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Trastuzumab-induced hepatotoxicity and analysis of adverse drug reaction: a case report

The Chinese Journal of Clinical Pharmacology.2017;33(10):936-938. doi:10.13699/j.cnki.1001-6821.2017.10.019

Objective To analyze the the characteristics,risk factors and treatment of trastuzumab-induced hepatotoxicity in patients with breast cancer.Methods To analyze by a case report of trastuzumab-induced hepatotoxicity in a patient with breast cancer in practice combined with 4 related case reports in literatures.Results and conclution Trastuzumab-induced liver toxicity may have the following characteristics:early occurrence;previous use of medication with the side effect of liver damage may be one of the causes of hepatotoxicity;the grade of hepatotoxicity often reaches grade 3 and grade 4;long duration of liver function recovery;hepatotoxicity induced by trastuzumab may be dose-related.Focusing on past medical history and medication history and regular monitoring of liver function may be one of the effective measures to determine hepatotoxicity intensively and to avoid serious complications.

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Effect of clinical pharmacist intervention on drug compliance and efficacy of patients after acute cerebral infarction

Jin WANG ; Ying-Hao HUO ; De-Qiang LI

The Chinese Journal of Clinical Pharmacology.2017;33(10):939-941. doi:10.13699/j.cnki.1001-6821.2017.10.020

Objective To analyze effect of clinical pharmacist intervention on drug compliance and efficacy of patients after acute cerebral infarction.Methods A total of 73 patients with acute cerebral infarction and intervention were randomly divided into control group (36 cases) and treatment group (37 cases).At the time of discharge,the control group adopted conventional nurse dispensing and short-answer presentation mode.The treatment group was instructed by the clinical pharmacist.Six months later,follow-up and evaluation of the two groups of patients with drug effects and compliance.Results The total effective rate was 70.27％ (26/37 cases) and 47.22％ (17/36 cases) in the treatment group and the control group,respectively.The overall pass rate of the mastery of medication was 78.38％ (29/37 cases) and 52.78％ (19/36 cases).The rate of drug withdrawal was 56.76％ (21/37 cases) and 30.56％ (11/36 cases) respectively.The rates of automatic withdrawal were 0 (0/37 cases) and 19.44％ (7/36 cases) There was statistical significance (P ＜ 0.05).Conclusion Clinical pharmacist intervention can significantly improve the therapeutic effect of patients with acute cerebral infarction after intervention,which improve the degree of medication and medication compliance.

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Clinical trial of polyene phosphatidylcholine capsule combined with Jueming Jiangzhi tablets in the treatment of non-alcoholic fatty liver disease

Di-Fang ZHU ; Bai-Yun ZHAO ; Meng-Fei ZHU

The Chinese Journal of Clinical Pharmacology.2017;33(10):942-944. doi:10.13699/j.cnki.1001-6821.2017.10.021

Objective To evaluate the clinical efficacy and safety of polyene phosphatidylcholine capsule combined with Jueming Jiangzhi tablets in the treatment of nonalcoholic fatty liver disease.Methods A total of 62 patients with nonalcoholic fatty liver disease were randomly divided into control group and treatment group,each group 31 cases.Patients in control group were given polyene phosphatidylcholine capsule 456 mg,three times a day.Patients in treatment group were given Jueming Jiangzhi tablets 2.7 g,3 times a day on the basis of control group.All patients were treated for 2 months.The clinical efficacy,leptin,level of liver function and adverse drug reactions in two groups were compared.Results After treatment,the total effective rate of treatment group was 87.10％ (27/31),had significant difference with that in control group,which was 64.52％ (20/31,P ＜ 0.05).After treatment,the serum leptin in control group and treatment group were (1.08 ± 0.17),(0.76 ± 0.89) μg · L-1,alanine aminotransferase were (50.82 ± 5.59),(34.97 ± 4.03) U· L-1,aspartate aminotransferase were (54.92 ± 6.02),(40.25 ± 4.53) U · L-1,total bilirubin were (30.11 ± 3.35),(27.89 ± 3.09) μmol · L-1,direct bilirubin were (18.02 ± 2.01),(13.60 ± 1.67) μmol · L-1,albumin were (35.92 ±4.45),(42.03 ±4.70) g · L-1,the difference had statistically significant (P ＜ 0.05).The adverse drug reactions in treatment group were mild gastrointestinal disorders,dizziness,headache,rash,total incidence rate of adverse reactions was 9.68％ (3/31 cases).The adverse drug reactions in control group were dizziness headache,vertigo,headache,rash,cirrhosis,total incidence rate of adverse drug reaction was 22.58％ (7/31 cases,P ＞ 0.05).Conclusion Polyene phosphatidylcholine capsule combined with Jueming Jiangzhi tablets in the treatment of nonalcoholic fatty liver disease have a higher clinical efficacy,high safety.

