1.Evidence-based evaluation and hierarchical management of off-label use of 5-aminolevulinic acid in photodynamic therapy
Jing MA ; Tingting LIU ; Xiaoshuang GOU ; Xue YANG ; Chen LI ; Fang LIU ; Yao LIU
China Pharmacy 2026;37(8):1056-1061
OBJECTIVE To provide reference for medical institutions to establish the record management mode and review rules of off-label use of 5-aminolevulinic acid (ALA) in photodynamic therapy based on the level of evidence. METHODS All ALA-containing outpatient prescriptions in the rational drug use system in our hospital from January 1, 2024 to December 31, 2025 were retrospectively collected. Based on the drug instructions, the current status of off-label use of ALA in photodynamic therapy was identified . The relevant studies in Micromedex, PubMed, CNKI, Wanfang Data and other databases were systematically searched as the relevant evidence-based evidence of ALA off-label use. According to the Off-label Drug Use Filing Standard of the hospital,the evidence-based evaluation method was used to evaluate the evidence-based evidence of ALA off-label use and carry out hierarchical management. RESULTS A total of 1 803 effective prescriptions were included, of which 676 (37.49%) were off-label use, distributed in the dermatology department (564 prescriptions,83.43%) and the plastic surgery department (112 prescriptions,16.57%). All 676 prescriptions were off-indications medication, involving ten types of skin diseases, primarily including moderate to severe acne (39.94%), skin warts (25.44%), Bowen’s disease (11.98%), and others. According to evidence-based evidence,off-label uses such as moderate to severe acne, actinic keratosis, and Bowen’s disease were managed according to the evidence categoryⅠ orⅡ.The uses of extramammary Paget’s disease and rosacea were managed according to the evidence category Ⅲ.The uses of lichen sclerosus and keloids were managed according to the evidence category Ⅳ.The results of evidence-based evaluation showed that 92.01% of off-label use in our hospital had high-level evidence-based support ( evidence category was gradeⅠ-Ⅱ). CONCLUSIONS Off-label uses supported by high-level evidence, such as moderate to severe acne, skin warts, and Bowen’s disease, can be managed under filing category Ⅰ or Ⅱ. For the use of lichen sclerosus and keloids, evidence-based evidence is insufficient and should be strictly restricted.The vast majority of ALA off-label use in our hospital has sufficient evidence-based basis.
2.Indobufen attenuates cerebral ischemia–reperfusion injury by inhibiting the NF-κB/Caspase-1/GSDMD pathway
Yiyin XU ; Dan XU ; Xue GOU ; Weirong FANG ; Yunman LI ; Hua SHAO ; Yongqing WANG
Journal of China Pharmaceutical University 2026;57(2):246-255
Indobufen is a new generation of antiplatelet agents and has been shown to have antithrombotic effects in animal models. However, its therapeutic potential and mechanisms against cerebral ischemia/reperfusion (I/R) injury remain unclear. In this study, we evaluated the in vivo neuroprotective effects of indobufen through both pretreatment and posttreatment regimens in a rat model of middle cerebral artery occlusion/reperfusion (MCAO/R). In vitro, human umbilical vein endothelial cells (HUVECs) subjected to oxygen-glucose deprivation/reoxygenation (OGD/R) were employed to investigate the relationship between indobufen and the pyroptosis-associated NF-κB/Caspase-1/GSDMD pathway. The pharmacodynamic tests revealed that indobufen ameliorated I/R injury by decreasing the level of thromboxane B2 (TXB2), infarct size, brain edema and neurological impairment in rats and rescuing cell pyroptosis in HUVECs. The underlying mechanisms were probably related to pyroptosis suppression by regulating the NF-κB/Caspase-1/GSDMD pathway. Overall, these studies indicate that indobufen exerts protective and therapeutic effects against I/R injury by pyroptosis suppression via downregulating NF-κB/Caspase-1/GSDMD pathway.
