OBJECTIVES: To explore the efficacy of DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy for management of cancer pain and provide reference for its standardized clinical application. Methods and. RESULTS: Recommendations were formulated based on literature review and expert group discussion, and consensus was reached following expert consultation. The consensus recommendations are comprehensive, covering the entire treatment procedures from preoperative assessment and preparation, surgical operation process, postoperative management and traditional Chinese medicine treatment to individualized treatment planning. The study results showed that the treatment plans combining traditional Chinese with Western medicine effectively alleviated cancer pain, reduced the use of opioid drugs, and significantly improved the quality of life and enhanced immune function of the patients. Postoperative follow-up suggested good treatment tolerance among the patients without serious complications. CONCLUSIONS The formulated consensus is comprehensive and can provide reference for clinicians to use DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy. The combined treatment has a high clinical value with a good safety profile for management of cancer pain.
Humans ; Medicine, Chinese Traditional ; Cancer Pain/therapy* ; Drugs, Chinese Herbal/therapeutic use* ; Drug Delivery Systems ; Pain Management/methods* ; China

Objective To discuss the improvement for the verification of inter-day precision of PS activity assay and the verification protocol for limits of quantitative of FⅧ:C and FⅨ:C assay,aiming at the problems in the performance verification of anticoagulant protein S(PS),coagulation factor Ⅷ activity(F Ⅷ:C)and coagulation factor Ⅸ activity(F Ⅸ:C)assay.Methods SYSMEX CN-6000 and supporting reagents were used,and low-and high-value quality control(QCs)were used as the study samples.Following the American Clinical and Laboratory Standards Institute(CLSI)document EP15-A3,an inter-day precision verification study of the PS activity assay was performed with three reagent preparation methods designed(specification-required method,instrument's manual method and improved method).The specification-required method was carried out completely according to the specification,and the instrument manual method involved allowing the required reagents to stand in the device for 30 minutes based on the specification-required method,and the improved method mixed and dispensed the reagents needed to be based on the specification-required method.To study the bottle variation of the same batch of reagents for the same sample,the acceptable range of external quality assessment(EQA)of the National Center for Clinical Laboratories(NCCL)was used as the evaluation standard.Following the CLSI EP25 document,the PS activity assay reagent onboard stability verification was performed with the specification-required method and the improved method.Following the CLSI EP17-A2 document,WS/T 514-2017"Establishment and Verification of Detection Capability for Clinical Laboratory Measurement Procedures"and the International Committee for Standardization in Hematology(ICSH)guidelines,the LoQ for FVIII:C and FIX:C assays was verified.The verification results were passed if the requirements of the specification were met.Results The verification result of inter-day precision(CVWL:12.9%～21.6%)of PS activity assay according to the specification method and the instrumental manual method exceeded the requirements of the specification(<10%CVWL at high levels,<20%CVWL at low levels).The results of inter-day precision verification with the improved method(CVWL:2.9%and 4.5%)were consistent with the requirements of the specification.The bottle variation exceeded the acceptable range of EQA.The improved method corrected the reagent on-board stability verification results of reagents(relative deviations of-4.24%～9.97%)by the specifications(high levels<10%,low levels<20%).The LoQ verification results for FⅧ:C and FⅨ:C assay were by the product specifications(FⅧ:C:0.75%～1.46%and 0.74%～1.40%;FⅨ:C:0.71%～1.27%and 0.70%～1.32%).Conclusion An improved method to improve the inter-day precision of PS activity detection is provided,and LoQ verification protocol for F Ⅷ:C and FⅨ:C assay is provided for clinical laboratory reference.

