1.Analysis on Quality Standard of Sennae Folium(Cassia angustifolia) Dispensing Granules Based on Standard Decoctions
Jinxin LI ; Xue DONG ; Shuai DUAN ; Guiyun CAO ; Jinghua ZHANG ; Yongfu LUAN ; Yongqiang LIN ; Xiaodi DONG ; Zhaoqing MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):192-200
ObjectiveTo establish the quality standards for Sennae Folium(Cassia angustifolia) dispensing granules based on standard decoctions. MethodsHigh performance liquid chromatography(HPLC) specific chromatograms were established for 15 batches of Sennae Folium(C. angustifolia) standard decoctions and 10 of Sennae Folium(C. angustifolia) dispensing granules from different manufacturers, and the similarity evaluation, hierarchical cluster analysis(HCA) and principal component analysis(PCA) were performed. Linear calibration with two reference substances(LCTRS) and quantitative analysis of multi-components by single-marker(QAMS) were established for the common peaks in the specific chromatograms to determine the contents of main components in the decoction pieces, standard decoctions and dispensing granules, and to calculate their transfer rates from decoction pieces to standard decoctions and dispensing granules. ResultsThe similarities of specific chromatograms of 15 batches of Sennae Folium(C. angustifolia) standard decoctions and 10 batches of Sennae Folium(C. angustifolia) dispensing granules were all greater than 0.95, and a total of 8 characteristic peaks were calibrated, and five of them were identified, including kaempferol-3,7-O-diglucoside, apigenin-6,8-di-C-glucoside, quercetin-3-O-gentianoside, sennoside B and sennoside A. HCA and PCA results showed that there were certain differences in the composition of different batches of standard decoctions, but no clustering was observed in the production area. As the standard decoctions, the extract rate of 15 batches of samples was 26.54%-45.38%, the contents of kaempferol-3,7-O-diglucoside, apigenin-6,8-di-C-glucoside, quercetin-3-O-gentianoside, sennoside B and sennoside A were 12.16-19.26, 2.57-4.94, 3.27-5.11, 6.75-11.39, 4.69-7.79 mg·g-1, and their transfer rates from decoction pieces to standard decoctions were 45.41%-79.02%, 29.12%-55.07%, 40.52%-67.90%, 24.72%-49.12%, 27.54%-49.34%, respectively. The extract rates of Sennae Folium(C. angustifolia) dispensing granules(C8-C10) were 38.10%-39.50%, the transfer rates of the above five components from decoction pieces to dispensing granules were 72.85%-73.58%, 53.43%-53.94%, 40.19%-40.74%, 24.62%-25.00%, 28.65%-29.11%, respectively, which were generally consistent with the transfer rates from decoction pieces to standard decoctions. ConclusionCompared with the relative retention time method, LCTRS has higher prediction accuracy and is more suitable for chromatographic columns. The established quality control standard of Sennae Folium(C. angustifolia) dispensing granules based on standard decoction is reasonable and reliable, and all indicators of samples from different manufacturers are within the range specified based on the standard decoction, which can provide reference for the quality control and process research of this dispensing granules.