3.Carvedilol to prevent hepatic decompensation of cirrhosis in patients with clinically significant portal hypertension stratified by new non-invasive model (CHESS2306)
Chuan LIU ; Hong YOU ; Qing-Lei ZENG ; Yu Jun WONG ; Bingqiong WANG ; Ivica GRGUREVIC ; Chenghai LIU ; Hyung Joon YIM ; Wei GOU ; Bingtian DONG ; Shenghong JU ; Yanan GUO ; Qian YU ; Masashi HIROOKA ; Hirayuki ENOMOTO ; Amr Shaaban HANAFY ; Zhujun CAO ; Xiemin DONG ; Jing LV ; Tae Hyung KIM ; Yohei KOIZUMI ; Yoichi HIASA ; Takashi NISHIMURA ; Hiroko IIJIMA ; Chuanjun XU ; Erhei DAI ; Xiaoling LAN ; Changxiang LAI ; Shirong LIU ; Fang WANG ; Ying GUO ; Jiaojian LV ; Liting ZHANG ; Yuqing WANG ; Qing XIE ; Chuxiao SHAO ; Zhensheng LIU ; Federico RAVAIOLI ; Antonio COLECCHIA ; Jie LI ; Gao-Jun TENG ; Xiaolong QI
Clinical and Molecular Hepatology 2025;31(1):105-118
Background:
s/Aims: Non-invasive models stratifying clinically significant portal hypertension (CSPH) are limited. Herein, we developed a new non-invasive model for predicting CSPH in patients with compensated cirrhosis and investigated whether carvedilol can prevent hepatic decompensation in patients with high-risk CSPH stratified using the new model.
Methods:
Non-invasive risk factors of CSPH were identified via systematic review and meta-analysis of studies involving patients with hepatic venous pressure gradient (HVPG). A new non-invasive model was validated for various performance aspects in three cohorts, i.e., a multicenter HVPG cohort, a follow-up cohort, and a carvediloltreating cohort.
Results:
In the meta-analysis with six studies (n=819), liver stiffness measurement and platelet count were identified as independent risk factors for CSPH and were used to develop the new “CSPH risk” model. In the HVPG cohort (n=151), the new model accurately predicted CSPH with cutoff values of 0 and –0.68 for ruling in and out CSPH, respectively. In the follow-up cohort (n=1,102), the cumulative incidences of decompensation events significantly differed using the cutoff values of <–0.68 (low-risk), –0.68 to 0 (medium-risk), and >0 (high-risk). In the carvediloltreated cohort, patients with high-risk CSPH treated with carvedilol (n=81) had lower rates of decompensation events than non-selective beta-blockers untreated patients with high-risk CSPH (n=613 before propensity score matching [PSM], n=162 after PSM).
Conclusions
Treatment with carvedilol significantly reduces the risk of hepatic decompensation in patients with high-risk CSPH stratified by the new model.
4.Serratia marcescens TF-1 for biodegradation of chlorobenzene contaminants in soil and its application in in-situ remediation of chemical industrial sites.
Fang GOU ; Yunchun SHI ; Hao CHEN ; Wenting FU ; Liangjie LI ; Zhilin XING ; Jiangfeng GUO
Chinese Journal of Biotechnology 2025;41(6):2483-2497
Chlorobenzene contaminants (CBs) pose a threat to the eco-environment, and functional strains hold considerable potential for the remediation of CB-contaminated sites. To deeply explore the application potential of functional bacteria in the in-situ bioremediation of CBs, this study focused on the biodegradation characteristics and degradation kinetics of CB and 1, 2-dichlorobenzene (1, 2-DCB) in soil by the isolated strain Serratia marcescens TF-1. Additionally, an in-situ remediation trial was conducted with this strain at a chemical industrial site. Batch serum bottle experiments showed that the degradation rate of CB at the concentrations ranging from 20 to 200 mg/L by TF-1 was 0.22-0.66 mol/(gcell·h), following the Haldane model, with the optimal concentration at 23.12 mg/L. The results from simulated soil degradation experiments indicated that the combined use of TF-1 and sodium succinate (SS) significantly enhanced the degradation of CBs, with the maximum degradation rate of CB reaching 0.104 d-1 and a half-life of 6.66 d. For 1, 2-DCB, the maximum degradation rate constant was 0.068 7 d-1, with a half-life of 10.087 d. The in-situ remediation results at the chemically contaminated site demonstrated that the introduction of bacterial inoculant and SS significantly improved the removal of CBs, achieving the removal rates of 84.2%-100% after 10 d. CB, 1, 4-dichlorobenzene (1, 4-DCB), and benzo[a]pyrene were completely removed. Microbial diversity analysis revealed that the in-situ remediation facilitated the colonization of TF-1 and the enrichment of indigenous nitrogen-fixing Azoarcus, which may have played a key role in the degradation process. This study provides a theoretical basis and practical experience for the in situ bioremediation of CBs-contaminated sites.
