ABSTRACT
Objective:To investigate the influencing factors of the therapeutic effect of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) in patients with epidermal growth factor receptor (EGFR) mutant advanced non-small cell lung cancer (NSCLC).Methods:The clinical data of 104 EGFR mutant advanced NSCLC patients who received EGFR-TKI treatment in Wuxi No.2 Hospital Affiliated to Nanjing Medical University from January 2015 to October 2019 were collected. The correlation of different types of EGFR mutation with the clinicopathological characteristics, the hematological examination results and the treatment mode of patients was analyzed. Cox proportional hazard model was used to analyze the association of the progression-free survival (PFS) time of patients receiving EGFR-TKI treatment with the different types of EGFR mutation, the clinicopathological characteristics, hematological related indexes and treatment mode. Kaplan-Meier method was used to analyze the independent influencing factors for the PFS of the stratified patients.Results:The overall disease control rate (DCR) of patients receiving EGFR-TKI treatment was 92.3% (96/104). Cox univariate analysis showed that the levels of carcinoembryonic antigen (CEA), carbohydrate antigen 125 (CA125), D-dimer, and previous surgical treatment history of patients receiving EGFR-TKI treatment were associated with PFS of patients (all P < 0.05). Cox multi-factor analysis showed that EGFR mutation type ( HR =2.371, 95% CI 1.298-4.332, P = 0.005), combination therapy ( HR = 0.489, 95% CI 0.245-0.978, P = 0.043) and choice of therapeutic drugs ( HR = 0.261, 95% CI 0.113-0.606, P = 0.002) were independent influencing factors for the PFS of patients receiving EGFR-TKI treatment. The PFS of EGFR 19 exon-mutant patients with advanced NSCLC was longer than that of those with EGFR 21 exon-mutant (median PFS time: 14.0 months vs.9.5 months, P<0.05); the PFS of combination of radiotherapy or chemotherapy was longer than that of EGFR-TKI single therapy (median PFS time: 15.0 months vs. 9.0 months, P<0.05), the PFS of patients receiving erlotinib was better than that of those receiving gefitinib ( P<0.05). According to EGFR mutation types, it was found that EGFR 19 exon-mutant patients receiving EGFR-TKI in first-line treatment could obtain better PFS than those who receiving EGFR-TKI in second-line and above treatment (median PFS time: 14.0 months vs. 9.5 months, P<0.05). When receiving EGFR-TKI, EGFR 19 exon-mutant patients with CA125 <85 U/ml could obtain longer PFS time than those with CA125 ≥85 U/ml (median PFS time: 14.0 months vs. 6.5 months, P<0.05). Conclusions:The therapeutic effect of EGFR-TKI in EGFR-mutant patients with advanced NSCLC is positive. EGFR 19 exon-mutant NSCLC patients with low-level CA125 receiving EGFR-TKI in first-line treatment can obtain better PFS.
ABSTRACT
Objective To investigate the preliminary clinical efficacy of percutaneous plate internal fixation with fracture reduction oriented forcep in the treatment of lower humeral fractures. Methods A retrospective case control study was conducted to analyze the clinical data of 46 patients with lower humeral fractures admitted to Wuzhong People's Hospital of Suzhou from October 2013 to March 2015. There were 25 males and 21 females, aged 19-76 years, with an average age of 45. 7 years. A total of 22 patients ( percutaneous group) were treated with minimally invasive percutaneous internal fixation with self-developed fracture reduction oriented forcep according to the dimensionality reduction method (DRM). The other 24 patients (control group) were treated with open reduction internal fixation. The length of incision, operation time, intraoperative blood loss, fracture healing time, the American Foot and Ankle Surgery Association ( AOFAS ) ankle-hindfoot score at the last follow-up, and postoperative complications were compared between the two groups. Results All patients were followed up for 12-24 months, with an average of 14. 6 months. There were statistically significant differences between percutaneous group and control group in incision length [(7.1 ±0.8)cm vs. (8.8 ±0.7)cm, operation time [(32.5 ±4.9)min vs. (39.2 ±4.3)min], intraoperative blood loss [(8.0 ±2.7) ml vs. (31.0 ± 11.4)ml], and fracture healing time (16.4 ±2.3)weeks vs. (19.5 ±2.9)weeks], respectively (all P<0.05). In percutaneous group, the AOFAS ankle-hindfoot score was (92.3 ±5.9)points (range, 75-99 points ) , and the overall results were good and excellent in 21/22 ( 96％) including excellent results in 18 patients, good in three, fair in one and poor in 0. In control group, the AOFAS ankle-hindfoot score was (91.8 ±4.9)points (range, 76-99 points), and the overall results were good and excellent in 23/24 (96％) including excellent results in 20 patients, good in three, fair in one and poor in 0. There was no significant difference in the excellent and good rate between two groups (P>0. 05). Poor wound healing was observed in one patient in control group. No case of nonunion was found in either group. Conclusion For lower humeral fractures, the percutaneous plate internal fixation with fracture reduction oriented forcep has the characteristics of simple operation, shortened operation time, reduced soft tissue injury and blood loss, and quick healing of the fracture, which is worthy of clinical application.
