OBJECTIVE: Larotaxel is a new chemical structure drug, which has not been marketed worldwide. Accordingly, the standard identification and quantification methods for larotaxel remain unclear. The spectrometric analyses were performed for verifying weight molecular formula, molecular weight and chemical structure of larotaxel. Besides, a quantification method was developed for measuring larotaxel in the liposomes. METHODS: The molecular formula, molecular weight and chemical structure of larotaxel were studied by using mass spectrometry (MS), infra-red (IR), nuclear magnetic resonance (NMR) and ultraviolet-visible (UV-vis) spectrometric techniques. The absorption wavelength of larotaxel was investigated by UV-vis spectrophotometry full-wavelength scanning. Besides, a quantification method was developed by high performance liquid chromatography (HPLC), and then validated by measuring the encapsulation efficacy of larotaxel liposomes. RESULTS: The four spectral characteristics of larotaxel were revealed and the corresponding standard spectra were defined. It was confirmed that larotaxel had the structure of tricyclic diterpenoids, with the molecular formula of C45H53NO14, the molecular weight of 831.900 1, and the maximum absorption wavelength of 230 nm. The quantitative method of larotaxel was established by using HPLC with a reversed phase C18 column (5 μm, 250 mm×4.6 mm), a mobile phase of acetonitrile-water (75:25, volume/volume), and a detection wavelength of 230 nm. The validation study exhibited that the established HPLC method was stable, and had a high recovery and precision in the quantitative measurement of larotaxel in liposomes. In addition, a new kind of larotaxel liposomes was also successfully prepared. The particle size of the liposomes was about 105 nm, with an even size distribution. And the encapsulation efficiency of larotaxel in the liposomes was above 80%. CONCLUSION The present study offers reference standard spectra of larotaxel, including MS, IR, NMR, and UV-vis, and confirms the molecular formula, molecular weight and chemical structure of larotaxel. Besides, the study develops a rapid HPLC method for quality control of larotaxel liposomes.
Chromatography, High Pressure Liquid ; Liposomes ; Magnetic Resonance Spectroscopy ; Taxoids

Pudilan Xiaoyan Oral Liquid has effects in clearing away heat and detoxifying,and is used to treat pharynx and throat swelling caused by the syndrome of excessive heat and toxin accumulation. Its efficacy is to relieve swelling and pain( redness,swelling and hot pain). It is included in the Chinese Pharmacopoeia of 2015 Edition,and has been listed in provincial health insurance directories of Shaanxi,Jiangsu,Liaoning,Hunan,Tianjin,Xinjiang and Hebei. It has been recommended by health departments of Beijing,Chongqing and other provinces as a preferred drug for the prevention and treatment of H1 N1 and HFMD,and listed in the diagnosis and Treatment Guide of HFMD by the Ministry of Health,the Clinical Application Guide of Chinese Patent Medicine edited by the Lung Department Disease Branch of China Association of Chinese Medicine,and the Clinical Practice Guide of Single Administration/Combined Administration of Antibiotics in Treatment of Common Infectious Diseases by China Association of Chinese Medicine. To further improve the clinician's understanding of drugs and better guide the rational clinical application,we invited front-line clinical experts from respiratory department,infectious department and dermatology of traditional Chinese and Western medicine to develop and compile the expert consensus. The consensus fully considered the clinical evidence and the expert clinical experience to give recommendations for clinical problems with evidence support and consensus suggestions for clinical problems without evidence support by the nominal group method.This consensus is based on clinical research evidence and expert experience in a simple and clear format,which provides a preliminary reference for the clinical use of the drug.
China ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Humans ; Medicine, Chinese Traditional ; Nonprescription Drugs

Objective To explore the value of miniprobe sonography (MPS) in differentiating Crohn??s disease (CD) and ulcerative colitis (UC). Methods 46 patients with active inflammatory bowel disease (IBD) were included into the patient group (16 patients with CD and 30 cases with UC). 20 healthy cases ( underwent physical examination in outpatient department) were recruited as the control group. All cases underwent MPS and high sensitive C-reactive protein (Hs-CRP) test.The MPS measurement index include thetotalwallthickness(TWT), mucosal thickness (MT), submucosal thickness (SMT), muscularispropria thickness (MPT), and the number of enlarged colic and paracolic lymph nodes. Results TheTWT, M, SM, MP(mm)and Hs-CRP(mg/L)in CD, UC and control group are 5.84 ± 1.42, 1.48 ± 0.23, 1.88 ± 0.28, 2.31 ± 0.85, 40.58 ± 19.33, 4.74 ± 1.01, 1.79 ± 0.35, 1.41 ± 0.25, 1.32 ± 0.34, 22.41 ± 15.25,2.86 ± 0.23, 0.97 ± 0.13, 1.06 ± 0.11, 0.64 ± 0.0 and 1.70 ± 0.65. TWT, MT, SMT, MPT and Hs-CRP in UC group has significant different with those in controp group(P<0.05). The mean value of TWT, MT, SMT, MPT and Hs-CRP in CD group are higher than those in UC group. M in UC group is higher than that in CE group. The difference is significant(P<0.05). 5 cases in CD and 2 cases with UC had enlarged colic or paracolic lymph nodes. Conclusions The MPS can distinctly observe the changesof different colonic tissue layers and the surrounding tissue structures in IBD patients,which helps for distinguishing active CD from UC.