2.Analysis on Quality Standard of Hedyotis Herba Dispensing Granules Based on Standard Decoction
Jinghua ZHANG ; Nana WU ; Yanan LYU ; Guiyun CAO ; Jiacheng XU ; Yongqiang LIN ; Xiaodi DONG ; Jinxin LI ; Zhaoqing MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):210-217
ObjectiveTo establish the specific chromatogram and quantitative analysis of multi-components by single-marker(QAMS) based on linear calibration using two reference substances(LCTRS), explore the consistency between Hedyotis Herba dispensing granules and standard decoction, and evaluate the quality of the dispensing granules. MethodsHigh performance liquid chromatography(HPLC) specific chromatogram was established based on 15 batches of Hedyotis Herba standard decoction and 10 batches of the dispensing granules, and LCTRS was used to locate chromatographic peaks. The actual retention times of 7 characteristic peaks in the specific chromatogram was measured on 24 different types of C18 columns, taking deacetyl asperulosidic acid and asperulosidic acid as the dual standard compounds, the retention times of the other 5 characteristic peaks were predicted and validated. Based on this, QAMS was developed to determine the contents of four components(deacetyl asperulosidic acid, deacetyl asperulosidic acid methyl ester, asperulosidic acid, and p-coumaric acid). Then, the relative correction factors of deacetyl asperulosidic acid, deacetyl asperulosidic acid methyl ester and p-coumaric acid were calculated using the reference peak of asperulosidic acid in the dual standard compounds, and each component was quantified accordingly. Finally, the consistency between the dispensing granules and standard decoction was assessed by taking extract rate of the standard decoction, consistency of the specific chromatograms, contents and transfer rates of the indicator components as indexes, and the quality of the dispensing granules was evaluated. ResultsThere were 7 common peaks in the characteristic chromatogram of samples of Hedyotis Herba standard decoction and the dispensing granules, and four of them were identified by reference standards, namely deacetyl asperulosidic acid(peak 1), deacetyl asperulosidic acid methyl ester(peak 3), asperulosidic acid(peak 6) and p-coumaric acid(peak 7). The similarity between the dispensing granules and the standard decoction was >0.9. The absolute deviation in the predicted retention time for each component by LCTRS was lower than that of the relative retention time method. The extract rate of the 15 batches of Hedyotis Herba standard decoction ranged from 7.89% to 14.60%, the contents of deacetyl asperulosidic acid, deacetyl asperulosidic acid methyl ester, asperulosidic acid and p-coumaric acid were 6.62-19.70, 3.83-17.99, 1.57-6.69, 1.62-4.52 mg·g-1, and the transfer rates of these components from decoction pieces to the standard decoction were 22.89%-39.60%, 34.03%-62.24%, 24.25%-43.70%, and 40.58%-73.71%, respectively. The extract rate, index component contents and transfer rates from decoction pieces to the three batches of Hedyotis Herba dispensing granules(P1-P3), produced by manufacturer A, were similar to those of the standard decoction prepared from the same batch of decoction pieces, and all fell within the specified range. The contents of the 4 indicator components in 7 batches of the dispensing granules(P4-P10) from manufacturers B-E were all within the range of the content converted from the standard decoction based on the quantity of the dispensing granules. ConclusionThe established specific chromatogram and QAMS based on LCTRS are reasonable and reliable. Based on the evaluation indicators of standard decoction yield, consistency of specific chromatograms, contents and transfer rates of the four index components, the 10 batches of Hedyotis Herba dispensing granules from various manufacturers have exhibited good consistency with the standard decoction, indicating that the current production process is relatively reasonable.
3.Quality Evaluation of Chuanxiong Rhizoma Dispensing Granules Based on HPLC Specific Chromatogram and Two Reference Substances for Determination of Multiple Components
Jinxin LI ; Xue DONG ; Shuai DUAN ; Guiyun CAO ; Jinghua ZHANG ; Yongfu LUAN ; Yongqiang LIN ; Xiaodi DONG ; Zhaoqing MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):246-253
ObjectiveTo establish the specific chromatogram of Chuanxiong Rhizoma dispensing granules(CRdg), and to evaluate its quality by chemometrics and two reference substances for determination of multiple components(TRSDMC). MethodsHigh performance liquid chromatography(HPLC) specific chromatograms were established using 13 batches of CRdg from 7 manufacturers, and preliminary quality evaluation was performed by similarity evaluation and chemometrics analysis. Eight characteristic peaks in the specific chromatogram of CRdg were measured on 22 different types of C18 columns, and the actual retention times were recorded. Taking chlorogenic acid(peak 1) and senkyunolide A(peak 8) as double standard compounds, the retention times of the eight characteristic peaks were predicted by linear calibration using two reference substances(LCTRS), and the method was validated on three other columns of different brands. Taking chlorogenic acid as reference peak, the relative correction factor method(RCFM) was used to quantify cryptochlorogenic acid, caffeic acid, ferulic acid, senkyunolide I and senkyunolide A, and the results were compared with the external standard method(ESM). ResultsThe similarities of specific chromatograms of 13 batches of CRdg were all >0.90, and a total of 8 characteristic peaks were calibrated, and six of them were identified, including chlorogenic acid(peak 1), cryptochlorogenic acid(peak 2), caffeic acid(peak 3), ferulic acid(peak 5), senkyunolide I(peak 6) and senkyunolide A(peak 8). Through chemometric analysis, it was found that ferulic acid, chlorogenic acid, senkyunolide I and cryptochlorogenic acid were the main components causing quality difference in CRdg, and the accuracy of LCTRS in predicting the retention time of 8 characteristic peaks was superior to that of the relative retention time method(RRT). Further comparison of the results obtained from RCFM and ESM showed that there was no statistically significant difference between the two methods. ConclusionA quality evaluation method for CRdg based on HPLC specific chromatogram and TRSDMC is established, its qualitative accuracy is better than that of RRT, the quantitative accuracy is similar to that of ESM, and 4 quality-differentiated components among different manufacturers are found. This method is stable and reliable, and has reference value for the quality evaluation of other dispensing granules.
