1.Therapeutic efficacy of Roujin formula in managing fibromyalgia patients with liver depression and spleen deficiency syndrome: A single-blinded randomized controlled trial
Jingsi FU ; Shiya WU ; Quan JIANG ; Juan JIAO
Science of Traditional Chinese Medicine 2025;3(1):62-68
Objective: Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by central sensitivity to pain, and it is universally acknowledged as a recalcitrant disease. A single-blind randomized controlled trial was conducted to assess the effectiveness and safety of the Roujin formula in treating FMS patients with liver depression and spleen deficiency syndrome, aiming to provide more scientific and effective treatment options. Methods: Forty-eight eligible participants were enrolled and randomly assigned to either the Roujin formula group (n = 24) or the placebo group (n = 24). The Roujin formula group received 150 mL of the Roujin formula twice daily, whereas the placebo group was given a tenth of the Roujin formula dosage, twice daily. The treatment lasted for 8 weeks, with a follow-up extending to 12 weeks. The primary outcome was the improvement in the pain Visual Analogue Scale (VAS) score, whereas secondary outcomes included enhancements in the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory-II (BDI-II), Revised Fibromyalgia Impact Questionnaire (FIQR), and 36-item Short-Form Health Survey (SF-36) scores. These measures were assessed at baseline and after 4, 8, and 12 weeks. The Patients’ Global Impression of Change (PGIC) was collected at week 12. Safety assessments were based on routine blood tests, urine tests, and liver and kidney function evaluations. Results: The improvement in the pain VAS score was significantly greater in the Roujin formula group than that in the placebo group at the 4-, 8-, and 12-week follow-ups (p < 0.05). At the 8-week treatment and the 12-week follow-up, improvements in PSQI and FIQR scores were also superior in the Roujin formula group compared with the placebo group (p < 0.05). There were no differences between the 2 groups in the improvement of BDI-II scores, SF-36 physical component summary, and mental component summary scores at any observation time points. At the 12-week follow-up, PGIC ratings were significantly better in the Roujin formula group (p < 0.05). There were 4 adverse events, all of which occurred in the Roujin formula group, including 3 cases of diarrhea and 1 case of stomach pain; no serious adverse events were reported during the study. Conclusion: The Roujin formula can effectively enhance the overall condition of FMS patients, relieve pain, improve sleep quality, and elevate physical and mental well-being. Only mild gastrointestinal reactions were observed. The Roujin formula may be a viable candidate for clinical implementation.
2.Therapeutic efficacy of Roujin formula in managing fibromyalgia patients with liver depression and spleen deficiency syndrome: A single-blinded randomized controlled trial
Jingsi FU ; Shiya WU ; Quan JIANG ; Juan JIAO
Science of Traditional Chinese Medicine 2025;3(1):62-68
Objective: Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by central sensitivity to pain, and it is universally acknowledged as a recalcitrant disease. A single-blind randomized controlled trial was conducted to assess the effectiveness and safety of the Roujin formula in treating FMS patients with liver depression and spleen deficiency syndrome, aiming to provide more scientific and effective treatment options. Methods: Forty-eight eligible participants were enrolled and randomly assigned to either the Roujin formula group (n = 24) or the placebo group (n = 24). The Roujin formula group received 150 mL of the Roujin formula twice daily, whereas the placebo group was given a tenth of the Roujin formula dosage, twice daily. The treatment lasted for 8 weeks, with a follow-up extending to 12 weeks. The primary outcome was the improvement in the pain Visual Analogue Scale (VAS) score, whereas secondary outcomes included enhancements in the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory-II (BDI-II), Revised Fibromyalgia Impact Questionnaire (FIQR), and 36-item Short-Form Health Survey (SF-36) scores. These measures were assessed at baseline and after 4, 8, and 12 weeks. The Patients’ Global Impression of Change (PGIC) was collected at week 12. Safety assessments were based on routine blood tests, urine tests, and liver and kidney function evaluations. Results: The improvement in the pain VAS score was significantly greater in the Roujin formula group than that in the placebo group at the 4-, 8-, and 12-week follow-ups (p < 0.05). At the 8-week treatment and the 12-week follow-up, improvements in PSQI and FIQR scores were also superior in the Roujin formula group compared with the placebo group (p < 0.05). There were no differences between the 2 groups in the improvement of BDI-II scores, SF-36 physical component summary, and mental component summary scores at any observation time points. At the 12-week follow-up, PGIC ratings were significantly better in the Roujin formula group (p < 0.05). There were 4 adverse events, all of which occurred in the Roujin formula group, including 3 cases of diarrhea and 1 case of stomach pain; no serious adverse events were reported during the study. Conclusion: The Roujin formula can effectively enhance the overall condition of FMS patients, relieve pain, improve sleep quality, and elevate physical and mental well-being. Only mild gastrointestinal reactions were observed. The Roujin formula may be a viable candidate for clinical implementation.
