Chinese Journal of Clinical Pharmacology and Therapeutics

Effect of pretreatment with pentamethylquercetin on mitochondrial function in rat cardiomyocyte

WAN Qing, PENG Yi-an, LIU Dan, HUANG Huang, LIU Ji-chun, HE Ming

2013, 18(1): 1-5.

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AIM: To explore the protective effect of pretreatment with pentamethylquercetin(PMQ) on anoxia/reoxygenation (A/R) injury and mitochondrial function in rat cardiomyocytes. METHODS: Primary neonatal SD rat cardiomyocytes were cultured and pretreated with PMQ in final dose of 10, 30, 100 μmol/L for 24 h, and then underwent A/R injury. After treatment, the activity of LDH was determined by auto-biochemistry analysator, cells viability was analyzed by MTT, cell apoptosis and mitochondrial membrane potential were detected by flow cytometry, opening of mitochondrial permeability transition pore (mPTP) was determined by Ca²⁺-induced swelling of isolated cardiac mitochondria.RESULTS: Pretreated with different dose of PMQ (10, 30,100 μmo/L) for 24 h could reduce LDH activity, increase cell viability, decrease cell apoptosis(P<0.05 or P<0.01)in dose-dependent manner; Moreover, pretreated with 30, 100 μmol/L PMQ for 24 h, mitochondrial membrane potential could be more stable(P<0.05 or P<0.01), and the opening of mPTP could be more lessened(P<0.05 or P<0.01). CONCLUSION: Pretreated with PMQ for 24 h could have Pharmacology delay protection, the mechanism involved in stabilizing mitochondrial membrane potential, inhibiting mPTP opening, and reducing cell apoptosis.

Effects of naringin and naringenin on the level of peroxisome proliferator-activated receptors δ in monocyte of diet-induced obese rats

YANG Ying, YUAN Bin, ZHOU Chun-yang, CHENG Long-xian

2013, 18(1): 6-10.

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AIM: To study the effects of naringin and naringenin on the expression of peroxisome proliferator-activated receptors δ(PPAR-δ) in peripheral blood monocyte of diet-induced obese rats. METHODS: The experimental animals were divided into normal diet control group, high-fat diet control group and high-fat diet groups treated with high or low dose of naringin and naringenin, respectively.After treated by high lipid emulsion garage except for normal diet control group, the high-fat diet rat models were established successfully.Then, vehicle (0.5%CMC) or different dosages of naringin or naringenin had been given to the rats for 8 weeks.The PPAR-δ mRNA expression was detected by reverse transcription polymerase chain reaction ( RT-PCR) , the serum levels of triglyceride, total cholesterol, high density lipoprotein-cholesterol,low density lipoprotein-cholesterol and very low density lipoprotein-cholesterol were measured respectively.RESULTS: Compared with the high-fat diet control group,the levels of triglyceride, total cholesterol, low density lipoprotein-cholesterol and very low density lipoprotein-cholesterol were decreased in high dose of naringin and naringenin groups(all P<0.01);the level of high density lipoprotein-cholesterol was increased(P<0.01);the expression of PPAR-δ mRNA in peripheral blood monocyte in high dose of naringin and naringenin groups was increased (P<0.05).The positive correlation between PPAR-δ(r=0.158, P<0.05) and triglyceride, total cholestero(r=0.147, P<0.05) were observed through correlation analysis. CONCLUSION: The high dosages of naringin and naringenin might reduce the levels of serum lipid and increase the expression of PPAR-δ in peripheral blood monocyte.

Effects of Agrimoni Pilosa aqueous extract on platelet aggregation, coagulation function and hemorheology

FEI Xian-ming, CHEN Yan, WU Wan-fei, JIANG Lei, QIU Lian-nv, ZHOU Yong-lie

2013, 18(1): 10-16.

