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1.
China Journal of Chinese Materia Medica ; (24): 5450-5455, 2021.
Article in Chinese | WPRIM | ID: wpr-921726

ABSTRACT

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.


Subject(s)
Humans , Adverse Drug Reaction Reporting Systems , Books , Drug-Related Side Effects and Adverse Reactions/epidemiology , European Union , Medicine, Chinese Traditional , Pharmacovigilance
2.
Chinese journal of integrative medicine ; (12): 361-368, 2015.
Article in English | WPRIM | ID: wpr-310838

ABSTRACT

<p><b>OBJECTIVE</b>To investigate whether I-tetrahydropalmatine (I-THP), an alkaloid mainly present in Corydalis family, could ameliorate early vascular inflammatory responses in atherosclerotic processes.</p><p><b>METHODS</b>Fluorescently labeled monocytes were co-incubated with human umbilical vein endothelial cells (HUVECs), which were pretreated with I-THP and then simulated with tumor necrosis factor (TNF)-α in absence of I-THP to determine if I-THP could reduce thecytokine-induced adhesion of monocytes to HUVECs. Then I-THP were further studied the underlying mechanisms through observing the transcriptional and translational level of intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) and the nuclear translocation of nuclear factor (NF)-κ B in HUVECs.</p><p><b>RESULTS</b>L-THP could block TNF-α-induced adhesion of monocytes to HUVECs and could significantly inhibited the expression of ICAM-1 and VCAM-1 on cell surface by 31% and 36% at 30 μ mol/L. L-THP pretreatment could also markedly reduce transcriptional and translational level of VCAM-1 as well as mildly reduce the total protein and mRNA expression levels of ICAM-1. Furthermore, I-THP attenuated TNF-α-stimulated NF-κ B nuclear translocation.</p><p><b>CONCLUSION</b>These results provide evidences supporting that I-THP could be a promising compound in the prevention and treatment of the early vascular inflammatory reaction in atherosclerosis by inhibiting monocyte adhesion to vascular endothelial cell through downregulating ICAM-1 and VCAM-1 in vascular endothelial cell based on suppressing NF-κ B.</p>


Subject(s)
Humans , Berberine Alkaloids , Pharmacology , Cell Adhesion , Cell Nucleus , Metabolism , Down-Regulation , Human Umbilical Vein Endothelial Cells , Cell Biology , Metabolism , Intercellular Adhesion Molecule-1 , Genetics , Metabolism , Monocytes , Cell Biology , Metabolism , NF-kappa B , Metabolism , Protein Transport , RNA, Messenger , Genetics , Metabolism , Signal Transduction , Transcription Factor RelA , Metabolism , Tumor Necrosis Factor-alpha , Pharmacology , Vascular Cell Adhesion Molecule-1 , Genetics , Metabolism
3.
China Journal of Chinese Materia Medica ; (24): 316-321, 2014.
Article in Chinese | WPRIM | ID: wpr-319607

ABSTRACT

Sailuotong (SLT) is a compound preparation composed of ginseng, ginkgo and saffron for the treatment of vascular dementia In order to identify its material foundation and provide evidence for therapeutic regimen, the pharmacokinetics and brain distribution of ginsenosides were investigated after intragastric administration of SLT. An LC-MS/MS method was developed for the determination of 7 ginsenosides in rat plasma simultaneously. Statistical analysis of obtained data demonstrated that the method has achieved the desired linearity, precision, accuracy and sensitivity. After administration of SLT at 60 mg x kg(-1) dose, 7 ginsengosides were all absorbed into systematic circulation. The quantitative and statistical analysis of gensenosides in plasma showed that protopanaxdiol saponins exhibited higher concentration and longer half life than protopanaxatriol saponins. The mean value of half life of ginsenosides Rg1, Re, Rb1, Rb2/b3, Rc and Rd were 15.26, 2.46, 18.41, 27.70, 21.86 and 61.58 h respectively. The peak concentration of them were 7.15, 2.83, 55.32, 30.22, 21.42, 8.81 microg x L(-1) respectively. The determination of brain distribution at different time after dosing revealed ginsenosides entered into brain promptly but the concentration declined along with time rapidly. The ginsenosides with higher concentration in brain were Rg1, Re, Rb1 and Rc. These findings demonstrated ginsenosides could be absorbed in blood and penetrated into brain rapidly. Some ginsenosides, especially Rg1 and Re, might be the main components directly effecting neurocyte in brain taking advantage of their better brain distribution. While ginsenosides of mostly protopanaxdiol saponins might protect brain mainly depending on peripheral efficacy in virtue of their long residence in blood, by which higher concentration could be reached after multiple dosing.


