1.Anlotinib as third- or further-line therapy for short-term relapsed small-cell lung cancer: subgroup analysis of a randomized phase 2 study (ALTER1202).
Jianhua SHI ; Ying CHENG ; Qiming WANG ; Kai LI ; Lin WU ; Baohui HAN ; Gongyan CHEN ; Jianxing HE ; Jie WANG ; Haifeng QIN ; Xiaoling LI
Frontiers of Medicine 2022;16(5):766-772
Patients with small-cell lung cancer (SCLC) relapse within months after completing previous therapies. This study aimed to investigate the efficacy and safety of anlotinib as third- or further-line therapy in patients with short-term relapsed SCLC from ALTER1202. Patients with short-term relapsed SCLC (disease progression within 3 months after completing ⩾ two lines of chemotherapy) in the anlotinib (n = 67) and placebo (n = 34) groups were analyzed. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival, objective response rate (ORR), disease control rate, and safety. Anlotinib significantly improved median PFS/OS (4.0 vs. 0.7 months, P < 0.0001)/(7.3 vs. 4.4 months, P = 0.006) compared with placebo. The ORR was 4.5%/2.9% in the anlotinib/placebo group (P = 1.000). The DCR in the anlotinib group was higher than that in the placebo group (73.1% vs. 11.8%, P < 0.001). The most common adverse events (AEs) were hypertension (38.8%), loss of appetite (28.4%), and fatigue (22.4%) in the anlotinib group and gammaglutamyl transpeptidase elevation (20.6%) in the placebo group. No grade 5 AEs occurred. For patients with short-term relapsed SCLC, third- or further-line anlotinib treatment was associated with improved survival benefit. Further studies are warranted in this regard.
Humans
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Lung Neoplasms/drug therapy*
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Treatment Outcome
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Neoplasm Recurrence, Local/chemically induced*
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Quinolines/adverse effects*
2.Therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma: a Meta analysis.
Yan WEI ; Dong-Sheng LI ; Jian-Jun LIU ; Jing ZHANG ; Hai-En ZHAO
Chinese Journal of Contemporary Pediatrics 2016;18(11):1100-1105
OBJECTIVETo evaluate the therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma.
METHODSThe databases CNKI, Wanfang Data, VIP, PubMed, EMbase, and BioMed Central were searched for randomized controlled trials (RCTs) of montelukast sodium combined with budesonide in the treatment of children with cough variant asthma. Data extraction and quality assessment were performed for RCTs which met the inclusion criteria, and RevMan 5.3 software was used to perform quality assessment of the articles included and Meta analysis.
RESULTSA total of 11 RCTs involving 1 097 patients were included. The results of the Meta analysis showed that compared with the control group (inhalation of budesonide alone), the observation group (inhalation of montelukast sodium combined with budesonide) had significantly higher overall response rate and more improved pulmonary function parameters including forced expiratory volume in the first second, percentage of forced expiratory volume in the first second, and peak expiratory flow, as well as significantly lower recurrence rate (P<0.01). The incidence of adverse events showed no significant difference between the two groups.
CONCLUSIONSInhalation of montelukast sodium combined with budesonide has a significant effect in children with cough variant asthma and does not increase the incidence of adverse events.
Acetates ; administration & dosage ; adverse effects ; Anti-Asthmatic Agents ; administration & dosage ; adverse effects ; Asthma ; drug therapy ; Bronchodilator Agents ; administration & dosage ; adverse effects ; Budesonide ; administration & dosage ; adverse effects ; Child ; Cough ; drug therapy ; Drug Therapy, Combination ; Humans ; Quinolines ; administration & dosage ; adverse effects
5.A randomized, controlled trial of artemisinin-piperaquine vs dihydroartemisinin-piperaquine phosphate in treatment of falciparum malaria.
Trieu Nguyen TRUNG ; Bo TAN ; Dang Van PHUC ; Jian-ping SONG
Chinese journal of integrative medicine 2009;15(3):189-192
OBJECTIVEThe study aimed to evaluate and compare the efficacy and safety of dihydroartemisinin-piperaquine phosphate (Artekin) and artemisinin-piperaquine (Artequick) in the treatment of uncomplicated falciparum malaria.
METHODSA total of 103 uncomplicated falciparum malaria patients were enrolled and randomly assigned to two groups: 52 cases in the Artequick group, and 51 cases in the Artekin group. The patients in the Artequick group were administered with Artequick, twice in 24 h, whereas the patients in the Artekin group were given Artekin 4 times in 2 days. The mean parasite clearance time, mean fever clearance time, 28-day cure rate and parasite recrudescence rates of the two groups were then compared.
RESULTSThe mean parasite clearance time and the mean fever clearance time were 43.2+/-13.9 h and 24.7+/-9.9 h, in the Artequick group, and 36.5+/-17.1 h and 22.7+/-11.2 h, in the Artekin group. In both groups the 28-day cure rate was 100%, and the parasite recrudescence rate was 0.
CONCLUSIONBoth medicines had high cure rates, low recrudescence rates, and no serious adverse reactions. The administration of Artequick, however, was more convenient and lower incidence of gastrointestinal side effects than that of Artekin, so as to increase the efficacy in the malaria population.
Adolescent ; Adult ; Anti-Infective Agents ; administration & dosage ; adverse effects ; Antimalarials ; administration & dosage ; Artemisinins ; administration & dosage ; adverse effects ; Drug Combinations ; Female ; Humans ; Integrative Medicine ; Malaria, Falciparum ; drug therapy ; Male ; Quinolines ; administration & dosage ; adverse effects ; Treatment Outcome ; Young Adult
6.Effects of intensive versus mild lipid lowering by statins in patients with ischemic congestive heart failure: Korean Pitavastatin Heart Failure (SAPHIRE) study.