4.Quality Evaluation of Chuanxiong Rhizoma Dispensing Granules Based on HPLC Specific Chromatogram and Two Reference Substances for Determination of Multiple Components
Jinxin LI ; Xue DONG ; Shuai DUAN ; Guiyun CAO ; Jinghua ZHANG ; Yongfu LUAN ; Yongqiang LIN ; Xiaodi DONG ; Zhaoqing MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):246-253
ObjectiveTo establish the specific chromatogram of Chuanxiong Rhizoma dispensing granules(CRdg), and to evaluate its quality by chemometrics and two reference substances for determination of multiple components(TRSDMC). MethodsHigh performance liquid chromatography(HPLC) specific chromatograms were established using 13 batches of CRdg from 7 manufacturers, and preliminary quality evaluation was performed by similarity evaluation and chemometrics analysis. Eight characteristic peaks in the specific chromatogram of CRdg were measured on 22 different types of C18 columns, and the actual retention times were recorded. Taking chlorogenic acid(peak 1) and senkyunolide A(peak 8) as double standard compounds, the retention times of the eight characteristic peaks were predicted by linear calibration using two reference substances(LCTRS), and the method was validated on three other columns of different brands. Taking chlorogenic acid as reference peak, the relative correction factor method(RCFM) was used to quantify cryptochlorogenic acid, caffeic acid, ferulic acid, senkyunolide I and senkyunolide A, and the results were compared with the external standard method(ESM). ResultsThe similarities of specific chromatograms of 13 batches of CRdg were all >0.90, and a total of 8 characteristic peaks were calibrated, and six of them were identified, including chlorogenic acid(peak 1), cryptochlorogenic acid(peak 2), caffeic acid(peak 3), ferulic acid(peak 5), senkyunolide I(peak 6) and senkyunolide A(peak 8). Through chemometric analysis, it was found that ferulic acid, chlorogenic acid, senkyunolide I and cryptochlorogenic acid were the main components causing quality difference in CRdg, and the accuracy of LCTRS in predicting the retention time of 8 characteristic peaks was superior to that of the relative retention time method(RRT). Further comparison of the results obtained from RCFM and ESM showed that there was no statistically significant difference between the two methods. ConclusionA quality evaluation method for CRdg based on HPLC specific chromatogram and TRSDMC is established, its qualitative accuracy is better than that of RRT, the quantitative accuracy is similar to that of ESM, and 4 quality-differentiated components among different manufacturers are found. This method is stable and reliable, and has reference value for the quality evaluation of other dispensing granules.
