We conducted a prospective study to assess the non-inferiority of adjuvant chemotherapy alone versus adjuvant concurrent chemoradiotherapy (CCRT) as an alternative strategy for patients with early-stage (FIGO 2009 stage IB-IIA) cervical cancer having risk factors after surgery. The condition was assessed in terms of prognosis, adverse effects, and quality of life. This randomized trial involved nine centers across China. Eligible patients were randomized to receive adjuvant chemotherapy or CCRT after surgery. The primary end-point was progression-free survival (PFS). From December 2012 to December 2014, 337 patients were subjected to randomization. Final analysis included 329 patients, including 165 in the adjuvant chemotherapy group and 164 in the adjuvant CCRT group. The median follow-up was 72.1 months. The three-year PFS rates were both 91.9%, and the five-year OS was 90.6% versus 90.0% in adjuvant chemotherapy and CCRT groups, respectively. No significant differences were observed in the PFS or OS between groups. The adjusted HR for PFS was 0.854 (95% confidence interval 0.415-1.757; P = 0.667) favoring adjuvant chemotherapy, excluding the predefined non-inferiority boundary of 1.9. The chemotherapy group showed a tendency toward good quality of life. In comparison with post-operative adjuvant CCRT, adjuvant chemotherapy treatment showed non-inferior efficacy in patients with early-stage cervical cancer having pathological risk factors. Adjuvant chemotherapy alone is a favorable alternative post-operative treatment.
Female ; Humans ; Uterine Cervical Neoplasms/drug therapy* ; Prospective Studies ; Quality of Life ; Neoplasm Staging ; Chemoradiotherapy ; Chemotherapy, Adjuvant/adverse effects* ; Adjuvants, Immunologic ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Retrospective Studies

We aimed to evaluate the effectiveness and safety of single-course initial regimens in patients with low-risk gestational trophoblastic neoplasia (GTN). In this trial (NCT01823315), 276 patients were analyzed. Patients were allocated to three initiated regimens: single-course methotrexate (MTX), single-course MTX + dactinomycin (ACTD), and multi-course MTX (control arm). The primary endpoint was the complete remission (CR) rate by initial drug(s). The primary CR rate was 64.4% with multi-course MTX in the control arm. For the single-course MTX arm, the CR rate was 35.8% by one course; it increased to 59.3% after subsequent multi-course MTX, with non-inferiority to the control (difference -5.1%,95% confidence interval (CI) -19.4% to 9.2%, P = 0.014). After further treatment with multi-course ACTD, the CR rate (93.3%) was similar to that of the control (95.2%, P = 0.577). For the single-course MTX + ACTD arm, the CR rate was 46.7% by one course, which increased to 89.1% after subsequent multi-course, with non-inferiority (difference 24.7%, 95% CI 12.8%-36.6%, P < 0.001) to the control. It was similar to the CR rate by MTX and further ACTD in the control arm (89.1% vs. 95.2%, P =0.135). Four patients experienced recurrence, with no death, during the 2-year follow-up. We demonstrated that chemotherapy initiation with single-course MTX may be an alternative regimen for patients with low-risk GTN.
Antineoplastic Combined Chemotherapy Protocols/adverse effects* ; Dactinomycin/adverse effects* ; Female ; Gestational Trophoblastic Disease/drug therapy* ; Humans ; Methotrexate/therapeutic use* ; Pregnancy ; Retrospective Studies

Objective To explore the CT and MRI imaging and clinicopathological features of extranodal NK/T cell lymphoma (NK/TCL). Methods Sixty-six patients with NK/TCL diagnosed from 2002 June to 2016 April in Beijing Tongren Hospital with intact CT and/or MRI imaging results were enrolled in this study. All the patients had tailed clinical information and follow-up. The imaging and clinicopathological features were analyzed retrospectively and their prognostic value on overall survival was analyzed. Results There were 49 males and 17 females with median age of 42 years. The median follow-up time was 18 months. The cases showed surrounding invasions including 10 cases (15.2 %) in soft palate, 5 cases (7.6 %) in hard palate, 2 cases(3.0 %) in tonsil, 8 cases(12.1 %) in upper lip, 13 cases(19.7 %) in maxillofacial soft tissue, 9 cases (13.6 %) in eyelid, 10 cases (15.2 %) in orbital, 3 cases (4.5 %) in maxilla, 6 cases (9.1 %) in pterygopalatine fossa,6 cases(9.1 %)in infratemporal fossa,3 cases(4.5 %)in skull base, 3 cases(4.5 %) in eyeball and 2 cases (3.0 %) in brain tissue. Kaplan-Meier survival analysis found that the 2-year overall survival rates of the patients with the involvement of hard palate, upper lip, maxillofacial soft tissue, eyelid, orbital, maxillary, eyeball and brain organizer were lower than those of the patients without the involvement of these sites(χ2values were 4.470,4.041,4.456,13.933,8.986,4.000,44.121,6.527,16.822,respectively, all P< 0.05). Further multivariate Cox regression analysis showed that maxilla and brain involvement were independent adverse factors (RR=34.717, 95 % CI 3.404-354.035, P=0.003; RR=37.545, 95 % CI 3.188-442.187, P= 0.004). Conclusions MRI and CT examinations are of great value in diagnosis and prognostic assessment of NK/TCL. Clinicians can make correct and timely diagnosis by comprehensive clinical, radiological and pathological features and can make a detailed clinical assessment to give patients appropriate treatment,thus improving the outcome of the NK/TCL patients.

