ObjectiveTo study the occurrence and influence factors of drug-induced injuries of vital organs caused by traditional Chinese medicine injection.MethodsChina Hospital Knowledge Database (CHKD) from 1993-2013 and case reports concerning adverse effects and drug-induced diseases caused by traditional Chinese medicine injection from Wanfang Data Knowledge Service Platformwere retrieved. Indicator systemwasestablished and relevant contentsweresummarized and analyzed.Results34 types of traditional Chinese medicine injectionswereincluded and 699 drug-induced diseasesweresummarized, taking up 53.98% of the total adverse effects. Among them, the top three included in the drug-induced diseaseswere acanthopanax injection, safflower injection and Mailuoning injection. The non-conformance between the traditional Chinese medicine injections in the literature and instructions mainly reflects unreasonable solvent selection, large compatibility concentration and usage and dosage beyond those specified in the instructions. ConclusionThe occurrence of drug-induced injuries of vital organs caused by traditional Chinese medicine injectionis relatively high, drug instructions shall be strictly followed in accordance with requirements during clinical application.

Etelcalcetide (ParsabivTM) is a second generation calcimimetic agent newly developed by Amgen,mainly used for the treatment of secondary hyperparathyroidism.Etetcalcetide not only decreases calcium concentration by directly binding with the calcium sensing receptor,but also reduces the parathyroid hormone level.The European Union has approved for chronic kidney disease patients with secondary hyperparathyroidism in dialysis with Etelcalcetide injection.This paper summarized the pharmacological effects,pharmacokinetics,clinical trials,and adverse reaction of Etelcalcetide.

Objective To study the effect and safety of conversion from calcineurin inhibitors to rapamycin in kidney transplantation recipients with chronic allograft nephropathy.Methods In 82 kidney transplant recipients enrolled in this study,72 cases were diagnosed as having chronic allograft nephropathy by biopsy.Recipients (SRL group) were administered with rapamycin after withdrawal of calcineurin inhibitors.The doses of CNI in other recipients (non-SRL group) were not changed.Renal function,proteinuria,blood pressure,blood fat,hepatic function and hemogram were observed for 24 months in each group.Results During the follow-up period,serum creatinine level was dropped significantly in SRL group (P＜0.05),but it was increased in non-SRL group (P＜0.05).SRL group showed increased proteinuria,serum cholesterol and triglycerides (P＜0.05),and reduced Plt (P＜0.05).According to the renal function before conversion,the recipients who were administered rapamycin divided into four groups.In group A (Scr ＜ 120 μmol/L),there was no significant difference in diverse variables before and after conversion.In group B (Scr 120-200 μmol/L and Banff Ⅰ-Ⅱ),renal function was improved,and proteinuria alleviated.In group C (Scr 120-200 μmol/L and Banff ＞ Ⅱ),and group D (Scr ＞200 μmol/L),renal function was damaged to varying degrees and proteinuria was deteriorated.Conclusion It is safe and effective for patients with chronic allograft nephropathy to convert from calcineurin inhibitors to rapamycin.

ObjectiveTo investigate the effects of cardioplegic solution enriched with different doses of glutathione on myocardial injury in children undergoing cardiac surgery under cardiopulmonary bypass (CPB).MethodsForty-eight ASA [Ⅱ or Ⅲ patients aged 2-5 yr undergoing repair of ventricular septal defect under CPB were randomly divided into 4 groups (n ＝ 12 each):control group (group C) and cardioplegic solution containing 3 different-dose of glutathione groups ( group G1-3 ).Glutathione 50,75,100 mg/kg were added to cardioplegic solution in group G1-3 respectively.Blood samples were collected before operation (T0),at 30 min after release of aortic cross-clamp (T1),at 6,12,24 h after termination of CPB (T2-4) for determination of plasma cTnI concentration.Myocardial specimens were obtained from right auricle before aortic cross-clamp and 15 min after release of aortic cross-clamp.The ultrastructure of myocardium was examined with scanning electron microscope.A mitochondrial FlaMeng semiquantitative analysis was done.ResultsThe plasma concentration of cTnI at T3,4 were significantly lower in groups G1,2 than in group C.The plasma concentration of cTnI at T1-4 were significantly lower in group G3 than in group C and group G1,2.The quantization score of myocardial mitochondria at 15 min after release of aortic cross-clamp were significantly lower in group G3 than in group C and group G1,2.Micorscopic examination showed that the injury to myocardial ultrastructure was attenuated in group G3 compared with group C.Conclusion Cardioplegic solution enriched with glutathione can reduce myocardial injury induced by CPB in a dose dependent manner.Glutathione 100 mg/kg can exert a visibly protective effect on myocardium.

