Adult ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Medicine, Chinese Traditional ; Methotrexate ; therapeutic use ; Mifepristone ; therapeutic use ; Phytotherapy ; Pregnancy ; Pregnancy, Ectopic ; diagnosis ; drug therapy

The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal ; adverse effects ; economics ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Product Surveillance, Postmarketing ; methods ; Quality Control ; Randomized Controlled Trials as Topic ; Respiratory Tract Infections ; drug therapy

Adult ; Aged ; Aged, 80 and over ; Carcinoma, Squamous Cell ; metabolism ; pathology ; Cyclin D1 ; metabolism ; Female ; Humans ; Immunohistochemistry ; Lymphatic Metastasis ; Male ; Middle Aged ; Mitogen-Activated Protein Kinase 1 ; metabolism ; Mitogen-Activated Protein Kinase 3 ; metabolism ; Mouth Mucosa ; chemistry ; metabolism ; pathology ; Mouth Neoplasms ; metabolism ; pathology ; Prognosis

Objective To investigate the clinical features of the patients with dermatomyositis (DM)complicated with interstitial lung disease(ILD).Methods The clinical manifestations and the laboratory data of the 20 patients with DM complicated with ILD were retrospectively analyzed.Results Among 169 DM patients,20(11.8％)were founded with ILD and 4 had no complaint of respiratory system.The ratio of male to female was 1∶2.33.The level of serum creatine kinase(CK)was elevated in 11 cases.Anti-Jo-1 antibody was positive in 4 cases.Bilateral infiltrates including ground-glass attenuation,interlobular septal thickening and reticular opacities were found by chest high resolution computed tomography.The impairment of lung function was manifested as the decreased diffusion capacity for carbon monoxide of the lung(DLCO)and restricted ventilatory function abnormalities.Fifteen cases showed hypoxemia or respiratory failure by arterial blood gas analysis.All patients were treated with glucocorticoid and/or immunosuppressive agents.Totally,14 patients had improved,while 2 patients with no improvement and 4 patients died with a mortality of 20％.Conclusions DM complicated with ILD which is easily missed has a high morbidity and mortality.The understanding of DM complicated with ILD should be enhanced,thus early diagnosis and intervention could be performed for better prognosis.

Objective To evaluate the relationship between severity of airway obstruction and peripheral arterial stiffness in patients with chronic obstructive pulmonary disease (COPD).Methods 81 COPD patients [aged (78.32 ± 6.98)yrs,73 males,8 females] from Jan 2008 to Oct 2012 were enrolledin Geriatric Department of Peking University First Hospital.All patients underwent spirometry and Holter evaluation,while age,sex,BMI,smoking pack-years,medical history,blood levels of lipid profiles,glucose,high sensitivity C reactive protein (hsCRP)and arterial oxygen pressure (PaO2)were recorded.The severity of airway obstruction was evaluated by spirometry.The patients were divided into two groups:mild/moderate group [forced expiratory volume in one second (FEV1％) predicted ≥ 50 ％,n=51] and severe group (FEV1％ predicted ＜ 50％,n=30).24-hour average heart rate (HR)was assessed by holter.Arterial stiffness was assessed by the brachial ankle pulse wave velocity (baPWV).The baPWV increment was considered to be a direct witness of arterial stiffness increase.Blood levels of lipid profiles,glucose,arterial oxygen pressure (PaO2)and hsCRP were compared between the two groups.Results Age,gender,smoking index,medical history of the two groups were matched.BMI was less in severe group than in mild/moderate group [(22.8± 4.2) kg/m2 vs.(25.3± 3.2) kg/m2,t=3.017,P＜0.05].24-hour average HR was higher in severe group than in mild/moderate group [(77.4± 12.7)bpm vs.(70.8± 9.6)bpm,t=-2.602,P＜0.05].The PaO2 was lower in severe group than in mild/moderate group [(74.6±13.0)mmHg vs.(82.4± 13.1)mmHg,t=2.456,P＜0.05].There were no differences in blood lipid profile and glucose levels between the two groups.76 patients (93.4％)were detected with peripheral arterial stiffness by baPWV＞14.00 m/s.baPWV was significantly increased in severe group as compared with mild/moderate group [(20.77 ± 3.71) m/s vs.(18.84 ± 1.88) m/s,t=-2.109,P＜0.05].hsCRP was significantly higher in severe group than in mild/moderate group [[(6.51±5.66)mg/L vs.(3.27±3.34)mg/L,t=-2.658,P＜0.01].Conclusions The morbidity of peripheral arterial stiffness is increased in patients with COPD.Progression of arterial stiffness is related to the severity of airway obstruction,which may be related to chronic inflammation,hypoxia,or excessive sympathetic activation.

