1.Development, reliability, and validity of a treatment-related quality of life scale for Chinese patients with multiple myeloma
Chunyan SUN ; Zhen CAI ; Bing CHEN ; Lijuan CHEN ; Wenming CHEN ; Kaiyang DING ; Juan DU ; Rong FU ; Chengcheng FU ; Da GAO ; Guangxun GAO ; Yanjuan HE ; Jian HOU ; Ming JIANG ; Fei LI ; Jian LI ; Juan LI ; Zhenyu LI ; Aijun LIAO ; Jing LIU ; Jun LUO ; Jianmin LUO ; Yanping MA ; Jianqing MI ; Ting NIU ; Hongling PENG ; Yongping SONG ; Luqun WANG ; Rong ZHAN ; Xi ZHANG ; Yu HU
Chinese Journal of Hematology 2025;46(8):713-721
Objective:To develop a treatment-related quality of life scale for Chinese patients with multiple myeloma (MM) and to test its reliability and validity.Methods:The initial scale was constructed through a literature search, Delphi expert correspondence, and cognitive testing. This study conducted a preliminary survey of 379 patients with MM and a formal survey of 865 patients from the hematology departments of 155 hospitals nationwide from February 2024 to March 2024. The final scale was obtained after conducting item analysis and reliability and validity tests on the initial scale.Results:The constructed scale contains 36 items covering six domains: physiological, psychological, social, treatment side effects, general health, and others. In the preliminary survey, the Cronbach’s alpha coefficient of each item ranged from 0.597 to 0.939, and the test-retest reliability was 0.747 ( P<0.001). Exploratory factor analysis extracted eight common factors with a cumulative variance contribution of 60.058%. In the formal survey, the Cronbach’s alpha coefficient of each item ranged from 0.484 to 0.930, and the test-retest reliability was 0.835 ( P<0.001). Confirmatory factor analysis revealed a comparative fit index of 0.750, a root-mean-square error of approximation of 0.090, and a root-mean-square residual of 0.067. Conclusion:The treatment-related quality of life scale for Chinese patients with MM designed in this study exhibited good reliability and validity, reflecting the impact of treatment on the quality of life of patients. This scale can provide a reference to clinicians for assessing the disease status of patients.
2.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
3.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
4.Development, reliability, and validity of a treatment-related quality of life scale for Chinese patients with multiple myeloma
Chunyan SUN ; Zhen CAI ; Bing CHEN ; Lijuan CHEN ; Wenming CHEN ; Kaiyang DING ; Juan DU ; Rong FU ; Chengcheng FU ; Da GAO ; Guangxun GAO ; Yanjuan HE ; Jian HOU ; Ming JIANG ; Fei LI ; Jian LI ; Juan LI ; Zhenyu LI ; Aijun LIAO ; Jing LIU ; Jun LUO ; Jianmin LUO ; Yanping MA ; Jianqing MI ; Ting NIU ; Hongling PENG ; Yongping SONG ; Luqun WANG ; Rong ZHAN ; Xi ZHANG ; Yu HU
Chinese Journal of Hematology 2025;46(8):713-721
Objective:To develop a treatment-related quality of life scale for Chinese patients with multiple myeloma (MM) and to test its reliability and validity.Methods:The initial scale was constructed through a literature search, Delphi expert correspondence, and cognitive testing. This study conducted a preliminary survey of 379 patients with MM and a formal survey of 865 patients from the hematology departments of 155 hospitals nationwide from February 2024 to March 2024. The final scale was obtained after conducting item analysis and reliability and validity tests on the initial scale.Results:The constructed scale contains 36 items covering six domains: physiological, psychological, social, treatment side effects, general health, and others. In the preliminary survey, the Cronbach’s alpha coefficient of each item ranged from 0.597 to 0.939, and the test-retest reliability was 0.747 ( P<0.001). Exploratory factor analysis extracted eight common factors with a cumulative variance contribution of 60.058%. In the formal survey, the Cronbach’s alpha coefficient of each item ranged from 0.484 to 0.930, and the test-retest reliability was 0.835 ( P<0.001). Confirmatory factor analysis revealed a comparative fit index of 0.750, a root-mean-square error of approximation of 0.090, and a root-mean-square residual of 0.067. Conclusion:The treatment-related quality of life scale for Chinese patients with MM designed in this study exhibited good reliability and validity, reflecting the impact of treatment on the quality of life of patients. This scale can provide a reference to clinicians for assessing the disease status of patients.