Objective:To investigate the interventional effects of the Fuzheng Huayu (FZHY) formula and its partial mechanistic role on cholestatic liver fibrosis in mice.Methods:Mdr2 gene knockout (Mdr2－/ －) mice were randomly divided into a model group, FZHY group, and Obeticholic acid group. Wild-type C57BL/6J mice of the same age served as the control group. Mdr2－/ －mice were given the corresponding drugs starting from the first day of 9 weeks of age by oral gavage in each group. The control and model groups were administered 0.3% sodium carboxymethylcellulose by oral gavage and were sacrificed at 12 weeks of age for specimen collection. High-speed biochemistry analyzer was used to detect serum alkaline phosphatase and alanine aminotransferase activity in mice. Hematoxylin-eosin staining and Sirius red staining were used to observe pathological changes in liver tissues. Hydroxyproline content was measured to assess collagen in liver tissues. Immunohistochemical staining, Western blotting, and real-time fluorescence quantitative PCR were used to detect the expression of fibrosis markers Col-I and alpha-smooth muscle actin in liver tissues. The expressional condition of cholangiocyte response markers Epcam, CK7, CK19, as well as Pcna, Mki67, and Ccnd1, inflammatory related factors Ccl2, Ccl5, Tnf-α, Il10, and Cxcl4, phosphorylated peroxisome proliferator-activated receptor alpha (PPARα) and nuclear factor kappa-B (NF-κB) were determined. Comparative analysis among multiple groups was performed using one-way ANOVA. The LSD method was used for comparisons between groups. Two-tailed statistical tests were used.Results:Compared with wild-type mice, Mdr2 －/ － mice had a significant increase in serum alanine aminotransferase and alkaline phosphatase activity ( P<0.001). The percentage of Sirius red-positive staining areas and hydroxyproline content in liver tissues was significantly increased ( P<0.01). The expression of Col-I, α-smooth muscle actin, Epcam, CK7, CK19, Pcna, Mki67, and Ccnd1, and the expression of Ccl2, Ccl5, Tnf-α, Il10, and Cxcl4 were significantly increased ( P<0.01); however, both FZHY and Obeticholic acid significantly reversed the increases in these indicators ( P<0.05; P<0.01). Further results showed that compared to wild-type mice, the expression of PPARα was significantly reduced in liver tissues of Mdr2 －/ － mice, while NF-κB was significantly enhanced ( P<0.01). In contrast, compared to Mdr2-/- mice, the expression of PPARα in the liver tissues of FZHY group mice was significantly increased ( P<0.05), while NF-κB was significantly inhibited ( P<0.05). Conclusion:FZHY can significantly improve liver fibrosis, cholangiocyte response, and inflammation in Mdr2 －/ － mice with spontaneously occurring cholestatic liver fibrosis, and its mechanistic role is related to the regulation of the PPARα/NF-κB pathway.

Objective To explore the efficacy of DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy for management of cancer pain and provide reference for its standardized clinical application.Methods and Results Recommendations were formulated based on literature review and expert group discussion,and consensus was reached following expert consultation.The consensus recommendations are comprehensive,covering the entire treatment procedures from preoperative assessment and preparation,surgical operation process,postoperative management and traditional Chinese medicine treatment to individualized treatment planning.The study results showed that the treatment plans combining traditional Chinese with Western medicine effectively alleviated cancer pain,reduced the use of opioid drugs,and significantly improved the quality of life and enhanced immune function of the patients.Postoperative follow-up suggested good treatment tolerance among the patients without serious complications.Conclusion The formulated consensus is comprehensive and can provide reference for clinicians to use DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy.The combined treatment has a high clinical value with a good safety profile for management of cancer pain.

