1.Clinical trial of ticagrelor tablets in the treatment of complex coronary artery disease
Shuai ZHOU ; Luo-Sha ZHAO ; Ke-Jun HUANG
The Chinese Journal of Clinical Pharmacology 2017;33(23):2335-2338
Objective To observe the clinical efficacy and safety of ticagrelor tablets in the treatment of complex coronary artery disease.Methods One hundred and twenty-five patients with complex coronary artery disease were randomly divided into control group (n =63 cases) and treatment groups (n =62 cases).Control group received clopidogrel hydrogen 300 mg per time before operation and 75 mg per time after operation,qd,orally.Treatment group was given ticagrelor 180 mg per time before operative and 90 mg per time after operation,qd,orally.Two groups were treated for 1 year.The clinical efficacy,cardiac function and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 87.10% (54 cases/62 cases) and 71.43% (45 cases/63 cases) with significant difference (P < 0.05).After treatment,the main indexes in treatment and control groups were compared:creatinine kinase-MB were (16.37 ±2.01) and (59.73 ± 10.62) μg · L-1,myoglobin were (42.08 ± 11.86) and (123.28 ± 50.63) μg · L-1,troponin T were (0.01 ±0.01) and (0.06 ± 0.03) μg · L-1,brain natriuretic peptide were (44.44 ± 3.11) and (68.62 ± 10.37) ng · L-1,left ventricular ejection fraction were (57.22 ± 1.61) % and (25.36±5.38)%,the differences were statistically significant (all P <0.05).The adverse drug reactions in two groups were bleeding,difficulty breathing and arrhythmia.The incidences of adverse drug reactions in treatment and control groups were 24.19% and 31.75% without significant difference (P > 0.05).Conclusion Ticagrelor tablets have a definitive clinical efficacy in the treatment of complex coronary artery disease,which can significantly improve the cardiac functions,without increasing the incidence of adverse drug reactions.
2.Clinical trial of simvastatin tablets combined with Wuling powder in the treatment of heart valve replacement
Xian-Hong TANG ; Li CONG ; Wei-Dong MA
The Chinese Journal of Clinical Pharmacology 2017;33(23):2339-2342
Objective To observe the clinical efficacy and safety of simvastatin tablets combined with Wuling powder in cardiac valve replacement.Methods A total of 100 patients with cardiac valve replacement were randomly divided into control group and treatment group with 50 cases per group.Control group was orally given simvastatin tablets 10 mg per time,bid,1 week before operation and from 2 days after operation for 1 week.Treatment group was orally given Wuling powder 6 g per time,tid,1 week before operation and from 2 days after operation for 1 week,on the basis of control group.The hemodynamic indexes,blood lipid indexes and adverse drug reactions were compared between two groups.Results Three days after operation,the main indexes in treatment and control groups were compared:whole high viscosity were (6.06 ±0.26) and (7.70 ±0.42) mPa · s,whole low viscosity were (10.31 ±0.35) and (12.30 ±0.38) mPa · s,plasma viscosity were (1.30 ± 0.23) and (2.69 ± 0.20) mPa · s,hematocrit were (46.59 ± 1.20) % and (52.97 ±0.65)%,with significant difference (all P < 0.05).One week after operation,the main indexes in treatment and control groups were compared:total cholesterol were (5.62 ± 0.21) and (6.11 ± 0.27) mmol · L-1,triglyceride were (1.76 ± 0.21) and (2.26 ± 0.24) mmol · L-1,low density lipoprotein cholesterol were (2.23 ±0.21) and (2.87 ± 0.23) mmol · L-1,high density lipoprotein cholesterol were (1.18 + 0.07) and (0.94 ±0.06) mmol · L-1,with significant difference (all P < 0.05).The adverse drug reactions in treatment group were abdominal pain,constipation and fatigue,which in control group were constipation and abdominal pain.The incidences of adverse drug reactions in treatment and control groups were 4.00% and 6.00% without significant difference (P > 0.05).Conclusion Simvastatin tablets combined with Wuling powder can significantly improve hemodynamics and blood lipid in patients with cardiac valve replacement,without increasing the incidence of adverse drug reactions.