5.Application of Artificial Intelligence in Sperm Quality Analysis and Sperm Screening
Jiyun PANG ; Wei HOU ; Yuxiang NONG ; Ang BIAN ; Wenming XU
Journal of Sichuan University (Medical Sciences) 2024;55(5):1322-1328
Infertility is a global health issue,and more and more people are hoping to have babies by means of assisted reproductive technology.However,there are still many challenges in fertilization and pregnancy outcomes.Sperm quality is a key factor affecting the success rate of assisted reproduction.Therefore,sperm quality screening is crucial for achieving breakthroughs in assisted reproduction technology.At present,with its capabilities in the field of image recognition,artificial intelligence(AI)is providing new ideas and methods for sperm screening.Various attempts have been made with AI-based models to evaluate indicators such as sperm morphology,DNA quality,and motility level,and some results have been achieved.Herein,we reviewed the application of AI in sperm quality analysis and selection,providing support for the future development of AI and the improvement in the fertilization rate and outcomes of assisted reproductive technology.
6.Current status and future perspectives of left ventricular assist devices
Yi WANG ; Zijun LI ; Jie YI ; Hao LI ; Ming CHEN ; Wenming HOU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(11):1670-1678
The implantation of a left ventricular assist device (LVAD) is an important therapeutic tool for patients with end-stage heart failure, which can either help patients transit to the heart transplantation stage or serve as destination therapy until the end of their lives. In recent years, the third generation of LVAD has evolved rapidly and several brands have been marketed both domestically and internationally. The number of LVAD implantations has been increasing and the long-term survival rate of implanted patients has improved, so this device has a broad development perspective. This article summarizes the current status, usage standards and precautions, and common complications after implantation of LVAD, as well as looks forward to the future development of LVAD, hoping to be helpful for researchers who are new to this field.
7.An evidence-based clinical guideline for the treatment of infectious bone defect with induced membrane technique (version 2023)
Jie SHEN ; Lin CHEN ; Shiwu DONG ; Jingshu FU ; Jianzhong GUAN ; Hongbo HE ; Chunli HOU ; Zhiyong HOU ; Gang LI ; Hang LI ; Fengxiang LIU ; Lei LIU ; Feng MA ; Tao NIE ; Chenghe QIN ; Jian SHI ; Hengsheng SHU ; Dong SUN ; Li SUN ; Guanglin WANG ; Xiaohua WANG ; Zhiqiang WANG ; Hongri WU ; Junchao XING ; Jianzhong XU ; Yongqing XU ; Dawei YANG ; Tengbo YU ; Zhi YUAN ; Wenming ZHANG ; Feng ZHAO ; Jiazhuang ZHENG ; Dapeng ZHOU ; Chen ZHU ; Yueliang ZHU ; Zhao XIE ; Xinbao WU ; Changqing ZHANG ; Peifu TANG ; Yingze ZHANG ; Fei LUO
Chinese Journal of Trauma 2023;39(2):107-120
Infectious bone defect is bone defect with infection or as a result of treatment of bone infection. It requires surgical intervention, and the treatment processes are complex and long, which include bone infection control,bone defect repair and even complex soft tissue reconstructions in some cases. Failure to achieve the goals in any step may lead to the failure of the overall treatment. Therefore, infectious bone defect has been a worldwide challenge in the field of orthopedics. Conventionally, sequestrectomy, bone grafting, bone transport, and systemic/local antibiotic treatment are standard therapies. Radical debridement remains one of the cornerstones for the management of bone infection. However, the scale of debridement and the timing and method of bone defect reconstruction remain controversial. With the clinical application of induced membrane technique, effective infection control and rapid bone reconstruction have been achieved in the management of infectious bone defect. The induced membrane technique has attracted more interests and attention, but the lack of understanding the basic principles of infection control and technical details may hamper the clinical outcomes of induced membrane technique and complications can possibly occur. Therefore, the Chinese Orthopedic Association organized domestic orthopedic experts to formulate An evidence-based clinical guideline for the treatment of infectious bone defect with induced membrane technique ( version 2023) according to the evidence-based method and put forward recommendations on infectious bone defect from the aspects of precise diagnosis, preoperative evaluation, operation procedure, postoperative management and rehabilitation, so as to provide useful references for the treatment of infectious bone defect with induced membrane technique.
