1.Processing technology of calcined Magnetitum based on concept of QbD and its XRD characteristic spectra.
De-Wen ZENG ; Jing-Wei ZHOU ; Tian-Xing HE ; Yu-Mei CHEN ; Huan-Huan XU ; Jian FENG ; Yue YANG ; Xin CHEN ; Jia-Liang ZOU ; Lin CHEN ; Hong-Ping CHEN ; Shi-Lin CHEN ; Yuan HU ; You-Ping LIU
China Journal of Chinese Materia Medica 2025;50(9):2391-2403
Guided by the concept of quality by design(QbD), this study optimizes the calcination and quenching process of calcined Magnetitum and establishes the XRD characteristic spectra of calcined Magnetitum, providing a scientific basis for the formulation of quality standards. Based on the processing methods and quality requirements of Magnetitum in the Chinese Pharmacopoeia, the critical process parameters(CPPs) identified were calcination temperature, calcination time, particle size, laying thickness, and the number of vinegar quenching cycles. The critical quality attributes(CQAs) included Fe mass fraction, Fe~(2+) dissolution, and surface color. The weight coefficients were determined by combining Analytic Hierarchy Process(AHP) and the criteria importance though intercrieria correlation(CRITIC) method, and the calcination process was optimized using orthogonal experimentation. Surface color was selected as a CQA, and based on the principle of color value, the surface color of calcined Magnetitum was objectively quantified. The vinegar quenching process was then optimized to determine the best processing conditions. X-ray diffraction(XRD) was used to establish the characteristic spectra of calcined Magnetitum, and methods such as similarity evaluation, cluster analysis, and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to evaluate the quality of the spectra. The optimized calcined Magnetitum preparation process was found to be calcination at 750 ℃ for 1 h, with a laying thickness of 4 cm, a particle size of 0.4-0.8 cm, and one vinegar quenching cycle(Magnetitum-vinegar ratio 10∶3), which was stable and feasible. The XRD characteristic spectra analysis method, featuring 9 common peaks as fingerprint information, was established. The average correlation coefficient ranged from 0.839 5-0.988 1, and the average angle cosine ranged from 0.914 4 to 0.995 6, indicating good similarity. Cluster analysis results showed that Magnetitum and calcined Magnetitum could be grouped together, with similar compositions. OPLS-DA discriminant analysis identified three key characteristic peaks, with Fe_2O_3 being the distinguishing component between the two. The final optimized processing method is stable and feasible, and the XRD characteristic spectra of calcined Magnetitum was initially established, providing a reference for subsequent quality control and the formulation of quality standards for calcined Magnetitum.
X-Ray Diffraction/methods*
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Drugs, Chinese Herbal/chemistry*
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Quality Control
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Particle Size
2.Relationships of C-reactive protein,procalcitonin and neutrophil-to-lymphocyte ratio with prognosis in neonates with respiratory distress syndrome of different etiologies
Zhenzhu MEI ; Hong XU ; Yingying LI ; Jinqiu ZHANG ; Rui ZHANG ; Qiaoqiao ZOU
Journal of Clinical Medicine in Practice 2025;29(14):75-79,87
Objective To investigate correlations of dynamic changes in serum C-reactive pro-tein(CRP),procalcitonin(PCT),and neutrophil-to-lymphocyte ratio(NLR)before and after symptomatic treatment with prognosis of neonates with neonatal respiratory distress syndrome(NRDS)of different etiologies.Methods A total of 110 premature infants were selected as study subjects and divided into neonatal infection group(group A)and fetal intrauterine distress group(group B)based on different causes of NRDS.Additionally,30 neonates with NRDS caused solely by prematurity were selected as control group.Serum CRP and PCT levels and NLR were compared among the three groups before and after treatment.Results There were statistically significant differences in oxygen therapy duration,ventilation duration,the proportion of infants requiring