3.Clinical trial of interferon combined with Tanreqing injection in the treatment of children with severe hand-foot-mouth disease
The Chinese Journal of Clinical Pharmacology 2017;33(23):2343-2346
Objective To observe the clinical effect of Tanreqing injection combined with interferon on serum inflammatory cytokines and troponin Ⅰ in the treatment of children with severe hand-foot-mouth disease.Methods A total of 164 children with severe hand-foot-mouth disease were randomly divided into control group and treatment group,82 cases in each group.Patients in two groups were given regular treatment and symptomatic treatment,vitamin and electrolytes administration,oral and skin care,and the implementation of specialist care.Patients in control group were given ribavirin 10 mg · kg-1,muscle injection,qd.Patients in treatment group were received Tanreqing injection 0.5 mL · kg-1 + 5% glucose injection 250 mL,qd and interferon α-2b injection 8.0 × 104 U · kg-1,muscle injection qd.Patients in two groups were treated for 6 d.After treatment,the clinical efficacy,levels of serum amyloid A (SAA),C-reactive protein (CRP),interleukin-6 (IL-6),interferon-γ(INF-γ),interleukin-1β (IL-1β),cardiac troponin Ⅰ (cTn Ⅰ) and adverse drug reactions were compared between the two groups.Results After treatment,the clinical efficiency in treatment group and control group were 92.68% (76 cases/86 cases) and 73.17% (60 cases/86 cases),with significant difference (P <0.05).Compared with control group,the body temperature,the rash subsided time,normal eating time,oral ulcer healing time and the average hospitalization time in treatment group were significantly shortened (P < 0.05).After treatment,the levels of SAA,CRP,IL-6,INF-γ,IL-1β,cTn Ⅰ in control group were (298.39 ± 23.57) mg · L-1,(8.01 ± 0.87) mg · L-1,(141.29 ± 15.34) μg · L-1,(11.30 ± 1.37) μg · L-1,(57.93 ± 6.58) ng · mL-1,(0.46 ± 0.06) ng · mL-1,had significant differences with those in treatment group,which were (140.39 ± 15.39)mg · L-1,(4.78 ± 0.50) mg · L-1,(111.20 ± 14.29) μg· L-1,(5.40 ±0.67) μg · L-1,(28.09 ±3.19)ng · mL-1,(0.20 ±0.03) ng· mL-1 (all P < 0.05).There were 4 cases of appetite loss,2 cases of eosinophilia,2 cases of gastric colic in treatment group,with the incidence of 9.76% (8 cases/82 cases).There were 4 cases of appetite loss,2 cases of gastric colic,4 cases of nausea and vomiting,with the incidence of 12.20% (10 cases/82 cases).There was no significant difference between the two groups (P > 0.05).Conclusion Tanreqing injection combined with interferon in the treatment of severe hand-foot-mouth disease in children was effective with high safety.
4.Clinical trial of immunoglobulin combined with aspirin enteric-coated tablets in the treatment of Kawasaki disease
Yang SHEN ; Jing SHAN ; Guang-Hui LIU ; Wei-Hua XU ; Yu-Qing CHEN ; Peng HU
The Chinese Journal of Clinical Pharmacology 2017;33(23):2347-2350
Objective To observe the clinical efficacy and safety of different usage of immunoglobulin combined with aspirin enteric-coated tablets in the treatment of Kawasaki disease.Methods Ninety patients with Kawasaki disease were randomly divided into control group and treatment group with 45 cases per group.Control group was given 1 g · kg-1 immunoglobulin with intravenous injection for 2 days + 40 mg · kg-1 aspirin enteric-coated tablets for 1 month,orally.Treatment group was given 2 g · kg-1 immunoglobulin with one-time intravenous injection + 40 mg · kg-1 aspirin enteric-coated tablets for 1 month,orally.The clinical efficacy,interleukin-6 (IL-6),IL-8,high sensitivity C-reaction protein (hs-CRP),tumor necrosis factor alpha (TNF-α) and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 95.56% (43/45 cases) and 84.44% (38/45cases) with significant difference (P <0.05).After treatment 1 month,the main indexes in treatment and control groups were compared:IL-6 were (6.18 ±2.10) and (9.10±3.19)pg · mL-1,IL-8 were (5.17 ±1.01) and (10.27 ±2.15)pg · mL-1,hs-CRP were (2.61 ±1.04) and (5.27±0.97)mg· L-1,TNF-α were (13.77 ±0.86) and (16.52 ±1.13)ng· L-1,the differences were statistically significant (all P < 0.05).The adverse drug reactions in treatment group were nausea and headache,which in control group were nausea,headache and chills.The incidences of adverse drug reactions in treatment and control groups were 17.78% and 13.33% without significant difference (P >0.05).Conclusion Single dose of 2 g · kg-1 immunoglobulin combined aspirin enteric-coated tablets have a better clinical efficacy in the treatment of Kawasaki disease than the double dose of 1 g · kg-1 immunoglobulin combined aspirin enteric-coated tablets,the former can significantly relieve the clinical symptoms and reduce the levels of serum inflammatory factors,without increasing the incidences of adverse drug reactions.