8.Fingerprint establishment of Huangqin decoction and study on spectrum-effect relationship of its antidermatophytic activity in different phase states
Chengying SHEN ; Wenming WU ; Xiongjun HOU ; Fengyi DENG ; Jie HE ; Jianxin HU
China Pharmacy 2023;34(6):687-692
OBJECTIVE To establish the fingerprint of Huangqin decoction (HQD), to separate the phase states and screen the active phase states of antidermatophytic activity so as to study the spectrum-effect relationship. METHODS HPLC method was adopted using baicalin as reference, the fingerprints of 10 batches of HQD were drawn and the similarity evaluation was carried out using the Similarity Evaluation System of Chromatographic Fingerprint of TCM (2012 edition) to determine the common peak; the phase states of HQD were separated and characterized by high-speed centrifugation and membrane dialysis. The minimum inhibitory concentrations (MIC) of HQD and its different phase states against Trichophyton mentagrophytes were determined simultaneously. Using the peak area of 37 common peaks as independent variable, MIC as dependent variable, Pearson correlation analysis was performed by using SPSS 21.0 software. RESULTS A total of 37 common peaks were obtained in HPLC fingerprints of 10 batches of HQD, with the similarity higher than 0.99. Ten components were identified, such as albiflorin, paeoniflorin, liquiritin apioside, baicalin, melaleuca glycoside A, wogonoside, baicalein, glycyrrhizic acid, wogonin and oroxylin A. HQD was split into 3 phase states, such as precipitation phase (HQD-P), solution phase (HQD-S) and nano phase (HQD-N). The morphology of HQD-P was irregular granular, and the average particle size was 4.670-91.522 μm. The morphology of HQD-S was uniform flakes, and no particle size was detected. HQD-N was spherical in shape and the particle size was (129.0±12.9) nm. MIC values of each phase state of HQD against T. mentagrophytes in different phase states were HQD-N (4.64 mg/mL) <HQD (5.85 mg/mL) <HQD-P (7.37 mg/mL) <HQD-S (12.89 mg/mL) at the same dosage. Pearson correlation analysis showed that the peak area of 25 of the 37 common peaks (including identified components) was significantly negatively correlated with MIC (absolute values of correlation coefficient>0.95 and P<0.05). CONCLUSIONS The chemical composition of 10 batches of HQD is consistent; HQD-N is the active phase state of HQD. Ten components such as paeoniflorin, liquiritin apioside and baicalin may be the main active components of HQD. The antidermatophytic effect of HQD is closely related to its component content and physical phase state.
9.Ongoing Positive Selection Drives the Evolution of SARS-CoV-2 Genomes
Hou YALI ; Zhao SHILEI ; Liu QI ; Zhang XIAOLONG ; Sha TONG ; Su YANKAI ; Zhao WENMING ; Bao YIMING ; Xue YONGBIAO ; Chen HUA
Genomics, Proteomics & Bioinformatics 2022;(6):1214-1223
SARS-CoV-2 is a new RNA virus affecting humans and spreads extensively throughout the world since its first outbreak in December,2019.Whether the transmissibility and pathogenicity of SARS-CoV-2 in humans after zoonotic transfer are actively evolving,and driven by adaptation to the new host and environments is still under debate.Understanding the evolutionary mechanism underlying epidemiological and pathological characteristics of COVID-19 is essential for predicting the epidemic trend,and providing guidance for disease control and treatments.Interrogating novel strategies for identifying natural selection using within-species polymorphisms and 3,674,076 SARS-CoV-2 genome sequences of 169 countries as of December 30,2021,we demonstrate with popula-tion genetic evidence that during the course of SARS-CoV-2 pandemic in humans,1)SARS-CoV-2 genomes are overall conserved under purifying selection,especially for the 14 genes related to viral RNA replication,transcription,and assembly;2)ongoing positive selection is actively driving the evolution of 6 genes(e.g.,S,ORF3a,and N)that play critical roles in molecular processes involving pathogen-host interactions,including viral invasion into and egress from host cells,and viral inhi-bition and evasion of host immune response,possibly leading to high transmissibility and mild symptom in SARS-CoV-2 evolution.According to an established haplotype phylogenetic relation-ship of 138 viral clusters,a spatial and temporal landscape of 556 critical mutations is constructed based on their divergence among viral haplotype clusters or repeatedly increase in frequency within at least 2 clusters,of which multiple mutations potentially conferring alterations in viral transmis-sibility,pathogenicity,and virulence of SARS-CoV-2 are highlighted,warranting attention.