re-intubation,hospital stay,and the number of apnea episodes among three groups(P<0.006).Before treatment,there was no sta-tistically significant difference in serum CRP levels between group A and group B(P>0.05).Ser-um CRP levels in group B were higher than those in the control group.Moreover,serum PCT levels was lower than the group A,and NLR in the group B were higher than those in the group A and the control group.CRP,PCT levels,and NLR in the group A were higher than those in the control group(P<0.05 or P<0.006).After treatment,serum CRP levels in all three groups decreased compared to before treatment.Serum PCT levels in the group A decreased compared to before treat-ment.NLR in both group A and group B decreased compared to before treatment,with statistically significant differences(P<0.006).There were statistically significant differences in serum CRP and PCT levels between the group A and the control group after treatment(P<0.006).After treat-ment,there was a statistically significant difference in serum CRP levels between the group B and the control group(P<0.006),but no statistically significant differences in PCT levels and NLR(P>0.05).Compared with group A,there was a statistically significant difference in PCT levels in the group B(P<0.006).Multivariate Logistic regression results showed that CRP,PCT,and NLR were independent influencing factors for the prognosis of infants in the group A.The receiver operat-ing characteristic curve analysis results showed that the areas under the curve(AUC)after treatment for serum CRP,PCT,and NLR alone in predicting prognosis in the group A were 0.789,0.738,and 0.758,respectively,and the AUC for combined prediction was 0.934.In the group B,the AUC for serum CRP,PCT,and NLR alone in predicting prognosis after treatment were 0.719,0.772,and 0.768,respectively,and the AUC for combined prediction was 0.886.The sensitivity and specificity of combined prediction in both groups were higher than those of each indicator alone,and the predictive value of their combined detection for the prognosis of premature infants in group A was higher than that in the group B.Conclusion There are differences in PCT levels and NLR before treatment among neonates with NRDS of different etiologies.After symptomatic treatment,CRP,PCT levels and NLR decrease in all three groups,indicating a good prognosis.
3.Chinese expert consensus on integrated case management by a multidisciplinary team in CAR-T cell therapy for lymphoma.
Sanfang TU ; Ping LI ; Heng MEI ; Yang LIU ; Yongxian HU ; Peng LIU ; Dehui ZOU ; Ting NIU ; Kailin XU ; Li WANG ; Jianmin YANG ; Mingfeng ZHAO ; Xiaojun HUANG ; Jianxiang WANG ; Yu HU ; Weili ZHAO ; Depei WU ; Jun MA ; Wenbin QIAN ; Weidong HAN ; Yuhua LI ; Aibin LIANG
Chinese Medical Journal 2025;138(16):1894-1896
4.Regulated cell death in age-related macular degeneration: Regulatory mechanisms and therapeutic potential.
Le-Le ZHANG ; Jia-Mei YU ; Zhong-Xi FAN ; Wen-Qi XIE ; Liang ZOU ; Feiya SHENG
Journal of Pharmaceutical Analysis 2025;15(11):101285-101285
Age-related macular degeneration (AMD) represents a predominant cause of blindness among older adults, with limited therapeutic options currently available. Oxidative stress, inflammation, and retinal pigment epithelium injury are recognized as key contributors to the pathogenesis of AMD. Regulated cell death plays a pivotal role in mediating cellular responses to stress, maintaining tissue homeostasis, and contributing to disease progression. Recent research has elucidated several regulated cell death pathways-such as apoptosis, ferroptosis, pyroptosis, necroptosis, and autophagy-that may contribute to the progression of AMD owing to cell death in the retinal pigment epithelium. These discoveries open new avenues for therapeutic interventions in patients with AMD. In this review, we provide a comprehensive summary and analysis of the latest advancements regarding the relationship between regulated cell death and AMD. Moreover, we examined the therapeutic potential of targeting regulated cell death pathways for the treatment and prevention of AMD, highlighting their roles as promising targets for future therapeutic strategies.