AIM:To observe the structural basis of ocular motility abnormalities in patients with congenital fibrosis of the extraocular muscles type Ⅰ ( CFEOM Ⅰ) due to missense mutations in the developmental kinesin KIF21A using high - resolution magnetic resonance imaging ( MRI) .
METHODS: Totally 11 affected individuals reported KIF21A mutations were correlated with MRI studies demonstrating extraocular muscles ( EOMs ) size, location, contractility, and innervation. EOMs and the motor nerve in the orbits were imaged with T1 weighted in a triplanar scan using a dual-phased coils with 2. 0mm thick. Motor nerves were imaged at the brainstem using head coils and 3D-FIESTA with 0. 6-mm thick.
RESULTS: Patients with CFEOM Ⅰ exhibited different degrees of hypoplasia of oculomotor nerve, the abducens nerve and the trochlear nerve were also affected, of which 8 cases of orbital section could see the signal of abnormal nerve dominated by oculomotor nerve to lateral rectus. The both sides of six EOMS in all patients exhibited variable atrophy and abnormal bright internal signal on T1 imaging, particularly severe for the superior rectus and levator muscles.
CONCLUSION: High - resolution MRI can directly demonstrate pathology of motor nerves,affected EOMs, and ‘Pulley' hypoplasia caused by CFEOM Ⅰ due to mutations in KIF21A,and these findings suggest that the neuronal hypoplasia is the etiological factor of CFEOM.

Objective To evaluate the effect of gastric compound on patients with middle-late gastric cancer of spleen deficiency and stasis toxin. Methods Ninety patients with middle-late gastric cancer of spleen deficiency and stasis toxin were randomly divided into combined group, chemotherapy group, and gastric compound group, 30 cases in each group. Patients in the combined group were treated with gastric compound and chemotherapy;patients in the chemotherapy group were treated with placebo;patients in the gastric compound group were treated with gastric compound. The changes of QLQ-C30 scale integral, fatigue scale intergral, TCM symptom intergral, Karnofsky integral, and toxic and side effects of digestive tract and myelosuppression were observed to evaluate the effect of gastric compound on quality of life in patients. Results The changes of QLQ-C30 scale integral, fatigue scale intergral, TCM symptom intergral, Karnofsky intergal in combined group were better than those in chemotherapy group and gastric compound group, with statistical significance (P<0.05). The changes of fatigue scale intergral and TCM symptom intergral in gastric compound group were better than those in chemotherapy group, with statistical significance (P<0.05). The myelosuppression and toxic and side effects of digestive tract of combined group was lighter than those of chemotherapy group, with statistical significance (P<0.01). Conclusion Gastric compound combined with chemotherapy can improve quality of life in patients with middle-late gastric cancer of spleen deficiency and stasis toxin, and reduce myelosuppression and toxic and side effects of digestive tract.

