1.Efficacy and safety of Liqingtong granules in the treatment of hyperuricemia: A randomized double-blind placebo-controlled pilot clinical trial
Jinlian Liu ; Yi Yang ; Meiyu Lv ; Wenting Fei ; Songrui Di ; Mei Luo ; Qing Lin ; Chun Wang ; Linyuan Wang ; Jianjun Zhang
Journal of Traditional Chinese Medical Sciences 2024;11(4):415-422
Objective:
To investigate the efficacy and safety of Liqingtong (LQT) granules in patients with dampness-heat hyperuricemia.
Methods:
A randomized, double-blind, placebo-controlled pilot trial was conducted at the 983rd Hospital of the Joint Logistic Support Force of the People's Liberation Army from March 15, 2023, to August 10, 2023. In total, 119 participants were enrolled in this trial, and participants were given either LQT granules or placebo for 60 days based on a health education. The primary outcome was serum uric acid (SUA) level, and the secondary outcome was the traditional Chinese medicine (TCM) symptom score, measured on days 0, 30, and 60. Safety indicators, including liver function, kidney function, blood routine, glucose, blood lipid, blood pressure, and heart rate were tested on days 0 and 60 of the trial. The data were analyzed using Prism 9 software, and the significance level was set at P < .05.
Results:
Among 119 participants, six in the LQT granule group and seven in the placebo group dropped out, and 106 participants completed clinical observation. Baseline information, including SUA levels, TCM symptom scores, and other clinical characteristics, did not differ between the groups. At the end of the trial, compared with baseline values, the SUA levels in the LQT granule group decreased (P < .001), and no significant change was observed in the placebo group (P = .422); compared with the placebo group, the SUA levels decreased in the LQT granule group (P = .001). Compared with baseline values, the total TCM symptom scores in the LQT granule group decreased (P < .001), with no change in the placebo group (P = .136). Safety indicators did not differ significantly between the two groups.
Conclusion
The pilot trial demonstrated the potential of LQT granules to lower SUA levels and improve symptoms of dampness and heat.
2.Establishment and preliminary clinical application of human intestinal fluid transplantation.
Chen YE ; Qi Yi CHEN ; Yin Mei YAN ; Xiao Qiong LV ; Chun Lian MA ; Ning LI ; Huan Long QIN
Chinese Journal of Gastrointestinal Surgery 2022;25(9):819-825
Objective: To explore and establish the preparation system of human intestinal fluid transplantation (HIFT) and HIFT capsule, and to preliminarily apply it to clinic. Methods: Strict standards for donor screening and management were established. The nasojejunal tube was catheterized into the distal jejunum, and then it was connected with an improved disposable sterile negative pressure collection device for the collection of human intestinal fluid. After that, it was prepared into capsules by filtering, adding 10% glycerin protectant and freeze-drying method. The amount of living bacteria was used as the standard of therapeutic dose. The living bacteria amount in fluid is ≥ 5.0×108 /mL and the living bacteria proportion is ≥ 83%; the living bacteria amount in powder is ≥ 2.0×106 /g and the living bacteria proportion is ≥ 81%; The observational indicators included: (1) the basic information of the donor, the amount of living bacteria in the HIF and powder. (2) Preliminary analysis of the treatment for ASD, which combined HIFT capsule with standard FMT capsule, from February to December 2021 (Clinical trial Registration Number: ChiCTR2100043929). Evaluation criteria: Trypan blue staining method was used to detect the living bacteria amount in fluid and powder. The Autism Behavior Checklist (ABC) and Childhood Autism Rating Scale (CARS) were used to evaluate the efficacy. Results: Compared with the parent donor, the standard donor was younger [(25.4±0.9) y vs. (30.7±3.2) y, t=-19.097, P=0.001] and had a lower body mass index [(19.7±0.5) kg/m2 vs. (20.8±1.3) kg/m2, t=-8.726, P=0.001], more in the living bacteria amount in powder [(7.47±1.52)×106/g vs. (5.03±1.38)×106/g, t=11.331, P=0.031], Chao index (205.4±6.8 vs. 194.2±7.2, t=10.415, P=0.001), and Shannon index (3.25±0.14 vs 2.72±0.27, t=19.465, P=0.001). The differences were statistically significant (all P<0.05). However, there were no significant differences in gender, drainage volume and total number of bacterial liquid colonies between the two groups (all P>0.05). Both the standard donor and the parent donor met the donor screening criteria, and the preparation fluid and powder met the treatment criteria. Eight patients received the treatment of HIFT combined with fecal microbiota transplantation (FMT). Preliminary statistical results showed that HIFT combined with FMT improved ABC and CARS at the 1st, 2nd, 3rd and 4th months. The differences were statistically significant (all P<0.05). No severe adverse reaction occurred. Conclusion: Based on the previous research on FMT preparation system and the clinical technology in our center, this study developed a high standard HIFT preparation system, and explored the clinical study of HIFT combined with FMT, in order to provide an innovative therapy for the treatment of diseases.
