1.Dingchan Granule (定颤颗粒) for Paroxysmal Atrial Fibrillation with Syndrome of Qi Stagnation and Blood Stasis:A Randomized,Double-Blinded,Placebo-Controlled Clinical Trial
Xiaozhen CHENG ; Xingjuan CHEN ; Weina LI ; Lu XIAO ; Yunhan WANG ; Yun XU ; Yueyue NIU ; Ling FENG
Journal of Traditional Chinese Medicine 2025;66(12):1233-1240
ObjectiveTo observe the clinical effectiveness and safety of Dingchan Granule (定颤颗粒) for paroxysmal atrial fibrillation with syndrome of qi stagnation and blood stasis. MethodsUsing a randomised, double-blind, placebo controlled study method, 90 patients with paroxysmal atrial fibrillation with qi stagnation and blood stasis syndrome were divided into 45 cases each in the treatment group and the control group. Both groups were given conventional western medicine treatment, and the treatment group was additionally treated with Dingchan Granule, while the control group was treated with Dingchan Granule placebo, both of which were taken orally for 8 g each time twice a day. Both groups were treated for 8 weeks. We compared the clinical effectiveness, the improvement of traditional Chinese medicine (TCM) symptoms and the recovery rate of atrial fibrillation between the two groups. We compared the number and duration of atrial fibrillation episodes, TCM symptoms score, atrial fibrillation symptom classification, 24-hour average ventricular rate, Pittsburgh Sleep Quality Index (PSQI), anxiety index, depression index before and after treatment, and evaluated the safety of the two groups. ResultsThe total clinical effectiveness rate in the treatment group was 82.22% (37/45), which was better than 60.00% (27/45) in the control group (P<0.05). The total effective rate of TCM syndrome effectiveness in the treatment group was 88.89% (40/45), which was better than 66.67% (30/45) in the control group (P<0.05); and the rate of atrial fibrillation regression in the treatment group was 26.67% (12/45), better than 6.67% (3/45) in the control group (P<0.05). The number and duration of atrial fibrillation episodes in both groups were significantly decreased (P<0.01), and the number and duration of atrial fibrillation episodes in the treatment group were lower than those in the control group (P<0.01). The TCM syndrome scores of both groups after treatment were significantly lower than before treatment (P<0.01), and the scores of the treatment group was lower than those of the control group (P<0.05). The severity of atrial fibrillation symptoms and the grading of atrial fibrillation symptoms in both groups after treatment were improved (P<0.01), and the degree of symptom improvement in the treatment group was better than that in the control group (P<0.01). The 24-hour average ventricular rate of both groups after treatment was significantly lower (P<0.01). The PSQI, anxiety index and depression index of the treatment group were all lower than before treatment (P<0.01), while the PSQI and anxiety index of the control group were both lower than before treatment (P<0.01 or P<0.05), the PSQI, anxiety index and depression index of the treatment group being lower than those of the control group (P<0.05 or P<0.01). No adverse events occurred in both groups, and no abnormalities were observed in blood, urine, stool routine, liver and kidney function, and coagulation function indexes. ConclusionDingchan Granule for paroxysmal atrial fibrillation with qi stagnation and blood stasis syndrome can alleviate clinical symptom, improve TCM symptom scores, increase atrial fibrillation recovery rate, stabilise the average ventricular rate, and significantly improve the quality of sleep, alleviate the anxiety and depression, with a good safety profile.
