Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional ; Nonprescription Drugs ; Consensus ; China ; Reference Standards ; Drugs, Chinese Herbal

Humans ; Neutrophils/pathology* ; Hematologic Neoplasms ; Sepsis ; Retrospective Studies ; Bacteremia

Moslae Herba is a commonly used aromatic Chinese medicinal with volatile oil as the main effective component and exhibits broad-spectrum antibacterial and antiviral effects. However, the irritation and instability of Moslae Herba volatile oil necessitate the preparation into a specific dosage form. In this study, the steam distillation method was employed to extract the Moslae Herba volatile oil. The content of thymol and carvacrol in Moslae Herba volatile oil was determined by HPLC as(0.111 9±0.001 0) and(0.235 4±0.004 7) mg·mL~(-1), respectively. Pseudo-ternary phase diagrams and surfactants compounding were applied in the selection of the optimal excipients(surfactant and cosurfactant). On this basis, a nanoemulsion was prepared from the Moslae Herba volatile oil and then loaded into pressure vessels to get sprays, whose stability and antibacterial activity were evaluated afterward. With clarity, viscosity, smell and body feeling as comprehensive indexes, the optimal formulation of the Moslae Herba volatile oil nanoemulsion was determined as follows: Moslae Herba volatile oil∶peppermint oil∶cremophor EL∶absolute ethanol∶distilled water 7.78∶1.58∶19.26∶6.15∶65.23. The as-prepared nanoemulsion was a light yellow transparent liquid, with Tyndall effect shown under the irradiation of parallel light. It has the pH of 5.50, conductivity of 125.9 μS·cm~(-1), average particle size of 15.45 nm, polydispersity index(PDI) of 0.156, and Zeta potential of-17.9 mV. Under a transmission electron microscope, the Moslae Herba volatile oil nanoemulsion was presented as regular spheres without adhesion and agglomeration. Stability test revealed that the Moslae Herba volatile oil nanoemulsion was stable at 4-55 ℃, which was free from demulsification and stratification within 30 days. After the centrifugation at 12 000 r·min~(-1) for 30 min, there was no stratification either. The nanoemulsion had good inhibitory effects on Escherichia coli, Staphylococcus aureus and resistant S. aureus strains, with the minimum inhibitory concentrations of 0.39, 3.12 and 1.56 mg·mL~(-1), respectively. The above results demonstrated that the nanoemulsion was prepared feasibly and showed stable physical and chemical properties and good antibacterial effects. This study provides a practicable technical solution for the development of anti-epidemic and anti-infection products from Moslae Herba volatile oil.
Anti-Bacterial Agents/pharmacology* ; Emulsions ; Methicillin-Resistant Staphylococcus aureus ; Microbial Sensitivity Tests ; Oils, Volatile ; Particle Size

Objective: To evaluate the impact of KIT D816 mutation on the salvage therapy in relapsed acute myeloid leukemia (AML) with t(8;21) translocation. Method: The characteristics of the first relapsed AML with t(8;21) translocation from 10 hospitals were retrospectively collected, complete remission (CR(2)) rate after one course salvage chemotherapy and the relationship between KIT mutation and CR(2) rate was analyzed. Results: 68 cases were enrolled in this study, and 30 cases (44.1%) achieved CR(2). All patients received KIT mutation detection, and KIT D816 mutation was identified in 26 cases. The KIT D816 positive group had significantly lower CR(2) compared with non-KIT D816 group (23.1% vs 57.1%, χ(2)=7.559, P=0.006), and patients with longer CR(1) duration achieved significantly higher CR(2) than those with CR(1) duration less than 12 months (74.1% vs 31.9%, χ(2)=9.192, P=0.002). KIT D816 mutation was tightly related to shorter CR(1) duration. No significant difference of 2 years post relapse survival was observed between KIT D816 mutation and non-KIT D816 mutation group. Conclusion: KIT D816 mutation at diagnosis was an adverse factor on the salvage therapy in relapsed AML with t(8;21) translocation, significantly related to shorter CR1 duration, and can be used for prediction of salvage therapy response. KIT D816 mutation could guide the decision-making of salvage therapy in relapsed AML with t(8;21) translocation.
Antineoplastic Combined Chemotherapy Protocols ; Cytarabine ; Humans ; Leukemia, Myeloid, Acute/therapy* ; Prognosis ; Retrospective Studies ; Salvage Therapy

BACKGROUNDElderly multiple myeloma (MM) patients often tend to suffer a variety of diseases, so the treatment of choice is very difficult for the elderly myeloma patients. The overall survival (OS) time and side effects with elderly patients are unclear in China. The study tried to find out the role of geriatric assessment in the Chinese elderly MM.

METHODSWe retrospectively analyzed the data of 628 newly diagnosed patients from six hospitals from June 2011 to June 2013. A geriatric assessment had been performed to assess comorbidities, cognitive, and physical status for these patients. The primary endpoint was to evaluate different physical states of elderly patients with OS time and treatment-related side effects.

