3.Clinical trial on exemestane in the treatment of postmenopausal women with advanced breast cancer.
Xiao-qing LIU ; San-tai SONG ; Ji-wei LIU ; Jun REN ; An-lan WANG ; Qing-xia FAN ; Ya-jie WANG ; Shu-ping SONG ; Guang-ru XIE ; Feng-zhan QIN ; Tian-feng WANG
Chinese Journal of Oncology 2003;25(5):504-506
OBJECTIVETo evaluate the response rate and adverse reactions of exemestane (a new aromatase inactivator) in the treatment of postmenopausal women with advanced breast cancer.
METHODSOne hundred and seventy-three patients with advanced breast cancer entered this study with two patients excluded because of postmenopausal time being less than one year. Therefore, 173 patients could be evaluated for adverse events and 171 patients could be evaluated for efficacy. Exemestane, 25 mg orally daily for 4 weeks as one cycle was given.
RESULTSIn the 171 patients evaluated for efficacy, 4 (2.3%) experienced a complete response (CR) and 40 (23.4%) a partial response (PR), with the overall response rate of 25.7%. Ninety patients (52.6%) had stable disease (SD), with 25 having SD for at least 24 weeks. The clinical benefit (CR + PR + SD > or = 24 weeks) was shown in 69 (40.4%) patients. Progressive disease (PD) was shown in 37 (21.6%) patients. The untreated patients had a higher objective response rate (33.8%) than the retreated ones (18.1%) with significant difference (P = 0.019 7). The response rates for soft-tissue, bone involvement and visceral metastasis were 32.8%, 23.9%, and 12.4% (P = 0.002). There was no significant difference in different ages, time of menopause, disease-free interval or receptor status (P > 0.05). Drug-related adverse events were gastric discomfort (17.9%), malaise (17.9%), nausea (13.9%), hot flushes (11.0%) and dysphoria (5.8%). Other side reactions and abnormal laboratory parameters were observed occasionally which were irrelevant.
CONCLUSIONExemestane can be used to treat postmenopausal women with advanced breast cancer giving only mild adverse reactions which are well tolerated.
Adult ; Aged ; Androstadienes ; adverse effects ; therapeutic use ; Antineoplastic Agents ; therapeutic use ; Aromatase Inhibitors ; Breast Neoplasms ; drug therapy ; Enzyme Inhibitors ; therapeutic use ; Female ; Humans ; Middle Aged ; Postmenopause
4.The clinical efficacy of epristeride in the treatment of benign prostatic hyperplasia.
Xiao-Bing JU ; Hong-Fei WU ; Li-Xin HUA ; Wei ZHANG ; Jie LI
National Journal of Andrology 2002;8(1):42-44
OBJECTIVESTo estimate the clinical safety, efficacy of Epristeride in the treatment of benign prostatic hyperplasia (BPH).
METHODSOne hundred and fourty-one BPH patients, aged from 50 to 83 years old [(66.18 +/- 6.41) yr], were given Epristeride tablets 5 mg p.o., twice daily for 120 days. To synthetically estimate the efficacy by the changing rate of international prostate symptom score (IPSS), maximum flow rate (Qmax), the volume of prostate (V) and the residual urine (Ru).
RESULTSThe total efficacy was 81.29%. The adverse reactions include 1 case (0.72%) of exanthem, 1 case (0.72%) of nausea and vomiting, 1 case (0.72%) of insomnia, 1 case (0.72%) of tinnitus and 3 cases (2.16%) of erectile dysfunction. Two patients discontinued the treatment due to the side effects (1.44%). There was no clinical significantly abnormal laboratory index during the treatment.
CONCLUSIONSEpristeride tablets was safe and effective in the treatment of BPH.
Aged ; Aged, 80 and over ; Androstadienes ; adverse effects ; therapeutic use ; Humans ; Male ; Middle Aged ; Prostatic Hyperplasia ; drug therapy ; Treatment Outcome
5.Interleukin-32, not reduced by salmeterol/fluticasone propionate in smokers with chronic obstructive pulmonary disease.
