OBJECTIVETo study the efficacy and safety of Shuanghuang Shengbai Granule (, SSG), a traditional Chinese herbal medicine, on myelosuppression of cancer patients caused by chemotherapy.

METHODSA total of 330 patients were randomly assigned to the treatment group (220 cases, analysed 209 cases) and the control group (110 cases, analysed 102 cases) with a 2:1 ratio by envelope method. The patients in the treatment group at the first day of chemotherapy started to take SSG for 14 days, while the patients in the control group took Leucogon Tablets. The changes of the blood routine, clinical symptoms and immune function in both groups were observed for safety and efficacy evaluation.

RESULTSAt the 7th day of chemotherapy, the white blood cells (WBCs) level in the treatment group was significantly higher than that in the control group (P<0.05). After treatment, the WBCs rate in the normal range accounted for 50.2% in the treatment group, the myelosuppression of WBCs and neutrophil were mainly grade I, while 8.1% and 5.7% of patients emerged grade III and grade IV myelosuppression, respectively. The incidence of myelosuppression of the treatment group was significantly lower than that of the control group (P<0.05). The total effective rate of Chinese medicine syndrome in the treatment group was significantly higher than that in the control group (84.2% vs. 72.5%, P<0.05). The immune cell levels in both groups were maintained in the normal range. Compared with that before treatment, the levels of CD3and CD4cells were significantly increased in the treatment group after treatment (P<0.05). The discrepancy of CD3and CD4cell activity before and after treatment in both groups were significantly different (P<0.05). No obvious adverse event occurred in both groups.

CONCLUSIONSSG had a protection effect on bone marrow suppression, and alleviated the clinical symptoms together with clinical safety.

Antineoplastic Agents, Phytogenic ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Granulocyte Precursor Cells ; drug effects ; Humans ; Immune Tolerance ; drug effects ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Neoplasms ; drug therapy ; Pancytopenia ; chemically induced ; prevention & control ; Treatment Outcome

Objective: To investigate the anti-prostate cancer (PCa) effect of roemerine in vitro and in vivo in the mouse model of PCa. METHODS: We detected the effects of roemerine on the proliferation, apoptosis and migration of PCa cells DU145, LNCaP, PC-3 and 22RV1, screened out the sensitive cell line and constructed a tumor-bearing model in mice for verification of the antitumor efficacy of roemerine in vivo. RESULTS: Roemerine inhibited the proliferation and migration of the DU145, LNCaP, PC-3 and 22RV1 cells and induced their apoptosis in different degrees, particularly those of the LNCaP cells. The average tumor weight was less in the roemerine intervention group (［1.99±0.95］ g) than in the control (［2.95±1.04］ g), the least in the high-dose roemerine (30 mg/kg) plus paclitaxel intervention group (［0.90±0.16］ g). The mean heart, liver, and kidney indexes were markedly lower in the roemerine (0.58±0.06, 6.20±0.42 and 1.49±0.33) than in the paclitaxel group (0.66±0.04, 6.99±0.72 and 1.95±0.34), while the mean spleen and thymus indexes were remarkably higher in the former (0.54±0.11 and 0.06±0.01) than in the latter (0.41±0.09 and 0.05±0.01). Pathological staining showed a lower degree of malignancy and metastasis in both the roemerine and the roemerine + paclitaxel intervention group than in the control, as well as a lower degree of visceral injury in the roemerine and roemerine + paclitaxel groups than in the paclitaxel group. CONCLUSIONS Roemerine has some anti-PCa effect and alleviates adverse reactions in paclitaxel combination administration.
Alkaloids ; therapeutic use ; Animals ; Antineoplastic Agents, Phytogenic ; adverse effects ; therapeutic use ; Apoptosis ; drug effects ; Cell Line, Tumor ; Cell Movement ; drug effects ; Cell Proliferation ; drug effects ; Disease Models, Animal ; Drug Therapy, Combination ; methods ; Drugs, Chinese Herbal ; therapeutic use ; Male ; Mice ; Mice, Nude ; Paclitaxel ; adverse effects ; therapeutic use ; Prostatic Neoplasms ; drug therapy

OBJECTIVETo assess the efficacy of vinorelbine (NVB)-based regimens in patients with metastatic triple negative breast cancer (mTNBC) pretreated with anthracyclines and taxanes.