Subject(s)
Animals , Male , Rats , Brain , Metabolism , Drugs, Chinese Herbal , Ginsenosides , Pharmacokinetics , Rats, Wistar , Time Factors
4.
China Journal of Chinese Materia Medica ; (24): 4357-4361, 2013.
Article in Chinese | WPRIM | ID: wpr-287583

ABSTRACT

<p><b>OBJECTIVE</b>To establish the "clinical-mimetic" Chinese medicine symptom complex score method for the coronary heart disease Chinese miniature swine model with phlegm-stasis cementation syndrome, in order to observe the effect of formula of removing both phlegm and blood stasis (TYTZ) on the Chinese medicine symptom complex score for the coronary heart disease Chinese miniature swine model with phlegm-stasis cementation syndrome.</p><p><b>METHOD</b>Totally 36 Chinese miniature swine were randomly divided to the normal control group, the model group, the Shujiangzhi group, and TYTZ groups with doses of 2.0, 1.0 and 0.5 g x kg(-1), with six in each group. Except for the normal control group, all of the other groups were fed with high fat diet for two weeks. The coronary heart disease model with phlegm-stasis cementation syndrome was established by injuring left anterior descending artery with interventional balloons and continuously feeding with high fat diet for eight weeks. After the operation, the groups were administered with drugs for eight weeks. Their main symptoms, accompanied symptoms, tongue and pulse signs of the coronary heart disease Chinese miniature swine with phlengm-stasis cementation syndrome were observed according to the symptom-graded scoring method.</p><p><b>RESULT</b>Compared with the model group, TYTZ in different doses could reduce the scores of main symptoms at the 6th and 10th week. Specifically, TYTZ in low dose could reduce the scores of tongue at the 6th week and the scores of accompanied symptoms, and tongue and pulse signs at the 10th week; And TYTZ in high dose could decrease all symptom scores at the 6th and 10th week (P < 0.05 or P < 0.01).</p><p><b>CONCLUSION</b>TYTZ can improve the scores of the main symptoms, accompanied symptoms, tongue and pulse signs in coronary heart disease Chinese miniature swine with phlegm-stasis cementation syndrome. It is suggested that the "clinical-mimetic" objective scoring for syndromes of Chinese miniature swine is of great significant to the development of new traditional Chinese medicine drugs.</p>


Subject(s)
Animals , Female , Male , Chemistry, Pharmaceutical , Coronary Disease , Blood , Diagnosis , Therapeutics , Medicine, Chinese Traditional , Methods , Swine , Swine, Miniature
5.
China Journal of Chinese Materia Medica ; (24): 4138-4143, 2013.
Article in Chinese | WPRIM | ID: wpr-287623

ABSTRACT

<p><b>OBJECTIVE</b>To discuss that pathogenesis evolvement regularity of Chinese miniature swine with phlege-stasis cementation syndrome of coronary heart disease.</p><p><b>METHOD</b>Eighteen Chinese miniature swine were randomly divided to the normal control group, the model group and the Danlou tablet group, with six swine in each group. Except for the normal control group, all of the other groups were fed with high fat diet for two weeks. The coronary heart disease model with phlegm-stasis cementation syndrome was established by injuring left anterior descending artery with interventional balloons and continuously feeding with high fat diet for eight weeks. The levels of BMI, hemorheological parameters, lipids in serum and inflammatory cytokines were observed at the 0th (before the experiment), 2nd (before operation or drug administration), 6th (four weeks after drug administration) and 10th week (eight weeks after drug administration) of study. The levels of TG and TC in liver and the pathological changes in coronary artery tissues were also observed at the end of study.</p><p><b>RESULT</b>Compared with the normal control group, the model group had showed significant increase in the levels of TC, TG, LDL-C and VLDL-C in serum (P < 0.01) from the second week to the end of the experiment, with notable rise in the whole blood viscosity under the shear rates of 5 s(-1) and 60 s(-1). At the 6th week, the levels of BMI and TG and TNF-alpha in serum significantly increased. At the 10th week, the levels of BMI and hs-CRP, IL-6 and TNF-alpha in serum significantly increased as well, with remarkable increase in coronary stenosis, intimal thickness and the ratio between intimal thickness and media thickness (P < 0.05 and P < 0.01), and significant rise in TC and TG in livers (P < 0.01). Compared with the model group, the Danlou tablet group showed obvious reduction in severity of coronary artery lesion, intimal thickness and lumen stenosis ratio and ratio between intimal thickness and media thickness (P < 0.01), BMI, TC, TG, LDL-C and VLDL-C in serum, TC and TG in liver, as well as hs-CRP, IL-6 and TNF-alpha levels in serum (P < 0.05 and P < 0.01), with notable decline in the whole blood viscosity under the shear rates of 5 s(-1) and 60 s(-1).</p><p><b>CONCLUSION</b>The interaction of phlegm, blood stasis and toxin syndromes helps promote the progress and development of AS plaques, which is the key pathogenesis of phlegm-stasis cementation syndrome in coronary heart disease.</p>