OBJECTIVE:To provide reference for rational use of Chinese patent medicine. METHODS:The influencing fac-tors of rational use of Chinese patent medicine was investigated in respects of the selection of Chinese patent medicine,drug combi-nation,usage and dosage,clinical evaluation,pharmacoeconomic evaluation. RESULTS&CONCLUSIONS:Chinese patent medi-cine is a characteristic product of traditional Chinese medicine. It is a complex and important issue to use Chinese patent medicine rationally. It should be considered in many ways,not only pay attention to the principle of clinical use of Chinese patent medicine, but also need to carry out clinical evaluation of Chinese patent medicine;at the same time,the economics of Chinese patent medi-cine should be focused on.

Objective To compare the dijference of prostate cancer detection rate (PCDR) between 12 + 1-core biopsy and 6-core biopsy of the prostate system guided by transrectal ultrasonography (TRUS).Methods The clinical data of 2 707 patients with prostate biopsy from July 1999 to June 2012 were retrospectively analyzed.These patients were 54 to 92 years old,mean age was 69 years old.The range of PSA was 0.02-158.56 ng/ml,with an average of 16.97 ng/mt.People in the range of PSA 0-4.00,4.01-10.00,10.01-20.00,20.01-30.00,and ＞ 30.00 were 161,826,827,312,581,respectively.The volume of the prostate ranged from 14.1 to 82.6 cm3,mean 47.9 cm3.The 1 603 cases before the July 2009 were performed 6-core biopsy guided by the finger,followed by 1104 TRUS-guided 12 + 1-core biopsy.In addition,after March 2012,60 patients accepeted the MRI examination before prostate biopsy.The strategy of prostate biopsy was medial 6-core,lateral 6-core,the 13th core was positioned at abnormal signal area of TRUS and MRI.Explore the difference of PCDR medial 6-core,lateral 6-core,systematic 12-and 12 + 1-core,and the difference of 13th core and the other 12 cores,with the cut off value of PSA quartile of 30 ng/ml and PV quartile of 46 cm3.Results Comparison of clinical characteristics of prostate biopsy between positive group and negative group was performed,and the result suggested that The positive outcome of prostate cancer biopsy was related with element such as high PSA,old age [(71.7 ±7.1)vs.(68.3 ± 8.1),P =0.008],large fPSA [(8.5 ± 36.4) vs.(2.3 ± 3.4),P ＜ 0.001],small prostate volume [(41.3 ±22.9) vs.(52.3 ±29.3),P ＜0.001],small value of f/t[(0.12 ± 0.07) vs.(0.17 ±0.10,P ＜0.001)],high density of PSA [(2.04 ± 9.36) vs.(0.32 ± 0.42),P ＜ 0.001],digital rectal examination [72.0％ (522/725) vs.23.1％ (457/1 982),P ＜ 0.001],irregular echo level [41.1％ (695/1 693) vs.28.0％ (284/1 014),P ＜ 0.001],hypoechoic [64.3％ (695/1 081) vs.17.5％ (284/1 626),P ＜ 0.001],microcalcifcation[56.8％ (586/1 032) vs.23.5％ (393/ 675),P ＜ 0.001].PCDR of 12 + 1-core biopsy was significantly higher than lateral 6-core biopsy[41.5％ (458/1 104)vs.37.0％ (408/1 104),P =0.033].However,PCDR of 12-core biopsy had no statistical differences with 6-core biopsy[40.7％ (449/1 104) vs.37.0％ (408/1 104),P =0.081].PCDR of TRUS-guided biopsy was higher than that of finger-guided biopsy in patients with PSA≤30 ng/ml and PV ＞46 cm3 [30.0％ (254/846)vs.22.2％ (284/1 280),P ＜0.001;31.7％ (124/391)vs.18.1％ (131/723),P ＜0.001].PCDR of the 13th core positioned at abnormal signal area of TRUS and MRI was higher than the average PCDR of other 12 cores [70.9％ (107/151) vs.56.6％ (3 109/5 496),P ＜ 0.001].Conclusion PCDR of TRUS-guided biopsy was higher than that of finger-guided biopsy in patients with PSA≤30 ng/ml and PV ＞46 cm3.PCDR of 12 + 1-core biopsy was significantly higher than that of lateral 6-core biopsy.However,PCDR of 12-core biopsy had no statistical differences with that of 6-core biopsy.PCDR of the 13th core positioned at abnormal signal area of TRUS was higher than the average PCDR of other 12 cores.