BACKGROUNDThe efficacy and safety of telmisartan combined with clopidogrel, leflunomide, or both drugs for immunoglobulin A nephropathy (IgAN) are unclear. This study was designed to evaluate the efficacy and safety of telmisartan combined with clopidogrel, leflunomide, or both drugs for IgAN.

METHODSIt is a multicenter, prospective, double-dummy randomized controlled trial. Primary IgAN patients were recruited in 13 renal units across Beijing, China, from July 2010 to June 2012. After a 4-week telmisartan (80 mg/d) wash-in, 400 patients continuing on 80 mg/d telmisartan were randomly assigned to additionally receive placebo (Group A), 50 mg/d clopidogrel (Group B), 20 mg/d leflunomide (Group C), or 50 mg/d clopidogrel and 20 mg/d leflunomide (Group D). The 24-week intervention was completed by 360 patients. The primary endpoint was change in 24-h proteinuria at 24 weeks. A linear mixed-effect model was used to analyze the changes at 4, 12, and 24 weeks. Generalized estimating equations were used to evaluate changes in hematuria grade. This trial was registered at the Chinese Clinical Trial Registry.

RESULTSThe effects of telmisartan combined with leflunomide on changes in proteinuria (0.36 [95% confidence interval (CI) 0.18-0.55] g/d, P < 0.001), in serum uric acid (76.96 [95% CI 57.44-96.49] μmol/L, P < 0.001), in serum creatinine (9.49 [95% CI 6.54-12.44] μmol/L, P < 0.001), and in estimated glomerular filtration rate (-6.72 [95% CI-9.46 to -3.98] ml·min-1·1.73 m-2, P < 0.001) were statistically significant, whereas they were not statistically significant on changes in systolic and diastolic blood pressure and weight (P > 0.05). Telmisartan combined with clopidogrel had no statistical effect on any outcome, and there was no interaction between the interventions. No obvious adverse reactions were observed.

CONCLUSIONSTelmisartan combined with leflunomide, not clopidogrel, is safe and effective for decreasing proteinuria in certain IgAN patients.

TRIAL REGISTRATIONchictr.org.cn, ChiCTR-TRC-10000776; http://www.chictr.org.cn/showproj.aspx?proj=8760.

Adolescent ; Adult ; Benzimidazoles ; adverse effects ; therapeutic use ; Benzoates ; adverse effects ; therapeutic use ; Blood Pressure ; drug effects ; China ; Creatinine ; blood ; Female ; Glomerular Filtration Rate ; drug effects ; Glomerulonephritis, IGA ; blood ; drug therapy ; Humans ; Isoxazoles ; adverse effects ; therapeutic use ; Kidney Function Tests ; Male ; Middle Aged ; Prospective Studies ; Ticlopidine ; adverse effects ; analogs & derivatives ; therapeutic use ; Treatment Outcome ; Uric Acid ; blood ; Young Adult

Objective To evaluate the impact of insulin resistance (IR) on prognosis in nondiabetic acute coronary syndrome patients.Methods In this prospective study,we enrolled 332 nondiabetic patients suffering from acute coronary syndrome.The patients were divided into three groups by HOMA-IR which calculated by formula:low HOMA-IR group (HOMA-IR ＜ 2),44 cases; moderate HOMA-IR group (2 ≤ HOMA2-IR ＜ 6),99 cases; high HOMA-IR group (HOMA≥6) with HOMA index,179 cases.The in-hospital medical records of patients were compared,and all patients were followed up for one year after discharge.Results Incidence of hypertension (P =0.013),dyslipidemia (P ＜ 0.001),faster resting heart rate (P ＜0.001) and number of triple vessel coronary artery disease (P =0.017)in high HOMA-IR group were significantly higher than in low and moderate HOMA-IR group.During follow-up,the major end-point events increased in proportion to IR grade:64.3％ (26/44) in the high HOMA-IR group,54.7％ (52/99)in moderate HOMA-IR group and 41.3％ (74/199)in low HOMA-IR group (P =0.034).Multivariable logistic regression analysis showed that high sensitivity C reactive protein(OR =1.012,95％CI:1.002-1.022,P =0.022),HOMA-IR (OR =1.250,95％ CI:1.043-1.497,P =0.015),triple vessel coronary artery disease (OR =5.914,95％ CI:2.947-11.868,P ＜ 0.001),ischemic changes on ECG(OR =5.495,95％ CI:2.925-10.324,P ＜ 0.001) and low left ventricular ejection fraction (LVEF ≤40％) (OR =13.205,95％ CI:5.000-34.661,P ＜ 0.001) were independent risk factor for major end-point events during follow-up.Conclusions Increased insulin resistance is linked with poor prognosis of nondiabetic patients with acute coronary syndrome.

BACKGROUNDAlthough heart transplantation has become a standard therapy for end-stage heart disease, there are few published studies regarding the use of transplant organs from marginal donors. Here we describe the clinical outcome we have obtained using marginal donor hearts.

