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OBJECTIVE:To investigate the effect of Changji’an capsules on abdominal pain and the molecular mechanism re-lated to calcitoningene-related peptide(CGRP)and corticosterone(CORT)in diarrhea-predominant irratable bowel syndrome(IBS-D)model rats. METHODS:After the rat models of IBS-D were established by the method of separation of breast mick combined with stimulation with acetic acid,the rats were randomly divided into model group(isometric normal saline),pinaverium bromide group(0.018 g/kg),and Changji’an capsules high,medium and low dose groups(2.812 g/kg,1.406 g/kg and 0.703 g/kg),and another SD rats were included in the normal control group(isometric normal saline). The drugs were given to the rats once a day for consecutive 14 d,ig. Injection of normal saline method was adopted to determine the rat’s sensibility to abdominal pain. The en-zyme-linked immunosorbent assay(ELISA)was adopted to determine the content of CORT in the serum of the rats. Subjected to re-verse transcription polymerse chain reaction(RT-PCR)was adopted to determine the expression of CGRP mRNA in the hypothala-mus and colon tissues of the rats. RESULTS:Compared with normal control group,threshold values of arching the back and stick-ing out the abdomen were decreased,the content of CORT in serum and expression of CGRP mRNA in the hypothalamus and co-lon tissues in model group were increased,with significant difference(P<0.01). Compared with model group,threshold values of arching the back and sticking out the abdomen were increased,the content of CORT in serum and expression of CGRP mRNA in the hypothalamus and colon tissues in pinaverium bromide group and Changji’an capsules high and medium dose groups were de-creased;the threshold value of arching the back in Changji’an capsules low dose group were increased,with significant difference (P<0.01 or P<0.05). CONCLUSIONS:Changji’an capsules can improve the abdominal pain in rats with IBS-D by a mechanism that may be related to the decrease in the expression of CGRP mRNA in the hypothalamus and colon tissues and the reduc-tion of the content of CORT in serum.
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OBJECTIVE:To explore the method for the scientific and standard management of clinical trial drugs. METHODS:By theory analysis and empirical analysis,the management model of clinical trial drugs in our hospital was introduced in terms of software and hardware construction of clinical trial pharmacy,the formulation of drug management system and standard operation procedure,regular quality control and drug information management platform construction,etc. RESULTS:In the experience of our hospital,it could safeguard the safety of drug use in subjects and scientificity and preciseness of drug clinical trial results through the concentrated administration trial drugs by full-time pharmacists according to national laws and regulations,management system and standard operation procedure,and regular quality control inspection by quality control group. CONCLUSIONS:Drug clinical trial institute strictly abide the requirements of Good Clinical Practice,strengthen the management of trial drugs and im-prove information management continuously,which is of important significance to construct standardized,detailed and high-effi-ciency centralized management system of clinical trial drugs.
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OBJECTIVE:To provide reference for rational drug use in the clinic. METHODS:The cases of disulfiram-like reac-tion collected from the First Affiliated Hospital of Guangzhou University of TCM from July 1st in 2012 to June 30st in 2014,were analyzed and compared retrospectively. The epidemiological characteristics,causes,clinical characteristics and treatment methods were summarized. RESULTS:Disulfiram-like reaction mainly occurred in male(86.59%),mainly in young and middle-aged men aged 21-50 years old (78.05%). It might be induced by using cephalosporin antibiotics (as cefoperazone,cefperazone/sulbactam, etc.),nitroimidazole (as metronidazole,tinidazole,etc.),drinking or contacting beverage,food or drug containing ethanol. This reaction involved the skin and its accessories system,circulatory system,digestive system,nervous system,respiratory system, etc. Its clinical manifestations mainly were skin flush,chest tightness,shortness of breath,palpitation,nausea,vomiting,dizzi-ness,headache,etc.,occasional confusion,drowsiness,xerostomia,etc. Response to the severe disulfiram-like reaction,the foun-dation treatment combined with symptomatic treatment showed a good effect with remission of symptoms in 1 to 3 hours and no deaths. CONCLUSIONS:When the drugs with mercapto-1-methyltetrazole perssad as cephalosporin antibiotics,nitro imidazoles, etc.,are used,we should avoid drinking or taking drugs or food containing ethanol,to prevent the occurrence of disulfiram-like re-action.
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To investigate the effects of carbamazepine (CBZ) on the plasma concentrations of valproic acid (VPA) and its toxic metabolite 2-propyl-4-pentenoic acid (4-ene VPA) in epileptic patients, the plasma concentrations of VPA and 4-ene VPA were determined, and the effect of CBZ on pharmacokinetics of VPA was evaluated. All patients had been divided into two groups (VPA group, n = 87; and VPA+CBZ group, n = 19). As compared to VPA group, the combination of CBZ significantly (P < 0.01) decreased the trough concentration of VPA [VPA group, (69.5 +/- 28.8) microg x mL(-1); VPA+CBZ group, (46.3 +/- 25.6) microg x mL(-1)] and does-adjusted VPA trough concentration [VPA group, (4.89 +/- 2.21) microg x mL(-1) x mg(-1) x kg(-1); VPA+CBZ group, (3.14 +/- 1.74) microg x mL(-1) x mg(-1) x kg(-1)]. However, the addition of CBZ did not influence the concentration of 4-ene VPA. The present study revealed that coadministration of CBZ can reduce VPA plasma concentration and may impact VPA clinical effect, therefore therapeutic drug mornitoring of VPA should be used when combined use of CBZ and VPA.