1.Influencing factors for poor prognosis of drug-induced liver injury in Chinese population: a systematic review
Weimei WANG ; Lidan WANG ; Jia MENG ; Ze PING ; Xiaoyan ZHANG
China Pharmacy 2026;37(5):665-669
OBJECTIVE To systematically evaluate the influencing factors affecting the poor prognosis of drug-induced liver injury (DILI) in the Chinese population, and to provide evidence-based support for early identification and interventions of DILI. METHODS Retrieved from PubMed, Medline, Embase, the Cochrane Library, CNKI, Wanfang database, China biomedical medicine database (CBM) and VIP, clinical studies (case-control studies, cohort studies) related to influencing factors for poor prognosis of DILI were collected from inception to May 31, 2025. After literature screening, data extraction and quality evaluation of included studies, meta-analysis was carried out by using RevMan 5.4 software. RESULTS A total of 17 literature were included, involving 4 078 DILI patients, of whom 673 were in the poor prognosis group and 3 405 were in the favorable prognosis group. Meta-analysis showed that history of liver disease (OR=2.47, 95%CI was 1.61-3.78, P <0.001), alcohol drinking history (OR=1.77, 95%CI was 1.22-2.56, P =0.003), Chinese herbal medicine/Chinese patent medicine (OR=1.87, 95%CI was 1.30-2.70, P <0.001), non-hepatocellular injury type (OR=1.70, 95%CI was 1.37-2.10, P <0.001), international normalized ratio (INR) elevated (OR=2.51, 95%CI was 1.97-3.19, P <0.001), and alanine transamine (ALT) elevated (OR=1.27, 95%CI was 1.14-1.41, P <0.001) were risk factors of poor prognosis in DILI. Higher albumin (ALB) level (OR=0.47, 95%CI was 0.39-0.57, P <0.001), elevated prothrombin activity (PTA) (OR=0.88, 95%CI was 0.85-0.91, P <0.001) and more than 2 kinds of hepatoprotective drugs (OR=0.62, 95%CI was 0.41-0.95, P =0.030) were protective factors for poor prognosis of DILI. CONCLUSIONS Patients with alcohol drinking history, history of liver disease, elevated INR, elevated ALT, taking Chinese herbal medicine/Chinese patent medicine, and non-hepatocellular injury type of DILI have a greater risk of poor prognosis, and higher ALB level, higher PTA and more than 2 kinds of hepatoprotective drugs can reduce the risk of poor prognosis of DILI.
2.Effect of Microorganisms on The Spoilage of Donkey Hides From Different Regions
Meng ZHANG ; Qiu-Mei LI ; Jia-Wei KANG ; Jie YU ; Xia LI ; Yue YU
Progress in Biochemistry and Biophysics 2026;53(3):754-766
ObjectiveDonkey hide is the sole legally designated raw material for the preparation of the traditional Chinese medicine Ejiao. The quality stability of donkey hide during preservation directly determines the efficacy and safety of Ejiao. This study focuses on the dynamic succession of microbial communities during the preservation of donkey hides from different origins, aiming to clarify the correlation between microbial biodiversity difference and the degradation profiles of hide collagen and critical biochemical components, thereby providing a theoretical foundation for developing targeted preservation strategies based on microbial regulation. MethodsDonkey hides originating from four different regions were subjected to an accelerated microbial aging assay to simulate the spoilage process. The microbial community succession was analyzed using high-throughput sequencing. Microstructure changes and pore structure characteristics were assessed by scanning electron microscopy and mercury intrusion porosimetry, respectively. Additionally, the content of major components, including lipids, proteins, and sugars were determined by biochemical methods. ResultsAfter 96 h of aging, the collagen fiber structure in Africa donkey hides (ADH) exhibited significant degradation and collapse, followed by Xinjiang donkey hides (XDH). Instead, the microstructure of Dong’e black donkey hides (DDH) and Peru donkey hides (PDH) remained relatively intact. The porosities of DDH, XDH, PDH, and ADH increased from 27.9%, 15.7%, 30.3%, and 46.2% to 36.5%, 52.6%, 42.8%, and 57.7%, respectively, during the aging process, which suggested that the originally compact fiber structure was disrupted by microbial aging. Fourier transform infrared spectrometer analysis revealed the amide bands in XDH exhibited relatively weak intensity, and no collagen amide I band was observed in ADH. Meanwhile, the lipid and protein contents decreased in all four types of donkey hides, indicating