OBJECTIVE:To investigate the effect and mechanism of Allii macrostemonis bulbus on blood lipid levels in hyperlipidemia model rats,and to provide reference for clinical use of Allii macrostemonis bulbus to reduce blood lipid. METHODS:A total of 10 normal rats were included in normal control group and given common diet. Other 50 rats were given hyperlipid diet to induce hyperlipidemia rat model. 40 model rats were randomly divided into model group(hyperlipid diet),Allii macrostemonis bulbus low-dose,medium-dose and high-dose groups(0.83,1.67,2.50 g/kg,fed by hyperlipid diet which containing 10%Allii macrostemonis bulbus 8.3,16.7,25.0 g/kg,fill with hyperlipid feed in patients with insufficient food intake). After fed for 45 d,the contents of TC,TG,LDL-C and HDL-C in serum of rats were detected. Liver,spleen,renal and cardiac indexes of rats were calculated. mRNA expression of low density lipoprotein receptor(LDLR)and liver X-receptor α(LXRα)were detected in liver tissue of rats. RESULTS:Compared with normal control group,the contents of TC and LDL-C in serum and liver index of rats were increased significantly in model group,while the content of HDL-C in serum and mRNA expressions of LDLR and LXR α in liver tissue were decreased significantly,with statistical significance(P<0.01). Compared with model group,the contents of TC and LDL-C in serum were decreased significantly in Allii macrostemonis bulbus groups,while the content of HDL-C was increased significantly. mRNA expressions of LDLR and LXR α in liver tissue were increased significantly in Allii macrostemonis bulbus medium-dose and high-dose groups,while liver and spleen indexes were decreased significantly,with statistical significance(P<0.05 or P<0.01). CONCLUSIONS:Allii macrostemonis bulbus shows good blood-lipid lowering effect,the mechanism of which may be associated with up-regulating mRNA expressions of LDLR and LXRα in liver tissue.

Objective To assess the effectiveness of uterine arterial embolization for the treatment of hysteromyomas and to discuss the factors related to the clinical results.Methods Super-selective uterine arterial embolization was performed in forty-five patients with hysteromyomas.Of 45 patients,multiple hysteromyomas were seen in 36 and solitary lesion in 9.The lesion was located at the myometrium in 41 cases,among them coexisted endometrioma was found in 5 cases and coexisted submucosal myoma in 2.The lesion was located submucous layer in the remaining 4 cases.The diagnosis was confirmed by imaging study and gynecological examination.After the operation,ultrasonography and laboratory tests were carried out in all patients to observe the tumor size.hormone levels and hemoglobin concentration.Results A total of 91 uterine arteries were found in 45 patients.including double left uterine arteries in one case.Successful catheterization was obtained in 87 arteries(95.6%).All forty-five patients were followed up for 6-36 months.Six months after the procedure the mean reduction of the tumor size was 69.3%.and the lesion completely disappeared in two cases.In the anemic patients the hemoglobin concentration returned to normal level.The main side-effects included low fever and pain at lower abdomen.Conclusion Uterine arterial embolization is a safe and effective treatment for hysteromyomas.

OBJECTIVETo observe the effects of polydatin on dynamic changes of excitatory amino acids in cerebrospinal fluid and water content of brain tissue of cerebral hemorrhage rats. And to discuss the therapeutic action and mechanisms of polydatin on brain hemorrhagic injured rats.

METHODA quantitative determination method of Asp and Glu was established by microdialysis-HPLC. The cerebral hemorrhage model in rats was induced by local injection of type VII collagenase. The dynamic changes of Asp and Glu in cerebrospinal fluid were observed on 0, 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 h of cerebral hemorrhage rats, and then the water content of brain tissue was detected.

RESULTThe content of Asp and Glu increased rapidly within 24 h after cerebral hemorrhage, and to the highest in 24 h, then decreased gradually. Compared with the cerebral hemorrhage model group, the content of Asp and Glu increased slowly in polydatin group, and there were significant differences in 12-72 h and 6-84 h (P < 0.01, P < 0.05), but there was no significant difference after 84 h and 96 h. Compared with sham group, water content of brain tissue significantly higher in model group, while significantly lower (P < 0.01) in polydatin group.

CONCLUSIONPolydatin can inhibit increasing content of Asp and Glu in cerebrospinal fluid dynamics, and significantly inhibit cerebral edema of cerebral hemorrhage rats. It shows that the mechanisms of anti-cerebral hemorrhage injury of polydatin may be related to increasing of excitatory amino acids after cerebral hemorrhage.