2.False-positive HIV-1 nucleic acid testing results in patients with severe thalassemia after receiving cell and gene therapy
Yifan ZHONG ; Jifei NIU ; Yue LI ; Jing LIU ; Xiaohui WANG ; Hao LI ; Yongxia GAN ; Guilian LI ; Chenli ZHENG ; Chenglong LI ; Yifan CAI ; Zijie YANG ; Wei TAN ; Xiaozhen CHEN ; Tiejian FENG ; Cong JIN ; Jin ZHAO
Chinese Journal of Laboratory Medicine 2024;47(4):451-454
A 11-year old female patient with severe thalassemia, receipt a lentivirus-based cell and gene therapy (CGT) therapy in Shenzhen Children′s Hosptial on July 27th, 2021. At the two follow-up visits after discharge, patient were continuously tested positive for HIV screening through HIV Ag/Ab Combo assay (chemiluminescence Immunoassay), and the viral load results of HIV-1 nucleic acid testing (NAT) were both>5 000 copies/ml. The patient can be diagnosed with HIV infection according to the National Guideline for Detection of HIV/AIDS(2020 Revised Edition). The thorough investigation findings and supplementary experiment results indicated that the false-positive HIV-1 NAT results was caused by cross-reactivity between the target sites detected by conventional HIV-1 NAT reagents and the lentiviral vectors fragments integrated into the genome of patient′s hematopoietic stem/progenitor cells. In conclusion, it is important for laboratories to select appropriate HIV-1 NAT testing platforms which won′t cause cross-reactivity for the testing of samples from patients who have been treated with HIV-derived vectors. It is also recommended to design and develop NAT testing platforms with multiple target regions labeled by different fluorescents for HIV NAT supplementation experiment to reduce the risk of false-positive diagnoses of HIV infection.
3.Study based on the impact of the timeliness of the first elective operation start time on the operating room costs
Zhihao TAN ; Yiliang CAI ; Jinhuan FENG ; Qin LI ; Xiaozhen XU ; Shishen XU ; Yanfu HUANG ; Jiachen CHEN
Modern Hospital 2024;24(9):1407-1410
Objective To analyze the timeliness of the start time of the first elective operation in a hospital and observe its impact on the operating room cost.Methods Make statistics and analysis on the opening of the first operation in a hospital,record the on-time opening rate of the first operation,analyze the reasons for the delay in the opening time of the first operation,formulate corresponding intervention measures and set up a"management team to improve the efficiency of operating room use".The on-time rate of the first operation,operation,cost control and the satisfaction of surgeons and patients were compared before and after the operation.Results The overall punctuality rate of the first operation was 53.74%,among which the colorectal sur-gery department had the highest punctuality rate of 63.16%,while the minimally invasive surgery department had the lowest punctuality rate of 45.45%.The main reasons for the delay of first operation(35.29%),failed anesthesia(30.88%),and the termination of the operation(17.65%);compared with before implementation,higher overtime time of nurses,shorter opening time and expected time,decreased interval between operation(P<0.05),lower frequency of centralized delivery and unnecessa-ry consumables cost within 1 month after implementation(P<0.05),and higher satisfaction of patients and physicians after im-plementation(P<0.05).Conclusion By improving the first elective operation on time,can effectively reduce the cost of the operating room,shorten the nurse overtime time,at the same time improve the satisfaction of doctors and patients,and improve the management efficiency of the operating room,the first operation on time improved,interval time and unnecessary consumables costs are significantly reduced,optimize the use efficiency of the operating room resources.