Hae Young LEE ; Hyun Jai CHO ; Hee Yul KIM ; Hee Kyung JEON ; Joon Han SHIN ; Suk Min KANG ; Sang Hong BAEK
The Korean Journal of Internal Medicine 2014;29(6):754-763
BACKGROUND/AIMS: This study was designed to evaluate the dose-effect relationship of statins in patients with ischemic congestive heart failure (CHF), since the role of statins in CHF remains unclear. METHODS: The South koreAn Pitavastatin Heart FaIluRE (SAPHIRE) study was designed to randomize patients with ischemic CHF into daily treatments of 10 mg pravastatin or 4 mg pitavastatin. RESULTS: The low density lipoprotein cholesterol level decreased by 30% in the pitavastatin group compared with 12% in the pravastatin (p < 0.05) group. Left ventricular systolic dimensions decreased significantly by 9% in the pitavastatin group and by 5% in the pravastatin group. Left ventricular ejection fraction (EF) improved significantly from 37% to 42% in the pitavastatin group and from 35% to 39% in the pravastatin group. Although the extent of the EF change was greater in the pitavastatin group (16% vs. 11%) than that in the pravastatin group, no significant difference was observed between the groups (p = 0.386). Exercise capacity, evaluated by the 6-min walking test, improved significantly in the pravastatin group (p < 0.001), but no change was observed in the pitavastatin group (p = 0.371). CONCLUSIONS: Very low dose/low potency pravastatin and high dose/high potency pitavastatin had a beneficial effect on cardiac reverse remodeling and improved systolic function in patients with ischemic CHF. However, only pravastatin significantly improved exercise capacity. These findings suggest that lowering cholesterol too much may not be beneficial for patients with CHF.
Aged
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Biological Markers/blood
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Cholesterol, LDL/*blood
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Down-Regulation
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Dyslipidemias/blood/diagnosis/*drug therapy/epidemiology
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Exercise Tolerance/drug effects
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Female
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Heart Failure/diagnosis/*drug therapy/epidemiology/physiopathology
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Humans
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Hydroxymethylglutaryl-CoA Reductase Inhibitors/*administration & dosage/adverse effects
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Male
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Middle Aged
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Myocardial Ischemia/diagnosis/*drug therapy/epidemiology/physiopathology
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Pravastatin/*administration & dosage/adverse effects
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Prospective Studies
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Quinolines/*administration & dosage/adverse effects
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Recovery of Function
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Republic of Korea
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Stroke Volume/drug effects
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Time Factors
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Treatment Outcome
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Ventricular Function, Left/drug effects
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Ventricular Remodeling/drug effects
7.Retrospective Comparison of Levofloxacin and Moxifloxacin on Multidrug-Resistant Tuberculosis Treatment Outcomes.
Jinwoo LEE ; Chang Hoon LEE ; Deog Kyeom KIM ; Ho Il YOON ; Jae Yeol KIM ; Sang Min LEE ; Seok Chul YANG ; Jae Ho LEE ; Chul Gyu YOO ; Choon Taek LEE ; Hee Soon CHUNG ; Young Whan KIM ; Sung Koo HAN ; Jae Joon YIM
The Korean Journal of Internal Medicine 2011;26(2):153-159
BACKGROUND/AIMS: To compare the effect of levofloxacin and moxifloxacin on treatment outcomes among patients with multidrug-resistant tuberculosis (MDR-TB). METHODS: A retrospective analysis of 171 patients with MDR-TB receiving either levofloxacin or moxifloxacin was performed. Treatment responses were categorized into treatment success (cured and treatment completed) or adverse treatment outcome (death, failure, and relapsed). RESULTS: The median age of the patients was 42.0 years. Approximately 56% of the patients were male. Seventeen patients had extensively drug-resistant tuberculosis, and 20 had a surgical resection. A total of 123 patients (71.9%) received levofloxacin for a median 594 days, and 48 patients (28.1%) received moxifloxacin for a median 673 days. Other baseline demographic, clinical, and radiographic characteristics were similar between the two groups. The moxifloxacin group had a significantly higher number of resistant drugs (p < 0.001) and a higher incidence of resistance to ofloxacin (p = 0.005) in the drug sensitivity test. The treatment success rate was 78.9% in the levofloxacin group and 83.3% in the moxifloxacin group (p = 0.42). Adverse reactions occurred at similar rates in the groups (p = 0.44). Patients in the moxifloxacin group were not more likely to have treatment success than those in the levofloxacin group (adjusted odds ratio, 0.76; 95% confidence interval, 0.24 to 2.43; p = 0.65). CONCLUSIONS: Both levofloxacin and moxifloxacin showed equivalent efficacy for treating MDR-TB.
Adult
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Antitubercular Agents/adverse effects/*therapeutic use
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Aza Compounds/adverse effects/*therapeutic use
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Case-Control Studies
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Chi-Square Distribution
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*Drug Resistance, Multiple, Bacterial
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Drug Therapy, Combination
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Extensively Drug-Resistant Tuberculosis/*drug therapy/microbiology/mortality
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Female
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Humans
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Logistic Models
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Male
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Middle Aged
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Mycobacterium tuberculosis/*drug effects/pathogenicity
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Odds Ratio
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Ofloxacin/adverse effects/*therapeutic use
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Quinolines/adverse effects/*therapeutic use
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Recurrence
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Remission Induction
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Republic of Korea
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Retrospective Studies
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Risk Assessment
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Risk Factors
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Time Factors
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Treatment Outcome
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Tuberculosis, Multidrug-Resistant/*drug therapy/microbiology/mortality