5.Repair effects of tauroursodeoxycholic acid in combination use with bone marrow mesenchymal stem cells transplantation on a rat model of spinal cord injury
Ya-qian WEN ; Chao-lun LIANG ; Kun-rui ZHENG ; Dian-weng XIE ; Hai-mei YANG ; Meng-di ZOU ; Da GUO ; Xing LI
Chinese Traditional Patent Medicine 2025;47(1):66-72
AIM To investigate the repair effects of tauroursodeoxycholic acid(TUDCA)combined with bone marrow mesenchymal stem cells(BMSCs)transplantation on spinal cord injury(SCI)in rats.METHODS The rats were randomly divided into the sham operation group,the model group,the TUDCA group,the BMSCs transplantation group and the combination therapy of TUDCA and BMSCs transplantation group,with the SCI rat model established by Allen's method.The next day after modeling,the rats of TUDCA and combination therapy groups were given 200 mg/kg TUDCA by gavage.On the 3rd day after modeling,rats in BMSCs transplantation group and combination therapy group were injected with 1 mL tuned bone marrow BMSCs(the 3rd generation,1× 106/mL)via tail vein.Rats in the sham operation group and the model group were given gastric perfusion of normal saline and injection of 1 mL PBS through tail vein.On the 3rd,7th and 14th day after modeling,the rats had their motor function of hind limbs observed and BBB score determined.After the corresponding drug administration,the rats had their movement track of hind limbs recorded by footprint experiment;their the protein expressions of IL-6,IL-10,Arg-1,PI3K and Akt in spinal cord tissue detected by Western blot;their pathological changes of spinal cord tissue observed by HE staining and Nissl staining;and their expressions of MAP2,GAP43 and GFAP detected by immunofluorescence staining.RESULTS Compared with the model group,the groups intervened with TUDCA,or BMSCs transplantation,or combination therapy shared improved hind limb function and spinal cord histomorphology(P<0.05);increased fluorescence intensity of MAP2 and GAP43,and protein expressions of IL-10,Arg-1,p-PI3K and p-Akt(P<0.05);decreased fluorescence intensity of GFAP and IL-6 protein expressions(P<0.05);among which the combination therapy group took the lead(P<0.05).CONCLUSION The combination therapy of TUDCA and BMSCs transplantation may restore the function of the rat model of SCI by reducing inflammatory reaction,alleviating secondary injury,and promoting axon and myelin regeneration via PI3K/Akt signaling pathway.
6.Changing prevalence and antibiotic resistance profiles of carbapenem-resistant Enterobacterales in hospitals across China:data from CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Wenxiang JI ; Tong JIANG ; Jilu SHEN ; Yang YANG ; Fupin HU ; Demei ZHU ; Yuanhong XU ; Ying HUANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yingchun XU ; Xiaojiang ZHANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Hong ZHANG ; Chun WANG ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2025;25(4):445-454
Objective To summarize the changing prevalence of carbapenem resistance in Enterobacterales based on the data of CHINET Antimicrobial Resistance Surveillance Program from 2015 to 2021 for improving antimicrobial treatment in clinical practice.Methods Antimicrobial susceptibility testing was performed using a commercial automated susceptibility testing system according to the unified CHINET protocol.The results were interpreted according to the breakpoints of the Clinical & Laboratory Standards Institute(CLSI)M100 31st ed in 2021.Results Over the seven-year period(2015-2021),the overall prevalence of carbapenem-resistant Enterobacterales(CRE)was 9.43%(62 342/661 235).The prevalence of CRE strains in Klebsiella pneumoniae,Citrobacter freundii,and Enterobacter cloacae was 22.38%,9.73%,and 8.47%,respectively.The prevalence of CRE strains in Escherichia coli was 1.99%.A few CRE strains were also identified in Salmonella and Shigella.The CRE strains were mainly isolated from respiratory specimens(44.23±2.80)%,followed by blood(20.88±3.40)%and urine(18.40±3.45)%.Intensive care units(ICUs)were the major source of the CRE strains(27.43±5.20)%.CRE strains were resistant to all the β-lactam antibiotics tested and most non-β-lactam antimicrobial agents.The CRE strains were relatively susceptible to tigecycline and polymyxins with low resistance rates.Conclusions The prevalence of CRE strains was increasing from 2015 to 2021.CRE strains were highly resistant to most of the antibacterial drugs used in clinical practice.Clinicians should prescribe antimicrobial agents rationally.Hospitals should strengthen antibiotic stewardship in key clinical settings such as ICUs,and take effective infection control measures to curb CRE outbreak and epidemic in hospitals.