10.Mid-term efficacy of Waveflex semi-rigid internal fixation system in the treatment of lumbar degenerative diseases
Kaiying CUI ; Wenming CHEN ; Guoyan LIU ; Ning YU ; Pengfei HOU ; Zhenyue ZHANG ; Yanke HAO
Chinese Journal of Orthopaedics 2021;41(17):1257-1266
Objective:To investigate the mid-term clinical efficacy and imaging changes of Waveflex semi-rigid internal fixation system combined with posterior lumbar interbody fusion (PLIF) in the treatment of double segmental lumbar degenerative diseases.Methods:The data of 51 patients with lumbar degenerative diseases who underwent surgery from September 2014 to September 2015 were retrospectively analyzed, including 29 males and 22 females, aged 65.5±5.6 years (range 58-73 years). Preoperative intervertebral space degeneration grade by University of California at Los Angeles (UCLA) and Pfirrmann intervertebral disc degeneration grade were recorded. 23 cases of primary responsible segments were treated with decompression, fixation and fusion, and adjacent secondary responsible or degenerative segments were treated with Waveflex semi-rigid internal fixation (combined group); 28 cases of double segments were treated with decompression, fixation and fusion (fusion group). Disc height index (DHI) and intervertebral foramina height (IFH) of the semi-rigid fixation segments, DHI and IFH of the upper adjacent intervertebral space, and horizontal displacement of the upper adjacent vertebral body (HD) were measured on lateral X-ray films of lumbar spine; In the fusion group, DHI and IFH adjacent to the upper vertebral space and HD adjacent to the upper vertebral body were measured. The efficacy was evaluated by short-form McGill Pain Questionnaire (SF-MPQ) and Oswestry disability index (ODI).Results:51 cases were followed up for 5.4±0.3 years (range 5.2-6.3 years). The low back and leg pain and function in the combined group and fusion group were significantly improved compared with those before operation. SF-MPQ and ODI at 3 months, 1 year, 5 years after operation were significantly different from those before operation ( P<0.05). In the combined group, the DHI of semi-rigid internal fixation segments before operation and 3 months, 1 year, 5 years after operation were 37.8%±7.6%, 37.9%±7.4%, 36.5%±6.9% and 36.0%±7.1% respectively ( P>0.05); The IFH of semi-rigid internal fixation segments before operation and 3 months, 1 year, 5 years after operation were 21.5±2.8, 21.4±2.8, 20.4±2.7, 19.4±2.4 mm respectively ( P<0.05); The DHI of the upper segment adjacent to semi-rigid internal fixation before operation and 3 months, 1 year, 5 years after operation were 37.1%±9.3%, 36.8%±9.1%, 35.2%±9.1%, 33.9%±8.8% respectively ( P>0.05); The IFH of the upper segment adjacent to semi-rigid internal fixation before operation and 3 months, 1 year, 5 years after operation were 21.9±3.0, 21.4±3.0, 20.4±2.9, 19.5±2.7 mm, respectively ( P<0.05). The HD of upper vertebral body adjacent to semi-rigid internal fixation before operation and 3 months, 1 year, 5 years after operation were 2.2±0.7, 2.3±0.5, 2.5±0.5, 2.8±0.5 mm respectively ( P<0.05). At the last follow-up, one case of semi-rigid titanium rod fracture, one case of screw loosening at semi-rigid internal fixation segment, three cases with unsatisfied numbness relief, and 2 cases of facet joint spontaneous fusion at semi-rigid fixation segment occurred in the combined group. Conclusion:Waveflex semi-rigid internal fixation can protect the degenerative lumbar intervertebral disc, and delay the degeneration of semi-rigid internal fixation segment and adjacent upper segment after interbody fusion, but long-term follow-up and study are needed.

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