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Diagnosis value of serum pepsinogen Ⅰ , gastrin-17, soluble human leukocyte antigen detection in gastric cancer

Yin-Li TAN ; He-An CHEN ; Fei LIU

The Chinese Journal of Clinical Pharmacology.2017;33(10):945-947. doi:10.13699/j.cnki.1001-6821.2017.10.022

Objective To observe the diagnosis value of serum pepsinogen Ⅰ (PG Ⅰ),gastrin-17 (G-17),soluble human leukocyte antigen (sHLA-G) detection in gastric cancer.Methods Ninety-four cases of newly diagnosed patients with gastric cancer were selected as treatment group Ⅰ,31 patients were divided into stage Ⅰ-Ⅱ and 63 patients with stage Ⅲ-Ⅳ according to TNM stage,another 37 cases of chronic atrophic gastritis patients as treatment group Ⅱ,44 cases of gastric intraepithelial neoplasia patients as treatment group Ⅲ,50 cases of healthy people as control group.The expression levels of serum PG Ⅰ were detected by chemiluminescence immunoassay,serum G-17 and plasma sHLA-G levels were detected by enzyme-linked immunosorbent assay,accorded to the PG Ⅰ,G-17,sHLA-G expression level to draw the receiver operating characteristic (ROC) curve,and the ROC curve of each index were analyzed.Results The peripheral blood PG Ⅰ of treatment Ⅰ,Ⅱ,Ⅲ groups and control group were (52.78 ± 8.14),(65.79 ± 9.07),(66.34 ± 9.15),(76.69±10.31)mg· L-1,G-17 were (9.87 ±0.76),(4.69 ±0.40),(4.69 ±0.40),(3.43±0.21) pmol · L-1,sHLA-G were (83.63 ± 13.29),(56.83 ± 8.58),(54.95 ± 8.37),(37.24 ± 5.91) U · mL-1,had significant difference compared with control group (P ＜ 0.05).The peripheral blood of PG Ⅰ in Ⅰ-Ⅱ group [(58.71 ±7.49)mg · L-1] was significantly higher than Ⅲ-Ⅳ group [(49.55 ± 6.42) mg · L-1].G-17 [(8.97 ± 0.67) pmol · L-1] and sHLA-G [(74.29 ± 8.94) U · mL-1] in Ⅰ-Ⅱ group were significantly lower than Ⅲ-Ⅳ group [(10.33 ± 0.84) pmol · L-1,(88.39 ± 10.38) U · mL-1] (P ＜ 0.05).Diagnosis of gastric cancer AUC in PG Ⅰ,G-17,sHLA-G were 0.792,0.692,0.853,AUC of sHLA-G significantly higher than PG Ⅰ and G-17 (P ＜0.05),PG Ⅰ AUC significantly higher than G-17 (P ＜0.05).The specificity(92.5％) and positive predictive value(88.9％) of sHLA-G were the highest,and the sensitivity(84.7％) and negative predictive value(81.8％) of PG Ⅰ were the highest.Conclusion PG Ⅰ significantly decrease in peripheral blood of patients with gastric cancer,G-17,sHLA-G significantly increase,PG Ⅰ,G-17,sHLA-G can be used as an effective complement for the diagnosis of gastric cancer.

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Clinical trial of gemcitabine combined with fludarabine and cyclophosphamide regimen in the treatment of non-Hodgkin lymphoma

Liang ZOU

The Chinese Journal of Clinical Pharmacology.2017;33(10):948-950. doi:10.13699/j.cnki.1001-6821.2017.10.023

Objective To investigate the clinical effect of gemcitabine combined with fludarabine and cyclophosphamide regimen in the treatment of non-Hodgkin lymphoma.Methods A total of 64 non-Hodgkin lymphoma patients were randomly divided into treatment group and control group,each group 32 cases.Control group was treated with gemcitabine 1000 mg · m-2,intravenous infusion for 30 min.Treatment group was given fludarabine 25 mg · m-2,cyclophosphamide 15 mg · m-2 on the basis of control group,intravenous infusion for 30 min.Four weeks a course,all patients were treated for 3 courses.The clinical efficacy,physical condition score,pain degree and adverse drug reaction in two groups were compared.Results After treatment,total effective rate in treatment group was 96.88％ (31/32 cases),had significant difference with that in control group,which was 78.13％ (27/32 cases,P ＜0.05).Kamofsky scores before and after treatment in treatment group were 58.69 ± 4.13,86.88 ± 3.48,with significant difference (P ＜ 0.05).The visual analogue scale (VAS) in treatment group and control group after treatment were 1.44 ± 1.21,4.13-± 1.36,with significant difference (P ＜ 0.05).There were 4 cases of white blood cells and platelets reduced,3 cases of allergy,1 case of nausea in treatment group,the incidence of adverse drug reactions was 25.00％ (8/32 cases).There were 7 cases of white blood cells and platelets reduced,5 cases of allergy,3 cases of nausea in control group,the incidence of adverse drug reactions was 46.88％ (15/32 cases),with no significant difference (P ＜ 0.05).Conclusion The clinical efficacy of gemcitabine combined with fludarabine and cyclophosphamide regimen in the treatment of non-Hodgkin lymphoma is better than single application of gemcitabine.It can not only improve patients' physical condition,but also can relieve the pain.