Yipeng DU ; Wei WANG ; Wei YANG ; Bei HE
Chinese Medical Journal 2014;127(9):1613-1618
BACKGROUNDThe interleukin (IL)-32/tumor necrosis factor (TNF) a pathway is supposed to play a key role in the amplification of the immune response in chronic obstructive pulmonary disease (COPD) inflammation. Inhaled corticosteroids (ICS) in combination with long-acting β2-agonists (LABA) have shown airway anti-inflammatory effects in recent studies, but the mechanism is still uncertain.
METHODSPatients were treated in a randomized, open-labeled, parallel group clinical trial with either a combination of salmeterol xinafoate/fluticasone propionate (SF; Seretide, GlaxoSmithKline) Diskus (50/500 µg twice daily) or ipratropium bromide/salbutamol (IS; Combivent, Boehringer Ingelheim) MDI (42 µg/240 µg quartic daily) for 12 weeks. At the start and the end of treatment, induced sputum was collected and the concentration of IL-32 and TNF-α, the number of neutrophils and eosinophils were measured.
RESULTSFollowing 12 weeks of treatment, a statistically significant fall from baseline in the concentration of TNF-α in sputum (P = 0.004) was seen after treatment with SF but not with IS. However, neither treatment had significant effects on the concentration of IL-32 in sputum. There was a decrease from baseline in the number of sputum neutrophils with SF that approached statistical significance (P = 0.028) but not with IS, while the number of sputum eosinophils did not change significantly from baseline in either treatment group. There was a statistically significant decline from baseline in the quality of life as assessed by the St George's respiratory questionnaire in both the SF (P = 0.004) and IS (P = 0.030) treatment groups, but no evidence of improvement in lung function was observed in either group.
CONCLUSIONThe sputum TNF-α and neutrophils, but not IL-32 and macrophages, could be reduced by ICS/LABA treatment, suggesting that IL-32 could be involved in the corticosteroid resistance of COPD inflammation.
Adult ; Aged ; Aged, 80 and over ; Albuterol ; analogs & derivatives ; therapeutic use ; Androstadienes ; therapeutic use ; Anti-Inflammatory Agents ; therapeutic use ; Drug Combinations ; Female ; Fluticasone-Salmeterol Drug Combination ; Humans ; Interleukins ; metabolism ; Male ; Middle Aged ; Pulmonary Disease, Chronic Obstructive ; drug therapy ; metabolism
6.Clinical observation on treatment of children's mild continuous asthma by Fangchuan Mixture combined with flixotide.
Chinese Journal of Integrated Traditional and Western Medicine 2007;27(11):993-995
OBJECTIVETo investigate the efficacy and mechanism of Fangchuan Mixture (FCM) in treating children with mild continuous asthma.
METHODSOne hundred and seventy-five patients in the three groups were treated with FCM (A), Flixotide (B), and the combination of FCM and Flixotide (C), respectively for 12 weeks. Their condition of asthma and TCM syndrome were observed, peak expiratory flow (PEF) and serum levels of immunoglobulin (Ig), interleukin-4 (IL-4) and interferon-gamma (IFN-gamma) were determined.
RESULTSAll the indexes determined were improved significantly in the three groups after treatment (P <0.05). Paired comparison among groups showed that the improvements in non-asthma time, time required beta-receptor activator, expectoration, complexion, appetite, and increasing serum IFN-gamma after treatment were superior in Group C than in Group A and B (P <0.05); the improvements in hidrosis, faint pulse and decreasing serum IL-4 level in Group A and C were better than those in Group B (P <0.05), and the effect for alleviating symptoms of rhinitis such as nasal obstruction and nasal discharge in Group C was more significant than that in Group B (P <0.05).
CONCLUSIONFCM could attenuate the allergic inflammation of bronchi to improve its hypersensitive state in children with asthma, and shows a cooperative action with Flixotide.
Adolescent ; Androstadienes ; therapeutic use ; Asthma ; drug therapy ; Bronchodilator Agents ; therapeutic use ; Child ; Child, Preschool ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Fluticasone ; Humans ; Male ; Phytotherapy ; Treatment Outcome
7.Advance and current status of exemestane and androstadienes in the treatment of breast cancer.