ABSTRACT
Background The extraocular muscles (EOMs) Pulley in primate is related to the function of EOMs,but there are arguments about that.The location of rabbit's eyes is different from the primate.Study on the structure of the extraocular muscle connective tissue in rabbit may play a role to analyze the function of the EOMs Pulley.Objective The structure of the connective tissue around EOMs in rabbit was studied,the difference between this structure in rabbit and homan' s EOMs Pulley in past reports was analyzed,and then,the role of EOMs Pulley to ocular movement was investigated.Methods Five adult rabbits were involved.The gross anatomy of an orbit in each rabbit was observed.The other orbit was processed with paraffin imbedding and coronal serial sections.A murine monocolonal antibody to α-smooth muscle actin(α-SMA) was used to show the smooth muscle,while Weigert stain was used to show muscle and collagen,and Masson trichrome stain to show the elastin.Results An encircling ring of collagen circled every EOM.The collagen ring was thin and connected to the orbital layer muscle fiber loosely.Collagen tissues coupled to adjacent EOMs.Less elastin fibers and scanty the smooth muscle cells were embedded in the collagen.Conclusions The connective tissue around rectus in rabbit is different from that in human with developed binocular ocular movements.It shows that connective tissue around EOMs may be related to the function of ocular movements.
ABSTRACT
Objective To investigate the rationality and safety of dengzhanxixin injection used in elderly inpatients. Methods The clinical data of 986 inpatients including 620 males and 366 females were collected, and questionnaires containing age, sex, discharge diagnosis, symptoms, drug dosage, course of treatment, laboratory examination, adverse drug reaction and drug effect were analyzed. Results For the 986 cases, the average age was(74.3±7.5)years. The average dose of dengzhanxixin injection was (38.2±4.4) ml, once daily by intravenous drip, and the average period of treatment was (10.8±5.2) days. The adverse reaction rate was 0.81%. The levels of blood glucose and hemoglobin were decreased after treatment(t orμ=1226.5,2620.0, both P<0.05), but there were no statistical differences in the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN) and white blood cell count (WBC) before and after treatment (t or μ=122.5, 405.0, 513.5, 996.5, 956.5, all P>0.05). Conclusions It is safe to use dengzhanxixin injection according to the medication description for elderly inpatients.
ABSTRACT
Objective To develop a method for measuring serum total glycerol by isotope dilution (ID)liquid chromatography tandem mass spectrometry(LC/MS/MS).Methods Serum samples were mixed with [13C3]-glycerol(internal standard)and treated with alcoholic potassium hydroxide to hydrolyze serum glycerides to glycerol.The natural glycerol and the internal standard were benzoylated with the Schotten-Baumann reaction and the benzoates were analyzed by LC/MS/MS.Results The correlation coefficients between the peak area ratios and glycerol concentrations were 0.999 9 and higher.The withinrun coefficients of variation(CV)for serum total glycerol analysis averaged 0.94%(ranged 0.21%～2.62%)and the total CV 1.15%(0.62%～2.00%).Results on certified reference materials(SRM 909b Level Ⅰ and LevelⅡ;GBW 09146 and GBW 09147)showed an averaged bias of 0.20%(-0.20%～1.06%).Conclusions An ID-LC/MS/MS method for serum total glycerol has been developed.The method iS highly specific and precise and may be used as a candidate reference method for serum total glycerol measurements.