Bacteria
;
Child
;
Fecal Microbiota Transplantation/methods*
;
Glycerol
;
Humans
;
Powders
;
Trypan Blue
3.Anti-aggregation Effect and Short-term Safety Evaluation of Low-dose Aspirin Therapy in the Elderly Chinese Population: a Multicenter Randomized Controlled Clinical Trial
Xia-Huan CHEN ; Mei-Lin LIU ; Ming-Fang QIN ; Yan-Mei SUN ; Tao TIAN ; Jin-Qiao LI ; Qing-Tan ZHANG ; Jun LI ; Yong-Jun MAO ; Zhi-Sheng JIA ; Zhi-Yong FANG ; Zhi-Ping LV ; Lian-Qi CUI ; Chun-Hui GAO ; Li-Na WANG ; Yong-Ming HUI ; Pei-Yan SHAN ; Xiao-Ping CHEN ; Peng-Fei YIN
Chinese Circulation Journal 2018;33(5):457-462
Objectives: This study aimed to observe the change of arachidonic acid-induced platelet aggregation rate (AA-Ag) and short-term adverse reactions after taking 50 or 100 mg/d aspirin(enteric-coated sustained-release formulation) or 100 mg/d aspirin (enteric-coated aspirin tablet)in the elderly Chinese population (aged 60 years or older). Methods: A total of 1 194 participants aged 60 or older, who should be recommended to take aspirin therapy due to medical reasons, were recruited and randomly assigned into three groups to receive enteric-coated sustained-release aspirin tablet (50 mg, once daily, group A), or 100 mg, once daily (group B) or enteric-coated aspirin tablet 100 mg once daily (group C), respectively. AA-Ag was measured after (14±3)days of aspirin treatment. Adverse events and bleeding events were recorded during the (28±3)days of follow-up. Results: The AA-Ag in group A (n=347), B (n=338) and C (n=332) post 14-day aspirin therapy were 6.65 (4.03,10.84)%, 5.89(3.22,10.03) % and 6.00(3.68,10.09) %, respectively (P>0.05). During the 28 days follow-up, the adverse events rate of group A (n=388), B (n=387) and C (n=385) was 3.87%,3.36%, and 7.95%, and the mild bleeding events rate was 3.09%, 2.33%, and 6.23%, respectively. Adverse events rate and mild bleeding events rate were significantly higher in group C than in group A and B (P<0.05). Conclusions: Compared with 100 mg-dose aspirin, 50 mg-dose aspirin achieves similar anti-platelet aggregation effect in this elderly Chinese population. The short-term adverse events and mild bleeding risk of aspirin with enteric-coated sustained-release formulation were fewer than that of enteric-coated formulation.