that these components served as the primary nutrient sources for the growth of microorganism. Notably, the most severe collagen degradation was observed in XDH and ADH. A substantial increase was detected in the total soluble sugar in PDH aging solution and hydroxyproline in the ADH aging solution, respectively. These results indicated that donkey hides exhibit distinct patterns of structural degradation and nutrient utilization. Furthermore, the viable cells number of donkey hides increased sharply after 48 h of aging. Metagenomic analysis revealed that the relative abundance of Euryarchaeota in ADH, PDH and XDH declining from initial 93.19%, 97.73% and 30.08% to 0.79%, 1.43% and 0.02% after 96 h, respectively. Conversely, a significantly increase was observed in the abundance of Bacillota, with a marked increase in ADH, peaking at 92.75%. Additionally, the abundance of Pseudomonadota in PDH increased from 0.10% to 87.84%, suggesting that Bacillota and Pseudomonadota may be key factors exacerbating donkey hide spoilage. Unlike the other three types of donkey hides, the dominant bacterial phylum in DDH shifted from Pseudomonadota to Bacteroidota, characterized by a substantial abundance increase of Bacteroidota from 0.13% to 44.22%. ConclusionRegional variation in origin significantly influence the microbial aging of donkey hides, leading to distinct patterns of structural deterioration and differential nutrient utilization. Therefore, implementing origin-specific preservation strategies, through the precisely controlling environmental factors to suppress harmful phyla such as Bacillota and Pseudomonadota, is crucial for enhancing the storage quality of donkey hides.
3.Analysis of Volatile Component Variations in Coptidis Rhizoma Processed with Euodiae Fructus Juice by HS-SPME-GC-MS Combined with Chemometrics and ROAV
Lin YAN ; Yun WANG ; Puling LI ; Lingbang MENG ; Zhe JIA ; Ying LI ; Ying LIU ; Min JIN ; Cun ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):218-225
ObjectiveTo analyze the volatile components in raw Coptidis Rhizoma, Euodiae Fructus juice-processed Coptidis Rhizoma (Yuhuanglian), and the processing adjuvant Euodiae Fructus juice, identify marker volatile components in the processed product, and elucidate the material basis changes during the processing with Euodiae Fructus juice. MethodsHeadspace solid-phase microextraction coupled with gas chromatography-quadrupole-time-of-flight mass spectrometry (HS-SPME-GC-Q-TOF-MS) was employed to analyze the volatile components in raw Coptidis Rhizoma, Yuhuanglian, and Euodiae Fructus juice. Chemometric analysis was performed to compare volatile components among samples and screen the marker components. Finally, the relative odor activity value (ROAV) was calculated to investigate odor characteristics. ResultsA total of 127 components were detected, with 27, 75, 84 volatile components identified in Euodiae Fructus juice, raw Coptidis Rhizoma, and Yuhuanglian, respectively. Processing with Euodiae Fructus juice significantly increased the number and content of volatile components. Chemometric analysis revealed significant changes in volatile components among the three sample types, allowing clear discrimination. After processing, 39 components such as methyl octanoate and allyl propionate were introduced, while 34 components including furfural and hexanoic acid increased in content, and 11 components including butyric acid and octanal decreased. Additionally, eight components, including zingiberene, 6-methyl-6-hepten-2-one, and 5-methyl-2-hexanone, were screened as marker components of Yuhuanglian. Moreover, processing enhanced the ROAV values of 2,5-dimethylpyrazine (roasted, nutty, coffee-like aroma), 3-ethylphenol, and guaiacol (smoky, woody aroma). Additionally, it incorporated 1-hepten-3-one from Euodiae Fructus juice and the newly generated 1-hexen-3-one, contributing mushroom and cucumber-like odors. The sensory profile of Yuhuanglian integrated nutty, roasted, smoky, and woody notes with the citrus and fruity aroma originally contributed by octanal. ConclusionThe processing with Euodiae Fructus juice introduced components from adjuvant, significantly altering the volatile component profile and enhancing the sensory odor characteristics of Yuhuanglian. This study provides a valuable reference for exploring the material basis of volatile components and establishing processing specifications for Yuhuanglian.