Subject(s)
Animals , Female , Male , Body Weight , Coronary Disease , Blood , Hemodynamics , Inflammation Mediators , Metabolism , Lipids , Blood , Liver , Metabolism , Medicine, Chinese Traditional , Swine , Swine, Miniature
6.
Chinese Journal of Endemiology ; (6): 678-680, 2012.
Article in Chinese | WPRIM | ID: wpr-643165

ABSTRACT

Objects To analyze the epidemiological characteristics of outbreaks of brucellosis in recent years in Gansu province,in order to provide a scientific basis for prevention and control of this disease.Methods Data of brucellosis cases from 2005 to 2010 in Gansu province were reviewed and retrospectively analyzed; the data included the outbreaks in different times,locations,groups,source of infection,and clinical manifestations.Results There were 8 brucellosis outbreaks among humans and animals in the nine administrative villages,seven townships (towns),six counties (districts) of the whole province in 5 years,a total of 66 of confirmed new cases.The source of infection was mainly the sheep (Small Tailed Han sheep and Cashmere goat),followed by dairy cow.The outbreak time was mainly in the May to August.Occupation distribution:of all the patients found in the past 6 years,farmers were 59 cases,accounting for 89.39% (59/66); students 4 cases,accounting for 6.06% (4/66);and herdsman 3 cases,accounting for 4.54%(3/66).Conclusions Brucellosis outbreaks increase significantly in recent years,and the epidemic situation is not optimistic.

7.
Chinese Journal of Oncology ; (12): 864-867, 2010.
Article in Chinese | WPRIM | ID: wpr-293464

ABSTRACT

<p><b>OBJECTIVE</b>To summarize the clinical experience of trastuzumab treatment in neoadjuvant, adjuvant, metastatic setting of Chinese patients with Her-2 positive breast cancer and evaluate the efficacy of trastuzumab in combination with chemotherapy.</p><p><b>METHODS</b>From January 2004 to December 2008, 141 outpatients with breast cancer treated with trastuzumab were investigated retrospectively. The follow-up time ranged from 3 to 319 months. The disease free survival time (DFS) of metastatic setting was calculated. The overall survival time (OS), time to treatment failure (TTF) and clinical response rate (CRR, including complete response, partial response and stable disease) of adjuvant, first-line, second-line therapy were analyzed statistically.</p><p><b>RESULTS</b>In the neoadjuvant regimen, paclitaxel plus carboplatin in combination with trastuzumab accounted for 66.7%, which achieved pathological complete response in 10 of 16 patients. In the adjuvant regimen, anthracycline or anthracycline followed by taxane accounted for 53.9%. The median DFS of 57 cases with metastatic diseases was 17 months. The CRR of first-line trastuzumab use in metastatic setting was 84.5%, compared with 44.4% of second-line use. The median TTF of first-line treatment was 24 months compared with 5 months of second-line treatment. Statistically significant differences were observed.</p><p><b>CONCLUSION</b>The regimen of paclitaxel plus carboplatin in combination with trastuzumab deserves wide clinical use. In metastatic setting, first-line treatment of trastuzumab plus chemotherapy can achieve a higher response rate than second-line treatment. Continued trastuzumab therapy combined with different chemotherapy treatment after disease progression may obtain additive clinical advantage.</p>