Objective To discuss the improvement for the verification of inter-day precision of PS activity assay and the verification protocol for limits of quantitative of FⅧ:C and FⅨ:C assay,aiming at the problems in the performance verification of anticoagulant protein S(PS),coagulation factor Ⅷ activity(F Ⅷ:C)and coagulation factor Ⅸ activity(F Ⅸ:C)assay.Methods SYSMEX CN-6000 and supporting reagents were used,and low-and high-value quality control(QCs)were used as the study samples.Following the American Clinical and Laboratory Standards Institute(CLSI)document EP15-A3,an inter-day precision verification study of the PS activity assay was performed with three reagent preparation methods designed(specification-required method,instrument's manual method and improved method).The specification-required method was carried out completely according to the specification,and the instrument manual method involved allowing the required reagents to stand in the device for 30 minutes based on the specification-required method,and the improved method mixed and dispensed the reagents needed to be based on the specification-required method.To study the bottle variation of the same batch of reagents for the same sample,the acceptable range of external quality assessment(EQA)of the National Center for Clinical Laboratories(NCCL)was used as the evaluation standard.Following the CLSI EP25 document,the PS activity assay reagent onboard stability verification was performed with the specification-required method and the improved method.Following the CLSI EP17-A2 document,WS/T 514-2017"Establishment and Verification of Detection Capability for Clinical Laboratory Measurement Procedures"and the International Committee for Standardization in Hematology(ICSH)guidelines,the LoQ for FVIII:C and FIX:C assays was verified.The verification results were passed if the requirements of the specification were met.Results The verification result of inter-day precision(CVWL:12.9%～21.6%)of PS activity assay according to the specification method and the instrumental manual method exceeded the requirements of the specification(<10%CVWL at high levels,<20%CVWL at low levels).The results of inter-day precision verification with the improved method(CVWL:2.9%and 4.5%)were consistent with the requirements of the specification.The bottle variation exceeded the acceptable range of EQA.The improved method corrected the reagent on-board stability verification results of reagents(relative deviations of-4.24%～9.97%)by the specifications(high levels<10%,low levels<20%).The LoQ verification results for FⅧ:C and FⅨ:C assay were by the product specifications(FⅧ:C:0.75%～1.46%and 0.74%～1.40%;FⅨ:C:0.71%～1.27%and 0.70%～1.32%).Conclusion An improved method to improve the inter-day precision of PS activity detection is provided,and LoQ verification protocol for F Ⅷ:C and FⅨ:C assay is provided for clinical laboratory reference.

Objective:To investigate the interventional effects of the Fuzheng Huayu (FZHY) formula and its partial mechanistic role on cholestatic liver fibrosis in mice.Methods:Mdr2 gene knockout (Mdr2－/ －) mice were randomly divided into a model group, FZHY group, and Obeticholic acid group. Wild-type C57BL/6J mice of the same age served as the control group. Mdr2－/ －mice were given the corresponding drugs starting from the first day of 9 weeks of age by oral gavage in each group. The control and model groups were administered 0.3% sodium carboxymethylcellulose by oral gavage and were sacrificed at 12 weeks of age for specimen collection. High-speed biochemistry analyzer was used to detect serum alkaline phosphatase and alanine aminotransferase activity in mice. Hematoxylin-eosin staining and Sirius red staining were used to observe pathological changes in liver tissues. Hydroxyproline content was measured to assess collagen in liver tissues. Immunohistochemical staining, Western blotting, and real-time fluorescence quantitative PCR were used to detect the expression of fibrosis markers Col-I and alpha-smooth muscle actin in liver tissues. The expressional condition of cholangiocyte response markers Epcam, CK7, CK19, as well as Pcna, Mki67, and Ccnd1, inflammatory related factors Ccl2, Ccl5, Tnf-α, Il10, and Cxcl4, phosphorylated peroxisome proliferator-activated receptor alpha (PPARα) and nuclear factor kappa-B (NF-κB) were determined. Comparative analysis among multiple groups was performed using one-way ANOVA. The LSD method was used for comparisons between groups. Two-tailed statistical tests were used.Results:Compared with wild-type mice, Mdr2 －/ － mice had a significant increase in serum alanine aminotransferase and alkaline phosphatase activity ( P<0.001). The percentage of Sirius red-positive staining areas and hydroxyproline content in liver tissues was significantly increased ( P<0.01). The expression of Col-I, α-smooth muscle actin, Epcam, CK7, CK19, Pcna, Mki67, and Ccnd1, and the expression of Ccl2, Ccl5, Tnf-α, Il10, and Cxcl4 were significantly increased ( P<0.01); however, both FZHY and Obeticholic acid significantly reversed the increases in these indicators ( P<0.05; P<0.01). Further results showed that compared to wild-type mice, the expression of PPARα was significantly reduced in liver tissues of Mdr2 －/ － mice, while NF-κB was significantly enhanced ( P<0.01). In contrast, compared to Mdr2-/- mice, the expression of PPARα in the liver tissues of FZHY group mice was significantly increased ( P<0.05), while NF-κB was significantly inhibited ( P<0.05). Conclusion:FZHY can significantly improve liver fibrosis, cholangiocyte response, and inflammation in Mdr2 －/ － mice with spontaneously occurring cholestatic liver fibrosis, and its mechanistic role is related to the regulation of the PPARα/NF-κB pathway.