4.Analysis of Volatile Component Variations in Coptidis Rhizoma Processed with Euodiae Fructus Juice by HS-SPME-GC-MS Combined with Chemometrics and ROAV
Lin YAN ; Yun WANG ; Puling LI ; Lingbang MENG ; Zhe JIA ; Ying LI ; Ying LIU ; Min JIN ; Cun ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):218-225
ObjectiveTo analyze the volatile components in raw Coptidis Rhizoma, Euodiae Fructus juice-processed Coptidis Rhizoma (Yuhuanglian), and the processing adjuvant Euodiae Fructus juice, identify marker volatile components in the processed product, and elucidate the material basis changes during the processing with Euodiae Fructus juice. MethodsHeadspace solid-phase microextraction coupled with gas chromatography-quadrupole-time-of-flight mass spectrometry (HS-SPME-GC-Q-TOF-MS) was employed to analyze the volatile components in raw Coptidis Rhizoma, Yuhuanglian, and Euodiae Fructus juice. Chemometric analysis was performed to compare volatile components among samples and screen the marker components. Finally, the relative odor activity value (ROAV) was calculated to investigate odor characteristics. ResultsA total of 127 components were detected, with 27, 75, 84 volatile components identified in Euodiae Fructus juice, raw Coptidis Rhizoma, and Yuhuanglian, respectively. Processing with Euodiae Fructus juice significantly increased the number and content of volatile components. Chemometric analysis revealed significant changes in volatile components among the three sample types, allowing clear discrimination. After processing, 39 components such as methyl octanoate and allyl propionate were introduced, while 34 components including furfural and hexanoic acid increased in content, and 11 components including butyric acid and octanal decreased. Additionally, eight components, including zingiberene, 6-methyl-6-hepten-2-one, and 5-methyl-2-hexanone, were screened as marker components of Yuhuanglian. Moreover, processing enhanced the ROAV values of 2,5-dimethylpyrazine (roasted, nutty, coffee-like aroma), 3-ethylphenol, and guaiacol (smoky, woody aroma). Additionally, it incorporated 1-hepten-3-one from Euodiae Fructus juice and the newly generated 1-hexen-3-one, contributing mushroom and cucumber-like odors. The sensory profile of Yuhuanglian integrated nutty, roasted, smoky, and woody notes with the citrus and fruity aroma originally contributed by octanal. ConclusionThe processing with Euodiae Fructus juice introduced components from adjuvant, significantly altering the volatile component profile and enhancing the sensory odor characteristics of Yuhuanglian. This study provides a valuable reference for exploring the material basis of volatile components and establishing processing specifications for Yuhuanglian.
5.Influence of pancreatic stent on pancreatitis after endoscopic retrograde cholangiopancreatography in patients with difficult common bile duct intubation
Meng WANG ; Yang YANG ; Hongyu ZHANG ; Xiao WANG ; Jia SHANG ; Jiansheng LI
Journal of Clinical Hepatology 2025;41(9):1877-1882
ObjectiveTo investigate the incidence rate of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in patients with difficult common bile duct intubation undergoing pancreatic duct stenting during surgery, as well as the effect of pancreatic duct stenting in the prevention and treatment of PEP, and to provide a basis for clinical treatment. MethodsA retrospective analysis was performed for the clinical data of 186 patients with biliary tract disease who underwent initial ERCP and had difficult common bile duct intubation in The First Affiliated Hospital of Zhengzhou University from January 2016 to December 2024, and according to the condition of pancreatic duct stenting, the patients were divided into control group with 73 patients (without pancreatic duct stenting), 5Fr-5 cm stent group with 67 patients, and 7Fr-5 cm stent group with 46 patients. The three groups were compared in terms of baseline data, intraoperative procedures, and postoperative outcomes. A one-way analysis of variance was used for comparison of normally distributed continuous data between multiple groups, and the least significant difference t-test was used for further comparison between two groups; the Kruskal-Wallis H rank sum test was used for comparison of non-normally distributed continuous data between multiple groups, and the Dunn method was used for further comparison between two groups; the chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups. The Logistic regression analysis was used to investigate the influencing factors for PEP in patients with difficult intubation during ERCP. ResultsThe overall incidence rate of PEP was 12.37% (23/186). Compared with the 5Fr-5 cm stent group and the 7Fr-5 cm stent group, the control group had a significantly higher incidence rate of PEP, a significantly higher score of postoperative abdominal pain, and a significantly longer length of postoperative hospital stay (all P0.01), and 55.56% of the patients in the control group had moderate-to-severe PEP. The univariate Logistic regression analysis showed that intradiverticular papilla, double guide wire intubation, needle knife precut, the application of basket and balloon for removal of common bile duct stones, intraoperative biopsy, pancreatic duct stenting, intubation time≤10 minutes, frequency of intubation≤5 times, preoperative CRP≤5 mg/L were influencing factors for PEP (all P0.05), and the multivariate Logistic regression analysis showed that intraoperative pancreatic duct stenting, needle knife precut, and intraoperative biopsy were independent influencing factors for the onset of PEP (all P0.05). ConclusionPancreatic duct stenting during ERCP can effectively reduce the risk of PEP in patients with difficult intubation, while needle knife precut and intraoperative biopsy can increase the risk of PEP in patients with difficult intubation.