METHODSClinical data of 48 patients diagnosed and treated for mTNBC between 2004 and 2012 at the Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) were retrospectively analyzed. All patients were pretreated with anthracyclines and at least one taxane in neo-adjuvant, adjuvant or chemotherapy for mTNBC and patients should be having at least one measurable metastatic lesion. Totally, 48 patients were included in this study, of which 21 cases received first-line chemotherapy and 27 cases received second-line chemotherapy. Based on the regimen they received, 22 patients were treated with NVB plus platinum (NP), and 26 patients with NVB plus capecitabine (NX).

RESULTSAfter 70 months follow-up, in the total group of patients, the objective response rate was 20.8%, clinical benefit rate was 43.8%, median progression free survival (PFS) was 4.4 months and median overall survival (OS) was 15.5 months. In addition, the ORR was significantly better in the NP arm versus NX arm (33.8% vs.7.7%, P=0.029) as well as PFS was statistically improved in the NP arm than NX arm (5.3 m vs. 3.0 m, P=0.023). Similar trend was observed in the OS, although the difference was not statistically significant (27.7 m vs. 14.8 m, P=0.077). In all, the most frequently reported adverse events were G1/2 gastrointestinal toxicity (68.8%) and neutropenia (62.5%) . No significant difference was observed between the NP arm and NX arm (P>0.05). The percentage of patients who delayed chemotherapy administration in the NP arm and NX arm was 9.1% (n=2), and 3.8% (n=1), respectively.

CONCLUSIONSNVB-based combination chemotherapy demonstrates moderate efficacy in mTNBC patients pretreated with anthracyclines and one taxane with manageable toxicity. NP regimen shows potential superiority over NX regimen, and should be further verified in randomized phase III clinical trial in larger cohort.

Anthracyclines ; therapeutic use ; Antibiotics, Antineoplastic ; adverse effects ; therapeutic use ; Antineoplastic Agents, Phytogenic ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Bridged-Ring Compounds ; therapeutic use ; Capecitabine ; administration & dosage ; Cisplatin ; administration & dosage ; Disease-Free Survival ; Humans ; Neutropenia ; chemically induced ; Retrospective Studies ; Taxoids ; therapeutic use ; Triple Negative Breast Neoplasms ; drug therapy ; pathology ; Vinblastine ; adverse effects ; analogs & derivatives ; therapeutic use

Risk monitoring of new Chinese patent anti-hepatoma drugs is tracking recognized risks and residual risks, identifying emerging risk and ensure the implementation of the plan, estimating the process of reducing effectiveness. The paper is mainly through understanding the status of Chinese patent anti-hepatoma drugs, the content, characteristic and analysis method of dynamic risk monitoring, and then select the risk control indicators, collect risk information. Finally, puts forward the thought of anti-hepatoma drugs listed evaluation in our country, and try to establish the model of dynamic risk management of anti-hepatoma drugs.
Antineoplastic Agents, Phytogenic ; adverse effects ; economics ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; Drug Discovery ; economics ; legislation & jurisprudence ; organization & administration ; Drug and Narcotic Control ; economics ; legislation & jurisprudence ; organization & administration ; Drugs, Chinese Herbal ; adverse effects ; economics ; therapeutic use ; Humans ; Liver Neoplasms ; drug therapy ; Product Surveillance, Postmarketing

Antineoplastic Agents, Phytogenic ; adverse effects ; therapeutic use ; Chemical and Drug Induced Liver Injury ; prevention & control ; Female ; Glutathione ; therapeutic use ; Humans ; Male ; Middle Aged ; Paclitaxel ; adverse effects ; therapeutic use

Antineoplastic Agents, Phytogenic ; adverse effects ; therapeutic use ; Camptothecin ; adverse effects ; analogs & derivatives ; therapeutic use ; Colorectal Neoplasms ; drug therapy ; genetics ; Diarrhea ; chemically induced ; Glucuronosyltransferase ; genetics ; Humans ; Neutropenia ; chemically induced ; Polymorphism, Single Nucleotide

Antineoplastic Agents, Phytogenic ; therapeutic use ; Camptothecin ; adverse effects ; analogs & derivatives ; therapeutic use ; Child ; Child, Preschool ; Female ; Hepatoblastoma ; drug therapy ; Humans ; Liver Neoplasms ; drug therapy ; Male ; Neoplasm Recurrence, Local ; drug therapy

