OBJECTIVE:To establish HPLC fingerprint sectrum of Rhaponticum uniflorum. METHODS:HPLC was performed on the column of Hypersil-ODS with mobile phase of 0.3% phosphoric acid-acetonitrile(gradient elution) at flow rate of 1.0 ml/min,detection wavelength was 220 nm,column temperature was 30 ℃ and volume injection was 10 μl. The luteolin was refer-ence,17 batches of R. uniflorum from different production places was analyzed and similarity evaluation system for chromatograph-ic fingerprint of TCM (2004 A edition)was adopted for the similarity analysis. RESULTS:There were totally 11 common peaks with similarity degree≥0.900 of 17 batches. According to the verification,the fingerprint spectrum and reference fingerprint spec-trum of R. uniflorum had good consistency. CONCLUSIONS:The established method is specific and stable,and can provide refer-ence for the identification and quality control of R. uniflorum.

OBJECTIVE:To establish a method for simultaneous determination of luteolin and apigenin in Mongolian medicine Scabiosa atropurea. METHODS:HPLC was performed on the column of Diamond C18 with mobile phase of acetonitrile-0.4%phos-phoric acid(34∶66,V/V)at a flow rate of 1.0 ml/min,the detection wavelength was 350 nm,column temperature was 30 ℃,and the injection volume was 10 μl. RESULTS:The linear range was 66-396 ng for luteolin(r=0.999 8)and 93-558 ng for apigenin (r=0.999 6);RSDs of precision,stability and reproducibility tests were lower than 2%;recoveries were 98.15%-101.79%(RSD=1.42%,n=6) and 98.66%-104.05%(RSD=1.81%,n=6),respectively. CONCLUSIONS:The method is simple with good precise,stability and reproducibility,and can be used for the simultaneous determination of luteolin and apigenin in Mongo-lian medicine S. atropurea.

OBJECTIVE:To establish the quality standard for Mongolian medicine Yishen powder. METHODS:TLC was used for the qualitative identification of Rheum palmatum and Terminalia chebula in the preparation;HPLC was used for the contents de-termination of aloe emodin,rhein,emodin,chrysophanol and physcion:the column was Inertsil C18 with mobile phase of metha-nol-0.1% phosphoric acid(gradient elution)at a flow rate of 1.0 mL/min,detection wavelength was 254 nm,column temperature was 35 ℃ and the injection volume was 10 μL. RESULTS:The TLC pots of R. palmatum and T. chebula were clear and well-sepa-rated,negative control without interference. The linear range was 23.55-117.75 ng for aloe emodin(r=0.9999),44.72-223.62 ng for rhein(r=0.9998),43.18-215.90 ng for emodin(r=0.9997),77.41-387.12 ng for chrysophanol(r=0.9999)and 46.02-230.10 ng for physcion (r=0.9997);RSDs of precision,stability and reproducibility tests were lower than 2.0%;recoveries were 95.80%-99.66%(RSD=1.21%,n=6),95.01%-98.07%(RSD=0.92%,n=6),95.06%-97.84%(RSD=0.5%,n=6),95.19%-97.66%(RSD=1.07%,n=6)and 95.07%-98.20%(RSD=0.95%,n=6). CONCLUSIONS:The established standard can be used for the quality control of Mongolian medicine Yishen powder.

Objective To analysis the long-term retention rate of Levetiraceram (LEV) monotherapy or combination therapy of infant epilepsy. Methods The clinical data of patients with infant epilepsy treated by LEV had been retrospectively analyzed from July 2006 to June 2007. Results Sixty patients with infant epilepsy treated by LEV had been recruited, 20 cases with partial seizures, 19 cases with generalized seizures, 21 cases with epilepsy syndrome. Among them 21 cases was intractable epilepsy. The retention rates of LEV in 6-month, 1-year, 2-year, 3-year and 4-year were 95.5%, 75.0%, 60.0%, 51.7%, and 38.3%. The most common reason for withdrawal was lack of effect (43.2%). COX regression model suggested that duration>1 month (RR=2.91, 95%CI:1.16~7.30) and refractory epilepsy (RR=2.30, 95%CI:1.22~4.32) were risk factors of withdrawal (all P<0.05). After treatment, the seizure frequency signiifcantly reduced compared with baseline (P<0.01). To the end of the follow-up, the efifciency was 100%and the complete remission rate was 69.57%in 23 cases continued treatment. The main side effect were fatigue (56.0%), and sleep increased, irritability, and so on. Conclusions LEV monotherapy or combination therapy has well long-term retention rate, maintains well efifcacy and tolerability in infant epilepsy.