METHODSWe analyzed 21 cases of orthotopic heart transplantation for end-stage heart disease performed in our department between September 2008 and July 2010. Of these patients, six received hearts from marginal donors and the remainder received standard-donor hearts. The two groups were compared in terms of both mortality and the incidence of perioperative complications such as infection, acute rejection, and right heart insufficiency.

RESULTSThe 1-year survival rate of both groups was 100%. Only one death was recorded in standard-donor group during follow-up. Patients who received marginal donor hearts (83%) experienced more early complications than did the standard-donor-heart group (13%), but the mortality of the two groups was the same. The duration of post-ICU stay was greater in the marginal donor group than in the standard-donor group, (35.5 ± 17.4) days and (21.7 ± 2.6) days, respectively (P < 0.05).

CONCLUSIONSThe use of marginal donor hearts increases the number of patients who can receive and benefit from transplants. However, it may introduce an increased risk of early complications, thus care should be taken both in the choice of patients who will receive marginal donor hearts and in the perioperative treatment of those for whom the procedure is performed.

Adult ; Antibodies, Monoclonal ; therapeutic use ; Female ; Heart Transplantation ; methods ; Humans ; Immunosuppressive Agents ; therapeutic use ; Male ; Methylprednisolone ; therapeutic use ; Middle Aged ; Recombinant Fusion Proteins ; therapeutic use ; Tissue Donors

Adolescent ; Adult ; Aged ; Blood Banks ; legislation & jurisprudence ; Blood Donors ; legislation & jurisprudence ; Child ; Female ; Hepatitis C ; epidemiology ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Young Adult

BACKGROUNDMyocardial infarction results in tissue necrosis, leading to cell loss and ultimately to cardiac failure. Implantation of skeletal muscle satellite cells into the scar area may compensate for the cell loss and provides a new strategy for infarct therapy. Vascular endothelial growth factor (VEGF) is a promising reagent for inducing myocardial angiogenesis. Skeletal myoblast transplantation has been shown to improve cardiac function in chronic heart failure models by regenerating muscle. We hypothesized that VEGF expression and vascular regeneration increased in infarcted myocardium by skeletal muscle satellite cells, which can promote vascular producing and improve survival environment in infarcted myocardium.

METHODSThe skeletal muscle satellite cells were implanted into the infarcted myocardium in a model through ligated left anterior artery in Louis Inbrad Strain rat. Specimens were got for identifying the expression of VEGF and the density of vascular by immunochemical method at two weeks after implantation.

RESULTSThe proliferation and differentiation of the skeletal muscle satellite cell was very well. The expression of VEGF was higher in the implanted group (146.83 +/- 2.49) than that in the control group (134.26 +/- 6.84) (P < 0.05). The vascular density in the implanted group (13.00 +/- 1.51) was also higher than that in the control (10.68 +/- 1.79) (P < 0.05).

CONCLUSIONThe implanted satellite cell could excrete growth factor that would induce angiogenesis and improve cell survival environment in infarcted myocardium.

Animals ; Cell Proliferation ; Cells, Cultured ; Myocardial Infarction ; physiopathology ; therapy ; Neovascularization, Physiologic ; RNA, Messenger ; analysis ; Rats ; Regeneration ; Satellite Cells, Skeletal Muscle ; cytology ; transplantation ; Vascular Endothelial Growth Factor A ; genetics

Background Myocardial infarction results in tissue necrosis, leading to cell loss and ultimately to cardiac failure. Implantation of skeletal muscle satellite cells into the scar area may compensate for the cell loss and provides a new strategy for infarct therapy. Vascular endothelial growth factor (VEGF) is a promising reagent for inducing myocardial angiogenesis. Skeletal myoblast transplantation has been shown to improve cardiac function in chronic heart failure models by regenerating muscle. We hypothesized that VEGF expression and vascular regeneration increased in infarcted myocardium by skeletal muscle satellite cells, which can promote vascular producing and improve survival environment in infarcted myocardium.Methods The skeletal muscle satellite cells were implanted into the infarcted myocardium in a model through ligated left anterior artery in Louis Inbrad Strain rat. Specimens were got for identifying the expression of VEGF and the density of vascular by immunochemical method at two weeks after implantation. Results The proliferation and differentiation of the skeletal muscle satellite cell was very well. The expression of VEGF was higher in the implanted group (146.83±2.49) than that in the control group (134.26±6.84) (P<0.05). The vascular density in the implanted group (13.00±1.51) was also higher than that in the control (10.68±1.79) (P<0.05). Conclusion The implanted satellite cell could excrete growth factor that would induce angiogenesis and improve cell survival environment in infarcted myocardium.

Animals ; Arteriosclerosis ; drug therapy ; Cholesterol, LDL ; blood ; Drugs, Chinese Herbal ; pharmacology ; Hyperlipidemias ; drug therapy ; Lipids ; blood ; Lipoproteins ; blood ; Lipoproteins, LDL ; blood ; Male ; Rabbits ; Tablets ; Triglycerides ; blood