Animals ; Aspartic Acid ; cerebrospinal fluid ; Cerebral Hemorrhage ; cerebrospinal fluid ; drug therapy ; Disease Models, Animal ; Drugs, Chinese Herbal ; therapeutic use ; Excitatory Amino Acids ; cerebrospinal fluid ; Glucosides ; therapeutic use ; Glutamic Acid ; cerebrospinal fluid ; Humans ; Male ; Rats ; Rats, Sprague-Dawley ; Stilbenes ; therapeutic use

OBJECTIVETo explore permeability of artificial blood-brain barrier (aBBB) by oxygen-glucose deprivation combined (OGD)-induced using tetramethylpyrazine combined with puerarin in vitro.

METHODRats were divided into normal control group, model group, tetramethylpyrazine group, puerarin group, tetramethylpyrazine-puerarin group and nimodipine group. Culture rat brain microvascular endothelial cells and astrocytes in vitro and build the OGD-induced aBBB damage model. Evaluate aBBB damage characteristics by TEER, gamma-GT, AKP and LDH. Determine contents of tetramethylpyrazine, puerarin, nimodipine and calculate drug permeating concentration of OGD-induced aBBB model by HPLC.

RESULTCompared with the model, the level of TEER was lower than the control group with significant difference (P < 0.01). The levels of gamma-GT, AKP in tetramethylpyrazine group, tetramethylpyrazine-puerarin group and nimodipine group were higher than the model group, the differences were significant (P < 0.01). Compared with tetramethylpyrazine group or puerarin group, the level of AKP of tetramethylpyrazine-puerarin group increased significantly (P < 0.01). The differences of levels of TEER, gamma-GT, AKP and LDH between tetramethylpyrazine-puerarin group and nimodipinthe group were significant (P < 0.05). Tetramethylpyrazine-puerarin group has a synergistic effect of increasing TEER, gamma-GT, AKP and reducing LDH. The permeating rate in tetramethylpyrazine-puerarin group was higher than tetramethylpyrazine group and puerarin group.

CONCLUSIONTetramethylpyrazine-puerarin can permeate aBBB more easily and protect aBBB. The cause may relate to reducing the permeability of the OGD-induced aBBB.

Animals ; Blood-Brain Barrier ; drug effects ; Drug Combinations ; Glucose ; physiology ; Isoflavones ; administration & dosage ; pharmacology ; Male ; Oxygen ; physiology ; Permeability ; Pyrazines ; administration & dosage ; pharmacology ; Rats ; Rats, Sprague-Dawley

OBJECTIVETo study the influence of the different combinations of the main active parts in Yangyintongnao granule on the pharmacokinetics parameters of the two active components--ligustrazine and puerarin using the method of total amount statistic moment for pharmacokinetics.

METHODCombinations were formed according to the dosages of the four active parts (alkaloid, flavone, saponin, naphtha) by orthogonal experiment L9 (3(4)). Blood concentrations of ligustrazine and puerarin were determinated by HPLC at different time. Zero rank moment (AUC) and one rank moment (MRT, mean residence time) of ligustrazine and puerarin have been worked out to calculate the total amount statistic moment parameters was analyzed of Yangyintongnao granule by the method of the total amount statistic moment. The influence of different compatibilities on the pharmacokinetics parameters was analyzed by orthogonal test.

RESULTFlavone has the strongest effect than saponin on the total AUC. Ligustrazine has the strongest effect on the total MRT. Saponin has little effect on the two parameters, but naphtha has more effect on both of them. It indicates that naphtha may promote metabolism of ligustrazine and puerarin in rat.

CONCLUSIONTotal amount statistic moment parameters can be used to guide for compatibilities of TCM.

Animals ; Data Interpretation, Statistical ; Disease Models, Animal ; Dose-Response Relationship, Drug ; Drugs, Chinese Herbal ; administration & dosage ; pharmacokinetics ; Humans ; Male ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; drug therapy

OBJECTIVETo observe the effect of 3'-methoxy puerarin on cerebral infarction volume and free radical change of focal cerebral ischemia-reperfusion injury in rats and discuss the protective effect of 3'-methoxy puerarin on the cerebral ischemic/ reperfusion injury.

METHODThe thread method was used to induce middle cerebral artery embolization, to establish the focal cerebral ischemia-reperfusion model. Rats were divided into five groups: the sham and model group, the two-dose group (5, 10 mg x kg(-1) x d(-1)) of 3'-methoxy puerarin and nimodipine group (5 mg x kg(-1) x d(-1)). The behavior changes and volume of cerebral infarction were observed, and the leves of SOD and the content of MDA were measured.

RESULT3'-methoxy puerarin could significantly improve the symptoms of neurological deficit and reduce the infarct volume, and increased SOD activity and reduced the content of MDA of cortex in cerebral ischemia-reperfusion injury rat, the action of 10 mg x kg(-1) of 3'-methoxy puerarin is more remarkable.

CONCLUSION3'-methoxy puerarin has protective effect on focal cerebral ischemia-reperfusion injury in rat.

Animals ; Brain Ischemia ; drug therapy ; prevention & control ; Disease Models, Animal ; Female ; Humans ; Isoflavones ; pharmacology ; Male ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; drug therapy ; prevention & control