5.Effects of tranexamic acid on bleeding volume and postoperative coagulation function after liver resection in patients with hepatocellular carcinoma
Xu-De WANG ; Hua-Gao LIU ; You-Zhi FANG ; Sheng-Bing KONG ; Xun WU ; Yong-Yi HU
The Chinese Journal of Clinical Pharmacology 2017;33(23):2351-2353
Objective To evaluate the effect of tranexamic acid on the blood loss and coagulation function after liver resection in patients with hepatocellular carcinoma (HCC).Methods Seventy patients with hepatectomy who underwent liver resection were randomly divided into control group and treatment group,each group 35 cases.Control group was given 0.9% NaCl injection 10 mg · kg-1.Treatment group was given tranexamic acid 10 mg · kg-1.Two groups were used at half an hour before operation.The surgical bleeding volume and postoperative coagulation function between two groups were compared.Results The operation time,time of hilar occlusion in treatment group were (157.98 ±22.36),(30.14 ±5.64) min,had no significant difference with those in control group,which were (154.98 ± 23.65),(28.79 ± 5.79) min (P > 0.05).The surgical blood transfusion,bleeding volume,infusion of erythrocyte suspension in treatment group were (879.65 ± 59.36) mL,(768.97 ± 45.65) mL,(1.36 ± 0.59) U,had significant differences with those in control group,which were (1054.91 ±61.32) mL,(869.64 ±46.69) mL,(2.01 ±0.65) U (all P <0.05).The percentage of activated thromboplastin (APTT),prothrombin time (PT),platelet (PLT) in treatment group at 24 h after operation were (41.56 ±5.46)s,(13.48 ±3.16)s,(167.89 ±35.87) × 109/L,had no significant difference with those in control group,which were (43.19 ± 5.69) s,(14.59 ± 2.49) s,(162.35 ± 41.59) × 109/L (all P >0.05).The fibrinogen (FIB) in treatment group and control group were (3.27 ±0.56),(3.01 ±0.59)g · L-1,with significant difference (P < 0.05).There was no adverse drug reactions in two groups during the treatment.Conclusion Giving methotrexate injection to hepatocarcinoma patients before liver resection can reduce the amount of surgical bleeding,and improve the patients' postoperative coagulation function.
6.Clinical trial of Kanglaite injection in gemcitabine combined cisplatin regimen chemotherapy for advanced non-small cell lung cancer
Yuan WANG ; Shuang HUI ; Min LI ; Cheng-Hui ZHANG
The Chinese Journal of Clinical Pharmacology 2017;33(23):2354-2356,2360
Objective To observe the clinical efficacy and safety of Kanglaite injection with gemcitabine combined cisplatin (GP) regimen in the treatment of advanced non-small cell carcinoma (NSCLC).Methods A total of 72 patients with NSCLC enrolled in our hospital from January 2013 to January 2015,were divided into treatment group and control group according to the order of admission.The control group was treated with GP regimen (1250 mg· m-2 gemcitabine + 75 mg · m-2 cisplatin),the treatment group was treated with Kanglaite injection 60 mL on the basis of control group.The levels of vascular endothelial growth factor (VEGF),tumor suppressor gene p53 (P53) antibody,anti-survivin antibody were determined by double antibody sandwich enzyme-linked immunosorbent assay.The quality life of patients was evaluated by the Karnofsky score.The clinical efficacy and adverse drugs reaction were investigated.Results After treatment,the total effective rate of the treatment group was significantly higher than that of control group [91.67% (33 cases/36 cases) vs 69.44% (25 cases/36 cases),P < 0.05].The improvement rate of quality of life in the treatment group was higher than the control group [63.89% (23 cases/36 cases) vs 19.44% (7 cases/36 cases)],significantly (P <0.05).The levels of VEGF,P53 and anti-Survivin in the treatment group were significantly lower than those of control group [(112.57 ± 10.84),(143.60 ± 10.90) ng · L-1;(2.82 ±0.25),(3.31 ±0.24) U · mL-1;(2.17 ±0.19),(3.15 ±0.30) U · mL-1] (all P <0.05).The toxicity rate of the treatment group was lower than that of control group [11.11% (4 cases/36 cases) vs 36.11% (13 cases/36 cases)] with significant difference (P <0.05).Conclusion Kanglaite injection can decrease the serum levels of VEGF,P53 and anti-Survivin antibody in patients with advanced NSCLC,which has good clinical curative effect and safety.