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AIM: To observe the in vitro effects of Agrimoni Pilosa aqueous extract on platelet aggregation, coagulation function and hemorheology, and to explore its related mechanisms of action on hemostatic and coagulation function. METHODS: Platelet rich plasma (PRP) and platelet poor plasma (PPP) from volunteers were mixed with 0, 4 , 20 and 80 g/L Agrimoni Pilosa aqueous extract. The maximal platelet aggregation rate (PAR) of PRP induced by adenosine diphosphate (ADP) with platelet aggregation analyzer, expression levels of P-selection and fibrinogen receptor (Fg-R) were detemined by Flow cytometry. Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (Fg) of PPP were detected with blood coagulation analyzer, respectively, blood cloting time (CT) and plasma ionized calcium (Ca²⁺) were detected with manual method and blood-gas analyzer, respectively, coagulable factor VII, VIII, IX and XI were detected by poor factor plasma correcting test. Blood viscosity, plasma viscosity and index of red cell aggregation were measured with hemorheology analyzer. RESULTS: At 4 g/L group, PAR, Fg-R and P-selectin expression levels were significantly lower than those at 0 g/L group (R<0.01). There was negative correlation between extract dose and any one of PAR, Fg-R and P-selectin level, but positive correlation between extract dose and inhibitory rate of platelet aggregation (R<0.01). At 4 g/L group, APTT, CT and FVII levels were remarkably higher , but PT, FVIII, FIX and FXI levels were lower, than those at 0 g/L group (R<0.01). APTT, CT and FVII levels showed positive correlation, but PT, FVIII, FIX and FXI levels showed negative correlation with extract dose (R<0.01). At 4 g/L group, levels of blood viscosity (1 s^-1 and 200 s^-1), plasma viscosity and index of red cell aggregation were markedly higher than those at 0 g/L group (R<0.01). They all indicated positive correlation with extract dose (R<0.01).CONCLUSION: Agrimoni Pilosa aqueous extract has anticoagulation efficacy mainly via platelet aggregation and coagulation function inhibition caused by inhibition of platelet Fg-R activation, secretion reaction and blood coagulable factors of intrinsic pathway, respectively. The extract is able to promote blood coagulating via activating blood coagulable factors of extrinsic pathway and increasing blood viscosity.

The effect and possible mechanism of curcumin on experimental necrotizing enterocolitis

LI Jin-chun, WEI Hong, WANG Xiao-ling, HAO Jing-mei, WEI Xiao-di

2013, 18(1): 17-23.

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AIM: To observe effects of curcumin on oxidative damage in intestines of newborn rats with necrotizing enterocolitis (NEC) , as well as investigate the potential mechanism of NEC. METHODS: Twenty four Sprague-Dawley (SD) rats were randomly divided into 3 groups right after birth. Rats in the groupⅠwere subjected to formula feeding, cold stress, hypoxic-reoxygenation treatment as well as LPS intragastric administration. NEC intestinal damage was evaluated by histological scoring. Animals in group II were managed according to the same way except the intraperitoneal injection with curcumin. Rats in Group Ⅲ were delivered naturally and were dam fed. All rats were weighed every day and sacrificed on the 4th day. Proximal intestines of ileocecal junction were undertaken pathological sectioning and evaluated for pathological scoring by hematoxylin and eosin (HE) staining. The activity of intestines malonaldehyde (MDA),superoxide dismutase (SOD) and the expression of heme oxygenase-1(HO-1) in all rats were also detected respectively. RESULTS: Compared with group Ⅲ, rats in groupⅡshowed better growing development, improved physical activity and milder intestine gross characteristics than groupⅠeven after the same stress. The pathological scores were significant different among these three groups (P<0.05). Intestinal MDA concentration increased with the severity of intestine injure (P<0.05). SOD activities of group I and II decreased than that of group III. There was a significant difference in the first two groups (P<0.05). The expression of HO-1 was significant increased in groupⅠand group Ⅱ.The difference between the two groups was statistical significant (P<0.05).CONCLUSION: Curcumin could alleviate the intestinal injure in the experimental necrotizing enterocolitis rats. The potentional mechanism might be reducing intestinal oxidative damage through upregulating the expression of HO-1, decreasing MDA concentration as well as enhancing the activity of SOD.

Effect of Quercetin on proliferation and invasion of colon carcinoma LOVO cells and the expression level of carcinoembryonic antigen

AN Chang-yong, XIE Gang, TANG Wei-xue, YANG Xiao-ding, ZHANG Cai-quan

2013, 18(1): 24-29.