5.ERK mediated C-Myc/PD-L1 synergy to investigate tumor suppression effect of Shenqi Yiliu decoction combined with cisplatin in combination with H22 hepatocellular carcinoma tumor bearing mice
Yuping YANG ; Yongqiang DUAN ; Min BAI ; Xin FENG ; Nan ZHOU ; Liren CAO ; Yarong LI ; Lan MA
Chinese Journal of Immunology 2024;40(3):586-591
Objective:To investigate the tumor suppressing effect of Shenqi Yiliu decoction combined with cisplatin via ERK-mediated C-Myc/PD-L1 phase-coordinated pathway on H22 hepatocellular carcinoma tumor-bearing mice and its mechanism.Meth-ods:In 60 SPF-grade male Kunming mice,10 mice were taken as blank group by random number table method,and the other 50 mice were replicated as H22 hepatocellular carcinoma tumor-bearing mouse model.After successful replication of the model,the model mice were randomly divided into model group,cisplatin group[2.5×10-3 g/(kg·3 d)],Shenqi Yiliu decoction low[13.515 g/(kg·d)],me-dium[27.03 g/(kg·d-1)],and high dose[27.030 g/(kg·d)]combined with cisplatin group[2.5×10-3 g/(kg·3 d)],10 mice in each group were treated for 13 d.After 24 h of the last dose,the mice were anesthetized and sacrificed,and the tumor inhibition rate,spleen index and thymus index of each drug group were determined;HE staining was performed to observe the histopathological changes of tumor in mice;ELISA kit was used to detect the contents of EGF and IFN-γ in tumor tissue homogenate;p-ERK1/2,C-Myc and PD-L1 protein expression in tumor tissue were detected by IHC and Western blot;ERK,C-Myc and PD-L1 mRNA expression levels in tumor tissue were detected by RT-PCR.Results:Compared with blank group,the average body mass and spleen index of mice in model group were decreased(P<0.05).Compared with model group,the tumor inhibition effect of each treatment group was obvious,and Shenqi Yiliu decoction combined with cisplatin group inhibited tumor growth in liver cancer mice in a dose-dependent way,im-proved the average body mass,spleen index and thymus index of mice,promoted the necrosis of tumor cells and increased the necrotic area.EGF and IFN-γ contents,P-ERK1/2,C-Myc,PD-L1 protein expressions and ERK,C-Myc,PD-L1 mRNA expression levels were decreased in tumor tissues(P<0.05).Compared with cisplatin group,the therapeutic effect of Shenqi decoction combined with cisplatin in medium and high dose groups was significant,and the difference was statistically significant(P<0.05).Conclusion:Shenqi Yiliu decoction combined with cisplatin effectively inhibited the tumor growth of H22 liver cancer tumor-bearing mice and significantly reduces the expression of C-Myc and PD-L1 proteins in the tumor tissues,which may be through the regulation of ERK signaling path-way-related protein expression to exert tumor suppressive effect.
6.Efficacy of Billroth II anastomosis versus Roux-en-Y anastomosis in laparoscopic distal gastrectomy for gastric cancer
Hui CAO ; Yongqiang JIANG ; Luohai LIU ; Tao ZHENG ; Bao JIANG
Chinese Journal of Primary Medicine and Pharmacy 2024;31(9):1363-1367
Objective:To investigate the efficacy of Billroth II anastomosis versus Roux-en-Y anastomosis in laparoscopic distal gastrectomy for gastric cancer. Methods:A case-control study was conducted to retrospectively analyze the clinical data of 110 patients who underwent laparoscopic distal gastrectomy for gastric cancer at the General Hospital of Huainan Oriental Hospital Group from January 2021 to December 2022. According to the different methods of gastrointestinal reconstruction after distal gastrectomy, the patients were divided into an observation group ( n = 61) and a control group ( n = 49). The observation group was treated with Roux-en-Y anastomosis, while the control group received Billroth II anastomosis. The intraoperative blood loss, operation time, postoperative recovery, early postoperative ambulation time, time to first flatus, food intake, length of hospital stay, and complications were compared between the two groups. Results:The operation time in the control group was (140.0 ± 31.5) minutes, which was significantly shorter than that in the observation group [(180.0 ± 30.5) minutes, t = 6.37, P < 0.05]. There were no statistically significant differences in intraoperative blood loss and early postoperative ambulation time between the two groups (both P > 0.05). In the control group, there were 8 cases of alkaline reflux gastritis (16.3%), 3 cases of afferent loop obstruction (6.1%), and 3 cases of dumping syndrome (6.1%). These proportions were significantly higher than those in the observation group, which reported 2 cases of alkaline reflux gastritis (3.3%), 1 case of afferent loop obstruction (1.6%), and 1 case of dumping syndrome (1.6%) (χ2 = 6.15, 4.54, 4.54, all P < 0.05). Conclusion:Using Roux-en-Y anastomosis for gastrointestinal reconstruction in patients undergoing laparoscopic distal gastrectomy for gastric cancer can help prevent against alkaline reflux gastritis, afferent loop obstruction, and dumping syndrome; however, it results in a longer surgical time compared with Billroth II anastomosis.