6.Programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in patients with advanced non-small cell lung cancer: A retrospective, multicenter, observational study.
Yuequan SHI ; Xiaoyan LIU ; Anwen LIU ; Jian FANG ; Qingwei MENG ; Cuimin DING ; Bin AI ; Yangchun GU ; Cuiying ZHANG ; Chengzhi ZHOU ; Yan WANG ; Yongjie SHUI ; Siyuan YU ; Dongming ZHANG ; Jia LIU ; Haoran ZHANG ; Qing ZHOU ; Xiaoxing GAO ; Minjiang CHEN ; Jing ZHAO ; Wei ZHONG ; Yan XU ; Mengzhao WANG
Chinese Medical Journal 2025;138(14):1730-1740
BACKGROUND:
This study aimed to investigate programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in treating patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting.
METHODS:
This retrospective, multicenter, observational study enrolled adult patients who received PD-1/PD-L1 antibody-based therapy in China and met the following criteria: (1) had pathologically confirmed, unresectable stage III-IV NSCLC; (2) had a baseline PD-L1 tumor proportion score (TPS); and (3) had confirmed efficacy evaluation results after PD-1/PD-L1 treatment. Logistic regression, Kaplan-Meier analysis, and Cox regression were used to assess the progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) as appropriate.
RESULTS:
A total of 409 patients, 65.0% ( n = 266) with a positive PD-L1 TPS (≥1%) and 32.8% ( n = 134) with PD-L1 TPS ≥50%, were included in this study. Cox regression confirmed that patients with a PD-L1 TPS ≥1% had significantly improved PFS (hazard ratio [HR] 0.747, 95% confidence interval [CI] 0.573-0.975, P = 0.032). A total of 160 (39.1%) patients experienced 206 irAEs, and 27 (6.6%) patients experienced 31 grade 3-5 irAEs. The organs most frequently associated with irAEs were the skin (52/409, 12.7%), thyroid (40/409, 9.8%), and lung (34/409, 8.3%). Multivariate logistic regression revealed that a PD-L1 TPS ≥1% (odds ratio [OR] 1.713, 95% CI 1.054-2.784, P = 0.030) was an independent risk factor for irAEs. Other risk factors for irAEs included pretreatment absolute lymphocyte count >2.5 × 10 9 /L (OR 3.772, 95% CI 1.377-10.329, P = 0.010) and pretreatment absolute eosinophil count >0.2 × 10 9 /L (OR 2.006, 95% CI 1.219-3.302, P = 0.006). Moreover, patients who developed irAEs demonstrated improved PFS (13.7 months vs. 8.4 months, P <0.001) and OS (28.0 months vs. 18.0 months, P = 0.007) compared with patients without irAEs.
CONCLUSIONS
A positive PD-L1 TPS (≥1%) was associated with improved PFS and an increased risk of irAEs in a real-world setting. The onset of irAEs was associated with improved PFS and OS in patients with advanced NSCLC receiving PD-1/PD-L1-based therapy.