3.Therapeutic efficacy of Roujin formula in managing fibromyalgia patients with liver depression and spleen deficiency syndrome: A single-blinded randomized controlled trial
Jingsi FU ; Shiya WU ; Quan JIANG ; Juan JIAO
Science of Traditional Chinese Medicine 2025;3(1):62-68
Objective: Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by central sensitivity to pain, and it is universally acknowledged as a recalcitrant disease. A single-blind randomized controlled trial was conducted to assess the effectiveness and safety of the Roujin formula in treating FMS patients with liver depression and spleen deficiency syndrome, aiming to provide more scientific and effective treatment options. Methods: Forty-eight eligible participants were enrolled and randomly assigned to either the Roujin formula group (n = 24) or the placebo group (n = 24). The Roujin formula group received 150 mL of the Roujin formula twice daily, whereas the placebo group was given a tenth of the Roujin formula dosage, twice daily. The treatment lasted for 8 weeks, with a follow-up extending to 12 weeks. The primary outcome was the improvement in the pain Visual Analogue Scale (VAS) score, whereas secondary outcomes included enhancements in the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory-II (BDI-II), Revised Fibromyalgia Impact Questionnaire (FIQR), and 36-item Short-Form Health Survey (SF-36) scores. These measures were assessed at baseline and after 4, 8, and 12 weeks. The Patients’ Global Impression of Change (PGIC) was collected at week 12. Safety assessments were based on routine blood tests, urine tests, and liver and kidney function evaluations. Results: The improvement in the pain VAS score was significantly greater in the Roujin formula group than that in the placebo group at the 4-, 8-, and 12-week follow-ups (p < 0.05). At the 8-week treatment and the 12-week follow-up, improvements in PSQI and FIQR scores were also superior in the Roujin formula group compared with the placebo group (p < 0.05). There were no differences between the 2 groups in the improvement of BDI-II scores, SF-36 physical component summary, and mental component summary scores at any observation time points. At the 12-week follow-up, PGIC ratings were significantly better in the Roujin formula group (p < 0.05). There were 4 adverse events, all of which occurred in the Roujin formula group, including 3 cases of diarrhea and 1 case of stomach pain; no serious adverse events were reported during the study. Conclusion: The Roujin formula can effectively enhance the overall condition of FMS patients, relieve pain, improve sleep quality, and elevate physical and mental well-being. Only mild gastrointestinal reactions were observed. The Roujin formula may be a viable candidate for clinical implementation.
4.Analysis of the use of national health insurance negotiated drugs in Tianjin Second People's Hospital from 2018 to 2022
Wenpeng FU ; Defa ZHANG ; Cheng LU ; Jingsi WANG
China Pharmacist 2024;27(2):317-324
Objective To understand the usage of national medical insurance negotiated drugs(hereinafter referred to as"negotiated drugs")at Tianjin Second People's Hospital and to provide references for optimizing and adjusting the hospital's drug catalog.Methods A retrospective study was conducted on the usage of negotiated drugs from January 1,2018 to December 31,2022 to compare changes in the unit price of drugs,the quantity and amount of sales,the usage frequency(DDDs)and the daily average cost(DDC),etc before and after the negotiation.Results Between 2018 and 2022,the varieties of negotiated drugs used in the hospital increased from the original 5 to 24.Among the 13 drugs analyzed for comparison,the unit prices of 11 drugs had been reduced after negotiation,and 7 drugs were included in the medical insurance and outpatient-specific disease payment directory.The average decrease in DDC was 36.43%,and the average increase in DDDs was 1 770.31%.The implementation of this policy had increased the accessibility of medication for patients and significantly increased sales quantity.Conclusion The quantity of sales of negotiated drugs significantly increased through reducing the unit price of drugs and including them in the scope of medical insurance payment,etc.These increase the pharmacoeconomic viability of negotiated drugs,effectively reduce the burden on patients,promote rational drug use in hospitals,and improve the access and efficiency of drugs.