4.Clinical observation of pemetrexed disodiun, carboplatin and psychological intervention in the treatment of elderly patients with advanced non-small cell lung cancer
Chinese Journal of Biochemical Pharmaceutics 2017;37(10):296-297
Objective To investigate the clinical efficacy of pemetrexed disodium, carboplatin and psychological intervention in the treatment of elderly patients with advanced non-small cell lung cancer. Methods 92 cases of elderly patients with advanced non-small cell lung cancer from February 2015 to February 2017 were randomly divided into study group (n=46) and control group (n=46) by the single and double number (hospital admission order).The control group was treated with carboplatin and pemetrexed disodium treatment, the study group was treated with carboplatin and pemetrexed disodium, combined with psychological intervention treatment, effects of treatment in elderly patients with advanced non-small cell lung cancer between two groups were recorded. Results The total effective rate of the study group (67.39%) was significantly higher than the control group (47.83%)with statistical significance (P<0.05), it suggested that the clinical efficacy of the study group in elderly patients with advanced non-small cell lung cancer is better. Conclusion The application of pemetrexed disodium, carboplatin, combined with psychological intervention treatment for elderly patients with advanced non-small cell lung cancer patients could significantly improve clinical efficacy, has positive significance to guarantee the quality of life of patients and life safety.
5.Impact of premature rupture of membranes on neonatal complications in preterm infants with gestational age <37 weeks.
Shun-Yan DUAN ; Xiang-Yong KONG ; Feng-Dan XU ; Hong-Yan LV ; Rong JU ; Zhan-Kui LI ; Shu-Juan ZENG ; Hui WU ; Xue-Feng ZHANG ; Wei-Peng LIU ; Fang LIU ; Hong-Bin CHENG ; Yan-Jie DING ; Tie-Qiang CHEN ; Ping XU ; Li-Hong YANG ; Su-Jing WU ; Jin WANG ; Li PENG ; Xiao-Lin ZHAO ; Hui-Xian QIU ; Wei-Xi WEN ; Ying LI ; Lan LI ; Zheng WEN ; Guo GUO ; Feng WANG ; Gai-Mei LI ; Wei LI ; Xiao-Ying ZHAO ; Yun-Bo XU ; Wen-Chao CHEN ; Huan YIN ; Xiao-Liang WANG ; Rui-Yan SHAN ; Mei-Ying HAN ; Chun-Yan YANG ; Zhi-Chun FENG
Journal of Southern Medical University 2016;36(7):887-891
OBJECTIVETo investigate the effect of premature rupture of the membrane (PROM) on neonatal complications in premature infants.
METHODSThe registration information of 7684 preterm infants with gestational age <37 weeks were collected from the cooperative units in the task group between January 1, 2014 to December 31, 2014. Specially trained personnel from each cooperative units filled in the unified form in a standardized format to record the gender, gestational age, birth weight, PROM, placental abruption, antenatal corticosteroid, Apgar score, amniotic fluid pollution, and complications of the infants. The data were analyzed comparatively between the cases with PROM and those without (control).
RESULTSThe preterm mortality rate was significantly lower but the incidences of ICH, NEC, ROP and BPD were significantly higher in PROM group than in the control group (P<0.05). The 95% confidence interval of the OR value was <1 for mortality, and was >1 for ICH, NEC, ROP and BPD. After adjustment for gestational age, birth weight, gender, mode of delivery, placental abruption, placenta previa, prenatal hormones, gestational diabetes mellitus (GDM), gestational period hypertension and 5-min Apgar score <7, the incidences of NEC, ROP and BPD were significantly different between the two groups (P<0.05) with 95% confidence interval of OR value >1, but the mortality rate and incidence of ICH were not significantly different between the two groups (P>0.05).
CONCLUSIONPROM is a risk factor for NEC, ROP and BPD in preterm infants, and adequate intervention of PROM can reduce the incidences of such complications as NEC, ROP and BPD in the infants.
Apgar Score ; Birth Weight ; Female ; Fetal Membranes, Premature Rupture ; pathology ; Gestational Age ; Humans ; Incidence ; Infant, Newborn ; Infant, Newborn, Diseases ; etiology ; Infant, Premature ; Pregnancy ; Risk Factors
6.Quality of life in women with cervical precursor lesions and cancer: a prospective, 6-month, hospital-based study in China.