7.Diagnosis and treatment understanding of Waldenstr?m macroglobulinemia in China: a cross-sectional study
Shuhua YI ; Wenjie XIONG ; Xinxin CAO ; Chunyan SUN ; Juan DU ; Huihan WANG ; Li WANG ; Ting NIU ; Zhongxing JIANG ; Yongqiang WEI ; Hua XUE ; Hongling CHU ; Lugui QIU ; Jian LI
Chinese Journal of Hematology 2024;45(2):148-155
Objective:To conduct a nationwide physician survey to better understand clinicians’ disease awareness, treatment patterns, and experience of Waldenstr?m macroglobulinemia (WM) in China.Methods:This cross-sectional study was conducted from February 2022 to July 2022 by recruiting clinicians with WM treatment experience from hematology, hematology-oncology, and oncology departments throughout China. Quantitative surveys were designed based on the qualitative interviews.Results:The study included 415 clinicians from 219 hospitals spread across thirty-three cities and twenty-two provinces. As for diagnosis, the laboratory tests prescribed by physicians for suspected WM patients were relatively consistent (92% -99% recommendation for laboratory, 79% -95% recommendation for pathology, 96% recommendation for gene testing, and 63% -83% recommendation for imaging examination). However, from a physician's perspective, there was 22% misdiagnosis occurred in clinical practice. The rate of misdiagnosis was higher in lower-level hospitals than in tertiary grade A hospitals (29% vs 21%, P<0.001). The main reasons for misdiagnosis were that WM was easily confused with other diseases, and physicians lacked the necessary knowledge to make an accurate diagnosis. In terms of gene testing in clinical practice, 96% of participating physicians believed that WM patients would require gene testing for MYD88 and CXCR4 mutations because the results of gene testing would aid in confirming diagnosis and treatment options. In terms of treatment, 55% of physicians thought that the most important goal was to achieve remission, while 54% and 51% of physicians wanted to improve laboratory and/or examination results and extend overall survival time, respectively. Among patients with treatment indications, physicians estimated that approximately 21% of them refused to receive treatment, mainly owing to a lack of affordable care and disease awareness. When selecting the most appropriate treatment regimens, physicians would consider patient affordability (63% ), comorbidity (61% ), and risk level (54% ). Regimens containing Bruton tyrosine kinase inhibitor (BTKi) were most widely recommended for both treatment-na?ve and relapsed/refractory patients (94% for all patients, 95% for treatment-na?ve patients, and 75% for relapsed/refractory patients), and most physicians recommended Ibrutinib (84% ). For those patients who received treatment, physicians reported that approximately 23% of patients did not comply with the treatment regimen due to a lack of affordability and disease awareness. Furthermore, 66% of physicians believe that in the future, increasing disease awareness and improving diagnosis rates is critical. Conclusions:This study is the first national physician survey of WM conducted in China. It systematically describes the issues that exist in WM diagnosis and treatment in China, such as a high rate of misdiagnosis, limited access to gene testing and new drugs, and poor patient adherence to treatment. Chinese doctors believe that improving doctors’ and patients’ understanding of WM is one of the most urgent issues that must be addressed right now.