4.Long-term outcomes and failure patterns of prophylactic cranial irradiation in limited-stage small cell lung cancer patients managed with modern chemoradiotherapy and diagnostic methods
Xuan LIU ; Zongmei ZHOU ; Zefen XIAO ; Qinfu FENG ; Dongfu CHEN ; Jima LYU ; Jun LIANG ; Nan BI ; Xin WANG ; Lei DENG ; Tao ZHANG ; Wenqing WANG ; Xiaozhen WANG ; Zhouguang HUI ; Lyuhua WANG
Chinese Journal of Radiation Oncology 2021;30(2):114-119
Objective:To evaluate the clinical efficacy and failure patterns of prophylactic cranial irradiation (PCI) in patients with limited-stage small cell lung cancer (LS-SCLC) on the basis of modern chemoradiotherapy and diagnostic techniques.Methods:In this retrospective study, clinical data of 201 LS-SCLC patients treated with chemotherapy (EP/CE regimens, ≥4 cycles) and intensity-modulated radiotherapy (IMRT) in Cancer Hospital of Chinese Academy of Medical Sciences from 2006 to 2014 were reviewed. All patients were primarily managed with concurrent or sequential chemoradiotherapy and achieved complete response (CR) or partial response (PR). Ninety percent of patients were revaluated for brain metastasis (BM) by MRI and 10% by CT scan. Long-term survival and failure patterns were compared between the PCI ( n=91) and non-PCI groups ( n=110). Results:The median follow-up time was 77.3 months (95% CI 73.0-81.5 months). The median overall survival (OS), 2-and 5-year OS rates were 58.5 months, 72.5% and 47.7% in the PCI group, and 34.5 months, 61.7% and 35.8% in the non-PCI group ( P=0.075). The median progression-free survival (PFS), 2-and 5-year PFS rate were 22.0 months, 48.0% and 43.4% in the PCI group, significantly higher than 13.9 months, 34.4% and 26.7% in the non-PCI group ( P=0.002). The 2- and 5-year cumulative incidence of BM were 6.6% and 12.2% in the PCI group, and 30.0% , 31.0% in the non-PCI group ( P=0.001). The median time and rate of BM as an isolated first site of relapse were 11.9 months and 4.4% in the PCI group, and 8.7 months and 25.5% in the non-PCI group ( P<0.001). Multivariate analysis showed that response after chemoradiotherapy ( P<0.001) and PCI ( P=0.033) were the independent prognostic factors for PFS. Stratified analysis demonstrated that PCI significantly improved the 5-year PFS in patients who achieved CR (72.7% vs. 48.0%, P=0.013), while it did not improve the 5-year PFS in patients who obtained PR (26.1% vs. 20.2%, P=0.213). Conclusion:In the new era of standard chemoradiotherapy and more accurate diagnostic methods for BM, PCI was associated with improved PFS and lower incidence of BM in LS-SCLC patients.
5.Analysis of local recurrence pattern for limited stage small cell lung cancer after IMRT plus chemotherapy
Wenbin YAN ; Xuan LIU ; Zongmei ZHOU ; Yuxia WANG ; Zefen XIAO ; Qinfu FENG ; Dongfu CHEN ; Jima L(U) ; Jun LIANG ; Lei DENG ; Tao ZHANG ; Wenqing WANG ; Nan BI ; Xin WANG ; Xiaozhen WANG ; Zhouguang HUI ; Luhua WANG
Chinese Journal of Radiation Oncology 2020;29(3):175-178
Objective To investigate localized regional recurrence after chemotherapy and chest radiotherapy in limited stage small cell lung cancer (LS-SCLC),and explore the relationship between recurrence location and radiotherapy and chemotherapy and its influencing factors.Methods From 2006 to 2014,pathological LS-SCLC treated in CAMS,125 patients had local recurrence,Kaplan-Meier statistical method was used to analyze the survival rate and PFS of each recurrence site.Log-rank was used to compare the survival rate of each group.Univariate analysis includes Chi-squareand t-test for the factors for the recurrence site.Multivariate analysis using Logistic regression.Results The 1-,2-and 5-year overall survival rates were 92.0%,46.4% and 14.7%,respectively.The median progression time was 12.96 months,The median survival time after progression was 1 1.5 months,and the 1-,2-,and 5-year overall survival rates were 45.0%,23.0%,and 10.0%,respectively.The recurrence sites include intrapulmonary recurrence (67 patients),regional lymph nodes (21 patients),simultaneous intrapulmonary and regional lymph nodes (28 patients),and contralateral or supraclavicular lymph nodes (9 patients).The median survival time were 23.96 months,24.76 months,23.23 months,and 18.66 months,and the 2-year survival rates were 49%,52%,46%,and1 1%,respectively (P=0.000,0.004,0.008).In 6 patients (4.0%),5 patients were located in the supraclavicular region,and 1 patient (0.8%) in the field.Conclusions For LS-SCLC undergoing IMRT and chemotherapy,the local failure location is mainly located in the pulmonary,and further treatment of the split dose and targets requires further clinical exploration.