Zhi-Mei ZHAO ; Xiong-Fei PAN ; Si-Han LV ; Yao XIE ; Shao-Kai ZHANG ; You-Lin QIAO ; Xiao-Rong QI ; Chun-Xia YANG ; Fang-Hui ZHAO
Chinese Journal of Cancer 2014;33(7):339-345
The overall survival of patients with cervical cancer has improved due to detection at an early stage and availability of comprehensive treatments in China. As patients' lives prolonged, it is important to understand their health-related quality of life (QoL) during and after treatment. We used the EQ-5D questionnaire to assess QoL of 194 patients with cervical lesions at Sichuan University West China Second Hospital between May 2010 and January 2011. Patients were surveyed before primary treatment and at 1, 3, and 6 months after primary treatment. Results showed a consistent decline in EQ-5D scores in the spectrum of cervical lesions at each time point after treatment (all P < 0.05). For patients with precursor lesions, there was an increasing trend along the timeline of treatment (P < 0.01). For patients with early-stage cervical cancer, EQ-5D scores declined in the first month (P = 0.01) and gradually increased to higher levels at 6 months post-treatment than those before treatment (P < 0.01). EQ-5D scores followed a similar trend in patients with advanced cervical cancer (P = 0.04), though they did not statistically rebound after 6 months (0.84 ± 0.19 vs. 0.86 ± 0.11, P = 0.62). Regarding advanced cervical cancer, EQ-5D scores for women above 40 years of age appeared to recover more rapidly and reached higher levels than those for women below 40 years (P = 0.03). Caution and extra care are recommended in the early period of cervical cancer treatment given the slight deterioration in the QoL, and in particular, for younger cervical cancer patients. Our study implies that health care providers may need to improve the health-related QoL of cervical cancer patients.
Age Factors
;
China
;
Female
;
Humans
;
Neoplasm Staging
;
Prospective Studies
;
Quality of Life
;
Surveys and Questionnaires
;
Uterine Cervical Dysplasia
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Uterine Cervical Neoplasms
8.Association between parental MTHFR gene polymorphism 677C/T and nonsyndromic cleft lip and palate in offspring.
Su-mei WANG ; Jian-hua WANG ; Jian-chun YU ; Bin WEI ; Ke-hua WANG ; Jin-yun LIU ; Yun-ling DONG ; Xue-mei LV
Chinese Journal of Medical Genetics 2012;29(4):464-467
OBJECTIVETo explore the association between parental genetic polymorphism of methylenetetrahydrofolate reductase (MTHFR) 677C/T and occurrence of nonsyndromic cleft lip with or without cleft palate (NSCL/P) in offspring in Shandong Province.
METHODSMTHFR genotypes were determined by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Parents of 89 NSCL/P patients treated at Qilu Hospital from August, 2006 to August, 2008 and those of 64 healthy children were recruited in this case-control study.
RESULTSFrequencies of T and C alleles in mothers of patients and healthy children were 65.73% and 46.09%, and 34.27% and 53.91%, respectively (Chi-square=13.663, P<0.01). Offspring whose mothers had T alleles were 2.243 times more likely to develop NSCL/P (95%CI: 1.408-3.572). Frequencies of T and C alleles in fathers of patients and healthy children were 62.92% and 55.47%, and 37.08% and 44.53%, respectively (Chi-square=2.222, P>0.05). The chance for parents of the patient and control groups to bear an affected fetus carrying homozygous mutations were 43% and 29%, respectively (P>0.05).
CONCLUSIONIn Shandong Province, maternal genotype for the MTHFR 677C/T polymorphism has a significant impact on the occurrence of NSCL/P in their offspring, whilst paternal genotype for this polymorphism may not be a risk factor for NSCL/P in their offspring.
Alleles ; Case-Control Studies ; Child ; Cleft Lip ; genetics ; Cleft Palate ; genetics ; Female ; Genotype ; Homozygote ; Humans ; Male ; Methylenetetrahydrofolate Reductase (NADPH2) ; genetics ; Polymorphism, Genetic
9.The expression of a novel estrogen receptor, GPR30, in epithelial ovarian carcinoma and its correlation with MMP-9.
