Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Male ; Double-Blind Method ; Drugs, Chinese Herbal/therapeutic use* ; Tic Disorders/drug therapy* ; Treatment Outcome

OBJECTIVE: To observe the effect of acupuncture on vascular endothelial function in patients of polycystic ovary syndrome (PCOS) with impaired glucose tolerance (IGT) and normal glucose tolerance (NGT). METHODS: A total of 140 patients with PCOS were divided into an IGT group (70 cases, 11 dropped off) and a NGT group (70 cases, 9 cases dropped off). The patients in the two groups were treated with full-cycle acupuncture at Zhongwan (CV 12), Guanyuan (CV 4), Qihai (CV 6), Tianshu (ST 25), etc. once every other day, 3 times a week, for 3 months. Before and after treatment, TCM symptom score, insulin resistance index [including fasting plasma glucose (FPG), 2-hour blood glucose (2hPG), fasting serum insulin (FINS), homeostasis model assessment of insulin resistance (HOMA-IR)] and vascular endothelial related factors [including asymmetric dimethylarginine (ADMD), endothelin-1 (ET-1), malondialdehyde (MDA), nitric oxide (NO)] were compared between the two groups; in addition, the obese subgroup and non-obese subgroup of the two groups were further compared. RESULTS: Compared before treatment, the TCM symptom scores, ADMD, ET-1 and MDA after treatment were decreased ( CONCLUSION Acupuncture could improve vascular endothelial function in PCOS patients, IGT patients have better efficacy than NGT patients, and obese patients have better efficacy than non-obese patients.
Acupuncture Therapy ; Blood Glucose ; Female ; Glucose ; Glucose Intolerance/therapy* ; Humans ; Insulin ; Insulin Resistance ; Polycystic Ovary Syndrome/therapy*

Objective To evaluate the effects of antiretroviral therapy(ART)for the prevention of mother-to-child transmission(PMTCT)of acquired immune deficiency syndrome(AIDS)on the growth and development of 18-month-old children born by human immunodeficiency virus(HIV)-positive pregnant women in Lingshan County,Guangxi Zhuang Autonomous Region,and provide scientific evidence for improving the ART medication plan for PMTCT.Methods Lingshan County,ranking the first in the HIV-epidemic counties of Guangxi,was selected as the research site.According to the design of retrospective case-control study,we assigned all the subjects into the case group and the control group:(1)The case group included the HIV-positive pregnant women who had received ART for PMTCT and their HIV-negative infants in Lingshan County from 2010 to 2017.The historical cards and PMTCT data of them were collected from the national PMTCT database.(2)The control group included the healthy pregnant women and their healthy babies born in the Lingshan Maternity and Infant Hospital in 2017,and the children's growth and development data were collected.The stunted growth in children was defined as at least one of the three main indicators of body height,body weight,and head circumference below the normal range.Results The number of HIV-positive mothers and their infants in the case group was 391 and 368,respectively,and 87.21%(341/391)and 95.38%(351/368)of mothers and infants respectively received ART medication.The HIV positive rate,mortality rate,and mother-to-child transmission rate of 18-month-old children were 1.36%(5/368),4.35%(16/368),and 2.01%(5/249),respectively.The incidence of stunted growth of 18-month-old children in the case group and the control group was 42.12%(155/368)and 23.06%(101/438),respectively,with significant difference(
Case-Control Studies ; China/epidemiology* ; Female ; Growth and Development ; HIV ; HIV Infections/prevention & control* ; Humans ; Infant ; Infectious Disease Transmission, Vertical/prevention & control* ; Mothers ; Pregnancy ; Pregnancy Complications, Infectious/drug therapy* ; Retrospective Studies

OBJECTIVE: To analyze the clinicobiological heterogeneity of NPM1 mutated (NPM1 METHODS: The NGS data based on 112 genes related to blood disease in 238 newly diagnosed patients with NPM1 RESULTS: Among all the patients, at least one co-mutation was detected out. The median number per case of the mutated genes, including NPM1 CONCLUSION Prognoses of AML involving less common NPM1 missense mutations should be stated on a case by case basis. The mutational landscape and co-occurrence and mutual exclusivity correlations of NPM1
Base Sequence ; High-Throughput Nucleotide Sequencing ; Humans ; Leukemia, Myeloid, Acute/genetics* ; Mutation ; Nuclear Proteins/genetics*