Objective:To explore the impact of artificial intelligence compressed sensing technology (CS-AI) on image quality in three-dimensional proton density weighted imaging (3D PDWI) of the unilateral hip joint.Methods:High-resolution unilateral hip imaging was conducted on 67 healthy volunteers at West China Hospital of Sichuan University from January to July 2023. Imaging was performed by using CS-AI 3D PDWI sequence with acceleration factors (AF) of 4, 6, 8, and 10, respectively. According to the AF, all subjects were divided into 4 groups: CS-AI 4, CS-AI 6, CS-AI 8 and CS-AI 10, with CS-AI 4 serving as a reference. Recording the scan time, the signal and noise intensity of the femoral head, muscle, and subcutaneous fat were measured by a senior radiologist and the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) were then calculated. Additionally, two observers provided ratings for overall image quality and artifacts in the 4 groups, and statistical analysis was performed using the Friedman rank-sum test.Results:The acquisition times for CS-AI 4, CS-AI 6, CS-AI 8, and CS-AI 10 were 5 min 49 s, 3 min 54 s, 2 min 56 s and 2 min 22 s, respectively. Compared to CS-AI 4, the scanning time for CS-AI 6, CS-AI 8, CS-AI 10 were reduced by 32.95%, 50.14%, 59.31%, respectively. The objective evaluation revealed that the SNR and CNR of the femoral head and muscle in groups CS-AI 6, CS-AI 8, and CS-AI 10 were slightly lower than those in group CS-AI 4 ( P<0.05), and the differences were statistically significant. However, no statistically significant differences were found among the 3 groups ( P>0.05). The subjective evaluation indicated that the overall image quality scores of group CS-AI 8 [3 (3,4)] did not significantly differ from those of group CS-AI 4 and CS-AI 6( P>0.05); The mean scores of group CS-AI 4 and CS-AI 6 were 4 (4, 4); Scores of group CS-AI 10 was 3(3, 3), which statistically significant differ from those of the other groups ( P<0.05). The artifacts rating for groups CS-AI 4, CS-AI 6, CS-AI 8 and CS-AI 10 were 4 (4, 4), 4 (4, 4), 3 (3, 4), and 2 (2, 3) respectively. When AF was set to 10, the images exhibited the most severe artifacts ( P<0.05). For other AF values, artifact ratings did not differ significantly ( P>0.05). Conclusion:The CS-AI 3D-PDWI sequence with acceleration factor 8 can acquire high-resolution images of the unilateral hip joint that meet clinical diagnostic requirements while reducing scanning time.

Objective To compare the value of stack-of-stars-volumetric interpolated breath-hold examination(Star-VIBE)and T1-volumetric interpolated breath-hold examination(T1-VIBE)MRI for displaying peripheral lung cancer.Methods Fifty-two patients with 56 peripheral lung cancer were prospectively enrolled,and chest Star-VIBE and T1-VIBE MRI were acquired.The morphological features were observed,and the subjective scores were recorded.The maximum diameter,signal-to-noise ratio(SNR)and contrast-to-noise ratio(CNR)of lesions were measured based on Star-VIBE and T1-VIBE MRI,respectively.Taken CT as the references,the value of Star-VIBE and T1-VIBE MRI for displaying peripheral lung cancer were compared.Results Star-VIBE MRI had higher scores for displaying spiculation sign,lobulation sign,pleural depression sign and halo sign than T1-VIBE(both P＜0.05).CNR and SNR of Star-VIBE MRI were significantly higher than those of T1-VIBE(both P＜0.001).No significant difference of the maximum diameter of lesions measured based on Star-VIBE and T1-VIBE MRI compared with CT was found,nor between Star-VIBE and T1-VIBE MRI(all P＞0.05).Conclusion Star-VIBE MRI had better value for displaying peripheral lung cancer than T1-VIBE.