Chlorobenzenes/isolation & purification*
;
Biodegradation, Environmental
;
Soil Pollutants/isolation & purification*
;
Serratia marcescens/metabolism*
;
Industrial Waste
;
Soil Microbiology
5.Carvedilol to prevent hepatic decompensation of cirrhosis in patients with clinically significant portal hypertension stratified by new non-invasive model (CHESS2306)
Chuan LIU ; Hong YOU ; Qing-Lei ZENG ; Yu Jun WONG ; Bingqiong WANG ; Ivica GRGUREVIC ; Chenghai LIU ; Hyung Joon YIM ; Wei GOU ; Bingtian DONG ; Shenghong JU ; Yanan GUO ; Qian YU ; Masashi HIROOKA ; Hirayuki ENOMOTO ; Amr Shaaban HANAFY ; Zhujun CAO ; Xiemin DONG ; Jing LV ; Tae Hyung KIM ; Yohei KOIZUMI ; Yoichi HIASA ; Takashi NISHIMURA ; Hiroko IIJIMA ; Chuanjun XU ; Erhei DAI ; Xiaoling LAN ; Changxiang LAI ; Shirong LIU ; Fang WANG ; Ying GUO ; Jiaojian LV ; Liting ZHANG ; Yuqing WANG ; Qing XIE ; Chuxiao SHAO ; Zhensheng LIU ; Federico RAVAIOLI ; Antonio COLECCHIA ; Jie LI ; Gao-Jun TENG ; Xiaolong QI
Clinical and Molecular Hepatology 2025;31(1):105-118
Background:
s/Aims: Non-invasive models stratifying clinically significant portal hypertension (CSPH) are limited. Herein, we developed a new non-invasive model for predicting CSPH in patients with compensated cirrhosis and investigated whether carvedilol can prevent hepatic decompensation in patients with high-risk CSPH stratified using the new model.
Methods:
Non-invasive risk factors of CSPH were identified via systematic review and meta-analysis of studies involving patients with hepatic venous pressure gradient (HVPG). A new non-invasive model was validated for various performance aspects in three cohorts, i.e., a multicenter HVPG cohort, a follow-up cohort, and a carvediloltreating cohort.
Results:
In the meta-analysis with six studies (n=819), liver stiffness measurement and platelet count were identified as independent risk factors for CSPH and were used to develop the new “CSPH risk” model. In the HVPG cohort (n=151), the new model accurately predicted CSPH with cutoff values of 0 and –0.68 for ruling in and out CSPH, respectively. In the follow-up cohort (n=1,102), the cumulative incidences of decompensation events significantly differed using the cutoff values of <–0.68 (low-risk), –0.68 to 0 (medium-risk), and >0 (high-risk). In the carvediloltreated cohort, patients with high-risk CSPH treated with carvedilol (n=81) had lower rates of decompensation events than non-selective beta-blockers untreated patients with high-risk CSPH (n=613 before propensity score matching [PSM], n=162 after PSM).
Conclusions
Treatment with carvedilol significantly reduces the risk of hepatic decompensation in patients with high-risk CSPH stratified by the new model.
6.Carvedilol to prevent hepatic decompensation of cirrhosis in patients with clinically significant portal hypertension stratified by new non-invasive model (CHESS2306)
Chuan LIU ; Hong YOU ; Qing-Lei ZENG ; Yu Jun WONG ; Bingqiong WANG ; Ivica GRGUREVIC ; Chenghai LIU ; Hyung Joon YIM ; Wei GOU ; Bingtian DONG ; Shenghong JU ; Yanan GUO ; Qian YU ; Masashi HIROOKA ; Hirayuki ENOMOTO ; Amr Shaaban HANAFY ; Zhujun CAO ; Xiemin DONG ; Jing LV ; Tae Hyung KIM ; Yohei KOIZUMI ; Yoichi HIASA ; Takashi NISHIMURA ; Hiroko IIJIMA ; Chuanjun XU ; Erhei DAI ; Xiaoling LAN ; Changxiang LAI ; Shirong LIU ; Fang WANG ; Ying GUO ; Jiaojian LV ; Liting ZHANG ; Yuqing WANG ; Qing XIE ; Chuxiao SHAO ; Zhensheng LIU ; Federico RAVAIOLI ; Antonio COLECCHIA ; Jie LI ; Gao-Jun TENG ; Xiaolong QI
Clinical and Molecular Hepatology 2025;31(1):105-118
Background:
s/Aims: Non-invasive models stratifying clinically significant portal hypertension (CSPH) are limited. Herein, we developed a new non-invasive model for predicting CSPH in patients with compensated cirrhosis and investigated whether carvedilol can prevent hepatic decompensation in patients with high-risk CSPH stratified using the new model.
Methods:
Non-invasive risk factors of CSPH were identified via systematic review and meta-analysis of studies involving patients with hepatic venous pressure gradient (HVPG). A new non-invasive model was validated for various performance aspects in three cohorts, i.e., a multicenter HVPG cohort, a follow-up cohort, and a carvediloltreating cohort.