AIM: To provide advice for the clinical trials during the outbreak by analyzing the clinical trial registration information of COVID-19 in China. METHODS: Clinical protocols of COVID-19 registered at the Chinese Clinical Trials Registry and clinicaltrials.gov before February 17, 2020 were collected and the type, distribution, design and interventions of the studies were analyzed.RESULTS:A total of 172 trials were retrieved, mainly distributed in Hubei, Zhejiang, Guangdong and Beijing. Among the 120 interventional studies, chemical drugs and biological products accounted for 45%, traditional Chinese medicine or integrative medicine therapy accounted for 40%, cell therapy accounted for 7%, and plasma therapy accounted for 2%. There were only 13 randomized, blinded and placebo controlled studies, accounting for 11%. Blank control reached 46% (control group with clinical routine treatment without placebo,test group with clinical routine treatment as the basic). HIV and antimalarial drugs were the most frequently used. CONCLUSION: Chinese clinical research capacity and awareness have been greatly improved, but it is somewhat disordered. It is necessary to pay attention to the necessity, scientific nature, ethics and quality management of clinical research. It is recommended to initiate clinical trials coordinated and unified demonstration and to collect the national case information for big data analysis by the state during an emergency outbreak.

OBJECTIVETo compare the differences in the clinical efficacy on post-stroke speech disorder between scalp electric acupuncture (EA) under anatomic orientation combined with rehabilitation training and simple rehabilitation training.

METHODSSixty patients of post-stroke speech apraxia were randomized into an observation group and a control group, 30 cases in each one. In the observation group, under anatomic orientation, the scalp EA was adopted to the dominant hemisphere Broca area on the left cerebrum. Additionally, the speech rehabilitation training was combined. In the control group, the speech rehabilitation training was simply,used. The treatment lasted for 4 weeks totally. The speech movement program module in the psychological language assessment and treatment system of Chinese aphasia was used for the evident of efficacy assessment. The scores of counting, singing scale, repeating phonetic alphabet, repeating monosyllable and repeating disyllable were observed in the patients of the two groups. The assessment was done separately on the day of grouping and 4 weeks after treatment.

RESULTSIn 4 weeks of treatment, the scores of counting, singing scale, repeating phonetic alphabet, repeating monosyllable and repeating disyllable were all improved as compared with those before treatment in the two groups (all P<0. 001). The results in the observation group were better than those in the control group (all P< 0. 05). The total effective rate was 100. 0% (30/30) in the observation group, superior apparently to 53. 3% (16/30) in the control group (P<0. 001).

CONCLUSIONThe scalp EA under anatomic orientation combined with' speech rehabilitation training obviously improves speech apraxia in stroke patients so that the speech disorder cani be relieved. The efficacy is better than that in simple rehabilitation training.

Acupuncture Points ; Adolescent ; Adult ; Aged ; Apraxias ; etiology ; physiopathology ; rehabilitation ; therapy ; Electroacupuncture ; Female ; Humans ; Language ; Male ; Middle Aged ; Speech Disorders ; physiopathology ; rehabilitation ; therapy ; Speech Therapy ; Stroke ; complications ; Young Adult