Subject(s)
Adult , Female , Humans , Middle Aged , Anthracyclines , Antibodies, Monoclonal, Humanized , Therapeutic Uses , Antineoplastic Agents , Therapeutic Uses , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Breast Neoplasms , Drug Therapy , Metabolism , Pathology , Bridged-Ring Compounds , Carboplatin , Chemotherapy, Adjuvant , Disease-Free Survival , Follow-Up Studies , Neoadjuvant Therapy , Neoplasm Metastasis , Neoplasm Recurrence, Local , Paclitaxel , Receptor, ErbB-2 , Metabolism , Retrospective Studies , Survival Rate , Taxoids , Trastuzumab , Treatment Failure
8.
Chinese Journal of Surgery ; (12): 511-515, 2009.
Article in Chinese | WPRIM | ID: wpr-238859

ABSTRACT

<p><b>OBJECTIVE</b>To identify predictive markers of the long-term outcome for neo-adjuvant chemotherapy (NC) in locally advanced breast cancer (LABC) treated with intravenous vinorelbine (V) and epirubicin (E) combination regimen.</p><p><b>METHODS</b>One hundred and nineteen patients with LABC were treated from September 2001 to May 2006. All patients were diagnosed as invasive breast cancer by 14G core needle biopsy and treated with three cycles of VE regimen before the operation. The patients were subjected to surgery and subsequently were given other three cycles of VE or cyclophosphamide+epirubicin+fluorouracil (CEF) regimen according to the clinical responses. Local-regional radiotherapy was applied to all patients after the chemotherapy and followed by hormone-therapy according to hormone receptor status. The impact of clinical, pathological, and immunohistochemical features on disease free survival (DFS) and overall survival (OS) was evaluated.</p><p><b>RESULTS</b>All patients were evaluable for responses: clinical complete response was documented in 27 patients (22.7%), 78 patients (65.5%) obtained partial clinical response. The pathological complete response was found in 22 cases (18.5%). Of the patients, 115 cases (96.6%) were followed-up for a median time of 63.4 months (range, 9-76 months), the 5-year DFS rate and OS rate was 58.7% and 71.3%, respectively. On multivariate analysis, high pre-Ki-67 (P=0.012) and post-Ki-67 expression (P=0.045), no pathological complete response after NC (P=0.034) were associated with the higher risk of disease relapse; high pre-Ki-67 (P=0.017) and post-Ki-67 expression (P=0.001), negative pre-ER (P=0.002) and no pathological complete response after NC (P=0.034) were associated with a shorter survival.</p><p><b>CONCLUSION</b>Pathological response in primary tumor, pre-Ki-67 and post-Ki-67 expression, pre-ER expression are important predictors of long-term outcome for LABC patients with three cycles of VE regimen before operation.</p>


Subject(s)
Adult , Aged , Female , Humans , Middle Aged , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Breast Neoplasms , Drug Therapy , Pathology , General Surgery , Chemotherapy, Adjuvant , Epirubicin , Follow-Up Studies , Lymphatic Metastasis , Prognosis , Retrospective Studies , Treatment Outcome , Vinblastine
9.
Chinese Journal of Surgery ; (12): 1397-1399, 2008.
Article in Chinese | WPRIM | ID: wpr-258394

ABSTRACT

<p><b>OBJECTIVE</b>To explore the clinical and pathological characteristics and treatment patterns and the factors influencing treatments of elderly patients with breast cancer.</p><p><b>METHODS</b>From January 2001 to December 2006, 647 female breast cancer patients over 65 years old were treated. The clinical records were reviewed. All patients were divided into three groups according to age, including 65 to 69 years old group, 70 to 74 years old group and 75 years or elder group. These 647 patients accounted for 13.4% of all breast cancer patients undergoing surgery during the same period. Major pathological type was invasive ductal carcinoma (79.3%). The patients who had chronic comorbid diseases of other systems accounted for 54.7%. Five hundred and eighty-six patients underwent modified radical mastectomy, accounting for 90.6%. Two hundred and thirty-three patients underwent postoperative adjuvant chemotherapy, accounting for 36.0%. The differences of clinicopathological characteristics and treatment patterns between three groups were tested by Chi-square test.</p><p><b>RESULTS</b>Older patients had more tumors with mucinous and other pathological types, less over-expression of Her2/Neu(+++), higher probability to have comorbidities, higher probability to undergo relatively conservative surgery, lower probability to receive postoperative chemotherapy, and higher probability to receive postoperative endocrine therapy alone.</p><p><b>CONCLUSIONS</b>Breast cancer in the elderly exhibits distinctive clinical and pathological characteristics. Treatment patterns they received are related to age.</p>