8.Effect of Shenqi Yiliu Prescription Combined with Cisplatin on Tumor in Hepatoma H22-bearing Mice Based on PTEN/PI3K/Akt Signaling Pathway
Xin FENG ; Yongqiang DUAN ; Min BAI ; Yuping YANG ; Liren CAO ; Junrui HU ; Yanhua SI ; Jing CHEN ; Zihan GONG ; Lan MA
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(3):96-103
ObjectiveTo investigate the tumor-suppressing effect of Shenqi Yiliu prescription combined with cisplatin in hepatoma H22-bearing mice based on the phosphatase and tensin homolog deleted on chromosome ten (PTEN)/phosphatidylinositol-3-kinase (PI3K)/protein kinase B (Akt) pathway. MethodH22-bearing mice were prepared and randomized into model group, cisplatin group, and cisplatin combined with high-, medium-, and low-dose Shenqi Yiliu prescription groups, with 10 mice in each group. Another 10 healthy mice were randomly selected as normal group. Shenqi Yiliu prescription was given by gavage with the high, medium, low dose of 54.06, 27.03, 13.515 g·kg-1·d-1, respectively, and cisplatin (2.5 mg·kg-1) was administered by intraperitoneal injection, twice a week. Normal group and model group received normal saline. After 13 days of treatment, mice were killed and the tumor inhibition rate was calculated. The pathomorphological changes of tumor were observed based on hematoxylin-eosin (HE) staining, and enzyme-linked immunosorbent assay (ELISA) and immunofluorescence method were used to detect the content of cyclin-dependent kinase inhibitor 1A (p21) and cyclin-dependent kinase inhibitor 1B (p27) in tumor tissue of mice. The levels of PTEN, PI3K and phosphorylated protein kinase B (p-Akt) in tumor tissue were measured by Western blot. ResultCompared with the model group, cisplatin alone and cisplatin in combination with the high-, medium-, and low-dose Shenqi Yiliu prescription decreased tumor mass (P<0.05), particularly the cisplatin in combination with the high-dose Shenqi Yiliu prescription. Necrosis of the tumor tissue was observed in each group, especially the cisplatin combined with high-dose Shenqi Yiliu prescription group. As compared with the model group, cisplatin alone and cisplatin in combination with the high-, medium-, and low-dose Shenqi Yiliu prescription raised the expression of p21, p27, and PTEN (P<0.05) and lowered the expression of PI3K and p-Akt (P<0.05), particularly the cisplatin in combination with high-dose Shenqi Yiliu prescription. ConclusionShenqi Yiliu prescription may regulate the expression of key molecules in PTEN/PI3K/Akt signaling pathway, thereby upregulating the expression of downstream proliferation inhibitors p21 and p27, further suppressing the tumor in H22-bearing mice, and enhancing the effect of chemotherapy.
9.Analysis on Quality Standard of Fraxini Cortex(Fraxinus chinensis) Dispensing Granules Based on Standard Decoction
Guiyun CAO ; Bo NING ; Jinmiao QIN ; Xuesong ZHUANG ; Daijie WANG ; Yongqiang LIN ; Xiaodi DONG ; Yi LUO ; Zhaoqing MENG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(13):122-129
ObjectiveTo establish the quality standard for Fraxini Cortex(Fraxinus chinensis) dispensing granules based on standard decoction, and to provide a basis for the quality control of this dispensing granules. MethodHigh performance liquid chromatography(HPLC) specific chromatograms of 15 batches of Fraxini Cortex(F. chinensis) standard decoctions and 3 batches of Fraxini Cortex(F. chinensis) dispensing granules were established with the mobile phase of 0.1% phosphoric acid aqueous solution(A)-acetonitrile(B) for gradient elution(0-10 min, 12%-15%B; 10-30 min, 15%-32%B) and the detection wavelength of 220 nm. And similarity evaluation, cluster analysis and principal component analysis(PCA) were also carried out. HPLC quantitative analysis of multi-components by single marker(QAMS) was established to determine the contents of the main components in the standard decoctions and dispensing granules. The contents of the corresponding components in Fraxini Cortex(F. chinensis) decoction pieces were also detected, and the transfer rates from decoction pieces to standard decoctions and dispensing granules were calculated. ResultThe similarities between specific chromatograms of 15 batches of Fraxini Cortex(F. chinensis) standard decoctions and 3 batches of Fraxini Cortex(F. chinensis) dispensing granules were all>0.9, and 7 common peaks were identified. The results of cluster analysis and PCA showed that there was some differences in the composition of different batches of standard decoctions, but did not show aggregation of origin. As the standard decoctions, the extract rate was 6.18%-11.62%, the contents of esculin, syringin, fraxin, esculetin, fraxetin, calceolarioside B were 44.92-103.51, 1.36-11.87, 33.26-90.73, 4.63-29.75, 2.40-16.86, 2.49-17.35 mg·g-1, and the transfer rates from decoction pieces to standard decoction were 25.21%-42.54%, 52.57%-88.84%, 43.43%-79.45%, 49.15%-88.27%, 49.22%-72.69%, 27.66%-47.67%, respectively. The extract rates of Fraxini Cortex(F. chinensis) dispensing granules were 10.4%-10.7%, the transfer rates of the above six components from decoction pieces to dispensing granules were 42.76%-43.17%, 80.01%-80.90%, 59.59%-59.88%, 51.35%-52.67%, 60.50%-60.93%, 37.98%-38.37%, respectively, which were generally consistent with the transfer rates from decoction pieces to standard decoctions. ConclusionThe established quality control standard of Fraxini Cortex(F. chinensis) dispensing granules based on standard decoctions is reasonable and reliable, which can provide reference for the quality control and process research of this dispensing granules.