Results:
In the meta-analysis with six studies (n=819), liver stiffness measurement and platelet count were identified as independent risk factors for CSPH and were used to develop the new “CSPH risk” model. In the HVPG cohort (n=151), the new model accurately predicted CSPH with cutoff values of 0 and –0.68 for ruling in and out CSPH, respectively. In the follow-up cohort (n=1,102), the cumulative incidences of decompensation events significantly differed using the cutoff values of <–0.68 (low-risk), –0.68 to 0 (medium-risk), and >0 (high-risk). In the carvediloltreated cohort, patients with high-risk CSPH treated with carvedilol (n=81) had lower rates of decompensation events than non-selective beta-blockers untreated patients with high-risk CSPH (n=613 before propensity score matching [PSM], n=162 after PSM).
Conclusions
Treatment with carvedilol significantly reduces the risk of hepatic decompensation in patients with high-risk CSPH stratified by the new model.
7.Continuous theta burst stimulation of multiple targets in the treatment of post-stroke aphasia
Fang ZHANG ; Boduo XIE ; Huaping GUO ; Lijie GOU
Chinese Journal of Physical Medicine and Rehabilitation 2025;47(9):804-808
Objective:To observe the clinical efficacy of continuous theta burst stimulation in the treatment of post-stroke aphasia (PSA).Methods:Forty-six patients with post-stroke aphasia were randomly divided into an observation group and a control group, with 23 cases in each group. In addition to conventional rehabilitation and speech-language therapy, the observation group received daily theta burst stimulation (cTBS) targeting the contralesional inferior frontal gyrus, the superior temporal gyrus, and the superior frontal gyrus. The control group received sham stimulation over the same areas. The treatment was 5 days per week for 3 weeks. Before and after the treatment, both groups were evaluated using the China Rehabilitation Research Center′s aphasia examination method (CRRCAE), the Boston diagnostic aphasia examination (BDAE), the brief mental scale (MMSE), and the Stroke Aphasia Quality of Life scale (SAQOL-39).Results:After the treatment, intra-group comparison showed significantly greater improvements among the observation group in terms of their average CRRCAE listening comprehension (112.74±8.935), repetition (115.74±16.015), speaking (99.91±6.273), oral reading (98.22±14.087), and reading (86.57±8.101) sub-scores and their average BDAE [3.00 (3.00, 4.00)], MMSE [21.00 (20.00, 24.00)] and SAQOL-39 (112.96±21.995) scores.Conclusions:Continuous theta burst transcranial magnetic stimulation can effectively improve the speech, cognition and life quality of persons with post-stroke aphasia. This therapy is worthy of clinical application and promotion.
8.Association analysis of childhood obesity and inflammatory bowel disease based on Mendel randomization
Wenhua FENG ; Fang GOU ; Yi ZHANG ; Rui LIANG ; Lei PENG ; Shaohua ZHANG
Chongqing Medicine 2025;54(8):1798-1803
Objective To explore the potential causal relationship between childhood obesity and the risk of inflammatory bowel disease(IBD)based on Mendel randomization(MR).Methods The genome-wide association study(GWAS)data for childhood obesity included 5 530 cases and 8 318 controls.The GWAS data for IBD included 5 673 cases and 213 119 controls.The GWAS data for ulcerative colitis included 4 320 cases and 210 300 controls.The GWAS data of Crohn's disease included 2 056 cases and 210 300 controls.The risk association between obesity and the occurrence of IBD was analyzed using the inverse variance weighted meth-od(IVW),general model,weighted model,weighted median,and MR-Egger.Results Fourteen independent single nucleotide polymorphisms(SNP)significantly associated with childhood obesity were screened out as instrumental variables.IVW analysis results showed that no potential causal association was found between childhood obesity and IBD(OR=1.048,95%CI:0.976-1.125),ulcerative colitis(OR=1.026,95%CI:0.946-1.113),and Crohn's disease(OR=1.123,95%CI:0.993-1.269,P>0.05).Conclusion There was no causal relationship between childhood obesity and the risk of IBD.