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AIM: To investigate the effect of Quercetin on proliferation and invasion of colon carcinoma LOVO cells as well as the expression level of carcinoembryonic antigen. METHODS: LOVO cells were treated with Quercetin at various concentrations,then determined for proliferation level by MTT assay,for cell adhesion and invasion of LOVO cell by tumor cell adhere to the vascular endothelial cell assay and transwell chamber invasion assay, and for the expression level of CEA by Immunocellulerchemistry (ICC), Western Blot and RT-PCR.RESULTS: Significantly, Quercetin showed dose-dependent inhibitory effect on proliferation of LOVO cells with an IC₅₀ of about 40 μmol/L, also improved the ability of LOVO cells adhere to the vascular endothelial cells and reduced the invasion ability of LOVO cells. Meanwhile, Quercetin significantly inhibited the protein and mRNA expression levels of CEA in LOVO cells.CONCLUSION: Quercetin has inhibition effect on the proliferation invasion ability of LOVO cells,also inhibit the protein and mRNA expression levels of CEA in LOVO cells.

Empirical study of photodynamic therapy combined with cinobufotalin on transplanted H₂₂ liver cancer by observing its influence on motilin,gastrin

SONG Li-bin, HE Deng-quan, SHEN Min-he

2013, 18(1): 30-33.

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AIM: To discuss the effect of photodynamic therapy(PDT)combined with anti-cancerdrugs cinobufotalin on transplanted H₂₂ liver cancer by observing its influence on motilin,gastrin. METHODS: The tumor inhibition rate and the levels of gastrin and motilin after Methyl esterification of chlorophyll (MECD)combined with cinobufotalin treating transplanted H₂₂ liver cancer were determined.RESULTS: The inhibitory rate of PDT combined with cinobufotalin Group,cinobufotalin Group, PDT Group was 51.69%,33.49%,26.50%,respectively.The motilin and gastrin were maintained at a certain level treated with PDT, it could reduce digestive tract reaction,such as nausea and vomit.CONCLUSION: Experiments show that PDT combined with cinobufotalin can strengthen obviously photosensitive killing effect on mice transplanted H₂₂ liver cancer, meanwhile,it can improve significantly the overall situation of mice. It has a practical significance and deserves recommendation.

Evaluation and calculation of the accumulation index in clinical pharmacokinetics

LI Xian-xing, LI Lu-jin, XU Ling, ZHENG Qing-shan

2013, 18(1): 34-38.

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AIM: To analyze and evaluate the accumulation index (R_ac) in clinical pharmacokinetics of multiple dosing administrations in order to obtain one reasonable method. METHODS: The plasma concentration-time data of arteether was simulated for 1000 subjects in multiple doses administration. The 20-40 subjects were sampled for 1000 time by the Boostrap method and values of R_ac were calculated by the AUC, C_max, C_trough and model. The values of R_ac were evaluated by their distributions. RESULTS: The AUC and C_max method were more stable than the C_trough and model method. If the efficacy or toxicity was related with the concentration, it was appropriate to use the C_max method, and if the efficacy or toxicity was related with the time, it was appropriate to use the AUC method. CONCLUSION: The drug accumulation is related with effectiveness and safety, and the reasonable choice of R_ac calculation method should be based on drug and data characteristics.

Meta-analysis: efficacy and safety of asarone on asthmatic bronchitis

XU Zhe, CHEN Qun, PU Zhi-chen, HU Hua, XIE Hai-tang

2013, 18(1): 39-45.

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AIM: To evaluate the efficacy and safety of asarone injection on asthmatic bronchitis. METHODS: The databases were retrieved from CNKI, VIP, CBM, PubMed,Chinese Technologic Journal Database (Weipu) and Wan Fang Digital Journal Full-text Database(before September 2012). The clinical researches about asarone injection in treating asthmatic bronchitis were collected to evaluate the clinical efficacy and safety by meta-analysis.RESULTS: 19 studies were included.The total effective rate of asarone group was higher than that of control group [OR=4.3 and 95%CI =(3.05,6.08),Z=8.3,P<0.00001].And all of other secondary outcome measures of asarone group including cough days, asthma days, wheeze disappeared time, chest X-ray back to normal time, hospital days were better than those of control group, the difference was statistically significant. Safety of asarone injection could not be evaluated because of the information was limited.CONCLUSION: Asarone injection is effective in the treatment of asthmatic bronchitis.

