2.Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
Ji YOU-XIN ; Zhang ZHONG-FA ; Lan KE-TAO ; Nie KE-KE ; Geng CHUAN-XIN ; Liu SHI-CHAO ; Zhang LING ; Zhuang XING-JUN ; Zou XIAO ; Sun LEI ; Zhang ZONG-CHUN
Chinese Medical Sciences Journal 2014;(1):7-14
Objective To explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma (HCC).
Methods In this three-center open-label study from November 2011 to May 2013, we randomly assigned 189 patients with advanced Child-Pugh class B or C HCC patients into two groups, one group with 95 patient to receive sorafenib (400 mg a time, twice a day) and the other group with 94 patients to receive best supportive care. The primary end points were progression-free survival and overall survival.
Results The median progression-free survival was 2.2 months and 1.9 months in the sorafenib group and best supportive care group respectively (Hazard ratio in the sorafenib group, 0.55; 95% confidence interval, 0.40-0.75;P=0.002). The median overall survival was 4.0 months and 3.5 months in the sorafenib group and best supportive care group respectively (Hazard ratio in the sorafenib group, 0.48;95%confidence interval, 0.35-0.68;P<0.001). The main adverse effect of sorafenib was rash and acne of the skin (in 51.7%patients). The incidences of severe rash, diarrhea, and dry skin were 5.6%, 5.6%, and 2.2%in the sorafenib group. One patient reached partial response in the sorafenib group.
Conclusions Sorafenib is safe in patients with liver function impaired advanced HCC. It is effective in terms of progression-free survival and overall survival compared with best supportive care. Liver functions are the important predictive factors.
3.Clinical Analysis of Bloodstream Infection after Hematopoietic Stem Cell Transplantation.
Ying-Ying WU ; Bei-Cai LIU ; Lian-Jin LIU ; Shi-Si YUAN ; Jie-Min WEI ; Li-Lin WANG ; Pei-Xi WANG ; Ji-Cong LIU ; Yong-Rong LAI ; Qiao-Chuan LI
Journal of Experimental Hematology 2022;30(1):292-297
OBJECTIVE:
To analyze the clinical characteristics of bloodstream infection (BSI) in patients treated by hematopoietic stem cell transplantation (HSCT).
METHODS:
The clinical characteristics, distribution of pathogenic bacteria causing BSI and drug sensitivity of 910 patients treated by HSCT in our department from January 2013 to June 2020 were retrospectively analyzed.
RESULTS:
Among 910 HSCT patients, 111 patients were diagnosed as BSI within 100 days after transplantation, and 98 patients showed BSI during the period of agranulocytosis. Multivariate analysis showed that the usage of anti-thymocyte globulin (ATG), long duration of agranulocytosis and low infusion volume of mononuclear cell (MNC) were the independent risk factors affecting BSI after HSCT. Among 121 pathogenic bacteria isolated, 76 Gram-negative (G-) bacteria (62.8%), 40 Gram-positive (G+) bacteria (33.0%), and 5 fungi (4.1%) were detected out. The top three pathogens were Escherichia coli, Staphylococcus epidermidis and Pseudomonas aeruginosa. The drug-resistance rates of Escherichia coli and Klebsiella pneumoniae to carbapenems was 14.3% and 7.7%, respectively, and Pseudomonas aeruginosa was 66.7%. The susceptibility of G+ bacteria to vancomycin, linezolid and teicoplanin was 97.5%, 100% and 100%, respectively. The crude mortality rate of the patients with BSI at 100 days after HSCT was significantly higher than that of patients without BSI (P<0.001).
CONCLUSION
The usage of ATG, long duration of agranulocytosis and low infusion volume of MNC are independent risk factors for BSI after HSCT. The pathogens after HSCT are mainly G- bacteria. Pseudomonas aeruginosa is highly resistant to carbapenems. Key words ;
Bacteremia/epidemiology*
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Bacteria
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Hematopoietic Stem Cell Transplantation
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Humans
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Retrospective Studies
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Sepsis
4.Protective mechanism of tetramethylpyrazine on cardiovascular system.
Chun-Kun YANG ; Qing-Quan PAN ; Kui JI ; Chuan-Chao LUO ; Zhuang TIAN ; Hong-Yuan ZHOU ; Jun LI
China Journal of Chinese Materia Medica 2023;48(6):1446-1454
Tetramethylpyrazine is the main component of Ligusticum chuanxiong. Studies have found that tetramethylpyrazine has a good protective effect against cardiovascular diseases. In the heart, tetramethylpyrazine can reduce myocardial ischemia/reperfusion injury by inhibiting oxidative stress, regulating autophagy, and inhibiting cardiomyocyte apoptosis. Tetramethylpyrazine can also reduce the damage of cardiomyocytes caused by inflammation, relieve the fibrosis and hypertrophy of cardiomyocytes in infarcted myocardium, and inhibit the expansion of the cardiac cavity after myocardial infarction. In addition, tetramethylpyrazine also has a protective effect on the improvement of familial dilated cardiomyopathy. Besides, the mechanisms of tetramethylpyrazine on blood vessels are more abundant. It can inhibit endothelial cell apoptosis by reducing oxidative stress, maintain vascular endothelial function and homeostasis by inhibiting inflammation and glycocalyx degradation, and protect vascular endothelial cells by reducing iron overload. Tetramethylpyrazine also has a certain inhibitory effect on thrombosis. It can play an anti-thrombotic effect by reducing inflammatory factors and adhesion molecules, inhibiting platelet aggregation, and suppressing the expression of fibrinogen and von Willebrand factor. In addition, tetramethylpyrazine can also reduce the level of blood lipid in apolipoprotein E-deficient mice, inhibit the subcutaneous deposition of lipids, inhibit the transformation of macrophages into foam cells, and inhibit the proliferation and migration of vascular smooth muscle cells, thereby reducing the formation of atherosclerotic plaque. In combination with network pharmacology, the protective mechanism of tetramethylpyrazine on the cardiovascular system may be mainly achieved through the regulation of phosphatidylinositol 3 kinase/protein kinase B(PI3K/Akt), hypoxia-inducible factor 1(HIF-1), and mitogen-activated protein kinase(MAPK) pathways. Tetramethylpyrazine hydrochloride and sodium chloride injection has been approved for clinical application, but some adverse reactions have been found in clinical application, which need to be paid attention to.