ABSTRACT
OBJECTIVE:To evaluate the current status and future trend of antibacterials utilization in our hospital.MET-HODS:A retrospective analysis was conducted on the use of antibacterials in our hospital in 2003～2005,covering sales value and application density(AD).RESULTS:Antibacterials as used in our hospital had been high in AD for the three years.In ran-ked order,the top three subcategories were quinolones,macrolides and lincosamides,represented respectively by levofloxacin,azithromycin and clindamycin.CONCLUSIONS:Antibacterials as used in our hospital are high in AD.Administration of antibacterials use during the perioperative period should be specially strengthened to avoid irrational combination medication.
ABSTRACT
Objective:To analyze adverse drug reactions(ADRs)associated with proprietary Chinese medicine occurring in Beijing Hospital.Method:The ADRs associated with proprietary Chinese medicine between 2002 and 2006 were collected and the associated information was retrospectively analyzed.Result:a total of 179 ADRs were analyzed. Most of them occurring in women patients(76.1%)with hyperplasia of mammary glands who took Xiaojin pills and Xi- huang pills(22.1% & 12%).The herbal medicine injections were the other most associated ones.The clinical appearances of ADRs were rash and bodily manifestation of hypersensitiveness.Condusion:The investigation of Chinese medicine ADR plays a very important role in the modernization of Chinese medicine.
ABSTRACT
OBJECTIVE:To evaluate1812cases of therapeutic drug monitoring(TDM)and the clinical drug utilization of cyclosporine.METHODS:Analysis and statistics of cyclosporine TDM data of1812cases(502subjects)in our hospital were carried out.RESULTS:Among all the1st TDM concentration,only41.4%was within the therapeutic window.Constituent ratios of patients whose drug concentration were monitored once,twice,or three times respectively was44.8%,16.3%and11.6%respectively.Among all the subjects undergoing3～4times of TDM,constituent ratio of patients whose drug con-centrations of the1st,2nd,3rd and4th TDM are within therapeutic window are40.6%,48.0%,50.0%and57.9%respec-tively.CONCLUSION:Although TDM is widely used,for some reasons,the constituent ratio of drug concentration within therapeutic window is low and the TDM times are much less than enough.Even TDM is multiple,the status of is not satisfac-tory,So clinics should pay more attention to the phenomenon that the patients’medication can’t be adjusted properly;Mean-while,it correlates with the expensive medication costs,etc.
ABSTRACT
OBJECTIVE:The aim of this study was to assess the irrational use of vancomycin to treat infections of the patients with severe renal dysfunction.METHODS:Combining the results of blood concentration monitoring for vancomycin and the clinical symptoms with Micromedex Kinetidex,we evaluated whether the vancomycin was administered rationally when the infected patients with severe renal dysfunction were treated.RESULTS:It really existed that the vancomycin was irra?tionally used among these three patients:①The first loading doses did not match the saturation principle.②Administration interval did not be regulated in time along with the T 1/2 change.③The clinical doctors did not clearly understand that the hem_ odialysis can not efficiently remove vancomycin from the blood.CONCLUSION:For the infected patients with severe renal dysfunction,it is necessary to monitor the serum concentration of vancomycin in order to insure the rational use of vancomycin to treat these infected patients.