Subject(s)
Aged , Aged, 80 and over , Female , Humans , Breast Neoplasms , Pathology , Therapeutics , Retrospective Studies
10.
Chinese Journal of Surgery ; (12): 745-747, 2006.
Article in Chinese | WPRIM | ID: wpr-300619

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the clinical efficacy and toxicity of vinorelbine (N) and epirubicin (E) as the neoadjuvant chemotherapy regimen in the treatment of locally advanced breast cancer (LABC).</p><p><b>METHODS</b>From September 2001 to December 2004, 158 patients with LABC were treated with NE chemotherapy before operation. Neoadjuvant chemotherapy containing vinorelbine (N), 25 mg/m(2) (days 1 and 8) and epirubicin (E), 60 mg/m(2) (days 1) was administered every 3 weeks for three cycles before local treatment.</p><p><b>RESULTS</b>Response in the breast: the clinical objective response was 81.6% [23.4% (37/158) cCR and 58.2% (92/158) PR], 16.5% (26/158) SD and 1.9% (3/158) PD. Pathological complete response was found in 29 cases (18.3%). Eighteen cases (26.5%) who have positive FNA result in the axillary lymphnode before chemotherapy showed negative result in the surgery specimen. The most common toxicities were neutropenia, alopecia and nausea/vomiting. Neutropenia grade 3 - 4 was reported in 111 patients (70.3%) and there was no toxic deaths.</p><p><b>CONCLUSIONS</b>The combination of vinorelbine and epirubicin is a very active and well-tolerated regimen as neoadjuvant chemotherapy for the LABC.</p>


Subject(s)
Adult , Aged , Female , Humans , Middle Aged , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Breast Neoplasms , Drug Therapy , Pathology , Chemotherapy, Adjuvant , Drug Administration Schedule , Epirubicin , Neoplasm Staging , Treatment Outcome , Vinblastine
11.
Chinese Journal of Surgery ; (12): 1036-1039, 2006.
Article in Chinese | WPRIM | ID: wpr-300564

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate MRI in diagnosing breast lesions which need biopsy.</p><p><b>METHODS</b>One hundred and eight patients were admitted to hospital for biopsies due to one hundred and sixteen suspicious lesions detected in their breasts. These lesions were detected by physical examination, mammography or ultrasonography. They were also administrated MRI examination before biopsy. The sensitivity and specificity of each diagnostic method were obtained and the radiologic-pathologic correlation was meanwhile calculated.</p><p><b>RESULTS</b>Seventy (60.3%) breast lesions were diagnosed malignancy. The sensitivity, specificity, accuracy, positive prognostic value and negative prognostic value of ultrasonography were 83.3%, 62.0%, 74.1%, 74.3% and 73.8%. Such data of mammography were 86.8%, 68.1%, 78.0%, 75.4% and 82.1%. And those of MRI were 97.1%, 73.9%, 87.9%, 85.0% and 94.4%.</p><p><b>CONCLUSION</b>MRI is superior to ultrasonography and mammography in diagnosing breast lesions, especially for the nonpalpable lesions.</p>


Subject(s)
Adult , Aged , Female , Humans , Middle Aged , Breast Diseases , Diagnosis , Pathology , Magnetic Resonance Imaging , Mammography , Sensitivity and Specificity , Ultrasonography, Mammary
12.
Chinese Journal of Surgery ; (12): 1322-1324, 2006.
Article in Chinese | WPRIM | ID: wpr-288598