7.Changing distribution and antibiotic resistance profiles of the respiratory bacterial isolates in hospitals across China:data from CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Ying FU ; Yunsong YU ; Jie LIN ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE ; Wenhui HUANG
Chinese Journal of Infection and Chemotherapy 2025;25(4):431-444
Objective To characterize the changing species distribution and antibiotic resistance profiles of respiratory isolates in hospitals participating in the CHINET Antimicrobial Resistance Surveillance Program from 2015 to 2021.Methods Commercial automated antimicrobial susceptibility testing systems and disk diffusion method were used to test the susceptibility of respiratory bacterial isolates to antimicrobial agents following the standardized technical protocol established by the CHINET program.Results A total of 589 746 respiratory isolates were collected from 2015 to 2021.Overall,82.6%of the isolates were Gram-negative bacteria and 17.4%were Gram-positive bacteria.The bacterial isolates from outpatients and inpatients accounted for(6.0±0.9)%and(94.0±0.1)%,respectively.The top microorganisms were Klebsiella spp.,Acinetobacter spp.,Pseudomonas aeruginosa,Staphylococcus aureus,Haemophilus spp.,Stenotrophomonas maltophilia,Escherichia coli,and Streptococcus pneumoniae.Each microorganism was isolated from significantly more males than from females(P<0.05).The overall prevalence of methicillin-resistant S.aureus(MRSA)was 39.9%.The prevalence of penicillin-resistant S.pneumoniae was 1.4%.The prevalence of extended-spectrum β-lactamase(ESBL)-producing E.coli and K.pneumoniae was 67.8%and 41.3%,respectively.The overall prevalence of carbapenem-resistant E.coli,K.pneumoniae,Enterobacter cloacae,Pseudomonas aeruginosa,and Acinetobacter baumannii was 3.7%,20.8%,9.4%,29.8%,and 73.3%,respectively.The prevalence of β-lactamase was 96.1%in Moraxella catarrhalis and 60.0%in Haemophilus influenzae.The H.influenzae isolates from children(<18 years)showed significantly higher resistance rates to β-lactam antibiotics than the isolates from adults(P<0.05).Conclusions Gram-negative bacteria are still predominant in respiratory isolates associated with serious antibiotic resistance.Antimicrobial resistance surveillance should be strengthened in clinical practice to support accurate etiological diagnosis and appropriate antimicrobial therapy based on antimicrobial susceptibility testing results.
8.Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique (version 2025)
Sihao HE ; Junchao XING ; Tongwei CHU ; Zhengqi CHANG ; Xigao CHENG ; Fei DAI ; Xiaobing JIANG ; Jie HAO ; Jiang HU ; Jinghui HUANG ; Tianyong HOU ; Fei LUO ; Bo LIAO ; Changqing LI ; Lei LIU ; Guodong LIU ; Peng LIU ; Sheng LU ; Weishi LI ; Yang LIU ; Zhen LIU ; Wei MEI ; Peifu TANG ; Bing WANG ; Bing WANG ; Ce WANG ; Hongli WANG ; Liang WANG ; Shengru WANG ; Xiaobin WANG ; Yang WANG ; Yingfeng WANG ; Zheng WANG ; Jianzhong XU ; Guoyong YIN ; Haiyang YU ; Qiang YANG ; Zhaoming YE ; Bin ZHANG ; Chengmin ZHANG ; Jun ZOU ; Qiang ZHOU ; Min ZHAO ; Rui ZHOU ; Xiaojun ZHANG ; Yongfei ZHAO ; Zhongrong ZHANG ; Zehua ZHANG ; Yingze ZHANG
Chinese Journal of Trauma 2025;41(11):1035-1047
For middle-aged and elderly patients with conditions such as spinal fractures and degenerative spinal diseases, spinal internal fixation is a core surgical procedure for reconstructing spinal stability, heavily relying on the biomechanical stability provided by pedicle screw systems. Whereas, these patients are often complicated by osteoporosis that can significantly compromise the stability of the bone-pedicle screw interface, leading to a marked increase in pedicle screw loosening and surgical failure rates. The bone cement-augmented pedicle screw technique, which involves injecting bone cement into the vertebral body or screw trajectory to optimize the mechanical properties of the bone-pedicle screw composite, has been proven to significantly enhance fixation strength and effectively prevent screw-related failures, thereby reducing the incidence of internal fixation failure in high-risk populations undergoing spinal fusion. However, the widespread clinical application of this technique has faced challenges such as