ABSTRACT
OBJECTIVE:The bioequivalence and pharmacokinetics of two kinds of domestic meloxicam tablets were studied in 20 healthy male volunteers METHODS:A dose of 15mg of domestic or imported meloxicam(test and reference preparation)was given according to arandomized 2-way cross-over design,blood samples were withdrawn up to 96 hours post administration,and plasma concentration of meloxicam was determined by high performance liquid chromatography(HPLC)method RESULTS:The peak plasma levels(Cmax)of meloxicam test drug and reference drug were (2 736 2?312 0)and(2 665 6?333 8)?g/L,respectively,the peak time(Tmax)were(4 25?1 16)h and(4 00?1 30)h,respectively,T1/2ke were(21 67?3 81)h and(21 05?3 30)h,respectively,and AUC0～t were(96 454 6?25 526 6)and(95 692 5?24 532 6)?g/(h?L),respectively There were no significant differences in AUC0～t,Tmax,Cmax and T1/2ke between two kinds of tablet CONCLUSION:The relative bioavailability data obtained in the study furnished definite proof of bioequivalence of both domestic meloxicam tablets and imported meloxicam tablets The relative bioavailablility of the test drug was(101 3?11 9)%
ABSTRACT
AIM To study bioequivalence of bambuteral and its metablites terbutaline in 20 healthy male volunteers. METHODS A single oral dose of domestic or imported bambuteral tablet was given according to a randomized 2-way cross-over design. The plasma bambuteral and terbutaline concentrations were determined by HPLC/MS. RESULTS The pharmacokinetic parametrs of domestic and imported bambuteral: AUC0-t were (52±21) μg*h*L-1 and (51±20) μg*h*L-1, Tmax were (2.9±0.9) h and (2.6±0.7) h, Cmax were (6.0±2.6) μg*L-1 and (6.2±2.9) μg*L-1, T1/2Ke were (11.2±2.3) h and (11.2±1.9) h, respectively; terbutaline: AUC0-t were (191±30) μg*h*L-1 and (197±37) μg*h*L-1; Tmax were (4.2±1.0) h and (4.2±1.0) h; Cmax were (10±5) μg*L-1 and (10±4) μg*L-1; T1/2Ke were (20±3) h and (21±4) h, respectively. The bioavaiability of the domestics was 102%±8% (bambuteral) and 100%±12% (terbutaline). CONCLUSION The results demonstrate that the two forms of bambuteral and terbutaline were bioequivalent by analysis of variance, two-one sided test and 90% confidential limit.
ABSTRACT
OBJECTIVE:To study the bioequivalence of suspension formulation of cefixime(A),capsule formulation of ce-fixime(B) and reference preparation(C: Cefixime Capsules or Cefspan) in human body.METHODS: The study was conducted as a 3- way crossover design in 18 healthy volunteers whose plasma concentrations of cefixime were determined by HPLC after receiving a single oral dose of 200 mg trial preparations or reference preparation.RESULTS:The main pharmacokinetics of the three preparations(A、B、C) were as follows after undergoing BIO3 program fitting:AUC0-1 were(18.54?6.31)mg?h-1?L-1, (16.10?5.51)mg?h-1?L-1 and (17.16?5.96)mg?h-1?L-1, Cmax were(2.63?0.76) mg?L-1, (2.43?0.78)mg?L-1 and (2.57?0.90)mg?L-1;tmax were(4.11?0.58)h,(4.56?0.51)h and (4.56?0.70)h,respectively .The relative bioavailability of cefixime suspensions(A) and cefixime capsules(B) were (108.8?12.3)% and (95.7?15.9)% ,respectively as against reference preparation(C) .CONCLUSION:The test formulations(A and B) were found bioequivalent to the reference formulation(C).
ABSTRACT
OBJECTIVE:To realize automatic central drug dispensing model in hospital pharmacy.METHODS:The construction,running condition,major function and flow-sheet of automatic oral drug dispensing system of our hospital was introduced,and the automatic drug dispensing system was compared with traditional dispensing system.RESULTS:The automatic oral drug dispensing system could enhance the speed and accuracy of drug dispensing,shorten waiting time of nurse,improve health condition and decrease medicine pollution.CONCLUSION:The automatic oral drug dispensing system is suitable for drug dispensing in hospitals and conducive to the enhancing of pharmaceutical care level.
ABSTRACT
OBJECTIVE: To discuss the characteristics and regular pattern of the adverse drug reactions(ADR) in our hospital.METHODS: A total of 314 ADR case reports collected by ADR monitoring center in our hospital during 2007 were analyzed statistically.RESULTS: 13 categories(178 kinds) of drugs and 338 cases were involved in the total 314 ADR case reports,mainly anti-infective agents(128 cases,38 kinds) and Chinese drugs preparation(51 cases,20 kinds).The ADR were manifested chiefly as lesions of skin and its appendants(134 cases) followed by gastro-intestinal lesion(56 cases).The patients showed a favorable turn and the death occurred in only 1 case.CONCLUSION: More attention should be paid to the monitoring of rational drug use to avoid or reduce the incidence of ADR.