Li-ping WANG ; Kun-wei SHEN ; Zhen-zhou SHAN
Chinese Journal of Oncology 2005;27(12):764-766
Androstadienes
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therapeutic use
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Antineoplastic Agents, Hormonal
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administration & dosage
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Aromatase Inhibitors
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administration & dosage
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Breast Neoplasms
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drug therapy
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Drug Administration Schedule
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Female
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Humans
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Nitriles
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administration & dosage
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Postmenopause
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Triazoles
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administration & dosage
8.Comparison of different drugs on the treatment of benign prostate hyperplasia.
Ning-chen LI ; Shi-liang WU ; Jie JIN ; Shao-peng QIU ; Chui-ze KONG ; Yong-sheng SONG ; Zhang-qun YE ; Guang SUN ; Ying-hao SUN ; Yu-cheng SUN ; Xiao-feng WANG ; Yan-qun NA
Chinese Journal of Surgery 2007;45(14):947-950
OBJECTIVETo compare the differences of the efficacy and different therapeutic drugs on the treatment of benign prostatic hyperplasia (BPH) in order to ensure the optimal indication for different BPH patients.
METHODSA randomized, parallel-controlled, multicenter clinical trial was conducted. From September 2002 to December 2003 906 BPH patients were enrolled into 7 therapeutic groups, including selective-adrenoceptor antagonist (terazosin, doxazosin tamsulosin and naftopidil), 5 alpha-reductase inhibitor (finasteride and epristeride) and natural product (cernilton). International Prostate Symptom Score (IPSS) and Quality of Life (QOL), uroflowmetry, total prostatic volume (TPV) and transitional zone volume and residual urine were used as efficacy criteria.
RESULTSAccording to the baseline, the IPSS and Qmax were significantly correlated to the prostatic volume and transitional zone volume (P < 0.01). At average follow-up of 6 months, significant improvements in IPSS, QOL, Qmax and residual urine volume were observed in each therapeutic group, and no difference in IPSS improvement was found among the groups. Prostatic volume and transitional zone volume were significant decreased in 5alpha-reductase inhibitor groups (P < 0.05). In patients with baseline TPV greater than 35.5 cm3, the improvement of Qmax was more significant than that in patients with TPV less than 35.5 cm3 in finasteride group (P < 0.01) (5.7 ml/s and 2.2 ml/s respectively), and more significant symptomatic improvements were also found in cernilton, doxazosin and naftopidil group. In each group, the improvement of symptom were more significant in patients with IPSS higher than 20 points (P < 0.01).
CONCLUSIONSEach drug observed in this study can improve the subjective and objective symptoms significantly for BPH patients, especially for patients with higher IPSS baseline. When using 5alpha-reductase inhibitor, prostatic volume can be decreased significantly and more obviously subjective and objective improvement can be found in the patients with TPV greater than 35.5 cm3.
5-alpha Reductase Inhibitors ; Adrenergic alpha-Antagonists ; therapeutic use ; Aged ; Aged, 80 and over ; Androstadienes ; therapeutic use ; Double-Blind Method ; Doxazosin ; therapeutic use ; Enzyme Inhibitors ; therapeutic use ; Finasteride ; therapeutic use ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Naphthalenes ; therapeutic use ; Piperazines ; therapeutic use ; Plant Extracts ; therapeutic use ; Prazosin ; analogs & derivatives ; therapeutic use ; Prostate ; drug effects ; pathology ; physiopathology ; Prostatic Hyperplasia ; drug therapy ; Quality of Life ; Secale ; Sulfonamides ; therapeutic use ; Treatment Outcome
9.Comparative study on effect of acupoint heat-sensitive moxibustion and Seretide on the symptoms of bronchial asthma at chronic persistent stage.
Nan-Chang SONG ; Jin-Bao HE ; Han-Bin XU ; Ji-Feng WU
Chinese Acupuncture & Moxibustion 2012;32(7):593-596
OBJECTIVETo observe the difference in the efficacy on the symptoms of bronchial asthma at the chronic persistent stage between acupoint heat-sensitive moxibustion and western medicine with Seretide.