Relationship between ERCC1 expression and sensitivity of platinum-based chemotherapy in NSCLC: a systematic review

XU Feng-hua, GUO Rong-rong, LI Xin, LONG Li-yan, ZHANG Gui-yun

2013, 18(1): 45-50.

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AIM: To evaluate the relationship between the expression of excision repair cross-complement 1 (ERCC1) gene and platinum-based chemotherapy sensitivity in non-small cell lung cancer. METHODS: Database including Medline (1991.1-2009.12), Pubmed, CBMDisc were searched and randomized clinical trials as well as retrospective case studies were collected. Meta analysis was executed using RevMan 4.2 software. RESULTS: One randomized controlled trial (RCT) and nine case reports were identified and anlyzed. The results of nine case reports indicated that the response rate of ERCC1-negative patients to platinum-based chemotherapy was obviously higher than that of ERCC1-positive patients(P=0.02). One retrospective research reported longer time to progression (TTP) (P<0.05) and two reported longer overall survival in ERCC1-negative patients (P<0.05) compared with those ERCC1-positive patients. The results of RCT indicated that adjuvant chemotherapy significantly prolonged survival among low ERCC1 expression patients compared with observation but not among patients with high ERCC1 expression. Better adjuvant regimen for high ERCC1 patients is needed.CONCLUSION: Low ERCC1 expression patients are benefit from platinum-based chemotherapy, but patients with high ERCC1 expression are not sensitive to platinum-based chemotherapy. ERCC1 is a useful biomarker to clinically predict the efficacy of adjuvant chemotherapy in NSCLC.

SAS programming for sample size and power calculation of measurement data in non-inferior trials

WEN Shi-mei, CHEN Yun-fei, LIU Hua

2013, 18(1): 51-54.

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AIM: To calculate sample size and power of measurement data in non-inferior trials using SAS programming. METHODS: Two calculation method, formula and SAS programming, were compared based on examples and the SAS macro for power was given as well. RESULTS: The calculation results of SAS programming was consistent with the formula, and SAS programming can directly give the result was more convenient without looking-up table to obtain the relevant parameters.CONCLUSION: It is helpful for investigator to have a better understanding at this programming to calculate sample size and power provided in this paper.

Pharmacokinetics of ivabradine in Chinese healthy volunteers

ZHENG Li-yun, GUO Xin, YU Peng, LIU Zhi, MA Yue-hui, YIN Yuan-hua, LUO Xi, CHENG Ze-neng

2013, 18(1): 55-62.

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AIM: To investigate the pharmacokinetics of ivabradine at single doses or multiple doses in Chinese healthy volunteers. METHODS: This open, random and doubled 3×3 latin clinical trial involved 12 healthy volunteers, who received three single doses and then multiple doses. The concentration of ivabradine and its active metabolite S-18982 in plasma were measured by liquid chromatography/tandem mass spectrometry and the pharmacokinetic parameters were calculated using WinNonlin program. RESULTS: The main pharmacokinetic parameters of ivabradine after single doses(5,10,15 mg)were as follows: C_maxwere(19±10),(47±24),(79±41) μg/L, respectively; t_max were(0.7±0.5),(0.6±0.3),(0.5±0.1) h, respectively; AUC_last were (58±32),(138±83),(189±115) μg·h·L^-1,respectively; AUC_inf were (59±32), (140±84), (191±116) μg·h·L^-1,respectively. The main pharmacokinetic parameters of S-18982 after single doses(5,10,15 mg)were as follows: t_max were (3.1±1.2),(7.9±2.8),(15.0±5.4) μg/L ,respectively; t_max were(1.1±0.8),(0.8±0.4),(0.6±0.1)h, respectively; AUC_last were (17±8), (47±19), (76±29) μg·h·L^-1,respectively; AUC_inf were (20±8),(52±21),(85±30) μg·h·L^-1, respectively. The parameters(C_max, t_max, AUC_last, AUC_inf )of ivabradine after multiple doses(5 mg)were(20±7) μg/L,(1.0±0.7)h, ( 67±32) μg·h·L^-1, (69±33) μg·h·L^-1,respectively; The parameters(C_max, t_max, AUC_last, AUC_inf)of S-18982 after multiple doses(5 mg)were:(4.5±1.3) μg/L,(1.1±0.8) h, (34±11) μg·h·L^-1,(39±13) μg·h·L^-1,respectively.CONCLUSION: After 5-15 mg single doses administration, the pharmacokinetic results show that ivabradine exhibits first order kinetic characteristics, but S-18982 is nonlinear. After 5 mg multiple doses administration, ivabradine and S-18982 reach stable state on day 5, and ivabradine shows no accumulation, but S-18982 exists accumulation phenomenon.