inaccurate clinical decision-making (indication and contraindication selection), non-standardized operative practices, and insufficient awareness of complication prevention, resulting in considerable variability in clinical outcomes and even severe complications. To address this, Prof. Luo Fei from First Affiliated Hospital of Army Medical University initiated the project and the Chinese Association Orthopaedic Surgeons organized relevant experts to develop the Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique ( version 2025), based on current evidence. The guidelines put forward 8 recommendations regarding the clinical value, scope of application, and operational standards of the technique, aiming to provide evidence-based medical support and technical standardization for clinical decision-making.
9.Clinical Randomized Controlled Trial of Traditional Chinese Medicine Compound Shenlong Decoction Granules in Treatment of Idiopathic Pulmonary Fibrosis
Qi SI ; Ningzi ZANG ; Mei WANG ; Weidong ZHENG ; Chuang LIU ; Yongming LIU ; Haoyang ZHANG ; Zhongxue ZHAO ; Jiyu ZOU ; Jingze LI ; Lijian PANG ; Xiaodong LYU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):237-245
ObjectiveTo assess the therapeutic effectiveness and safety of the traditional Chinese medicine compound Shenlong decoction in addressing the symptoms of pulmonary deficiency and stasis in patients with idiopathic pulmonary fibrosis (IPF). MethodsSixty eligible patients with lung deficiency and collateral stasis syndrome of IPF were randomly assigned to the observation (30 patients) and control groups (30 patients). All patients underwent standard Western medical therapy. Additionally,the observation group received Shenlong decoction granules,while the control group received a placebo. Both treatments were packaged in four doses of 10.5 g each,taken twice daily for three months. The indexes of the patients during the treatment cycle were observed,and the main indexes include traditional Chinese medicine (TCM) syndrome scores and 6 min walk test (6MWT). The secondary indexes include pulmonary function test [actual value/expected value of total lung volume (TLC%),actual value/expected value of vital capacity(FVC%),actual/predicted diffusing capacity of the lung for carbon monoxide(DLCO%),actual/predicted forced expiratory volume in one second (FEV1%),and FEV1/ forced vital capacity (FVC)],blood gas analysis [arterial blood diathesis partial pressure of oxygen (PaO2),partial pressure of carbon dioxide (PaCO2),and arterial oxygen saturation (SaO2)],serum inflammatory factors [transforming growth factor-β1 (TGF-β1),interleukin-4 (IL-4),interleukin-13 (IL-13),interleukin-12 (IL-12),and gamma-interferon (IFN-γ)],and quality of survival evaluation [St George's Respiratory Questionnaire (SGRQ) score]. The patients' clinical manifestations were determined at the end of the treatment, and the occurrence of adverse events was recorded. ResultsA total of 53 patients completed the study,comprising 27 in the control group and 26 in the observation group. Upon completion of the treatment period,the control group achieved a total effective rate of 33.33% (9/27),whereas the observation group demonstrated a total effective rate of 53.85% (14/26),which was statistically superior to the control group (χ2=4.034,P<0.05). After the treatment,the TCM syndrome scores,6MWT,DLCO%,FEV1%,PaO2,PaCO2,TGF-β1,IL-4,IL-13,IL-12,and IFN-γ in the two groups were all significantly improved (P<0.01). Compared with those in the control group after treatment at the same period,the TCM syndrome scores,6MWT,PaO2,and PaCO2 were significantly improved in the observation group after 60 days and 90 days of medication (P<0.01). Three months after the end of medication,the SGRQ score in the observation group showed significant improvement when compared to that in the control group (P<0.05),and no severe adverse events were reported during the follow-up period. ConclusionCompound Shenlong decoction can alleviate clinical symptoms such as shortness of breath and wheezing in patients with lung deficiency and collateral stasis syndrome of IPF,enhance exercise tolerance,improve the quality of life,and have certain potential advantages in improving pulmonary function.