RESULTSAn additive scoring system (range: 0-5), based on age, Katz's Activity of Daily Living (ADL) and Lawton's Instrumental Activity of Daily Living (IADL) ≤5 and Charlson Comorbidity Index (CCI) was developed to identify three groups: fit (score = 0); intermediate-fitness (score = 1); and frail (score ≥2). The 3-year OS was 63% in fit patients, 63% in intermediate-fitness patients, and 49% in frail patients ≥3 hematologic adverse events (AEs) were documented in 45 (35.4%) fit, 34 (34%) intermediate-fitness, and 121 (30.2%) frail patients. The risk of a grade ≥3 hematologic AEs was not significantly increase in intermediate-fitness (hazard ratios [HR]: 0.99, 95% confidence interval [CI]: 0.54-1.47, P = 1.000) and in frail patients (HR: 1.16, 95% CI: 0.70-1.93, P = 0.558) compared with fit ones.

CONCLUSIONSMM occurs earlier in life and being advanced when the diagnosis is made in the mainland of China. The overall survival in frailty with International Staging System (ISS) II/III was the worst in all patients.

Activities of Daily Living ; Aged ; China ; Cognition ; physiology ; Female ; Geriatric Assessment ; methods ; Humans ; Kaplan-Meier Estimate ; Male ; Multiple Myeloma ; mortality ; physiopathology ; psychology ; Retrospective Studies

OBJECTIVETo investigate the risk factors for the development of congenital anal atresia in neonates.

METHODSA total of 70 neonates who were admitted to 17 hospitals in Foshan, China from January 2011 to December 2014 were enrolled as case group, and another 70 neonates who were hospitalized during the same period and had no anal atresia or other severe deformities were enrolled as control group. Univariate and multivariate logistic regression analyses were used to investigate the risk factors for the development of congenital anal atresia.

RESULTSThe univariate analysis revealed that the age of mothers, presence of oral administration of folic acid, infection during early pregnancy, and polyhydramnios, and sex of neonates showed significant differences between the case and control groups (P<0.05). The multivariate logistic regression analysis revealed that infection during early pregnancy (OR=18.776) and male neonates (OR=9.304) were risk factors for congenital anal atresia, and oral administration of folic acid during early pregnancy was the protective factor (OR=0.086).

CONCLUSIONSInfection during early pregnancy is the risk factor for congenital anal atresia, and male neonates are more likely to develop congenital anal atresia than female neonates. Supplementation of folic acid during early pregnancy can reduce the risk of congenital anal atresia.

Anus, Imperforate ; etiology ; Female ; Humans ; Infant, Newborn ; Logistic Models ; Male ; Pregnancy ; Risk Factors

The present study isolated 17 compounds from the tubers of Bletilla striata (Orchidaceae), using various chromatographic techniques. Their structures were identified based on their physical-chemical properties and spectroscopic analyses. Among them, two new 2-isobutylmalates, named bletimalates A (1) and B (2), together with other fifteen known compounds (3-17), were isolated and identified. Additionally, compounds 3, 4, and 8 were isolated from this plant for the first time.
Malates ; chemistry ; isolation & purification ; Molecular Structure ; Orchidaceae ; chemistry ; Plant Extracts ; chemistry ; isolation & purification ; Plant Tubers ; chemistry

OBJECTIVETo determine the difference of post-operative mortality between ORIF (open reduction internal fixation) and hip replacement for the treatment of intertrochanteric fracture in elderly by using survival analysis.

METHODSThe clinical data of 110 patients above 60 years old who underwent surgical treatment (ORIF or hip replacement) for the intertrochanteric fracture between April 2003 and May 2013 were retrospectively analyzed. Among the patients, 83 cases were treated with ORIF (ORIF group), there were 32 males and 51 females, aged from 61.44 to 98.75 years old with an average of (78.52 ± 7.98) years old; and 27 cases were treated with hip replacement (arthroplasty group), there were 8 males and 19 females, aged from 71.82 to 96.54 years old with an average of (79.99 ± 6.11) years old. A survival analysis was performed on the clinical data by using SPSS 110 software. The survival rate of 1-year,2-year, 5-year and the mean survival time for the total patients, the mortality rate of 1-year, 2-year in each group, the survival rate of 1-year, 2-year and mean survival time and survival curve in each group were included.