Comparative study of corticosteroid injection and home exercise in treatment of adhesive capsulitis

HUANG De-gang, DONG Li-jun, XUAN Hua-bing, HE Hua-zheng

2013, 18(1): 62-65.

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AIM: To assess whether intraarticular corticosteroids improves the outcome of a comprehensive exercise programme in patients with adhesive capsulitis. METHODS: The patients were randomly assigned into two groups: Group A patients were given intraarticular corticosteroid (1 mL, 7 mg compound betamethasone injection+2% lidocaine+2 mL NS), repeated it again two weeks later, followed by a comprehensive home exercise programme. Group B patients were given guide about comprehensive home exercise programme. All injections were done under ultrasound guiding. Record the SPADI scores at 0 weeks,6 weeks and 3 months. Data analysis was performed using VAS 1.0.RESULTS: The scores of Shoulder Pain and Disability Index were statistically different between the two groups at 6 weeks and 3 months, with the better scores in Group A, the difference of the mean between two groups were more than 10 scores.CONCLUSION: Intraarticular corticosteroids have the additive effect of providing rapid pain relief, intraarticular corticosteroid therapy could be advised concomitantly with exercise.

Analysis of therapeutic effect of montelukast in elderly stable patients with moderate on severe chronic obstructive pulmonary disease

ZHAO Tian, GU Liang, DU Jian-zong, QIN Guang-yue

2013, 18(1): 66-70.

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AIM: To evaluate the efficacy and safety of montelukast in elderly patients affected by stable moderate to severe chronic obstructive pulmonary disease(COPD). METHODS: In this randomized, prospective, single-blind, and controlled study, 60 COPD patients treated with formoterol plus budesonide were randomized to receive treatment of oral montelukast for 6 months(montelukast group) or not(control group).The baseline dyspnea index(BDI), the St George's Respiratory Questionnaire (SGRQ) scores, pulmonary function tests(PFTs), induce sputum and the levels of LTB₄ were compared before and after the treatment in two groups.RESULTS: 47 patients had completed the study, no severe montelukast relevant side effects were reported during the observation period. After the treatment,the BDI was increased in the two groups,but the SGRQ score and the percentage of neutrophil of induced sputum were decreased(P<0.05),the pulmonary functions were not markedly improved(P>0.05). Compared with the control group,the percentage of neutrophils of induced sputum in montelukast group was decreased;the BDI,the SGRQ score,the levels of LTB₄ had significant improvement,there were statistically significant difference(P<0.05).CONCLUSION: The treatment of montelukast added to inhaled budesonide and formoterol in elderly stable patients with moderate to severe COPD is effective and safe.

Observation of short-term therapeutic and adverse effect of lentinan and gemcitabine plus cisplatin as the first-line treatment for advanced non-small cell lung cancer

ZHAO Wen-ying, CHEN Dong-yun, CHEN Jing-hua

2013, 18(1): 71-77.