Objective To measure the expression of interleukin-13 (IL-13) and its receptors in mycosis fungoides (MF) lesions,and to investigate their clinical significance.Methods A total of 34 paraffin-embedded specimens of MF,which was confirmed by clinical and histopathological features,immunophenotyping and/or T-cell receptor gene rearrangements,were collected from Hangzhou Third People's Hospital between January 2010 and March 2016.According to the tumor-node-metastasis (TNM) staging system,5 patients were at stage I A,9 at stage Ⅰ B,17 at stage Ⅱ A,and 3 at stage Ⅱ B.Ten normal skin tissue specimens served as controls.Immunohistochemical study was conducted to measure the expression of IL-13,IL-13Rα1 and IL-13Rα2.Results IL-13,IL-13Rα1 and IL-13Rα2 were all expressed in atypical lymphoid cells and epidermotropic lymphoid cells in MF lesions at various stages.IL-13Rα2 was highly expressed in all the MF lesions.None of IL-13 and its receptors were expressed in normal skin tissues and lymphocytes.The expression rates of IL-13 and its receptors in MF lesions increased along with the progression of MF.Additionally,the expression rates of IL-13 (10.00％ ± 3.14％),IL-13Rα1 (21.43％ ± 6.88％) and IL-13Ro2 (31.14％ ± 6.38％) significantly decreased in MF lesions at stage Ⅰ compared with those at stage Ⅱ (27.50％ ± 11.00％,39.45％ ± 9.43％,44.40％ ± 11.15％,respectively,all P ＜ 0.05),but no significant differences were observed between stage Ⅰ A and Ⅰ B,or between stage Ⅱ A and Ⅱ B (P ＞ 0.05).Conclusion IL-13 and its receptors,especially IL-13Rα2,may be expected to serve as biomarkers for early diagnosis of MF and prediction of its biological behaviors.

Femoral Neoplasms ; pathology ; Humans ; Perivascular Epithelioid Cell Neoplasms ; pathology

OBJECTIVETo demonstrate the effects and mechanisms of Qifu decoction( QFD) on renal interstitial fibrosis (RIF) in model rats with yang-deficiency syndrome.

METHODThe rats were randomly divided into 3 groups, the Sham group (Group A), the Model group (Group B), the Qifu decoction group (Group C) and the Enalapril group (Group D). The RIF model was established by adenine administrated and unilateral ureteral obstruction (UUO) of the left ureter. After the model was successfully established, the rats in Group C and D were administrated with QFD or the Enalapril suspension,while the rats in Group A and B were administrated with distilled water. All rats were administrated for 3 weeks. Before administration and at the end of week 1, 2 and 3, the rats were weighted, and 24 h urinary protein excretion (Upro), urinary β2-microglobulin (Uβ2-MG) and urinary N-acetyl-D-glucosaminidase (NAG) were examined, respectively. All rats were killed after administration for 3 weeks. Blood and renal tissues were collected, renal morphology and tubulointerstitial morphology were evaluated, respectively. Serum cyclic adenosine monophosphate (cAMP), cyclic guanosine monophosphate (cGMP), blood urea nitrogen (BUN), serum creatinine (Scr) and uric acid (UA) were detected, respectively. The protein expressions of E-cadherin, α-smooth muscle actin(α-SMA), transforming growth factor-β1 (TGF-β1), onnective tissue growth factor (CTGF) extracellular signal-regulated protein kinase 1/2(ERK1/2) and phosphorylated-ERK1/2 (p-ERK1/2) in kidney were evaluated, respectively.

RESULTQFD ameliorated serum cAMP level and the rate of cAMP/cGMP, attenuated urinary β2-MG level, NAG level and renal tubulointerstitial fibrosis, increased E-cadherin protein expression, and reduced α-SMA, TGF-β1, CTGF and p-ERK1/2 protein expressions in the kidney. However, QFD had no influence on renal function in vivo. In addition, these effects were better than those of the model rats treated by Enalapril.

CONCLUSIONQFD could alleviate yang-deficiency parameters, as well as urinary β2-MG level and NAG level in model rats induced by adenine administration and UUO. Moreover, QFD could improve EMT and RIF by up-regulating E-cadherin protein expression, and down-regulating α-SMA, TGF-β1, CTGF and p-ERK1/2 protein expressions, the key molecular in ERK1/2 signaling pathway.

Animals ; Drugs, Chinese Herbal ; pharmacology ; Extracellular Signal-Regulated MAP Kinases ; antagonists & inhibitors ; Fibrosis ; Kidney ; drug effects ; pathology ; Kidney Diseases ; drug therapy ; pathology ; MAP Kinase Signaling System ; drug effects ; Male ; Rats ; Rats, Sprague-Dawley ; Ureteral Obstruction ; complications ; Yang Deficiency ; complications