6.Comparison of intracranial venous pressures in patients with idiopathic intracranial hypertension under awake setting or general anesthesia
Xinbin GUO ; Sen WEI ; Xiaozhen SUN ; Xin DENG ; Feng FAN ; Dongdong LI ; Zhen CHEN ; Sheng GUAN
Chinese Journal of Neuromedicine 2020;19(9):958-960
Objective:To investigate the changes of mean venous sinus pressure (MVP) and trans-stenosis pressure gradient in patients with idiopathic intracranial hypertension (IIH) under awake setting and general anesthesia.Methods:Thirty-eight patients with IIH accepted venous sinus stent implantation in our hospital from January 2010 to January 2020 were chosen in our study; their clinical data were analyzed retrospectively. The manometry results of these 38 patients were recorded under awake setting and general anesthesia before stenting; MVP and trans-stenosis pressure gradient were obtained and compared.Results:MVP in the superior sagittal sinus, torcular, transverse sinus and sigmoid sinus showed no significant difference between patients under awake setting and general anesthesia ( P>0.05). Mean trans-stenosis pressure gradient in patients under awake setting ([22.784±7.606] mmHg) was significantly higher as compared with that in patients under general anesthesia ([18.388±8.992] mmHg, P<0.05). Conclusion:Mean trans-stenosis pressure gradient in patients under awake setting is higher as compared with that in patients under general anesthesia, and selection for venous sinus stent implantation should be decided by trans-stenosis pressure gradient in patients under awake setting.
7. Study on safety of adjuvant radiotherapy concurrent with weekly chemotherapy for stage ⅡB-ⅣA esophageal carcinoma after radical resection
Wenjie NI ; Shufei YU ; Jinsong YANG ; Wencheng ZHANG ; Zongmei ZHOU ; Hongxing ZHANG ; Dongfu CHEN ; Qinfu FENG ; Jima LYU ; Jun LIANG ; Xiaozhen WANG ; Xin WANG ; Lei DENG ; Wenqing WANG ; Tao ZHANG ; Nan BI ; Zefen XIAO
Chinese Journal of Oncology 2019;41(6):415-420
Objective:
To evaluate the tolerability and short-term efficacy of chemo-radiotherapy in 125 patients with stage ⅡB-ⅣA esophageal carcinoma after radical resection.
Methods:
We retrospectively evaluated the rate of completion, toxicity and survival of patients undergoing adjuvant concurrent chemo-radiotherapy after radical resection of esophageal carcinoma from January 2004 to December 2014 in our institution. The survival rate was determined by the Kaplan-Meier method and analyzed using the log-rank test. Multivariate prognostic analysis was performed using the Cox proportional hazard model.