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AIM: To evaluate the short-term therapeutic and adverse effect of lentinan(LNT) and gemcitabine(GEM) plus cisplatin(DDP)(GP regimen)as the first-line treatment for advanced non-small cell lung cancer(NSCLC). METHODS: A total of 71 patients were randomly assigned to two regimens. 71 advanced NSCLC cases diagnosed by clinical pathology or cellular biopsy were divided into control group treated with GP regimen and observation group treated with lentinan and GP regimen. The usage of GP was gemcitabine 1000 mg/m²,d1,d8;cisplatin 25 mg/m², i.v.,d1-d3; for intravenous use in control group; based on the above,in observation group,lentinan was administered by 1 mg, twice a week intravenously.The chemotherapy interval was 21 days,and the clinical therapeutic and adverse effect were assessed after 2 to 4 cycles. RESULTS: Among 35 cases in observation group(LNT +GP group):13 patients had PR,19 patients had SD and 3 patients had PD.RR and DCR was 37.1%(13/35)and 91.4%(32/35)respectively. TTP was 6.8 months,MST was 12.3 months and the 1-year survival rate was 45.7%(16/35);while those of control group (GP group):13 patients had PR,18 patients had SD and 5 patients had PD. RR and DCR was 36.1%(13/36)and 86.1%(31/36)respectively. TTP was 6.5 months,MST was 11.6 months and the 1-year survival rate was 41.7%(15/36).The variance of short-term therapeutic effect had no statistic significance(P>0.05).The improve rate of Karnofsky Performance Status(KPS) was 77.1%(27/35) and 38.9%(14/36)for observation group and control group(P<0.05),respectively.The main side-effects of the two groups included hematologic toxicites,digestive tract reaction and hairloss.The incidence of Ⅲ/Ⅳ neutropenia was significantly less incurred in observation group than that in control group(14.3%/36.1%,P<0.05); The incidence of Ⅲ/Ⅳ nausea and vomiting was less incurred in observation group than that in control group(11.4%/19.4%, P>0.05).CONCLUSION: LNT combined with GP regimen as the first-line treatment for advanced NSCLC can ameliorate life quality,enhance efficacy and reduce side-effects.So lentinan can become an important remedy adjuvant of chemotherapy.

Ziprasidone plus a mood stabilizer in subjects with patients with manic or mixed episode of bipolar disorders

REN Zhi-bin, CHEN Zheng-xin, JIN Wei-dong, MA Yong-chun, CHEN Jiong, XING Bao-ping, WANG He-qiu

2013, 18(1): 78-82.

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AIM: To explore efficacy and safety of ziprasidone combining lithium carbonate or valproate in the treatment of patients with manic and mixed episode of bipolar disorders. METHODS: The 68 patients meeting criteria of manic episode or mixed episode of bipolar disorder in CCMD-3 were randomly divided into experiment group( combination of ziprasidone and lithium carbonate or valproate) and control group( single using of lithium carbonate or valproate) and observed for 6 weeks.The Yong Manic Rating Scale(YMRS) and treatment emergent symptom scale(TESS)were individually used for the assessment of efficacy and safety.RESULTS: The score of YMRS was decreased significantly in the both groups after treatment(F=9.05,P<0.01;F=6.10,P<0.01).And the score of YMRS at 1st weekend in experiment group was significantly higher than that in control group,and this difference sustained for 6 weeks.The cure rate in experiment group was higher than that in control group after treating for 6 weeks.The scores of YMRS in experiment group were 21.4±8.4,14.6±5.5,8.9±3.3,6.5±3.4,respectively at 1 weekend, 2 weekend and 3 weekend;and the scores of YMRS in control group were 23.9±7.2,20.9±8.1,17.8±7.8,12.8±8.9,respectively.There was significant difference between the experiment group and control group(P<0.01). The changes of decreasing score of symptoms were in experiment group 6.1±3.5,12.9±4.8,20.1±5.3,21.4±5.5; and the changes of decreasing score of symptoms in control group were 2.1±3.0,6.8±4.5,11.5±5.6,14.4±5.3,respectively. There was significant difference between the experiment group and control group(P<0.01). The effective rate and cure rate in experiment group was significantly higher than that in control group(68.5% vs 48.5%, χ²=4.47,P<0.05;54.3%vs 18.2%, χ²=9.52,P<0.01). Both groups have not serious side effects. There were no difference in dropout rate due to less efficacy and side effects. CONCLUSION: The effects of ziprasidone combination with lithium carbonate or valproate in the treatment of manic episode and mixed episode of bipolar disorder is better than that of single lithium carbonate or valproate.

Clinical observation of stable angina pectoris with the treatment of Wumei Wan

XIE Xiang-zhi, XU Guo-lei, WU Xin-fang, CHEN Jun

2013, 18(1): 83-85.

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AIM: To observe the clinical efficacy of treatment of stable angina pectoris with Wumei Wan. METHODS: A randomized controlled clinical trial were carried out , 78 patients with stable angina pectoris were randomly divided into Wumei Wan group and control group,patients from Wumei Wan group were treated with Wumei Wan and patients from control group were treated with common treatment. The treatment was lasted for 4 weeks. Clinical efficacy was assessed through the change of clinical symptoms, ECG, Seattle Angina scale score. RESULTS: Compared with the control group,after four weeks of treatment, the improving clinical symptoms and quality of life in Wumei Wan group was better, and there was statistically significant difference (P<0.05);there was statistically significant difference in improving ECG (P>0.05). CONCLUSION: Wumei Wan can effectively improve the clinical symptoms of patients with angina pectoris and improve the patient's quality of life.