Hui-Di LIU ; Yan YAN ; Xue-Feng CAO ; Pei-Zhu TAN ; Hai-Xia WEN ; Chun-Mei LV ; Xiao-Mei LI ; Guo-Yi LIU
Acta Physiologica Sinica 2010;62(6):524-528
The aim of the present study is to investigate the expression of a novel estrogen receptor, G protein-coupled receptor 30 (GPR30) and its correlation with matrix metalloproteinases-9 (MMP-9) in epithelial ovarian cancer (EOC). Ovary tissues were obtained from 39 female patients, including 30 cases of EOC and 9 cases of benign ovarian tumor. Four normal ovary tissues were used as control. Immunohistochemical staining was used to detect the expressions of GPR30 and MMP-9. Chi square test, Fisher's exact test and Spearman's rank correlation analysis were used for statistical analysis. The results showed that GPR30 overexpression rate in EOC cases was significantly higher than those in benign ovarian tumor and normal ovary cases. Whereas MMP-9 overexpression rate in EOC cases was significantly higher than that in normal ovary cases, without any difference to that in benign ovarian tumor cases. To demonstrate the relationship between GPR30 and clinicopathological variables of EOC, we further analyzed the pathology type, FIGO stage and age of patients sampled in our study. The analysis showed there were significant differences of GPR30 overexpression rate among various pathology types and different FIGO stages (P<0.05), and no significant difference of both GPR30 and MMP-9 among three age groups (P>0.05). Moreover, GPR30 expression was positively correlated with MMP-9 (r(s)=1.000, P=0.002). These results suggest that GPR30 may be involved in the invasion and metastasis of EOC, being a potential index of EOC early diagnosis and malignancy grade prediction.
Adult
;
Aged
;
Biomarkers
;
metabolism
;
Cystadenocarcinoma, Serous
;
metabolism
;
Female
;
Humans
;
Matrix Metalloproteinase 9
;
metabolism
;
Middle Aged
;
Neoplasms, Glandular and Epithelial
;
metabolism
;
Ovarian Neoplasms
;
metabolism
;
Receptors, Estrogen
;
metabolism
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Receptors, G-Protein-Coupled
;
metabolism
;
Young Adult
10.Analyses of serological and genetic characteristics on novel H1N1 influenza A virus from the infected patient in Shenzhen.
Chun-Li WU ; Xiao-Wen CHENG ; Xing LV ; Jian-Fan HE ; Yun-Mei HUANG ; Xin WANG ; Shi-Song FANG ; Ren-Li ZHANG ; Jin-Quan CHENG
Chinese Journal of Virology 2010;26(6):453-459
Analysis of serological and genetic characteristics on 2009 swine-origin influenza A (H1N1) virus (S-OIV) isolated from four patients with severe disease in Shenzhen were performed. Microneutralization assay showed that the neutralizing antibody titers of the infected patients did not exceed 1 : 20 in a short term post infection, which could not neutralize the viruses efficiently. Hemagglutination inhibition (HI) tests confirmed that the antigenicity of S-OIV from the patients was distinct from the seasonal influenza A virus, but similar to the reference strains of S-OIV. Phylogenetic and molecular analysis showed that S-OIV from the patients still belonged to the classical swine lineages and did not have the genetic characteristics of highly pathogenic influenza virus. Several amino acid residue mutations on HA protein were detected, which seemed not to affect the virulence and pathogenicity of the viruses. Further, A His 275 Tyr mutation on NA protein of a virus strain was detected, which induced the oseltamivir resistance of the virus.
Amino Acid Sequence
;
Antibodies, Neutralizing
;
immunology
;
Antibodies, Viral
;
immunology
;
Child
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Child, Preschool
;
China
;
Female
;
Humans
;
Influenza A Virus, H1N1 Subtype
;
classification
;
enzymology
;
genetics
;
isolation & purification
;
Influenza, Human
;
immunology
;
virology
;
Male
;
Molecular Sequence Data
;
Mutation
;
Phylogeny
;
Sequence Alignment
;
Viral Proteins
;
chemistry
;
genetics
;
Young Adult


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