Humans
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Carcinoma, Non-Small-Cell Lung/metabolism*
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Male
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Female
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Retrospective Studies
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Middle Aged
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Lung Neoplasms/metabolism*
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Aged
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B7-H1 Antigen/metabolism*
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Programmed Cell Death 1 Receptor/metabolism*
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Adult
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Aged, 80 and over
;
Immune Checkpoint Inhibitors/therapeutic use*
7.Research progress in pharmacological effects of puerarin.
Xiao-Wei MENG ; Feng-Mei GUO ; Qian-Qian WANG ; Jia-Rong LI ; Ni ZHANG ; Fei QU ; Rong-Hua LIU ; Wei-Feng ZHU
China Journal of Chinese Materia Medica 2025;50(11):2954-2968
Traditional Chinese medicine(TCM), a treasure of the Chinese nation, contains abundant chemical components and demonstrates unique pharmacological activities, showing important values in clinical applications. With profound connotations and broad application prospects, TCM urgently needs us to further explore and conduct systematic research. Puerarin is a small-molecule natural isoflavonoid carbon glycoside extracted from plants of Pueraria. It is also the main active ingredient of Puerariae Lobata Radix, a Chinese herbal medicine with both medicinal and edible values. Puerarin has a variety of pharmacological effects such as blood pressure-lowering, anti-atherosclerosis, anti-ischemia-reperfusion injury, antithrombotic, anti-tumor, anti-inflammatory, liver-protecting, nerve cell-protecting, and intestinal microbiota-regulating effects. It is also an active ingredient that has been widely studied. This article comprehensively reviews the research progress in the pharmacological effects and molecular mechanisms of puerarin over the years, aiming to provide references and theoretical support for the in-depth research and development as well as clinical application of puerarin.
Isoflavones/chemistry*
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Humans
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Animals
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Drugs, Chinese Herbal/chemistry*
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Pueraria/chemistry*
8.Mechanism related to bile acids metabolism of liver injury induced by long-term administration of emodin.
Jing-Zhuo TIAN ; Lian-Mei WANG ; Yan YI ; Zhong XIAN ; Nuo DENG ; Yong ZHAO ; Chun-Ying LI ; Yu-Shi ZHANG ; Su-Yan LIU ; Jia-Yin HAN ; Chen PAN ; Chen-Yue LIU ; Jing MENG ; Ai-Hua LIANG
China Journal of Chinese Materia Medica 2025;50(11):3079-3087
Emodin is a hydroxyanthraquinone compound that is widely distributed and has multiple pharmacological activities, including anti-diarrheal, anti-inflammatory, and liver-protective effects. Research indicates that emodin may be one of the main components responsible for inducing hepatotoxicity. However, studies on the mechanisms of liver injury are relatively limited, particularly those related to bile acids(BAs) metabolism. This study aims to systematically investigate the effects of different dosages of emodin on BAs metabolism, providing a basis for the safe clinical use of traditional Chinese medicine(TCM)containing emodin. First, this study evaluated the safety of repeated administration of different dosages of emodin over a 5-week period, with a particular focus on its impact on the liver. Next, the composition and content of BAs in serum and liver were analyzed. Subsequently, qRT-PCR was used to detect the mRNA expression of nuclear receptors and transporters related to BAs metabolism. The results showed that 1 g·kg~(-1) emodin induced hepatic damage, with bile duct hyperplasia as the primary pathological manifestation. It significantly increased the levels of various BAs in the serum and primary BAs(including taurine-conjugated and free BAs) in the liver. Additionally, it downregulated the mRNA expression of farnesoid X receptor(FXR), retinoid X receptor(RXR), and sodium taurocholate cotransporting polypeptide(NTCP), and upregulated the mRNA expression of cholesterol 7α-hydroxylase(CYP7A1) in the liver. Although 0.01 g·kg~(-1) and 0.03 g·kg~(-1) emodin did not induce obvious liver injury, they significantly increased the level of taurine-conjugated BAs in the liver, suggesting a potential interference with BAs homeostasis. In conclusion, 1 g·kg~(-1) emodin may promote the production of primary BAs in the liver by affecting the FXR-RXR-CYP7A1 pathway, inhibit NTCP expression, and reduce BA reabsorption in the liver, resulting in BA accumulation in the peripheral blood. This disruption of BA homeostasis leads to liver injury. Even doses of emodin close to the clinical dose can also have a certain effect on the homeostasis of BAs. Therefore, when using traditional Chinese medicine or formulas containing emodin in clinical practice, it is necessary to regularly monitor liver function indicators and closely monitor the risk of drug-induced liver injury.