Comparing study on therapeutic of outpatients with agitated or anxiety depression by combination of SSRI and sodium valproate RX

XIE JIAN-ping, REN Zhi-bin, MA Yong-chun, TANG Jian-liang, JIN Wei-dong

2013, 18(1): 86-89.

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AIM: To observe the efficacy and safety of selective serotonin reuptake inhibitors (SSRI) collaborating with Sodium Valproate RX on the treatment of depression with agitation or anxiety. METHODS: Totally 80 cases which conform to the diagnostic criteria of depression with agitation or anxiety were randomly divided into the treatment group (using SSRI collaborating with Sodium Valproate RX) and the control group (only using SSRI), each group had 40 cases. The efficacy and safety were assessed by Hamilton Depression Rating Scale (HAMD), Hamilton anxiety rating scale (HAMA), Young Mania Rating Scale (YMRS) and Treatment Emergent Side-Effect Scale (TESS) at pretreated, 1-week, 2-week, 4-week and 8-week after treatment. RESULTS: 2 cases dropout for lost in 40 cases of the treatment group. The effective rate and full remission rate were 28.9%(11/38)and 7.9%(3/38),36.8%(14/38)and 13.2%(5/38),50%(19/38)and 28.9%(11/38),89.5%(34/38)and 52.6%(20/38) at 1-week, 2-week, 4-week and 8-week after treatment in treatment group . Meanwhile 3 cases dropout in 40 cases of the control group for side reactions (1 for swiching to mania ). The effective rate and full remission rate were 21.6%(8/37)and 5.4%(2/37),32.4%(12/37)and 8.1%(3/37),43.2%(16/37)and 18.9%(7/37),54.1%(20/37)and 32.4%(12/37)at 1-week, 2-week, 4-week and 8-week after treatment in control group. Compared with before treatment, the levels of HAMD,HAMA,YMRS had significant difference at 1-week, 2-week, 4-week and 8-week after treatment in two groups (P<0.01).There was no significant difference of the overall number of adverse reaction between the two groups (P>0.05). CONCLUSION: The combination of SSRI and Sodium Valproate RX maybe one of better ways in the treatment of depression.with agitation or anxiety for their better efficacy and higher safety than the sole using of SSRI.

Control study on perospirone and quetiapine in the treatment of senile dementia patients with behavioral and psychological symptoms

ZHOU Yong, WANG Yan, LIU Li-na

2013, 18(1): 90-94.

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AIM: To compare the clinical efficacy and safety of perospirone and quetiapine in the treatment of senile dementia patients with behavioral and psychological symptoms. METHODS: 106 cases of senile dementia patients were randomly divided into the perospirone group and the quetiapine group. The efficacy and adverse reaction were evaluated by Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD), Cohen-Mansfield Agitation Inventory (CMAI), Mini-Mental State Examination (MMSE), Activity of Daily Life (ADL) and Treatment Emergent Symptoms Scale (TESS) in baseline and after 12 weeks of treatment. RESULTS: After 12 weeks of treatment, the efficiacy rate was 82.0% in perospirone group and 85.7% in quetiapine group.There were no significant differences between the two groups (P>0.05). The scores of BEHAVE-AD and other factors were significantly decreased after the 12 weeks of treatment with perospirone, especially factors of hallucinations, behavior disorders and aggressive behavior (P<0.01). The MMSE and ADL scores of two groups after the 12 weeks of treatment were higher than the scores before treatment, but there were no significant differences between before and after treatment. The adverse reactions of perospirone group was lower than that of quetiapine group, but there were no significant differences between the two groups. CONCLUSION: Compared with quetiapine, perospirone has similar efficacy and safety in the treatment of behavioral and psychological symptoms of senile dementia, and fewer adverse reactions were found in perospirone group.

Application of dexmedetomidine combined with propofol used for painless enteroscope

ZHAO Gang, CAI Jian-ming, LU Mu, YU Mi-ling

2013, 18(1): 95-99.