The aim of this study was to compare safety and efficacy of 4 homogenous overlapping drug-eluting stents (DES) in acute myocardial infarction (AMI) patients. We selected 1,349 consecutive patients (62.1 +/- 14.9 yr, 69.4% male) who received homogenous overlapping DESs in diffuse de novo coronary lesions from Korea Acute Myocardial Infarction Registry from April 2006 through September 2010. They were divided into 4 groups based on type of DES implanted - Paclitaxel (PES), Sirolimus (SES), Zotarolimus (ZES) and Everolimus (EES)-eluting stents. Primary endpoint was 12-month MACE. We also studied EES versus other DESs (PES + SES + ZES). Mean stent length was 26.2 +/- 7.5 mm and mean stent diameter was 3.1 +/- 0.4 mm. Average number of stents used per vessel was 2.2 +/- 0.5. Incidence of major adverse cardiac events (MACE) in PES, SES, ZES, and EES groups were 9.5%, 9.2%, 7.5%, and 3.8%, respectively (P = 0.013). In EES group, overall MACE and repeat revascularization were lowest, and no incidence of stent thrombosis was observed. Non-fatal MI was highest in PES, almost similar in SES and EES with no incidence in ZES group (P = 0.044). Cox proportional hazard analysis revealed no differences in the incidence of primary endpoint (P = 0.409). This study shows no significant differences in 12-month MACE among 4 groups.
Acute Disease ; Aged ; Aged, 80 and over ; Antineoplastic Agents, Phytogenic/adverse effects/*therapeutic use ; Coronary Angiography ; Drug-Eluting Stents/*adverse effects ; Female ; Humans ; Immunosuppressive Agents/adverse effects/*therapeutic use ; Male ; Middle Aged ; Myocardial Infarction/*drug therapy/mortality/pathology ; Myocardial Revascularization ; Paclitaxel/adverse effects/therapeutic use ; Proportional Hazards Models ; Registries ; Republic of Korea ; Sirolimus/adverse effects/analogs & derivatives/therapeutic use ; Survival Analysis

The aim of this study was to compare safety and efficacy of 4 homogenous overlapping drug-eluting stents (DES) in acute myocardial infarction (AMI) patients. We selected 1,349 consecutive patients (62.1 +/- 14.9 yr, 69.4% male) who received homogenous overlapping DESs in diffuse de novo coronary lesions from Korea Acute Myocardial Infarction Registry from April 2006 through September 2010. They were divided into 4 groups based on type of DES implanted - Paclitaxel (PES), Sirolimus (SES), Zotarolimus (ZES) and Everolimus (EES)-eluting stents. Primary endpoint was 12-month MACE. We also studied EES versus other DESs (PES + SES + ZES). Mean stent length was 26.2 +/- 7.5 mm and mean stent diameter was 3.1 +/- 0.4 mm. Average number of stents used per vessel was 2.2 +/- 0.5. Incidence of major adverse cardiac events (MACE) in PES, SES, ZES, and EES groups were 9.5%, 9.2%, 7.5%, and 3.8%, respectively (P = 0.013). In EES group, overall MACE and repeat revascularization were lowest, and no incidence of stent thrombosis was observed. Non-fatal MI was highest in PES, almost similar in SES and EES with no incidence in ZES group (P = 0.044). Cox proportional hazard analysis revealed no differences in the incidence of primary endpoint (P = 0.409). This study shows no significant differences in 12-month MACE among 4 groups.
Acute Disease ; Aged ; Aged, 80 and over ; Antineoplastic Agents, Phytogenic/adverse effects/*therapeutic use ; Coronary Angiography ; Drug-Eluting Stents/*adverse effects ; Female ; Humans ; Immunosuppressive Agents/adverse effects/*therapeutic use ; Male ; Middle Aged ; Myocardial Infarction/*drug therapy/mortality/pathology ; Myocardial Revascularization ; Paclitaxel/adverse effects/therapeutic use ; Proportional Hazards Models ; Registries ; Republic of Korea ; Sirolimus/adverse effects/analogs & derivatives/therapeutic use ; Survival Analysis

We encountered a patient with cystoid macular edema (CME) secondary to paclitaxel use. A 57-year-old man presented with gradual decreased bilateral vision. His chemotherapeutic regimen consisted of bevacizumab, paclitaxel (175 mg/m2 for 5 months), and carboplatin. Optical coherence tomography imaging revealed bilateral CME greater than 500 microm. However, one year later, visual acuity was improved, best-corrected Snellen visual acuity was 40 / 80 in each eye, and CME was spontaneously improved. Our study confirmed that macular edema associated with paclitaxel use shows spontaneous resolution and improvement of visual acuity after a change of chemotherapeutic regimen.
Adenocarcinoma/drug therapy ; Antineoplastic Agents, Phytogenic/*adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Humans ; Lung Neoplasms/drug therapy ; Macular Edema/*chemically induced ; Male ; Middle Aged ; Paclitaxel/*adverse effects ; Remission, Spontaneous ; Tomography, Optical Coherence ; Visual Acuity