Results:
122 patients received more than 50 Gy dose (97.6%). A total of 52 patients received more than 5 weeks chemo-radiotherapy (41.6%), while 73 patients underwent only 1-4 weeks (58.4%). The median following up was 48.4 months. 8 patients lost follow up (6.4%). The 1-year and 3-year overall survival rate were 91.6% and 57.0%, respectively, with a median survival time of 64.4 months. The 1-year and 3-year disease free survival rate were 73.2% and 54.3%, respectively, with a median disease free survival time of 59.1 months. The most common acute complications associated with chemo-radiotherapy were myelosuppression, radiation esophagitis and radiation dermatitis, the majority of which were Grade 1-2. Of the 125 patients, there were 59 cases of recurrence, including 23 cases with local regional recurrence, 26 cases with hematogenous metastasis, and 8 cases with mixed recurrence. Univariate analysis showed that the numbers of concurrent chemotherapy was associated with the overall survival (
8.Study on safety of adjuvant radiotherapy concurrent with weekly chemotherapy for stage ⅡB?ⅣA esophageal carcinoma after radical resection
Wenjie NI ; Shufei YU ; Jinsong YANG ; Wencheng ZHANG ; Zongmei ZHOU ; Hongxing ZHANG ; Dongfu CHEN ; Qinfu FENG ; Jima LYU ; Jun LIANG ; Xiaozhen WANG ; Xin WANG ; Lei DENG ; Wenqing WANG ; Tao ZHANG ; Nan BI ; Zefen XIAO
Chinese Journal of Oncology 2019;41(6):415-420
Objective To evaluate the tolerability and short?term efficacy of chemo?radiotherapy in 125 patients with stageⅡB?ⅣA esophageal carcinoma after radical resection. Methods We retrospectively evaluated the rate of completion, toxicity and survival of patients undergoing adjuvant concurrent chemo?radiotherapy after radical resection of esophageal carcinoma from January 2004 to December 2014 in our institution. The survival rate was determined by the Kaplan?Meier method and analyzed using the log?rank test. Multivariate prognostic analysis was performed using the Cox proportional hazard model. Results 122 patients received more than 50 Gy dose (97.6%). A total of 52 patients received more than 5 weeks chemo? radiotherapy (41.6%), while 73 patients underwent only 1?4 weeks (58.4%). The median following up was 48.4 months. 8 patients lost follow up ( 6.4%). The 1?year and 3?year overall survival rate were 91.6%and 57.0%, respectively, with a median survival time of 64.4 months. The 1?year and 3?year disease free survival rate were 73.2% and 54.3%, respectively, with a median disease free survival time of 59.1 months. The most common acute complications associated with chemo?radiotherapy were myelosuppression, radiation esophagitis and radiation dermatitis, the majority of which were Grade 1?2. Of the 125 patients, there were 59 cases of recurrence, including 23 cases with local regional recurrence, 26 cases with hematogenous metastasis, and 8 cases with mixed recurrence. Univariate analysis showed that the numbers of concurrent chemotherapy was associated with the overall survival (P=0.006). But receiving more than 5 weeks was not the prognostic factor compared to 1 to 4 weeks chemotherapy (P=0.231). Multivariate analysis showed that only the numbers of concurrent chemotherapy was an independent prognostic factor ( P = 0.010 ). Conclusions Postoperative radiotherapy concurrent with weekly chemotherapy could improve the overall survival and decrease the recurrence for stage ⅡB?ⅣA esophageal carcinoma after radical resection. However, the completion rate of chemotherapy was low, so it was necessary to explore reasonable regimens to improve the completion rate and carry out prospective randomized controlled trial.