Objective:To explore the clinical application and effect of repairing the donor site of ipsilateral fibular hallux flap with the transverse V-Y advancement flap of the great toe.Methods:Form January 2017 to January 2020, the donor sites of the ipsilateral fibular hallux flap were repaired by the transverse V-Y advancement flap of the great toe in the Department of Hand Surgery, 521 Hospital of Weapon Industry on 20 patients, including 16 males and 4 females with an average age of 33 (18-52) years old. First, the donor site of the fibular hallux flap was sutured to reduce the size of wound. The width of the remaining wound was 0.4 to 1.6 cm, and the area of the remaining wound was 0.5 cm×0.8 cm-1.6 cm×1.8 cm. Then the remaining wound was repaired with the transverse V-Y advancement flap of the ipsilateral great toe. The distance for transfer of transverse advancement V-Y flap was 0.2-0.8 cm, and the area of the transverse V-Y advancement flap was 1.0 cm×1.4 cm-1.8 cm×2.4 cm. The end of postoperative follow-up was scheduled in July 2021. The follow-up items included: survival of the transverse V-Y advancement flap, wound infection, appearance, shape, texture and sensation of the V-Y advancement flap, pain on the V-Y advancement flap and the great toe, cold tolerance and the scar condition at the donor site of the ipsilateral fibular hallux flap and the V-Y advancement flap, the appearance, sensation and flexion and extension of the great toe at the donor site, other discomforts in the donor site of great toe, walking and other functions affected by the discomforts.Results:The postoperative follow-up lasted from 12 to 18(average of 14) months. All the V-Y advancement flaps survived without infection at the donor sites of the great toe, and donor sites healed primarily. The appearance, shape and texture of the advancement V-Y flap were close to the skin of the same area of the contralateral great toe. The TPD of the V-Y advancement flap and the ipsilateral great toe ranged from 4 to 7 mm. The average score of the Visual analog scale(VAS) was 0.3 and 0.6 respectively in the evaluation of cold tolerance of the advancement V-Y flap and the ipsilateral great toe. The average score of the Vancouver scar scale(VSS) was 0.2 and 1.2 respectively in the scar evaluation of the V-Y advancement flap and the ipsilateral great toe. There was no visual difference between the appearance of the great toe at the donor site and the contralateral toe. There was no pain and other discomfort on the V-Y advancement flap and the ipsilateral great toe. The functions of the donor foot were not affected in walking, running, jumping and tiptoeing in all cases.Conclusion:It is a simple, safe and effective method to repair the donor site of the small-area ipsilateral fibular hallux flap by the transverse V-Y advancement flap of the great toe. It only causes a small wound but the appearance and function of the ipsilateral great toe can be repaired with a transverse V-Y advancement flap of the great toe.

Objective:To explore the clinical efficacy and adverse reactions of albumin-bound paclitaxel (Nab-P) and conventional paclitaxel combined with cisplatin and concurrent radiotherapy for the treatment of patients with locally advanced esophageal squamous cell carcinoma.Methods:Forty-nine patients with locally advanced esophageal squamous cell carcinoma admitted to the First People's Hospital of Suqian from November 2016 to May 2020 were included. Of the 49 patients, 23 cases were treated with Nab-P combined with cisplatin and concurrent radiotherapy (NP group), 26 cases were treated with conventional paclitaxel combined with cisplatin and concurrent radiotherapy (TP group). All patients received 2 cycles of chemotherapy. The curative efficacy was evaluated one month after the end of radiotherapy, and the curative effect and adverse reactions of the two treatment regimens were compared.Results:The objective remission rate in NP group was 78.3% (18/23), and the disease control rate was 100.0% (23/23). The objective response rate in TP group was 61.5% (16/26), and the disease control rate was 92.3% (24/26). The objective response rate and disease control rate in NP group were higher than those in TP group, but the differences were not statistically significant (both P > 0.05). The common adverse reactions were mainly hair loss, loss of appetite, bone marrow suppression, radiation esophagitis, radiation pneumonia, malaise and myalgia. The incidence rate of grade 3-4 acute bone marrow suppression in NP group (8.7%, 2/23) was lower than that in TP group (38.5%, 10/26), and the difference was statistically significant ( χ2 = 4.35, P = 0.037). The incidence rate of myalgia in NP group (26.1%, 6/23) was lower than that in TP group (61.5%, 16/26), and the difference was statistically significant ( χ2 = 4.85, P = 0.028). Conclusions:Nab-P combined with cisplatin and concurrent radiotherapy has good efficacy in the treatment of patients with locally advanced esophageal squamous cell carcinoma, and the incidence rate of adverse reactions is lower than that of conventional paclitaxel combined with cisplatin and concurrent radiotherapy, so that the regimen is safe.