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System evaluation of the effect and safety of double maintenance-dose clopidogrel on patients after percutaneous coronary intervention

Yue CHEN ; Hui TIAN ; Wan-Yu FENG

The Chinese Journal of Clinical Pharmacology.2017;33(10):951-953. doi:10.13699/j.cnki.1001-6821.2017.10.024

Objective To evaluate the effect and safety of double maintenance-dose clopidogrel on patients after percutaneous coronary intervention.Methods We searched CNKI,VIP,CBM,PubMed,EMBase,the Cochrane library database published article about double maintenance doses clopidogrel and 100 mg aspirin for PCI patients.The forest plot was drawn by RevMan 5.2,statistical software from the literature data and the funnel plot was also drawn to check the literature publication bias.Results A total of 12 Chinese papers were selected.Meta analysis results were as follows:Compared with 75 mg-maintenance dose,150 mg-maintenance dose reduced the rate of platelet aggregation [MD =-2.31,95％CI =(-2.98,-1.64),P＜0.05];in the treatment group and the control group,the incidences of major adverse cardiac events and minor adverse cardiac events were 3.93％ and 10.76％,with statistically significant difference (P ＜ 0.05);the incidences of major bleeding events were 1.56％ and 0.47％,without statistically significant difference (P ＞ 0.05);the incidences of non-major bleeding events were 7.40％ and 6.21％,and the difference was not statistically significant (P ＞ 0.05).Conclusion Compared with 75 mg-maintenance dose clopidogrel on patients after percutaneous coronary intervention,150 mg-maintenance dose exerted better inhibitory effect on platelet aggregation with a reduced incidence of major adverse cardiac events.Moreover,the incidences of major bleeding event risk and non-major bleeding events between the two doses showed no significant difference.

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Meta-analysis of gabapentin for the treatment of skin itching and sleep quality improving in uremic patients

Wen-Jin WANG ; Wen-Hui CHEN ; Ying YAO

The Chinese Journal of Clinical Pharmacology.2017;33(10):954-956. doi:10.13699/j.cnki.1001-6821.2017.10.025

Objective To evaluate the efficacy and safety of gabapentin for the treatment of pruritus and sleep quality improving in uremic patients.Methods PubMed,Cochrane Library,EMbase,EBSCO,CNKI,WanFang Date and WeiPu Date were searched for the randomized controlled trials (RCTs) of gabapentin in treatment of uremic pruritus from the date of their establishment to April 15,2016.Treatment group received gabapentin capsules.Control group received placebo or antihistamine and so on.Meta-analysis were performed with RevMan 5.3 software including the total effective rate and the visual analogue scale (VAS) and the pittsburgh sleep quality index (PSQI).Results 13 RCTs involving 657 patients meeting the inclusion criteria.The results of meta-analyses showed that gabapentin could increase the total effective rate by 1.61 times (P ＜0.001) and decrease the VAS (P ＜0.001) and PSQI (P ＜ 0.001),with significant differences.Conclusion Gabapentin has demonstrated efficacy and safety in the treatment of uremic pruritus.

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Research status of pharmacological action of Curcumin

Wei-Feng LI ; Jian-Lan JIANG

The Chinese Journal of Clinical Pharmacology.2017;33(10):957-960. doi:10.13699/j.cnki.1001-6821.2017.10.026

Curcuma belongs to ginger plants,was one of commonly used Chinese medicine.In recent years,the study found that Curcumin in turmeric has a variety of pharmacological activities,including anti-tumor,anti-inflammatory,antioxidant and other pharmacological effects.We reviewed the pharmacological activity and mechanism of Curcumin in order to promote the development and utilization of Curcumin.