METHODSSixty-four cases were randomly divided into a heat-sensitive moxibustion group (32 cases) and a western medication group (32 cases). In the heat-sensitive moxibustion group, the sensitized points located between Feishu (BL 13) and Geshu (BL 17) or in the region 6-cun lateral from the 1st and the 2nd intercostal spaces of the chest were selected. The heat-sensitive moxibustion was adopted, continuously for 8 days, once per day. In the later 22 days of the 1st month, 12 treatments should be ensured. Two months later, 15 treatments should be guaranteed each month. The time of each treatment was 30 to 90 min. Totally 50 treatments were required. In the western medication group, Seretide inhaler was adopted, one inhalation each time, twice per day, for 3 months totally. The asthmatic symptoms were scored for the patients in two groups and the comparison was made between the two groups.
RESULTSAfter 3 months of treatment, the asthmatic symptom scores were all improved for the patients in the heat-sensitive moxibustion group and the western medication group as compared with those before treatment (both P < 0.05). In 6 months of follow-up visit, the asthmatic symptom scores in the heat-sensitive moxibustion group were stable, but those in the western medication group were reduced, there was significant difference between the two groups (P < 0.05).
CONCLUSIONThe acupoint heat-sensitive moxibustion effectively relieves the clinical symptoms for the patients with bronchial asthma at the chronic persistent stage. Its efficacy is similar to that of Seretide inhaler. But the long-term efficacy of the heat-sensitive moxibustion is much better.
Acupuncture Points ; Adolescent ; Adult ; Albuterol ; analogs & derivatives ; therapeutic use ; Androstadienes ; therapeutic use ; Asthma ; therapy ; Chronic Disease ; Drug Combinations ; Female ; Fluticasone-Salmeterol Drug Combination ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Moxibustion ; methods
10.Salmeterol/fluticasone treatment reduces circulating C-reactive protein level in patients with stable chronic obstructive pulmonary disease.
Yong-Jiang TANG ; Ke WANG ; Tao YUAN ; Ting QIU ; Jun XIAO ; Qun YI ; Yu-Lin FENG
Chinese Medical Journal 2010;123(13):1652-1657
BACKGROUNDEvidence suggests that systemic inflammation may play an important role in the progression and morbidity of chronic obstructive pulmonary disease. It remains controversial whether inhaled corticosteroid in combination with a long-acting beta(2)-adrenoceptor agonist can attenuate systemic inflammation. We evaluated the effect of salmeterol/fluticasone propionate on circulating C-reactive protein level in stable chronic obstructive pulmonary disease patients.
METHODSAn open-label clinical trial was conducted to recruit 122 outpatients with stable moderate-to-severe chronic obstructive pulmonary disease from department of respiratory medicine in two teaching hospitals between June 2007 and March 2008. Patients were randomized into two groups (1:1) to receive either the combination of 50 microg salmeterol and 500 microg fluticasone twice daily (n = 61), or the combination of 206 microg albuterol and 36 microg ipratropium q.i.d (n = 61) over 6 months. Circulating C-reactive protein concentrations were measured before randomization and during the follow-up. The efficacy of treatment was also assessed by spirometry, as well as health status and dyspnea score at baseline and after 6-month treatment.
RESULTSBaseline characteristics of two groups were similar. Compared with ipratropium/albuterol, the combination of salmeterol/fluticasone significantly reduced circulating level of C-reactive protein (-1.73 vs. 0.08 mg/L, respectively, P < 0.05) after 6-month treatment. Forced expiratory volume in one second (FEV(1)) and health status also improved significantly in salmeterol/fluticasone group compared with ipratropium/albuterol. Salmeterol/fluticasone treatment subjects who had a decrease of circulating C-reactive protein level had a significant improvement in FEV(1) and St George's Respiratory Questionnaire total scores compared with those who did not (185 vs. 83 ml and -5.71 vs. -1.79 units, respectively, both P < 0.01).
CONCLUSIONSalmeterol/fluticasone treatment reduced circulating C-reactive protein concentration in clinically stable moderate-to-severe chronic obstructive pulmonary disease patients after 6-month treatment.
Albuterol ; analogs & derivatives ; therapeutic use ; Androstadienes ; therapeutic use ; C-Reactive Protein ; metabolism ; Female ; Fluticasone ; Humans ; Male ; Middle Aged ; Pulmonary Disease, Chronic Obstructive ; drug therapy ; metabolism ; Salmeterol Xinafoate ; Treatment Outcome