9.Study on safety of adjuvant radiotherapy concurrent with weekly chemotherapy for stage ⅡB?ⅣA esophageal carcinoma after radical resection
Wenjie NI ; Shufei YU ; Jinsong YANG ; Wencheng ZHANG ; Zongmei ZHOU ; Hongxing ZHANG ; Dongfu CHEN ; Qinfu FENG ; Jima LYU ; Jun LIANG ; Xiaozhen WANG ; Xin WANG ; Lei DENG ; Wenqing WANG ; Tao ZHANG ; Nan BI ; Zefen XIAO
Chinese Journal of Oncology 2019;41(6):415-420
Objective To evaluate the tolerability and short?term efficacy of chemo?radiotherapy in 125 patients with stageⅡB?ⅣA esophageal carcinoma after radical resection. Methods We retrospectively evaluated the rate of completion, toxicity and survival of patients undergoing adjuvant concurrent chemo?radiotherapy after radical resection of esophageal carcinoma from January 2004 to December 2014 in our institution. The survival rate was determined by the Kaplan?Meier method and analyzed using the log?rank test. Multivariate prognostic analysis was performed using the Cox proportional hazard model. Results 122 patients received more than 50 Gy dose (97.6%). A total of 52 patients received more than 5 weeks chemo? radiotherapy (41.6%), while 73 patients underwent only 1?4 weeks (58.4%). The median following up was 48.4 months. 8 patients lost follow up ( 6.4%). The 1?year and 3?year overall survival rate were 91.6%and 57.0%, respectively, with a median survival time of 64.4 months. The 1?year and 3?year disease free survival rate were 73.2% and 54.3%, respectively, with a median disease free survival time of 59.1 months. The most common acute complications associated with chemo?radiotherapy were myelosuppression, radiation esophagitis and radiation dermatitis, the majority of which were Grade 1?2. Of the 125 patients, there were 59 cases of recurrence, including 23 cases with local regional recurrence, 26 cases with hematogenous metastasis, and 8 cases with mixed recurrence. Univariate analysis showed that the numbers of concurrent chemotherapy was associated with the overall survival (P=0.006). But receiving more than 5 weeks was not the prognostic factor compared to 1 to 4 weeks chemotherapy (P=0.231). Multivariate analysis showed that only the numbers of concurrent chemotherapy was an independent prognostic factor ( P = 0.010 ). Conclusions Postoperative radiotherapy concurrent with weekly chemotherapy could improve the overall survival and decrease the recurrence for stage ⅡB?ⅣA esophageal carcinoma after radical resection. However, the completion rate of chemotherapy was low, so it was necessary to explore reasonable regimens to improve the completion rate and carry out prospective randomized controlled trial.
10.Clinical efficacy and prognostic factors of intensity-modulated radiotherapy combined with chemotherapy for limited-stage small cell lung cancer
Xuan LIU ; Zongmei ZHOU ; Yuxia WANG ; Xin DONG ; Dongfu CHEN ; Zefen XIAO ; Qinfu FENG ; Jima LYU ; Jun LIANG ; Xiaozhen WANG ; Zhouguang HUI ; Lyuhua WANG ; Yexiong LI ; Weibo YIN
Chinese Journal of Radiation Oncology 2018;27(3):256-260
Objective To investigate the clinical efficacy and prognosis of intensity-modulated radiotherapy(IMRT)combined with chemotherapy for limited-stage small cell lung cancer(LS-SCLC). Methods A retrospective analysis was performed on the clinical data of 484 LS-SCLC patients treated with chemoradiotherapy in our center from 2006 to 2014. The patients with partial or complete response to IMRT received prophylactic cranial irradiation(PCI). The Kaplan?Meier method was used to calculate survival rates, and the log-rank test and Cox regression were used for univariate and multivariate analyses, respectively. Results In all the patients, the follow-up rate was 93%;the median overall survival(OS) time was 23.8 months;the 2-,3-,and 5-year OS rates were 48.7%,39.8%,and 28.6%,respectively;the median progression-free survival(PFS)time was 14.1 months;the 2-, 3-, and 5-year PFS rates were 34.4%,30.5%, and 28.3%, respectively. The incidence rates of grade ≥3 bone marrow suppression, grade ≥2 radiation esophagitis, and grade ≥2 radiation pneumonitis were 26.9%, 24.8%, and 18.4%, respectively, in SCLC patients after IMRT. The objective response rate was 84.5%. The univariate analysis showed that age, smoking history, TNM stage, PCI, and the number of chemotherapy cycles before radiotherapy were prognostic factors for OS(P= 0.006, 0.001, 0.047, 0.000, and 0.046). The multivariate analysis showed that smoking history and PCI were independent prognostic factors(P=0.001 and 0.000).Conclusions IMRT combined with chemotherapy achieves satisfactory clinical outcomes in the treatment of LS-SCLC. Smoking history and PCI are independent prognostic factors for OS of LS-SCLC patients.

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