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AIM: To investigate the safety and efficacy of dexmedetomidine(DEX) combined with propofol for sedation of patients undergoing painless enteroscope. METHODS: Sixty six patients with ASA I-II requiring enteroscope were randomized to (Group D, n=33) and (Group P, n=33). After venous pass way was conducted, the mean arterial pressure(MAP), heart rate(HR),hemoglobin oxygen saturation levels(SpO₂)were recorded. Group D received DEX 0.1μg/kg and Group P received saline placebo 3 mL initial loading dose, followed by propofol 1.5mg/kg, according to the body activity and operation time, whether to add propofol 30-50 mg or not. And the consumed dose of propofol, the body movement response, respiratory depression were recorded. RESULTS: Compared with Group D, the total administered dose of propofol, the time of patients awaken, the body activity in Group P were increased. During the painless anesthesia, propofol could lead to the circulation inhibition and the heartbeat was significantly quickened. Dexmedetomidine has little influence on the circulation, but it induced the decreased of heart rate. CONCLUSION: There were more efficacy and safe for DEX combined with propofol for sedation of patients undergoing painless enteroscope.

Research progress on pharmaceutical necessities affecting the cytochrome P450

OUYANG Dong-Sheng, SHUAI Fang-Wen, ZHOU Hong-Hao

2013, 18(1): 99-102.

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Pharmaceutical necessities could affect the activity of cytochrome P450 enzyme(CYP1A2,CYP2C9,CYP2C19,CYP2D6 and CYP3A4) and further influence drug metabolism, efficacy and safety. The biological effect research of pharmaceutical necessities should be taken seriously. This paper summarizes the research progress through reading lots of domestic and overseas relative literatures carrying on the analysis and comprehensive.

Research progress in application of multi-component mixtures of enhancers in transdermal drug delivery

YU Wen-ying, ZHANG Liang, CHEN Guo-shen, YE Jin-cui

2013, 18(1): 103-109.

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Research study showed that multi-component mixtures of enhancers had significant permeation enhancing ability than permeation enhancers alone, with low skin irritancy and low systemic toxicity. It can be concluded that multi-component mixtures of enhancers, will have a better development, while taking further research on permeation enhancement mechanism and high-throughput screening method. According to domestic and foreign literatures, application of multi-component mixtures of enhancers in transdermal drug delivery were presented. The review focused on the following aspects: (1) drug transport across skin; (2) permeation enhancement mechanism; (3) high-throughput screening of transdermal formulations and application practice.

Regulation on miRNA to osteoporosis

WANG Ping, YIN Tao, ZHOU Bo-ting

2013, 18(1): 110-114.

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miRNAs are endogenous non-coding single-stranded small RNA molecule and are predicted to regulate 30% of all human genes by targeting mRNA sequences in their 3'UTR. As important post-transcriptional regulators, miRNAs play a positive role in various biological processes, including proliferation, differentiation, apoptosis, metabolism, and so on. Recent studies have indicated that miRNAs are associated with caner, cardiac disease, diabetes, Parkinson syndrome and multidrug resistance. Herein the article reviews the regulation on miRNAs to osteoporosis.

Benefit-risk Evaluation of Bevacizumab in the treatment of Breast Cancer

WANG Sheng-ye, DU Xiang-hui

2013, 18(1): 115-120.

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Recently, bevacizumab in the treatment of advanced breast cancer is controversial. Although the E2100 had doubled the progression-free survival when bevacizumab was added to chemotherapy, this magnitude of benefit could not be replicated in subsequent studies. Furthermore, individual studies and meta-analyses failed to demonstrate an overall survival benefit with the addition of bevacizumab to different chemotherapy regimens. The US FDA has withdrawn the approval of bevacizumab as a therapeutic option for the treatment of metastatic breast cancer in November, 2011; because that it cannot prolong the overall survival time. In addition, this agent is associated with an increased incidence of serious adverse events such as hypertension, congestive heart failure and thromboembolism, and its cost is likely to be a consideration in its use worldwide. Reevaluation of the benefit-versus-risk is indispensable. Biomarker-based studies aiming to identify the subpopulation of patients most likely to benefit from the addition of bevacizumab to standard chemotherapy in breast cancer should be a research priority in future.

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