI in brachial plexus injury.Methods Total 98 patients with brachial plexus injury were examined by MRI before operation.Fifty-four of 98 patients MR imaging were obtained by 0.5 Tesla scanner and other 44 patients were obtained by 1.5 Tesla scanner.The scanning sequences include: SE T_1WI,T_2WI,FFE T_2WI and T_2WI SPIR. Exploration of the supraclavicular plexus was carried out and the MR imaging were compared with the operative finding in 63 patients.Thirty-five patients who had not surgery were followed-up.Results MR imaging found pre-ganglionic injuries in 45 patients and post-ganglionic injuries in 56 patients.Pre-and post-ganglionic injuries simultaneously in 16 patients among them.MR imaging can not find injury sings in 13 patients.The positive rate was 86.73%.MR imaging finding of pre-ganglionic injuries include:(1) Spinal cord edema and hemorrhage,2 patients (4.44% ).(2)Displacement of spinal cord,17 patients (37.78%).(3)Traumatic meningoceles,37 patients (82.22%).(4)Absence of roots in spinal canal, 25 patients(55.56% ).(5)Scarring in the spinal cnanl,24 patients (53.33%).(6)Denervation of erector spine,13 patients (28.89%).MR imaging finding of post-ganglionic injuries include:(1)Trunk thickening with hypointensities in T_2WI,23 patients (41.07%).(2)Nerve trunk complete loss of continuity with disappeared of nerve structure,16 patients (28.57%).(3)Continuity of nerve trunk was well with disappearance of nerve structure,14 patients(25.00%).(4)Traumatic neurofibroma,3 patients (5.36%).Conclusion MR imaging can reveal Pre-and post-ganglionic injuries of brachial plexus simultaneously.MR imaging is able to determine the location (pre-or post-ganglionic)and extent of brachial plexus injury,provided important information for treatment method selection.

To improve 3-ketosteroid-△1-dehydrogenase (KSDH) activity and the transformation level for androst-4-ene-3,17-dione,3-ketosteroid-△1 -dehydrogenase gene (ksdD) from Arthrobacter simplex was cloned into plasmid pWB980 and expressed in B. subtilis WB600 under the control of promoter P43. The molecular weight of expressed enzyme was about 55kDa by SDS-PAGE analysis. The activitities assayed by spectrophotometrical method of intracellular and extracellular soluble enzyme were 110 ± 0.5mU and 15 ± 0.6mU per milligram of protein respectively. The transformation rate of androst-4-ene-3,17-dione by the B. subtilis recombinant cells was 45.3%. Compared with Arthrobacter simplex, the enzyme activity of KSDH expressed in B. subtilis was improved about 30 fold, and the transformation level of androst-4-ene-3,17-dione by the B.subtilis recombinant cells was improved about 10 fold. The recombinant B. subtilis cells used in biotransformation of steroids provided a new way for steroid medicines production.

Objective To investigate the daily total fluoride intake in relating to the prevalence of skeletal fluorosis in two villages in Jiangsu Province,in order to provide the scientific evidences for the control and prevention of endemic fluorosis.Methods Adults sampled from a high-fluoride Village,Wamiao,and a low-fluoride Village,Xinhuai,were surveyed in this study according to the fluoride concentration in their household shallow well.The average daily total fluoride intake from difierent sources and the skeletal fluorosis were investigated in each subject.Then the subjects from two villages were allocated into five subgroups(＜2.00,2.00～,3.00～,4.00～,≥5.00 mg/d),the relation fluoride intake and prevalence of osteofluorosis was analyzed.Results The prevalence of skeletal fluorosis in Wamiao Village was 31.06%(41/132),but no skeletal fluorosis case(0/35)was found in Xinhuai Village.According to the daily total fluoride intake,subjects with higher daily total fluoride intake tended to associated with a higher prevalence of skeletal fluorosis in a significant dose-response relationship(regression equation:y=2.624-6.855x+3.424x2:r=0.997).The benchmark dose lower limitation of daily total fluoride intake with 95% confidencewas 2.50 mg/d calculated according to this dose-response relationship,the reference dose(RfD)was 2.50 mg/d.In Wamiao Village a significant difference was also found between daily total fluoride intake in 41 subjects[(5.09±1.20)mg/d]with X-ray detectable skeletal fluorosis and in 91 subjects[(3.08±1.12)mg/d]without X-ray detectable skeletal fluorosis(t=-9.32,P＜0.01).Conclusions These findings indicate that the daily total fluoride intake has a significant dose-response relationship with the prevalence of skeletal fluorosis in an endemic fluorosis area associated with high-fluoride drinking water;and the RfD in this study was lower than that in the national standard of"Chinese hygienic standard for daily total fluoride intake(WS/T 87-1996)"(3.50 mg/d).

Nineteen comprehensive hospital information system (HIS) data are collected. Cleaning up the database, then analysis the patients' information. Using the basic description method and association rules to analysis the data. Analysis the data come from HIS database, we found that in 2 110 patients, main five complications are Henoch Schonlein purpura nephritis, upper respiratory tract infections, renal insufficiency, virus infection and glomerulonephritis (chronic), treatment of chemical drugs with sugar cortical hormone and anti infection drugs, such as intravenous input cephalosporin drugs. Traditional Chinese medicine with blood-activating and stasis-resolving medicine, heat clearing and detoxifying medicine. Combination scheme with blood-activating and stasis-resolving medicine joint glucocorticoid, followed by blood-activating and stasis-resolving medicine combined antiallergic drugs, heat-clearing and detoxifying medicine combined antiallergic drugs. Promoting blood circulation and removing blood stasis is an important part of traditional Chinese medicine treatment in patients with Henoch Schonlein purpura.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anti-Allergic Agents ; therapeutic use ; Child ; Child, Preschool ; Female ; Glucocorticoids ; therapeutic use ; Hospitals ; Humans ; Infant ; Infant, Newborn ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Purpura, Schoenlein-Henoch ; complications ; diagnosis ; drug therapy ; Young Adult

The study was to research the clinical characteristics of Shenmai injection treating tumor based on hospital information system, including the characteristics of the age, the sex, the dosage, the course of the treatment and the combination drugs. The data of tumor patients injected with Shenmai injection was analyzed. The information was collected from the hospital information system (HIS) in twenty hospitals of grade III-A. The method of frequencies and association rules was used in this reaearch. The patients over 45 years old were up to 3 338, about 79.36% of the whole. The ratio of male and female was 1.73: 1. The hospitalization day between 15 and 28 was most. The complications of the hypertension and coronary heart disease happened most. The support was 5.939% and 5.099% respectively. Fifty-five patients had the traditional Chinese medicine (TCM) syndrome of Qi-Yin deficiency, about 14.78% of the whole. There were 8 491 patients treated with the single dose of 81 to 100 mL, about 48.70% of the whole. The main combination drugs were dexamethasone, tropisetron and maxolon. The confidence was 44.63%, 31.22% and 20.53% respectively. The information from HIS showed that tumor patients used Shenmai injection were most quinquagenarian with smooth condition. The dose of the Shenmai injection sometimes was higher than that of the drug use instructions in clinical. Shenmai injection was most often combined with glucocorticoid, antemetic and nutritional support medicine when treating tumor in clinical.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Drug Combinations ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Hospital Information Systems ; Humans ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Neoplasms ; drug therapy ; Young Adult