5.Survey of height and weight of children and adolescents at different Tanner stages in urban China
Jiaqi PU ; Jianwei ZHANG ; Ruimin CHEN ; Mireguli MAIMAITI ; Jingsi LUO ; Shaoke CHEN ; Di WU ; Min ZHU ; Chunlin WANG ; Zhe SU ; Yan LIANG ; Hui YAO ; Haiyan WEI ; Rongxiu ZHENG ; Hongwei DU ; Feihong LUO ; Pin LI ; Shuting SI ; Wei WU ; Ke HUANG ; Guanping DONG ; Yunxian YU ; Junfen FU
Chinese Journal of Pediatrics 2021;59(12):1065-1073
Objective:To investigate the status of height and weight of 3-18-year-old children and adolescents in urban China, and to provide a basis for establishing puberty phase specific curves for age-specific height and age-specific weight.Methods:A cross-sectional survey of 218 185 children and adolescents aged 3-18 years in urban China was conducted by using the method of stratified random cluster sampling from January 2017 to December 2019. The sampling areas included 12 provinces municipalities in China and autonomous regions in total. Data were collected on weight, height, waist circumference, hip circumference and secondary sexual characteristics. The generalized additive model for location, scale, and shape (GAMLSS) was employed to establish percentile reference values and growth curves of height and weight for boys and girls aged 3-18 years. Wilcoxon rank sum test was applied to compare the P 50 value of height and weight between children of each Tanner stage and children of the same age ignoring the different puberty phase. Results:The 3rd, 50th, and 97th percentile curves for height and weight for age were developed for boys and girls aged 3-18 years. The 3rd, 50th, and 97th percentile curves for age-specific height and age-specific weight for each puberty phase were developed for boys and girls. Compared with all children ignoring the different puberty phase, boys aged 9 and over and girls aged 7 and over who are at Tanner stage 1 showed shorter height and lighter weight than those of the same age group (all P<0.01), the difference ranges of height at P 50 are -4.0 to -0.6 cm for boys, and -4.4 to 0.5 cm for girls; the difference ranges of weight are -4.8 to 0.4 kg for boys, and -4.0 to -0.3 kg for girls; children at Tanner stage 2 & 3 initially were taller and heavier than those of the same age group; and later grew shorter and lighter than those of the same age group, the two sets of curves cross over; boys aged 16 and under and girl aged under 14 who are at Tanner stage 4 were taller and heavier than those of the same age group (all P<0.01), the difference ranges of height at P 50 are 0.2 to 10.0 cm for boys, and 0.2 to 9.4 cm for girls; the difference ranges of weight at P 50 are 0.7 to 10.9 kg for boys, and 1.0 to 11.2 kg for girls, and the differences showed narrowing trend with age. Conclusion:The puberty phase specific growth curves of age-specific height and age-specific weight for boys and girls aged 3-18 years are established, it is useful for clinical work to evaluate physical development of children at different puberty phases.
6.Application of SNP-array technology in the genetic analysis of pediatric patients with growth retardation.
Shiyu LUO ; Chunyun FU ; Shujie ZHANG ; Jin WANG ; Xin FAN ; Jingsi LUO ; Rongyu CHEN ; Xuyun HU ; Haisong QIN ; Chuan LI ; Shan OU ; Qifei LI ; Shaoke CHEN
Chinese Journal of Medical Genetics 2017;34(3):321-326
OBJECTIVETo explore the value of single nucleotide polymorphism array (SNP-array) for the analysis of pediatric patients with growth retardation.