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate three biopsy methods which are currently used in stereotactic breast biopsy.</p><p><b>METHODS</b>A total of 361 cases of stereotactic breast biopsies were carried out since 2000, including 73 cases of true cut core needle biopsies (ST-CNB), 74 cases of vacuum assisted biopsies (ST-VAB) and 214 cases of excisional biopsies. After medium follow-up time of 18 months (6 to 66 months), the accuracy as well as the clinical benefits of the three stereotactic biopsy procedures were analyzed retrospectively.</p><p><b>RESULTS</b>The cancer miss rate of stereotactic wire localized excisional biopsy, ST-CNB and ST-VAB is 0, 2.7% and 0 respectively. Under-estimate rate of minimal invasive biopsy was 33% in atypical ductal hyperplasia (ADH) and 53% in ductal carcinoma in situ (DCIS). The minimal invasive procedure is superior to surgical procedure in terms of operation time, breast cosmetic outcome and complications, etc. Furthermore, 69% of the surgeries for suspicious lesion were waived.</p><p><b>CONCLUSIONS</b>Stereotactic minimal invasive breast biopsy, especially ST-VAB, is an accurate, safty and convenient diagnosis technique and could be considered as the first line choice for mammographic moderate suspicious breast lesions (BIRADS-4). However, further excisional biopsy is recommended for atypical hyperplasia. Stereotactic excisional biopsy could be directly used for diagnosis of mammographic highly suspicious breast lesions (BIRADS-5).</p>


Subject(s)
Female , Humans , Biopsy , Methods , Biopsy, Needle , Breast , Pathology , Breast Diseases , Diagnostic Imaging , Pathology , Follow-Up Studies , Mammography , Sensitivity and Specificity
13.
Chinese Journal of Oncology ; (12): 126-128, 2005.
Article in Chinese | WPRIM | ID: wpr-331211

ABSTRACT

<p><b>OBJECTIVE</b>To investigate the clinical response, pathological complete response (pCR), tumor resection rate and safety of neoadjuvant chemotherapy with docetaxel and epirubicin (ET) for locally advanced breast cancer (LABC).</p><p><b>METHODS</b>From March to December 2001, 40 women with LABC, aged from 28-67 (medium 48) years were alloted. Twenty patients had clinical stage IIIa disease, 15 had stage IIIb disease and 5 stage IV patients who had ipsilateral sura-clavicular metastasis. The dose was: epirubicin (E) 60 mg/m2, docetaxel (T) 75 mg/m2 every 3 weeks, with G-CSF given preventively. After 2 cycles of ET, a pilot clinical response evaluation was performed by investigators for each patient to decide if she should receive another 1-2 cycles of ET before surgery or radiation therapy.</p><p><b>RESULTS</b>Thirty-eight patients received 2-3 cycles of ET regimen. The pCR, clinical complete response (cCR) and clinical partial response (cPR) rates were 15.0%, 20.0% and 52.5%, respectively. Tumor resection rate in this group was 92.5%. Incidence of III/IV Grade neutropenia was 8.4%/14.0% of cycles, and 3 patients suffered from neutropenia with fever. Non-hematological adverse events were alopecia, nausea, vomiting, fluid retention, myalgia, arthralgia and nail disorders, which were mild to moderate.</p><p><b>CONCLUSION</b>Neo-adjuvant chemotherapy with a combination of docetaxel and epirubicin is effective and well tolerated by women with locally advanced breast cancer.</p>


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Breast Neoplasms , Drug Therapy , General Surgery , Carcinoma, Ductal, Breast , Drug Therapy , General Surgery , Chemotherapy, Adjuvant , Drug Administration Schedule , Epirubicin , Neutropenia , Paclitaxel , Remission Induction
14.
Acta Pharmaceutica Sinica ; (12): 208-211, 2004.
Article in Chinese | WPRIM | ID: wpr-301113

ABSTRACT

<p><b>AIM</b>To develop an HPLC-ESI-MS assay for determination of trimebutine in human plasma and to investigate the pharmacokinetics and bioequivalence of two trimebutine tablets in human.</p><p><b>METHODS</b>After being made alkaline with saturated sodium bicarbonate, plasma was extracted by cyclohexane and separated by HPLC on a reversed-phase C18 column with a mobile phase of 10 mmol x L(-1) ammonium acetate buffer solution (pH 3.5)-methanol (18:82). HPLC-ESI-MS was performed in the selected ion monitoring (SIM) mode using target ions at m/z 388 for trimebutine and m/z 280 for the internal standard (sibutramine, IS). The fragmentor voltage was 50 V. A randomized cross-over design was performed in 20 healthy volunteers. In the two study periods, a single 100 mg dose of each tablet was administered to each volunteer.</p><p><b>RESULTS</b>Calibration curve was linear over the range of 0.3 - 150 microg x L(-1). The main pharmacokinetic parameters of T1/2, Tmax and Cmax were (9.2 +/- 2.8) h, (1.0 +/- 0.3) h and (40 +/- 20) microg x L(-1) for the reference tablet; (9.2 +/- 2.3) h, (0.9 +/- 0.4) h and (41 +/- 20) microg x L(-1) for the test tablet. The relative bioavalability of the test tablet was (97 +/- 13)%. The results of variance analysis and two one-sided t-test showed that there was no significant difference between the two formulations in the AUC and Cmax.</p><p><b>CONCLUSION</b>The assay was proved to be sensitive, accurate and convenient. The two formulations were bioequivalent.</p>