9.Evaluation of registration accuracy of MIM system using liver biomechanical deformation model
Xiao-fang GOU ; Xiu-xia FENG ; Song FAN
Chinese Medical Equipment Journal 2025;46(2):49-55
Objective To evaluate the registration accuracy of progressive biomechanical shrinkage set of MIM system to provide registration evaluation data support for registration demand scenarios such as treatment response feedback and dose stacking in tumor adaptive radiotherapy.Methods The CT images of a fresh pork liver with 60 gold markers in different shrinkage states at different heating time were used as the phantom images containing gold markers,and the phantom images without gold markers were obtained by replacing the pixel values at the high-density points containing the gold markers with the pixel averages of the pork liver tissue near the gold marker points.Secondly,the two types of phantom images were introduced into MIM system for registration by two methods of deformable image registration(DIR)and contour boundary-based hybrid deformable image registration(HY-DIR).Finally,the mean values of target registration errors(TRE)were cal-culated between the real gold marker points and the ones by registrating respectively all the gold marker points,23 internal points and 37 superfacial points.The Dice coefficients and Hausdorff distances were computed,and correlation and difference analyses were carried out between four groups of DIR with gold marker,HY-DIR with gold marker,DIR without gold marker and HY-DIR without gold marker.SPSS 25.0 software was used for statistical analysis.Results At 30 s time-phase,the mean values of TRE ranged from 2.14 to 2.20 mm,and the Dice coefficients were all 0.94;at 60-90 s time-phase,the mean values of TRE were from 3.02 to 5.32 mm,and the Dice coefficients were restricted between 0.95 and 0.97;at 110-200 s time-phase,the mean values of TRE were higher than 4 mm,and the Dice coefficients were from 0.93 to 0.96.The Hausdorff distance had high mean value at 30-200 s time-phase,with a minimum value of 3.85 mm and a maximum value of 17.91 mm.The mean value and standard deviation of TRE of the superfacial gold marker points were all higher than those of the internal points.In case of registration by DIR the Dice coefficients had medium-strength correlations with the TRE mean values of the internal points and all the points(0.4<r<0.6).In case of registration by HY-DIR the Dice coefficients did not correlated with the TRE mean values(r<0.2).In terms of TRE mean value there were significant difference between DIR with gold marker group and HY-DIR with gold marker group(P=0.026)and between DIR with gold marker group and DIR without gold marker group(P=0.036).Conclusion When MMI software is used for self-addaptive radiotherapy registration,satisfactory results are obtained at 30 s time-phase;at 60-90 s time-phase(volume shrinkage lower than 20%),some low registration errors occur and need artificial correction;at 100-200 s time-phase(volume shrinkage higher than 20%),high registration errors appear while the registration with gold markers be haves better than that without gold markers and DIR gains advantages over HY-DIR.[Chinese Medical Equipment Journal,2025,46(2):49-55]
10.Investigation report of radiotherapy personnel and equipment in Gansu Province
Anmei ZHENG ; Shihong WEI ; Xiyi WEI ; Fang DONG ; Qiuyan GOU ; Bangcai WANG ; Qing GUO ; Zhengqing YIN ; Haixia SONG
Chinese Journal of Radiation Oncology 2025;34(3):226-232
Objective:To investigate the personnel, equipment, new technology of various radiotherapy units in Gansu Province, aiming to deeply understand the current status of radiotherapy in Gansu Province.Methods:From March 2023 to March 2024, the data of personnel, equipment and technology of different radiotherapy units in Gansu Province were investigated via online questionnaire survey and offline field visits by Gansu Provincial Quality Control Center for Radiation Oncology. The questionable data were reviewed, logical verification and outlier identification were conducted, and all information was entered according to the principle of double entry. Qualitative data were described by frequency (percentage).Results:As of March 2024, there are 26 radiotherapy units in Gansu Province, including 7 units in Lanzhou, capital city of Gansu Province and none in Linxia Hui Autonomous Prefecture and Gannan Tibetan Autonomous Prefecture. The ratio of radiotherapy physicians and physicists was 2.71 vs. 1, lower than the national level of 3.51 vs. 1. Radiotherapy physicians with intermediate and senior titles accounted for 66.2%, 54% for physicists with intermediate and senior titles and 34.0% for therapists with intermediate and senior titles, respectively. There were 1.70 accelerators per million population in Gansu Province. Among 42 accelerators in Gansu Province, 40 were linac and 2 heavy ion accelerators. In Lanzhou, 7 radiotherapy units had 17 linac, and the remaining 11 cities had 23 linac. All 40 linac could perform 3D conformal radiotherapy and intensity-modulated radiotherapy. The high-end equipment could apply advanced technologies such as volumetric modulated arc radiotherapy, stereotactic body radiotherapy, optical surface-guided radiation therapy and adaptive radiation therapy, etc. Relevant data in this survey were improved compared with those in the national surveys conducted in 2006, 2015 and 2019. Conclusions:The radiotherapy status has developed in Gansu Province, whereas uneven development still exists among regions. According to the actual demands of equipment, talents and technology in each region, the structural adjustment should be oriented to the underdeveloped cities and counties in the province to meet the local medical needs.

Result Analysis
Print
Save
E-mail