METHODSOne hundred eighty one children with growth retardation were enrolled. DNA was extracted from peripheral samples from the patients, and whole genome copy number variations (CNVs) were detected using Illumina Human Cyto SNP-12. All identified CNVs were further analyzed with reference to databases including ClinGen, ClinVar, DECIPHER, OMIM and DGV as well as comprehensive review of literature from PubMed to determine their pathogenicity.
RESULTSForty seven patients (26%) with abnormal CNVs were detected, which included 12 known microdeletions/microduplications syndrome (26%), 10 pathogenic non-syndromic CNVs (21%), 3 numerical chromosome aberrations (6%), 3 unbalanced translocations (6%), 4 pathogenic mosaicisms (9%) and 15 cases with unknown clinical significance (32%). After excluding obvious numerical and/or structural chromosomal abnormalities, this study has detected 15 pathogenic microdeletions/microduplications sized 5 Mb or less, which may be missed by routine chromosomal karyotyping. In addition, there were 3 cases with loss of heterozygoisty (LOH) containing known or predicted imprinting genes as well as 2 cases with suspected parental consanguinity.
CONCLUSIONSNP-array technology is a powerful tool for the genetic diagnosis of children with growth disorders with advantages of high resolution and improved accuracy.
Adolescent ; Child ; Child, Preschool ; Chromosome Aberrations ; DNA Copy Number Variations ; Developmental Disabilities ; diagnosis ; genetics ; Female ; Humans ; Infant ; Karyotyping ; Male ; Oligonucleotide Array Sequence Analysis ; methods ; Polymorphism, Single Nucleotide
7.Genome-wide copy number variations analysis in 64 patients with unexplained intellectual disability
Chunyun FU ; Xin FAN ; Shiyu LUO ; Jiasun SU ; Yiping SHEN ; Yue ZHANG ; Shujie ZHANG ; Xuyun HU ; Rongyu CHEN ; Jingsi LUO ; Chuan LI ; Shaoke CHEN
Chinese Journal of Applied Clinical Pediatrics 2017;32(12):924-927
Objective To investigate the genetic basis of patients with intellectual disability,and to assess the application of single nucleotide polymorphisms (SNP)-array in the molecular diagnosis of intellectual disability.Methods Sixty-four patients with intellectual disability who were identified in Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region from January 2013 to June of 2015 were enrolled.Genomic DNA was extracted from peripheral blood and was analyzed with Illumina Humancyto SNP-12 300K gene array chip.All identified copy number variants (CNVs) were analyzed with references from databases such as ClinVar,DECIPHER,OMIM and DGV(Database of Genomic Variants),as well as comprehensive literature review from PubMed database to determine the pathogenicity of CNVs.Results Sixteen cases of the above 64 patients were found to have CNVs with genomic alterations,including 6 cases microdeletions/microduplications associated with known syndromes,3 cases microdeletions and microduplications with clear clinical relevance (non-syndrome),1 case numerical chromosome aberration,1 case unbalanced translocation and 5 cases CNVs of unknown clinical significance.The detection rate was 25% (16/64 cases).Among these 16 abnormalities,6 cases of them could not be detected by using karyotyping analysis because their sizes were less than 5 Mb,and the smallest detected missing fragment was 0.53 Mb.Conclusion SNP-array gene chip technique with the advantages of higher efficiency,high-resolution and good accuracy,which can be applied to the genetic diagnosis of intellectual disability.
8.Gene array analysis in 56 cases of children with growth retardation
Chunyun FU ; Shaoke CHEN ; Rongyu CHEN ; Xin FAN ; Jingsi LUO ; Chuan LI
Journal of Clinical Pediatrics 2014;(12):1119-1121
Objective To investigate the genetic basis of the children with growth retardation. Methods From January to October 2013, the 56 patients with growth retardation were enrolled in this study. Genomic DNA was extracted from peripheral blood and was analyzed with gene array chips. Results Abnormalities were found in 12 patients (6 cases of sex chromosome abnormalities and 6 cases of autosomal aberration) and the detection rate was 21.4%. Four patients had the copy-number variations of smaller than 2.5Mb in size which could not be found by karyotyping analysis. Conclusions SNP-array gene chip could be used in the genetic diagnosis of growth retardation.

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