Objective To investigate clinical features of chronic actinic dermatitis (CAD) in Kunming of Yunnan Province.Methods From October 2008 to October 2013,CAD in-patients in our hospital were selected and their general conditions,outcomes of photo-sensitive test and photo-patch test were analyzed in details.Results (1) Among 169 CAD patients,gender ratio (male:female) was 8.9:1.The lesions were mainly distributed on the exposed areas.(2) Photo-sensitive tests of 93 patients showed that the average value of UVA-MPPDwas 7.39 JPcm2 and that of UVB-MED was 20.91 mJPcm2.(3) The results of photo-patch test in 83 patients showed that 48 patients (67.8％) had positive reactions in patch test,and the most common contactant was balsam peru.Fifty-eight patients (69.9％) had positive reactions in photo-patch test indicating that the most common contactant in photo-patch test was balsam peru.Conclusions CAD appears mostly in the middle aged and the aged males and the lesions are mainly distributed on exposed areas.The most common contactants in photo-patch test are balsam peru and perfumed compounds.

Objective:To explore and discuss the differences of pregnancy contents and inform formats in in-formed consent form ( ICF) for the drug clinical trial between China and foreign countries. Methods:We collected Chinese and foreign ICFs for drug clinical trial that had been audited by the Ethics Committee of the third Xiangya Hospital for the past five years. Based on the relevant domestic and foreign law, we concluded the element stand-ards and inform formats about pregnancy inform. By analyzing the integrity of the whole elements, the inform rate of every element and the using rate of every inform format, we compared the differences of pregnancy contents and in-form formats between Chinese ICFs and foreign ICFs. Results:The total number of ICFs was 177 in this study, in-cluding 107 Chinese ICFs and 70 foreign ICFs. The integrity rate of pregnancy in Chinese ICFs was statistically lower than them in foreign ICFs (19% vs. 56%, P=0. 000). Compared with foreign ICFs, the low informed ele-ments were the study of the pregnancy risk (32% vs. 73%, P=0. 000), the pregnancy test during the following-up period (33% vs. 56%, P=0. 002) and the measurements for contraception (22% vs. 53%, P=0. 000). Conclusion:The integrity level of pregnancy content in Chinese ICFs was lower than that of the foreign ICFs. And the three elements including pregnancy risk study, pregnancy test during the following-up period and measure-ments for contraception was obviously defected. Pregnancy informing forms of informed consent in China was inferi-or to abroad.

Objective To noninvasively predict isocitrate dehydrogenase(IDH)status of glioma via combining imaging and clini-cal features before surgery,so as to provide basis for individualized clinical treatment decision.Methods A total of 47 patients with glioma confirmed by pathological and molecular genetic tests were included,including 20 with IDH mutant type and 27 with IDH wild type.After diffusion tensor imaging(DTI)scanning,fractional anisotropy(FA)and mean diffusivity(MD)values of tumor paren-chyma were calculated.Combining DTI parameters with MRI morphological features of tumor,blood neutrophil/lymphocyte ratio(NLR)and patient's age,binary logistic regression model was established to effectively predict IDH status of glioma patients before surgery.Results There were significant differences in FAmean/FANAWM,MDmin,NLR,tumor location and age between IDH mutant type and IDH wild type groups(P<0.05).The binary logistic regression model concluding,FAmean/FANAWM,MDmin,cystic degeneration,NLR and age,predicted IDH status of glioma with area under the curve(AUC)of 0.961 and 95%confidence interval(CI)of 0.914-1.00.Conclusion The regression model established via combining DTI,MRI morphological features and blood NLR has great performance in classifying IDH status of glioma,and can help predict IDH status noninvasively before surgery,so as to assist clinical individualized treatment.

Early phase trials refer to the early exploratory stage of transferring drug development into clinical trials. With China's strong encouragement for innovative drug research and development and enterprises vigorous investment, a large number of innovative drugs have entered early clinical trials. Early phase trials are generally based on innovative diagnosis and treatment mechanisms, pharmaceutical technology and drug delivery methods. Their research design are complex and diverse, and the new technology such as computer simulation are also widely used in the early phase trial process. These aspects are major challenges for the scientific and ethical review of early phase trials. Based on the characteristics of early phase trials, this article analyzes the ethical issues in early clinical trials such as risk uncertainty, therapeutic misunderstanding, subject compensation, breakthrough treatment, etc., and puts forward ethical countermeasures and suggestions.