BACKGROUND: Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis. METHODS: This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12. RESULTS: A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period. CONCLUSION: Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis. TRIAL REGISTRATION ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.
Antibodies, Monoclonal/therapeutic use* ; Antibodies, Monoclonal, Humanized ; China ; Double-Blind Method ; Humans ; Psoriasis/drug therapy* ; Severity of Illness Index ; Treatment Outcome

OBJECTIVE: To compare the clinical effect of the combined treatment of acupuncture, moxibustion, Chinese herbal medicine and western medication and simple western medication on polycystic ovary syndrome (PCOS) of kidney deficiency and blood stagnation pattern and explore the effect on endometrial receptivity and the expression of serum homeobox gene A10 (HOXA10). METHODS: A total of 60 patients with PCOS of kidney deficiency and blood stagnation pattern were randomized into a combined treatment group and a western medication group, 30 cases in each one. In the western medication group, on the fifth day of menstruation, clomiphene citrate tablets were taken orally, 50 mg each time, once daily, consecutively for 5 days. On the day when the follicle diameter was ≥ 18 mm, chorionic gonadotrophin for muscular injection, a dose of 10 000 U was given. Before sleep, the aspirin enteric-coated tablets were taken orally, 50 mg (except during menstruation). In the combined treatment group, on the base of the treatment as the western medication group, acupuncture and moxibustion were adopted and the Chinese herbal for tonifying the kidney and activating blood circulation was taken orally. The acupoints were Guanyuan (CV 4), Qihai (CV 6), Zusanli (ST 36), Sanyinjiao (SP 6), Zigong (EX-CA 1), etc. Acupuncture was remained for 30 min each time, once every two days and discontinued during menstruation. Chinese herbal was given from the 3rd day of menstruation till the onset of the next menstruation, one dose each day. After consecutive treatment for 3 menstrual cycles in the two groups, the real-time polymerase chain reaction (RT-PCR) method was adopted to determine the expression of serum HOXA10 before and after treatment in the patients of the two groups. The endometrial thickness at ovulatory phase, uterine arterial flow 7 days after ovulation [including uterine arterial pulsatility index (PI), resistance index (RI), peak systolic velocity (PSV)/end diastolic velocity (EDV), meaning S/D], pregnancy rate and the score of Chinese medicine symptoms before and after treatment were compared in the patients between the two groups. RESULTS: ① After treatment, the expression of serum HOXA10 was higher than that before treatment in the patients of the two groups ( CONCLUSION The combined treatment with acupuncture, moxibustion and medication effectively improves endometrial receptivity and uterine arterial flow in the patients with PCOS of kidney deficiency and blood stagnation pattern and increases pregnancy rate. The therapeutic effect is better than the simple western medication and its mechanism is probably related to the regulation of serum HOXA10 expression.
Acupuncture Points ; Acupuncture Therapy ; Female ; Genes, Homeobox ; Homeobox A10 Proteins ; Humans ; Kidney ; Moxibustion ; Polycystic Ovary Syndrome/genetics* ; Pregnancy

Exhaled breath condensate (EBC) was analyzed by gas chromatography-mass spectrometry (GC-MS / MS) in childhood asthma and healthy control, aiming to find the potential markers of EBC in children with asthma, and provide a scientific reference for its pathogenesis and early screening. EBC samples were collected from 21 asthmatic children (age (8. 2 ±1. 6) years) and 17 healthy children ( age (8. 1 ±1. 3) years). GC-MS / MS was used to obtain the full scan data of chemical components. Cluster analysis was performed on the two groups of metabolites by principal component analysis (PCA), and potential biomarkers were found using Metaboanalyst 3. 0 attributable metabolic pathways. The results showed that the EBC metabolic maps of asthmatic group and normal group were very different, and eight endogenous potential biomarkers were identified, suggesting that starch and sucrose metabolism, lysine degradation, aminoglycan nucleoside metabolism, phenylalanine metabolism may play important roles in the development of asthma in children.