Subject(s)
Adult , Humans , Male , Area Under Curve , Chromatography, High Pressure Liquid , Gastrointestinal Agents , Pharmacokinetics , Spectrometry, Mass, Electrospray Ionization , Tablets , Therapeutic Equivalency , Trimebutine , Pharmacokinetics
15.
Chinese Journal of Oncology ; (12): 664-668, 2004.
Article in Chinese | WPRIM | ID: wpr-331236

ABSTRACT

<p><b>OBJECTIVE</b>To demonstrate the impact of hypoxia on ER-alpha in both breast cancer tissue and cell line, and its relationship with hypoxia-related parameters.</p><p><b>METHODS</b>Expression of ER-alpha in 51 breast cancer patients with ER positive determined by ligand-binding assay was examined by immunohistochemistry and compared with CA-IX and Glut-1. Impact of hypoxia on breast cancer cell line MCF-7 (ER-alpha positive) was observed by Western Blot and RT-PCR.</p><p><b>RESULTS</b>Of 51 breast cancer patients, 49 were ER-alpha positive. Regional decrease of ER-alpha expression was consistently observed in peri-necrotic regions as compared to distant regions in both in-situ carcinomas (n=29, P <0.0001) and invasive carcinomas (n=20, P=0.0001), which was closely associated with the induction of CA-IX and Glut-1 in hypoxia (P <0.0001). The decreased expression of ER-alpha protein and mRNA in breast cancer cell lines were attributed to hypoxia and not to other stress factors, such as reduced glucose, low pH, and products released from necrotic or hypoxic cells. Chronic intermittent hypoxia could cause persistent down-regulation of ER-alpha in the MCF-7 breast cancer cell line.</p><p><b>CONCLUSION</b>Regional hypoxia in breast cancer is associated with the reduced ER-alpha expression, and intermittent hypoxia can cause persistent down-regulation. Hypoxia may therefore contribute to the progression of ER-alpha negative status and potentially to the development of resistance to endocrine therapy.</p>


Subject(s)
Female , Humans , Antigens, Neoplasm , Metabolism , Breast , Metabolism , Pathology , Breast Neoplasms , Metabolism , Pathology , Carbonic Anhydrase IX , Carbonic Anhydrases , Metabolism , Carcinoma in Situ , Metabolism , Pathology , Carcinoma, Ductal, Breast , Metabolism , Pathology , Cell Hypoxia , Cell Line, Tumor , Down-Regulation , Estrogen Receptor alpha , Genetics , Metabolism , Glucose Transporter Type 1 , Hypoxia , Metabolism , Monosaccharide Transport Proteins , Metabolism , RNA, Messenger , Genetics
16.
China Oncology ; (12)2001.
Article in Chinese | WPRIM | ID: wpr-675121

ABSTRACT

Purpose:To investigate method of early detection of breast cancer with microcalcification observed by mammograph but without palpable mass clinlcally.Methods:Stereotatic core needle biopsy (SCNB) were performed in 35 patients with calcification observed by mammography,and 29 people received stereotatic needle localized breast biopsies (NLBB).All tissues were routinely processed.Microscopic analysis of calcification and morphologic analysis of calcifica- tion were done,as well as histologic diagnosis.Results:Among the 35 specimens of SCNB,microscopic calcification,in- traductal carcinoma and invasive ductal carcinoma were detected in 24,8,and 4 respectively.Calcification was identified in 25 of the 29 cases of NLBB.Five cases of intraductal carcinoma,six cases of invasive ductal carcinoma as well as one case of invasive lobular carcinoma were diagnosed in these 29 patients.Conclusions:With close cooperation among pathol- ogists,surgeons and radiologists,the application of SCNB and NLBB may benefit the early detection of breast cancer with microcalcification observed by mammograph but without mass being palpable clinically and finaly improve the survival of breast cancer patients.

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