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Clinical trial of naloxone hydrochloride in the treatment of severe traumatic brain injury in mild hypothermia environment

Rong GAO ; Chun-Lei SHAN

The Chinese Journal of Clinical Pharmacology.2017;33(11):963-965. doi:10.13699/j.cnki.1001-6821.2017.11.001

Objective To evaluate the clinical efficacy and safety of naloxone hydrochloride in the treatment of severe traumatic brain injury in mild hypothermia environment.Methods A total of 162 cases with severe traumatic brain injury were randomly divided into control group (n =81 cases) and treatment group (n =81 cases).Control group was given conventional therapy and mild hypothermia treatment.On the basis of control group,treatment group was received naloxone hydrochloride injection 0.3 mg · kg-1 · d-1,continued intravenous infusion,qd.Two groups were both treated for 7 d.The levels of serum matrix metalloproteinase-9 (MMP-9) and S100 calcium-binding protein (S100-B),clinical efficacy and safety were compared in two groups.Results After treatment,the total effective rates in treatment group and control group were 82.72％ (67/81 cases),67.91％ (55/81 cases),with significant difference (P ＜ 0.05).After treatment,serum MMP-9 were (38.64 ±5.42),(24.48 ±3.41) μg · mL-1 in control group and treatment group;serum S100-B were (0.98 ± 0.14),and (0.15 ± 0.05) μg · L-1 in control group and treatment group.There was statistically significant difference between two groups (P ＜ 0.05).The adverse drug reactions including gastrointestinal reactions,liver and renal dysfunction in control and treatment groups,the incidence were 11.11％ (9/81 cases) and 7.41％ (6/81 cases),respectively,without significant difference (P ＞ 0.05).Conclusion The treatment of naloxone hydrochloride can significantly reduce the levels of serum MMP-9 and S100-B in patients with severe traumatic brain injury in mild hypothermia environment,and improve clinical efficacy with high safety.

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Clinical trial of salmeterol xinafoate and fluticasone propionate powder for inhalation in the treatment of chronic obstructive pulmonary disease

Yu-Ling SUI ; Xue-Tang LI ; Yu-Cai LIU ; Yan-Li GAO ; Yong-Feng WANG

The Chinese Journal of Clinical Pharmacology.2017;33(11):966-969. doi:10.13699/j.cnki.1001-6821.2017.11.002

Objective To investigate the clinical efficacy and safety of salmeterol xinafoate/ fluticasone propionate in the treatment of chronic obstructive pulmonary disease(COPD).Methods A total of 70 patients with COPD were randomly divided into control group and treatment group,35 cases in each group.Patients in the two groups were all given regular treatment.Patients in the control group were given inhalation treatment with 18 μg tiotropium bromide powder inhalation,qd.Patients in the treatment group were given 50 μg salmeterol fluticasone propionate powder,qd.Patients in the two groups were treated for three cycles (28 days per cycle).The clinical efficacy,pre-and post-treatment of forced vital capacity (FVC),one second forced expiratory volume (FEV1),peak expiratory flow rate value(PEF),FEV1 / FVC,the predicted percentage of FEV1 and PEF value,St.George Hospital Respiratory Questionnaire (SGRQ),multi factor grading system (BODE:body mass index,airflow obstruction,dyspnea and exercise capacity) index score and the incidence of adverse reaction were compared between the two groups.Results After treatment,the total clinical effective rates in the treatment group and the control group were 91.43％ (32/35 cases) and 77.14％ (27/35 cases),respectively,with statistically significant difference (P＜0.05).After treatment,the FEV1 in the treatment group and the control group were(1.86 ± 0.19)L and (1.42 ± 0.17) L,respectively.The FEV1/FVC were (42.93 ± 4.25) ％ and (39.73 ± 3.68) ％,respectively.The PEF were (3.69 ±0.37)L and(3.11 ±0.35)L,respectively.The FEV1/Predicted value were(48.57 ±4.97)％ and (44.47 ±4.51)％,respectively.The PEF/ Predicted value were (48.92 ±5.05)％ and (41.53 ± 4.55)％,respectively.The SGBQ score were (44.97 ±4.96) and (42.01 ±4.67) points,respectively.The BODE score were (5.98 ±0.59) and (5.67 ± 0.59) points.There were statistically significant differences in all the items above between the two groups(P ＜ 0.05).The adverse drug reactions in the treatment group were headache (1 case),tremor (1 case) and palpitation (1 case),while headache(2 cases),tremor(1 case) and hoarseness(2 cases) were found in the control group.The rates of adverse drug reaction in the treatment group and the control group were 8.57％ (3/35 cases) and 14.29％ (5/35 cases) respectively,and no statistical significance was found (P ＞ 0.05).Conclusion Salmeterol xinafoate/fluticasone propionate was safe and effective in the clinical treatment of COPD.

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