Mice
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Animals
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Endothelial Cells/metabolism*
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Phosphatidylinositol 3-Kinases/metabolism*
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Myocardial Infarction
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Myocardium/metabolism*
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Myocytes, Cardiac
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Thrombosis
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Inflammation
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Apoptosis
5.Sorafenib in liver function impaired advanced hepatocellular carcinoma.
You-xin JI ; Zhong-fa ZHANG ; Ke-tao LAN ; Ke-ke NIE ; Chuan-xin GENG ; Shi-chao LIU ; Ling ZHANG ; Xing-jun ZHUANG ; Xiao ZOU ; Lei SUN ; Zong-chun ZHANG
Chinese Medical Sciences Journal 2014;29(1):7-14
OBJECTIVETo explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma (HCC).
METHODSIn this three-center open-label study from November 2011 to May 2013, we randomly assigned 189 patients with advanced Child-Pugh class B or C HCC patients into two groups, one group with 95 patient to receive sorafenib (400 mg a time, twice a day) and the other group with 94 patients to receive best supportive care. The primary end points were progression-free survival and overall survival.
RESULTSThe median progression-free survival was 2.2 months and 1.9 months in the sorafenib group and best supportive care group respectively (Hazard ratio in the sorafenib group, 0.55; 95% confidence interval, 0.40-0.75; P=0.002). The median overall survival was 4.0 months and 3.5 months in the sorafenib group and best supportive care group respectively (Hazard ratio in the sorafenib group, 0.48; 95% confidence interval, 0.35-0.68; P<0.001). The main adverse effect of sorafenib was rash and acne of the skin (in 51.7% patients). The incidences of severe rash, diarrhea, and dry skin were 5.6%, 5.6%, and 2.2% in the sorafenib group. One patient reached partial response in the sorafenib group.
CONCLUSIONSSorafenib is safe in patients with liver function impaired advanced HCC. It is effective in terms of progression-free survival and overall survival compared with best supportive care. Liver functions are the important predictive factors.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; administration & dosage ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; mortality ; pathology ; Cross-Over Studies ; Disease-Free Survival ; Female ; Humans ; Kaplan-Meier Estimate ; Liver Function Tests ; Liver Neoplasms ; drug therapy ; mortality ; pathology ; Male ; Middle Aged ; Neoplasm Invasiveness ; Neoplasm Staging ; Niacinamide ; administration & dosage ; adverse effects ; analogs & derivatives ; therapeutic use ; Phenylurea Compounds ; administration & dosage ; adverse effects ; therapeutic use ; Treatment Outcome ; Young Adult
6.Safety and efficacy of China-made sildenafil citrate in the treatment of erectile dysfunction.
De-Feng LIU ; Ji-Chuan ZHU ; Hui JIANG ; Kai HONG ; Qing-Quan XU ; Zhan-Ju HE ; Tian-Ming PAN ; Shen-Rong ZHUANG ; Xin GAO ; Bin ZHANG ; Xi-Shuang SONG ; Tao JIANG ; Zhe ZHANG ; Han WU
National Journal of Andrology 2017;23(1):43-48
Objective:
To evaluate the safety, efficacy and tolerability of China-made sildenafil citrate (Jinge) in the treatment of ED.
METHODS:
We conducted a multi-center, randomized, double-blind and placebo-controlled clinical trial among 222 ED patients in five urological or andrological clinics of China. The patients were randomly assigned to receive sildenafil citrate (SC, n = 111) or placebo (n = 111) for 8 weeks. We obtained and analyzed the demographic and clinical characteristics of the patients, the scores of International Index of Erectile Function (IIEF), the success rate of sexual intercourse, and the incidence of adverse events.
RESULTS:
No statistically significant differences were found between the patients of the SC and those of the placebo group in the mean age ([47.2±11.32] yr vs [46.67±13.08] yr, P>0.05), psychological etiology (27.93% vs 23.42%, P>0.05), organic etiology (21.62% vs 29.73%, P>0.05) or mixed etiology (50.45% vs 46.85%, P>0.05), nor in height, weight, nationality, or history of smoking, drinking or allergy. Compared with the placebo controls, the SC-treated patients showed significant increases in the excellence rate of effectiveness (29.91% vs 78.90%, P<0.01), success rate of sexual intercourse (29.16% vs 63.87%, P<0.01), and total effectiveness rate (34.58% vs 77.98%, P<0.01). The effectiveness rates on organic, psychogenic and mixed types ED were remarkably higher in the SC group (64.52%, 83.33%, and 82.14%) than in the placebo control (46.15%, 21.21%, and 25.00%) (P<0.01). Mild or temporary adverse events were observed in 32 cases in the SC group as compared with 13 in the placebo control.
CONCLUSIONS
China-made sildenafil citrate is an effective, safe and well-tolerated drug for ED of different etiologies in the Chinese population.
Aged
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China
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Coitus
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Double-Blind Method
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Drug Compounding
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Erectile Dysfunction
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drug therapy
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etiology
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Humans
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Male
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Phosphodiesterase 5 Inhibitors
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therapeutic use
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Sildenafil Citrate
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therapeutic use
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Smoking
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Treatment Outcome