10.A multicenter randomized controlled trial of domestic robot-assisted and conventional total knee arthroplasty.
Yicheng LI ; Xiaogang ZHANG ; Li CAO ; Yongqiang SUN ; Ye YE ; Jie XIE ; Yihe HU ; Zhong LI ; Bensen TANG
Chinese Journal of Reparative and Reconstructive Surgery 2023;37(11):1326-1334
OBJECTIVE:
To investigate the accuracy, safety, and short-term effectiveness of a domestic robot-assisted system in total knee arthroplasty (TKA) by a multicenter randomized controlled trial.
METHODS:
Between December 2021 and February 2023, 138 patients with knee osteoarthritis who received TKA in 5 clinical centers were prospectively collected, and 134 patients met the inclusion criteria were randomly assigned to either a trial group ( n=68) or a control group ( n=66). Seven patients had lost follow-up and missing data, so they were excluded and the remaining 127 patients were included for analysis, including 66 patients in the trial group and 61 patients in the control group. There was no significant difference ( P>0.05) in gender, age, body mass index, side, duration of osteoarthritis, Kellgren-Lawrence grading, preoperative Knee Society Score (KSS) and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score between the two groups. The trial group completed the TKA by domestic robot-assisted osteotomy according to the preoperative CT-based surgical planning. The control group was performed by traditional osteotomy plate combined with soft tissue release. Total operation time, osteotomy time of femoral/tibial side, intraoperative blood loss, and postoperative complications were recorded and compared between the two groups. The radiographs were taken at 5 and 90 days after operation, and hip-knee-ankle angle (HKA), lateral distal angle of femur (LDFA), and posterior tibial slope (PTS) were measured. The difference between the measured values of the above indexes at two time points after operation and the preoperative planning target values was calculated, and the absolute value (absolute error) was taken for comparison between the two groups. The postoperative recovery of lower limb alignment was judged and the accuracy was calculated. KSS score and WOMAC score were used to evaluate the knee joint function of patients before operation and at 90 days after operation. The improvement rates of KSS score and WOMAC score were calculated. The function, stability, and convenience of the robot-assisted system were evaluated by the surgeons.
RESULTS:
The total operation time and femoral osteotomy time of the trial group were significantly longer than those of the control group ( P<0.05). There was no significant difference in the tibial osteotomy time and the amount of intraoperative blood loss between the two groups ( P>0.05). The incisions of both groups healed by first intention after operation, and there was no infection around the prosthesis. Nine patients in the trial group and 8 in the control group developed lower extremity vascular thrombosis, all of which were calf intermuscular venous thrombosis, and there was no significant difference in the incidence of complications ( P>0.05). All patients were followed up 90 days. There was no significant difference in KSS score and WOMAC score between the two groups at 90 days after operation ( P>0.05). There was significant difference in the improvement rate of KSS score between the two groups ( P<0.05), while there was no significant difference in the improvement rate of WOMAC score between the two groups ( P>0.05). Radiological results showed that the absolute errors of HKA and LDFA in the trial group were significantly smaller than those in the control group at 5 and 90 days after operation ( P<0.05), and the recovery accuracy of lower limb alignment was significantly higher than that in control group ( P<0.05). The absolute error of PTS in the trial group was significantly smaller than that in the control group at 5 days after operation ( P<0.05), but there was no significant difference at 90 days between the two groups ( P>0.05). The functional satisfaction rate of the robot-assisted system was 98.5% (65/66), and the satisfaction rates of stability and convenience were 100% (66/66).
CONCLUSION
Domestic robot-assisted TKA is a safe and effective surgical treatment for knee osteoarthritis, which can achieve favorable lower limb alignment reconstruction, precise implant of prosthesis, and satisfactory functional recovery.
Humans
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Arthroplasty, Replacement, Knee/methods*
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Osteoarthritis, Knee/surgery*
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Blood Loss, Surgical
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Robotics
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Knee Joint/surgery*
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Knee Prosthesis
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Retrospective Studies

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