7.Expression of E-cadherin in esophageal cancer tissue and its relationship with postoperative recurrence
Yan-Bing HAO ; Li WANG ; Yu RONG ; Dong WEI ; Yan-Ming LI ; Wan-Sheng CHEN
The Chinese Journal of Clinical Pharmacology 2017;33(23):2357-2360
Objective To explore the expression of E-cadherin (E-cad) in esophageal cancer tissue and its relationship with postoperative recurrence.Methods Sixty cases of esophageal cancer patients who underwent surgical treatment and retained complete tumor tissue slice in our hospital from October 2014 to October 2015 were selected,60 cases of tumor tissue,20 cases of adjacent normal tissue.The expression of E-cad in esophageal cancer tissue and adjacent normal tissue was detected by immunohistochemistry.Results The positive expression rate of E-cad in esophageal squamous cell carcinoma tissue was 43.33% (26 cases/60 cases),significantly lower than 85.00% (51 cases/60 eases) in adjacent normal tissue (P <0.01).The expression of E-cad in high/ medim differentiation and poor differentiation,depth of invasion without muscle and deep muscle layer,lymph node metastasis or not had significant difference (P <0.05 or P <0.01).There was no significant difference in the expression of E-cad between less than Ⅲ period and Ⅲ and more period (P>0.05).The positive expression rate of E-cad was 32.00% (8 cases/ 25 cases) in recurrence group,lower than 51.43% (18 cases/35 cases) in no recurrence group,but there was no significant difference (P > 0.05).Conclusion The expression of E-cad in esophageal cancer tissue is down-regulated,and is related to the degree of tumor differentiation,depth of myometrial invasion and lymph node metastasis whether or not,but it's not directly related to postoperative recurrence.
8.Clinical trial of insulin glulisine combined with insulin glargine in the treatment of type 2 diabetes patients with secondary failure to oral hypoglycemia agents
Shu-Long GUO ; You-Xiao ZENG ; Shao-Ya WANG ; Yun-Zong LIAN ; Xue-E HUANG ; Shu-Yan WU
The Chinese Journal of Clinical Pharmacology 2017;33(23):2361-2363,2386
Objective To compare the clinical efficacy and safety of insulin glulisine (GLU) and insulin aspam(ASP) combined with insulin glargine (GLA) in type 2 diabetes patients (T2DM) with secondary failure to oral hypoglycemic agents.Methods One hundred and twenty cases of T2DM with secondary failure to oral hypoglycemia agents were randomly divided into control group (n =60 cases) and treatment group (n =60 cases).The control group received subcutaneous injection of ASP before 0-10 min three meals daily,and the treatment group received subcutaneous injection of GLU before 0-10min three meals daily.The two groups were treated with subcutaneous injection of GLA,once daily.The initial dose of ASP and GLU were 0.8 U · kg-1 · d-1,and the initial dose of GLA was 0.2 U · kg-1 · d-1.Two groups of patients were hospitalized for 2 weeks.The changes of blood glucose,cases and days of blood glucose of achieving target were compared after treatment of hospitalization.The improvement of HbAlc and the frequency of hypoglycemia were observed after treatment of 12 weeks.Results The days of 2-hour postprandial blood glucose(2 h PG) of achieving target in the treatment group and the control group were (10.01 ± 1.99)d and (10.93 ± 1.52)d with 57 cases and 47 cases,and the days of fasting plasma glucose,postprandial blood glucose and 2 h PG of achieving target were (10.31 ± 1.04) d and (11.03 ± 1.38) d with 48 cases and 40 cases(all P < 0.05).After treatment 12 weeks,the HbAlc in treatment and control groups were (6.78 ±0.59)% and (7.07 ±0.49)% without significant difference (P > 0.05).During treatment of 12 weeks,the adverse drug reactions in the two groups were mainly hypoglycemic events,the incidence of hypoglycemia in the treatment group was 30.00%,and 25.00% in the control group,the difference was not statistically significant (P > 0.05).Conclusion Both GLU combined with GLA or ASP combined with GLA have similar efficacy and safety for T2DM with secondary failure to oral hypoglycemic agents.GLU combined with GLA is more rapid in controlling 2 h PG of these patients.