Objective To investigate the physicochemical properties and immunomodulatory activities of crude polysaccharides and their fractions from Sophorae Flavescentis Radix. Methods The crude polysaccharide (SFP-100) was obtained successively by boiling Sophorae Flavescentis Radix in water, ethanol precipitating, dialyzing and freeze drying. SFP-100 was separated withDEAE-cellulose column to obtain three fractions, and these fractions were fruther separated with Sephadex G-100 column to obtain their sub-fractions. The sugar content was determined by phenol-sulfuric acid method, the molecular distribution was determined with gel filtration chromatography, and the monosaccharide composition was analyzed with capillary electrophoresis after PMP derivatization. The immunobiological activities were estimated by measuring the proliferation of mouse spleen lymphocytes as well as the IFN-secretion in mouse splenocytes and the TNF-α secretion in mouse peritoneal macrophages. Results The yield of SFP-100 from Sophorae Flavescentis Radix was 4.83％ and sugar content was 71.62％. SFP-100 was separated into three fractions SFP-100-A, SFP-100-B and SFP-100-C, whose yields were 3.5％, 25.6％ and 16.7％, and the sugar content was 85.99％, 72.09％ and 24.30％, respectively.The monosaccharide composition and their molar ratio for SFP-100-A, SFP-100-B and SFP-100-C were Ara∶Glc∶Gal=7.16∶91.02∶1.82, Xyl∶Ara∶Glc∶Rha∶Gal∶GalA=0.05∶1.00∶0.85∶0.04∶0.35∶0.43, and Xyl∶Ara∶Glc∶Rha∶Gal∶GlcA∶GalA=0.20∶1.00∶0.33∶0.36∶0.45∶0.55∶14.37, respectively. SFP-100-B was further separated into two sub-fractions SFP-100-B-a and SFP-100-B-b with Sephadex G-100, and the other two sub-fractions SFP-100-C-a and SFP-100-C-b were also obtained with the same Sephadex G-100 from SFP-100-C. SFP-100-B-a showed a main wide peak, which had the relative molecular weight 1.02×105 and monosaccharide composition Ara∶Glc∶Rha∶Gal = 1.00∶0.06∶0.02∶0.29. Meanwhile, the relative molecular weight and monosaccharide composition were 5.43×104 and Xyl∶Glc =1.00∶3.81 for the main peak of SFP-100-C-a, and 2.75×104 and Ara∶Glc∶Rha∶Gal∶GlcA∶GalA=1.00∶2.10∶0.57∶0.74∶1.09∶33.75 for the main peak of SFP-100-C-b, respectively. The crude polysaccharides SFP-100 and its fractions, SFP-100-B and SFP-100-C, as well as the sub-fractions, SFP-100-B-a, SFP-100-B-b and SFP-100-C-a, increased the proliferation of spleen cells, all in a dose-dependent manner. Further, SFP-100 could improve the secretion of IFN-γ and TNF-α in spleen cells, while SFP-100-B, SFP-100-C, SFP-100-B-a and SFP-100-B-b could stimulate the secretion of IFN-γ. Conclusion The crude polysaccharides of Sophorae Flavescentis Radix and their fractions showed a good immunomodulatory activity, which may be related to the clinical use of Sophorae Flavescentis Radix for the anti-HBV and anti-inflammatory therapy.

OBJECTIVES: To analyse the genetic polymorphisms of 19 autosomal STR loci in Han population of east, middle-northwest and southwest-south Shandong and to explore its genetic relationships among the population of these three regions. METHODS: STR loci of 1 044 unrelated Han individuals in three Shandong regions were typed with a Goldeneye® DNA ID System 20A kit. The allele frequency and population genetics parameters of 19 autosomal STR loci were statistically analysed by Modified-Powerstates software. The genetic distances among the population in three regions were calculated by Arlequin v3.5 software. The phylogenetic tree was conducted using MEGA v4.0 software. RESULTS: Fifteen of 19 autosomal STR loci were detected with the H values greater than 0.7, PIC values greater than 0.7, and DP values greater than 0.9 in the populations of all three Shandong regions. Among the populations in these three regions, the genetic distance between the populations in middle-northwest and southwest-south Shandong was closest （F_st=0.000 16）, followed by east and southwest-south Shandong （F_st=0.0003 6）. The genetic distance between the populations in east and middle-northwest Shandong was the farthest （F_st=0.000 66, P<0.05）. CONCLUSIONS The 19 autosomal STR loci show good genetic polymorphisms in Han population of three Shandong regions, and 15 of them are high. There are genetic differences between the populations in east and middle-northwest Shandong.
Asian People/genetics* ; China ; Ethnicity ; Gene Frequency ; Genetic Loci/genetics* ; Genetics, Population ; Humans ; Microsatellite Repeats ; Phylogeny ; Polymorphism, Genetic/genetics*