10.Clinical Randomized Controlled Trial of Traditional Chinese Medicine Compound Shenlong Decoction Granules in Treatment of Idiopathic Pulmonary Fibrosis
Qi SI ; Ningzi ZANG ; Mei WANG ; Weidong ZHENG ; Chuang LIU ; Yongming LIU ; Haoyang ZHANG ; Zhongxue ZHAO ; Jiyu ZOU ; Jingze LI ; Lijian PANG ; Xiaodong LYU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):237-245
ObjectiveTo assess the therapeutic effectiveness and safety of the traditional Chinese medicine compound Shenlong decoction in addressing the symptoms of pulmonary deficiency and stasis in patients with idiopathic pulmonary fibrosis (IPF). MethodsSixty eligible patients with lung deficiency and collateral stasis syndrome of IPF were randomly assigned to the observation (30 patients) and control groups (30 patients). All patients underwent standard Western medical therapy. Additionally,the observation group received Shenlong decoction granules,while the control group received a placebo. Both treatments were packaged in four doses of 10.5 g each,taken twice daily for three months. The indexes of the patients during the treatment cycle were observed,and the main indexes include traditional Chinese medicine (TCM) syndrome scores and 6 min walk test (6MWT). The secondary indexes include pulmonary function test [actual value/expected value of total lung volume (TLC%),actual value/expected value of vital capacity(FVC%),actual/predicted diffusing capacity of the lung for carbon monoxide(DLCO%),actual/predicted forced expiratory volume in one second (FEV1%),and FEV1/ forced vital capacity (FVC)],blood gas analysis [arterial blood diathesis partial pressure of oxygen (PaO2),partial pressure of carbon dioxide (PaCO2),and arterial oxygen saturation (SaO2)],serum inflammatory factors [transforming growth factor-β1 (TGF-β1),interleukin-4 (IL-4),interleukin-13 (IL-13),interleukin-12 (IL-12),and gamma-interferon (IFN-γ)],and quality of survival evaluation [St George's Respiratory Questionnaire (SGRQ) score]. The patients' clinical manifestations were determined at the end of the treatment, and the occurrence of adverse events was recorded. ResultsA total of 53 patients completed the study,comprising 27 in the control group and 26 in the observation group. Upon completion of the treatment period,the control group achieved a total effective rate of 33.33% (9/27),whereas the observation group demonstrated a total effective rate of 53.85% (14/26),which was statistically superior to the control group (χ2=4.034,P<0.05). After the treatment,the TCM syndrome scores,6MWT,DLCO%,FEV1%,PaO2,PaCO2,TGF-β1,IL-4,IL-13,IL-12,and IFN-γ in the two groups were all significantly improved (P<0.01). Compared with those in the control group after treatment at the same period,the TCM syndrome scores,6MWT,PaO2,and PaCO2 were significantly improved in the observation group after 60 days and 90 days of medication (P<0.01). Three months after the end of medication,the SGRQ score in the observation group showed significant improvement when compared to that in the control group (P<0.05),and no severe adverse events were reported during the follow-up period. ConclusionCompound Shenlong decoction can alleviate clinical symptoms such as shortness of breath and wheezing in patients with lung deficiency and collateral stasis syndrome of IPF,enhance exercise tolerance,improve the quality of life,and have certain potential advantages in improving pulmonary function.

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