9.Clinical trial of arsenic trioxide in the treatment of patients with middle and high risk myelodysplastic syndrome
The Chinese Journal of Clinical Pharmacology 2017;33(23):2364-2367
Objective To observe the effects of arsenic trioxide combined with cytrarabine + aclacinomycin A + granulocyte-colony stimulating factor (CAG regimen) in the treatment of middle and high risk myelodysplastic syndrome (MDS).Methods One hundred and two patients with middle and high risk myelodysplastic syndrome were randomly divided in-to control group and treatment group,51 cases in each group.Patients in control group were treated with CAG regimen (cytrarabine 10 mg·m-2 · d-1,subcutaneous injection,ql2 h for 2 weeks;aclacinomycin A 20 mg· d-1,intravenous injection for 1 week;granulocyte-colony stimulating factor 200 μg · m-2 · d-1,subcutaneous injection,q12 h for 2 weeks;rest at third and fourth week).Patients in treatment group were treated with arsenic trioxide 10 mg · d-1,intravenous injection for 1 week,rest at third and fourth week) on the basis of control group.Three months a courses,all patients were treated for two courses.Apoptosis of hematopoietic cells in two groups were analyzed by flow cytometry before and after treatment.B cell lymphoma-2 (Bcl-2) and Bcl-associated X protein (Bax)expression levels in two groups were detected by Western blot before and after treatment.Chnical effect and the incidence of adverse drug reaction in two groups were compared.The long-term efficacy was evaluated in two groups.Results The total efficiency in treatment group and control group were 78.43% (40 cases/51 cases),60.78% (31 cases/51 cases),with significant difference (P < 0.05).Compared with those before treatment,bone marrow cells apoptosis rate and Bax expression levels in the two groups were significantly increased,while Bcl-2 expression level of was significantly decreased (P < 0.05).The change in treatment group was more significantly compared with control group(P <0.05).Follow-up results showed that 1,2 and 3 years cumulative survival rates in treatment group were 84.31% (43 cases/51 cases),74.51% (38 cases/51 cases)and 60.78% (31 cases/51 cases),which had significant differences with those in control group,which were 80.39%(41 cases/51 cases),64.71% (33 cases/51 cases) and 47.06% (24 cases/51 cases).The adverse drug reactions in two groups were mainly exhibits fatigue,somnolence,mild liver and kidney injury,nausea and vomiting.The incidence of adverse reactions in control group and treatment group were 47.06% (24 cases/51 cases) and 41.18% (21 cases/51 cases),without signiticant difference (P > 0.05).Conclusion Arsenite combined with CAG regimen can effectively induce the apoptosis of abnormal clones in the treatment of middle and high risk myelodysplastic syndrome,delay the survival time of patients,had significant clinical efficacy with mild adverse drug reactions.
10.Clinical trial of latamoxef sodium injection combined with metronidazole tablets in the treatment of children with intestinal ganglion cell disease
Hong-Tu MA ; Xiao-Qing LI ; Yi WANG ; Wei LIU ; Zhen-Hua GUO
The Chinese Journal of Clinical Pharmacology 2017;33(23):2368-2370
Objective To observe the clinical efficacy and safety of latamoxef sodium injection combined with metronidazole tablets in the treatment of intestinal ganglion cell disease.Methods A total of 90 patients with intestinal ganglion cells were randomly divided into control group and treatment group,with 45 cases per group.All patients were treated with laparoscopic assisted radical resection of the large intestine.After operation,control group was given metronidazole 0.4 g,tid,orally.The treatment group was given latamoxef sodium injection 2.0 g,qd,intravenous injection,on the basis of control group.Two groups were treated for 21 d.The clinical efficacy and adverse drug reactions in two groups were compared.Results After treatment,the total effective rates in treatment group and control group were 93.33% (42 cases/45 cases) and 80.00% (36 cases/45 cases),with significant difference (P <0.05).The main adverse drug reactions in treatment group were enterocolitis,constipation and urinary retention,with the incidence of 8.89% (4 cases/45 cases).The adverse drug reactions in control group were small bowel disease,rectal muscle sheath infection,constipation and urinary retention,with the incidence of 31.11% (14 cases/45 cases).The difference was statistically significant between the two groups (P < 0.05).Conclusion The combination of cefotaxime sodium and metronidazole could improve the therapeutic effect and reduce the incidence of adverse drug reactions.