RESULTSAll wounds achieved primary healing and no deaths were found in stay hospital. All patients were followed up from 1 to 125 months with an average of (46.93 ± 29.53) months. Among all 110 cases, 31 were dead and 79 survived. The survival rate of 1-year, 2-year and 5-year was (90.7 ± 2.8)%, (82.5 ± 3.9)% and (57.6 ± 6.5)%, respectively,while the ensemble mean survival time was (84.137 ± 5.902) months. The mortality rate of 1-year, 2-year in ORIF group was 7.2% and 12.0%, respectively; and in arthroplasty group, there was 14.8% and 25.9%, respectively. There was no significant difference in mortality rate of 1-year and 2-year between two groups. According to the survival analysis of the ORIF group, the survival rate of 1-year, 2-year was (92.6 ± 2.9)%, and (85.8 ± 4.3)%, respectively, and the mean survival time was (87.508 ± 6.063) months. In arthroplasty group, the survival rate of 1-year, 2-year was (85.2 ± 6.8)% and (73.9 ± 8.5)%,and the mean survival time was (67.294 ± 11.180) months. There was significant difference in mean survival time between two groups (P < 0.05).

CONCLUSIONORIF can achieve a better postoperative survival compare with hip replacement in treating intertrochanteric fracture in elderly.

Aged ; Aged, 80 and over ; Arthroplasty, Replacement, Hip ; Female ; Fracture Fixation, Internal ; Hip Fractures ; mortality ; surgery ; Humans ; Male ; Middle Aged ; Prognosis ; Retrospective Studies

OBJECTIVETo investigate the effects of FTY720 on apoptosis in multiple myeloma cell line U266 and to clarify the molecular mechanism of apoptosis induced by FTY720.

METHODSU266 cells were treated with 2.5, 5, 10 and 20 µmol/L of FTY720 for 24 hours, the apoptotic rates were tested by flow cytometry with Annexin-V-FITC/PI staining. Then U266 cells were treated with 20 µmol/L FTY720 for 0, 6, 16 and 24 hours, the apoptotic rates were tested. U266 cells were treated with DMSO and FTY720 separately and then were stained with DAPI for 5 min. Drop the cells to the slides and cover the slide with the glass. The cells were observed by fluorescence microscopy. U266 cells were treated with 5 µmol/L FTY720 or together with different doses of Z-VAD-fmk (12.5, 25, 50 µmol/L), a pancaspase inhibitor, for 24 hours, then the cell viability was tested by CCK-8. U266 cells were treated with 2.5, 5, 10 and 20 µmol/L of FTY720 for 24 hours, the expression of cleaved caspase-3 was tested by Western blot. U266 cells were treated with 0, 5, 10 and 20 µmol/L of FTY720 for 24 hours, the expressions of MCL-1, survivin, BCL-2, BID, BAX, BAK, P-ERK were tested by Western blot.

RESULTSThe apoptotic rate increased in U266 cells treated with FTY720 and showed the characteristic of time-dependent and dose-dependent manner. Karyopyknosis and nuclearfragmentation could be observed in U266 cells treated with FTY720 after being stained with DAPI under fluorescent microscope. The same effect was not observed in the cells treated with DMSO. Z-VAD-fmk could rescue the apoptosis in U266 cells treated with FTY720 in dose-dependent manner. The expression of MCL-1, survivin and BCL-2 decreased in U266 cells treated with FTY720. The cleavage of BID could be observed in U266 cells treated with FTY720. FTY720 had no effect on the expression of BAX, BAK and P-ERK.

CONCLUSIONFTY720 can induce the apoptosis in U266 cells, the apoptosis was Caspase-3-depended. The apoptosis induced by FTY720 is due to the decrease of MCL-1, survivin and BCL-2, which are the inhibitors of apoptosis. Meanwhile, the apoptosis was also due to the activation of BID, which is pro-apoptotic protein.

Amino Acid Chloromethyl Ketones ; Apoptosis ; Caspase 3 ; Cell Line, Tumor ; Cell Survival ; Fingolimod Hydrochloride ; Humans ; Inhibitor of Apoptosis Proteins ; Multiple Myeloma

Objective To discuss the CT manifestations of multi-parasite infection in liver to improve the diagnostic accuracy. Methods A total of 11 patients with ELISA-proved multi-parasite infection in liver were enrolled in this study.The plain and dynamic enhanced CT scans were performed.The imaging findings including the number,distribution,size,shape,density,enhancement and degree intratumaral features,cholangiectasis and abdominal lymphadenopathy were retrospectively analyzed.Results A single lesion of multi-parasite infection in liver was detected in 6 patients and multiple lesions were in other 5.The lesions in 8 patients were located in a single lobe of the liver,and involved in several hepatic lobes in other 3.The maximum diameter of the lesion ranged from 1.7 cm to 6.3 cm with an average diameter of 4.4 cm.Irregular lesions were found in 7 patients and round ones in shape were in other 4.Plain CT showed the lesions with low-intensity.All lesions were mild to moderate inhomogeneous enhancement on portal vein phase,presented honeycomb-like or separated enhancement with cholangiectasis (n=2)and abdominal lymphadenopathy (n=2).Conclusion The CT manifestations on portal vein phase in combination with clinical data are useful for the diagnosis of multi-parasite infection in liver.