Emodin/administration & dosage*
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Bile Acids and Salts/metabolism*
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Animals
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Male
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Liver/injuries*
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Chemical and Drug Induced Liver Injury/genetics*
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Drugs, Chinese Herbal/adverse effects*
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Humans
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Rats, Sprague-Dawley
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Mice
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Rats
9.Establishment of different pneumonia mouse models suitable for traditional Chinese medicine screening.
Xing-Nan YUE ; Jia-Yin HAN ; Chen PAN ; Yu-Shi ZHANG ; Su-Yan LIU ; Yong ZHAO ; Xiao-Meng ZHANG ; Jing-Wen WU ; Xuan TANG ; Ai-Hua LIANG
China Journal of Chinese Materia Medica 2025;50(15):4089-4099
In this study, lipopolysaccharide(LPS), ovalbumin(OVA), and compound 48/80(C48/80) were administered to establish non-infectious pneumonia models under simulated clinical conditions, and the correlation between their pathological characteristics and traditional Chinese medicine(TCM) syndromes was compared, providing the basis for the selection of appropriate animal models for TCM efficacy evaluation. An acute pneumonia model was established by nasal instillation of LPS combined with intraperitoneal injection for intensive stimulation. Three doses of OVA mixed with aluminum hydroxide adjuvant were injected intraperitoneally on days one, three, and five and OVA was administered via endotracheal drip for excitation on days 14-18 to establish an OVA-induced allergic pneumonia model. A single intravenous injection of three doses of C48/80 was adopted to establish a C48/80-induced pneumonia model. By detecting the changes in peripheral blood leukocyte classification, lung tissue and plasma cytokines, immunoglobulins(Ig), histamine levels, and arachidonic acid metabolites, the multi-dimensional analysis was carried out based on pathological evaluation. The results showed that the three models could cause pulmonary edema, increased wet weight in the lung, and obvious exudative inflammation in lung tissue pathology, especially for LPS. A number of pyrogenic cytokines, inclading interleukin(IL)-6, interferon(IFN)-γ, IL-1β, and IL-4 were significantly elevated in the LPS pneumonia model. Significantly increased levels of prostacyclin analogs such as prostaglandin E2(PGE2) and PGD2, which cause increased vascular permeability, and neutrophils in peripheral blood were significantly elevated. The model could partly reflect the clinical characteristics of phlegm heat accumulating in the lung or dampness toxin obstructing the lung. The OVA model showed that the sensitization mediators IgE and leukotriene E4(LTE4) were increased, and the anti-inflammatory prostacyclin 6-keto-PGF2α was decreased. Immune cells(lymphocytes and monocytes) were decreased, and inflammatory cells(neutrophils and basophils) were increased, reflecting the characteristics of "deficiency", "phlegm", or "dampness". Lymphocytes, monocytes, and basophils were significantly increased in the C48/80 model. The phenotype of the model was that the content of histamine, a large number of prostacyclins(6-keto-PGE1, PGF2α, 15-keto-PGF2α, 6-keto-PGF1α, 13,14-D-15-keto-PGE2, PGD2, PGE2, and PGH2), LTE4, and 5-hydroxyeicosatetraenoic acid(5S-HETE) was significantly increased, and these indicators were associated with vascular expansion and increased vascular permeability. The pyrogenic inflammatory cytokines were not increased. The C48/80 model reflected the characteristics of cold and damp accumulation. In the study, three non-infectious pneumonia models were constructed. The LPS model exhibited neutrophil infiltration and elevated inflammatory factors, which was suitable for the efficacy study of TCM for clearing heat, detoxifying, removing dampness, and eliminating phlegm. The OVA model, which took allergic inflammation as an index, was suitable for the efficacy study of Yiqi Gubiao formulas. The C48/80 model exhibited increased vasoactive substances(histamine, PGs, and LTE4), which was suitable for the efficacy study and evaluation of TCM for warming the lung, dispersing cold, drying dampness, and resolving phlegm. The study provides a theoretical basis for model selection for the efficacy evaluation of TCM in the treatment of pneumonia.