M2e gene of three copies for H5N1 subtype AIV was synthesized and fused with human mycobacterium tuberculosis hsp70 gene.The fused gene was cloned into the prokaryotic expression vector to get pET-3M2e and pET-3M2e-hsp70.Recombinant protein r3M2e and r3M2e-hsp70 were successfully expressed induced with IPTG and purified with Ni2+-NTA collumn.Following that,the immunity of the recombinant protein was analysized with Western blot.20-day-old AIV non-immunized chickens were vaccined with r3M2e and r3M2e hsp70,at the same time,Trx and KLH-M2e inoculated chickens were served as vector and positive controls.Two weeks after the primary vaccination,every group was boosted with the same vaccine as in the primary vaccination.The humoral immunity of the vaccined chickens was evaluated with antibody detection against M2e,cytopathic suppression test,and indirect fluorescence assay.The cellular immunity was estimated according to lymphocyte subtype analysis with flow cytometry and M2e specific cytokine detection.Four weeks after the boost vaccine,all groups were challenged with 100EID50 AIV of H9N2 subtype,and the virus from swabs was detected with Real-time PCR.Results indicated that r3M2e hsp70 vaccined chicken developed the better humoral and cellular immune response,also,made a better performance compared with r3M2e vaccined group in virus challenge.

Objective To analyze the alterations of serum protein fingerprint in patients with hypertensive disorder complicating pregnancy(HDCP),screen serum biomarker and establish a diagnostic model of HDCP.Methods Surface-enhanced laser desorption lionization-time of flight-mass spectrometry (SELDI-TOF-MS)technology was used to analyze serum including 25 cases of HDCP patients and 30 cases of age-,gravity-and parity-matched healthy term pregnant women on IMAC3-Cu proteinchip before delivery. Biomarker Wizard and Biomarker Pattern software was used to detect protein peaks significantly different between HDCP and controls,and establish a primary diagnostic model of HDCP.This model was further evaluated by blind test using other 16 parts of serum protein fingerprint.Results Ten protein peaks were significantly different at the molecular range of 2000-50 000(P

Lifitegrast is a novel inhibitor of integrin,which can take effect by blocking the binding of intercellular adhesion molecule 1 and integrin lymphocyte function associated antigen 1.In July 2016,the U.S.Food and Drug Administration (FDA) officially approved the application of lifitegrast ophthalmic solution 5％ (commodity name XiidraTM).Clinical trials of the drug include a 12-week phase II clinical trial and three 12-week phase III clinical trials for dry eye disease patients.The results of clinical trials have demonstrated the efficacy and safety of the drug.Lifitegrast is the first FDA approved drug to improve and treat dry eye symptoms,and other similar drug is only cyclosporine.It is believed that in the near future clinical application of lifitegrast will be more extensive.

The pharmacokinetics of 6beta-naltrexol (6beta-NOL) following single intramuscular administration and multiple intramuscular injection once per day for seven days was studied in 4 Beagle dogs. Plasma concentration of 6beta-NOL in dogs was analyzed by a combination of high performance liquid chromatography (HPLC) and electrochemical detection with naloxone (NLX) as internal standard. After single intramuscular injection of 0.2 mg x kg(-1) 6beta-NOL, the plasma concentration-time curve of the drug was found to fit to a two compartment model with first-order absorption. The main parameters of single dosing were as follows: t1/2alpha was (0.26 +/- 0.23) h, t1/2beta was (4.77 +/- 1.65) h, C(max) was (81.65 +/- 5.61) ng x mL(-1), t(peak) was (0.27 +/- 0.07) h, CL(s) was (1.20 +/- 0.06) L x kg(-1) x h(-1), V/F(c) was (1.94 +/- 0.15) L x kg(-1), and AUC(0-t) was (166.82 +/- 7.68) ng x h x mL(-1), separately. After multiple intramuscular injection of 0.2 mg x kg(-1) 6beta-NOL once per day for seven days, the plasma concentration-time curve of the drug fitted to a two compartment model with first-order absorption too. The main parameters of the last dosing were as follows: t1/2alpha was (0.19 +/- 0.18) h, t1/2beta was (5.79 +/- 1.50) h, C(max) was (79.82 +/- 10.5) ng x mL(-1), t(peak) was (0.18 +/- 0.08) h, CL(s) was (1.12 +/- 0.07) L x kg(-1) x h(-1), V/F(c) was (2.10 +/- 0.27) L x kg(-1), and AUC(0-t) was (173.23 +/- 9.49) ng x h x mL(-1), separately. The difference of the parameters between the first and the last dosing was not significant, showing that the plasma kinetics of 6beta-naltrexol was not changed after multiple administrations. In the course of multiple administration, the peak and valley concentration of plasma 6beta-naltrexol were (79.03 +/- 10.3) and (1.50 +/- 0.93) ng x mL(-1), respectively. No clear adverse events were noted during this study. These results showed that plasma 6beta-naltrexol fits to a two compartment model with first-order absorption in dog after intramuscular administration and their pharmacokinetic parameters were reported. There was no remarkable change on plasma pharmacokinetics of 6beta-naltrexol after multiple intramuscular administrations.
Animals ; Chromatography, High Pressure Liquid ; Dogs ; Half-Life ; Injections, Intramuscular ; Male ; Naltrexone ; administration & dosage ; analogs & derivatives ; pharmacokinetics