Animals
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Disease Models, Animal
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Mice
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Pneumonia/genetics*
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Medicine, Chinese Traditional
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Male
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Humans
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Cytokines/immunology*
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Female
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Lipopolysaccharides/adverse effects*
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Lung/drug effects*
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Drugs, Chinese Herbal
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Ovalbumin
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Mice, Inbred BALB C
10.Specific effect of inserted sham acupuncture and its impact on the estimation of acupuncture treatment effect in randomized controlled trials: A systematic survey.
Xiao-Chao LUO ; Jia-Li LIU ; Ming-Hong YAO ; Ye-Meng CHEN ; Arthur Yin FAN ; Fan-Rong LIANG ; Ji-Ping ZHAO ; Ling ZHAO ; Xu ZHOU ; Xiao-Ying ZHONG ; Jia-Hui YANG ; Bo LI ; Ying ZHANG ; Xin SUN ; Ling LI
Journal of Integrative Medicine 2025;23(6):630-640
BACKGROUND:
The use of inserted sham acupuncture as a placebo in randomized controlled trials (RCTs) is controversial, because it may produce specific effects that cause an underestimation of the effect of acupuncture treatment.
OBJECTIVE:
This systematic survey investigates the magnitude of insert-specific effects of sham acupuncture and whether they affect the estimation of acupuncture treatment effects.
SEARCH STRATEGY:
PubMed, Embase and Cochrane Central Register of Controlled Trials were searched to identify acupuncture RCTs from their inception until December 2022.
INCLUSION CRITERIA:
RCTs that evaluated the effects of acupuncture compared to sham acupuncture and no treatment.
DATA EXTRACTION AND ANALYSIS:
The total effect measured for an acupuncture treatment group in RCTs were divided into three components, including the natural history and/or regression to the mean effect (controlled for no-treatment group), the placebo effect, and the specific effect of acupuncture. The first two constituted the contextual effect of acupuncture, which is mimicked by a sham acupuncture treatment group. The proportion of acupuncture total effect size was considered to be 1. The proportion of natural history and/or regression to the mean effect (PNE) and proportional contextual effect (PCE) of included RCTs were pooled using meta-analyses with a random-effect model. The proportion of acupuncture placebo effect was the difference between PCE and PNE in RCTs with non-inserted sham acupuncture. The proportion of insert-specific effect of sham acupuncture (PIES) was obtained by subtracting the proportion of acupuncture placebo effect and PNE from PCE in RCTs with inserted sham acupuncture. The impact of PIES on the estimation of acupuncture's treatment effect was evaluated by quantifying the percentage of RCTs that the effect of outcome changed from no statistical difference to statistical difference after removing PIES in the included studies, and the impact of PIES was externally validated in other acupuncture RCTs with an inserted sham acupuncture group that were not used to calculate PIES.
RESULTS:
This analysis included 32 studies with 5492 patients. The overall PNE was 0.335 (95% confidence interval [CI], 0.255-0.415) and the PCE of acupuncture was 0.639 (95% CI, 0.567-0.710) of acupuncture's total effect. The proportional contribution of the placebo effect to acupuncture's total effect was 0.191, and the PIES was 0.189. When we modeled the exclusion of the insert-specific effect of sham acupuncture, the acupuncture treatment effect changed from no difference to a significant difference in 45.45% of the included RCTs, and in 40.91% of the external validated RCTs.
CONCLUSION
The insert-specific effect of sham acupuncture in RCTs represents 18.90% of acupuncture's total effect and significantly affects the evaluation of the acupuncture treatment effect. More than 40% of RCTs that used inserted sham acupuncture would draw different conclusions if the PIES had been controlled for. Considering the impact of the insert-specific effect of sham acupuncture, caution should be taken when using inserted sham acupuncture placebos in RCTs. Please cite this article as: Luo XC, Liu JL, Yao MH, Chen YM, Fan AY, Liang FR, Zhao JP, Zhao L, Zhou X, Zhong XY, Yang JH, Li B, Zhang Y, Sun X, Li L. Specific effect of inserted sham acupuncture and its impact on the estimation of acupuncture treatment effect in randomized controlled trials: A systematic survey. J Integr Med. 2025; 23(6):630-640.
Acupuncture Therapy/methods*
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Humans
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Randomized Controlled Trials as Topic
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Placebo Effect
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Placebos
;
Treatment Outcome

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