1.Efficacy Analysis of RCT of Arsenic-containing TCM Compound in Treatment of Myelodysplastic Syndrome Based on MMRM and Win Ratio
Daxiang SUN ; Peizhen JIANG ; Haixia DI ; Bing WU ; Qifeng LIU ; Jian LIU ; Jiahe LIANG ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):251-259
ObjectiveThis paper aims to conduct a secondary analysis of a randomized controlled trial on the treatment of myelodysplastic syndrome (MDS) with deficiency of both the spleen and kidney and blockage of toxin and blood stasis with an arsenic-containing traditional Chinese medicine compound, by applying the mixed model for repeated measure (MMRM) and the method of stratified composite outcome with win ratio. The analysis includes the assessment of hematological efficacy and the composite outcome evaluation of adverse reactions, so as to more comprehensively assess the therapy of this regimen. MethodsThe MMRM and win ratio methods were used to evaluate the efficacy of a prospective,multi-center,double-blind,randomized controlled study. The blood routine (hemoglobin concentration,neutrophil count, and platelet count) and biochemical indexes (aspartate aminotransferase,alanine aminotransferase,serum creatinine,and serum ferritin) of the patients were detected at the time of enrollment and at the end of each course of treatment in the laboratory department of Xiyuan Hospital. The patients' syndromes at the time of enrollment and after treatment were recorded and scored according to the therapy standard of traditional Chinese medicine for diseases and syndromes. MMRM was used to analyze the blood routine indexes of the experimental group and the control group. This method has the advantages of high data reliability and dynamic efficacy under intervention and time. The win ratio method was used to evaluate the composite outcome of traditional Chinese medicine syndrome scores and biochemical indexes according to the priority and to verify the clinical safety of arsenic-containing traditional Chinese medicine compound. ResultsThe results of MMRM analysis showed that the hemoglobin concentration of patients in the group with arsenic-containing traditional Chinese medicine compound increased significantly compared with that before treatment in the group,while that in the placebo group decreased significantly (P<0.01). When compared with that after treatment in the placebo group,the hemoglobin concentration of patients in the group with arsenic-containing traditional Chinese medicine compound increased significantly,and the mean difference of least squares (LS) was statistically significant (P<0.01). When compared with those before treatment in the group,there were no statistically significant differences in the neutrophil count and platelet count in both groups. After treatment,there were no statistically significant differences in the neutrophil count, platelet count, and the mean difference of LS between the two groups. The analysis results of win ratio showed that the group with arsenic-containing traditional Chinese medicine compound had a significant advantage in the comparison of composite outcomes,with a win ratio (95% CI) of 2.01 (1.24-3.27) (P<0.01),and that the possibility of "winning" in terms of safety was 2.01 times that of the placebo group. The safety advantage of the group with arsenic-containing traditional Chinese medicine compound mainly came from the traditional Chinese medicine syndrome scores,renal function indexes, and iron reserve capacity indexes,and the number of winning times was less than that of losing times in the comparison of liver function outcomes. ConclusionThe MMRM analysis proves that the arsenic-containing traditional Chinese medicine compound can significantly improve the hemoglobin concentration of patients with myelodysplastic syndrome with refractory cytopenia and multilineage dysplasia (MDS-RCMD) of the type of deficiency of both the spleen and kidney and blockage of toxin and blood stasis. This conclusion is not interfered with by time trends and individual relationships and methodologically improves the credibility of the therapy of the arsenic-containing traditional Chinese medicine compound in treating MDS. Four outcomes are evaluated by the win ratio method,namely traditional Chinese medicine syndromes,liver function,renal function, and iron reserve capacity,proving that the arsenic-containing traditional Chinese medicine compound has the comprehensive advantages of improving the survival quality of the patients and reducing adverse reactions. The win ratio outcome provides clear comparative indexes for the evaluation of adverse reactions,making it easier for regulatory authorities,medical staff, and patients to understand the safety of the arsenic-containing traditional Chinese medicine compound in clinical application.
2.Population Characteristics of Arsenic-containing TCM Compounds in the Treatment of Platelets in Myelodysplastic Syndrome
Jian LIU ; Wenru WANG ; Peizhen JIANG ; Kaizhi LU ; Qinlong ZHENG ; Haixia DI ; Lijuan YAO ; Bing WU ; Jiangwei WAN ; Qifeng LIU ; Ruibai LI ; Xudong TANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(9):154-160
Objective To compare the differences of baseline characteristics of patients with myelodysplastic syndrome(MDS)who achieved platelet(PLT)response after arsenic-containing TCM compounds combined with Western medicine treatment.Methods Totally 72 MDS patients were selected from 12 outpatient departments and wards,such as Xiyuan Hospital,China Academy of Chinese Medical Sciences,Dongfang Hospital,Beijing University of Chinese Medicine from October 2021 to October 2024.Among them,45 patients received arsenic-containing TCM compounds combined with Western medicine treatment,27 patients received Western medicine treatment.The blood routine[white blood cell(WBC)count,hemoglobin,PLT,neutrophil count],TCM syndrome scores,safety indicators,and adverse events were observed before and after three courses of treatment.The efficacy of all patients was evaluated,and the baseline characteristics of patients who achieved PLT response in the arsenic-containing TCM compounds group and the Western medicine treatment group were compared.Results Comparing the differences of baseline characteristics of the two groups,it was found that the patients who achieved PLT response in the arsenic-containing TCM compounds group were compared with those in the Western medicine treatment group:Age<60 years old(P=0.038),longer disease duration(P=0.012),lower WBC(P=0.017),lower reticulocyte percentage(P=0.037),lower blood urea nitrogen(P=0.046),lower high-density lipoprotein cholesterol(P=0.014),and lower N-terminal pro-B-type natriuretic peptide(P=0.034),abnormal electrocardiogram(P=0.013),high blasts(P=0.009),grade 0 reticular fiber staining(P<0.01),normal chromosome karyotype(P<0.01),gene mutation(P<0.01)and high TCM syndrome scores(P=0.013)were found.Conclusion Arsenic-containing TCM compounds consisting of Qinghuang Powder and Bushen Jianpi Decoction combined with Western medicine is used to treat MDS.Patients with age<60 years old,long disease duration,low WBC count,low reticulocyte percentage,low blood urea nitrogen,low high-density lipoprotein cholesterol,low N-terminal pro-B-type natriuretic peptide,abnormal electrocardiogram,high blasts,grade 0 reticular fiber staining,normal chromosome karyotype,gene mutation and high TCM syndrome score are more likely to obtain PLT response.
3.Analysis on Characteristics of Peripheral Blood Recovery in Treatment of Aplastic Anemia with Bushen Shengxue Method and Yiqi Yangxue Method Combined with Western Medicine
Yaoyin ZHANG ; Jiaqi HE ; Chaochang ZHANG ; Wenru WANG ; Yubin DING ; Jinhuan WANG ; Ruirong XU ; Haixia DI ; Jiangwei WAN ; Qifeng LIU ; Haixia WANG ; Antao SUN ; Xudong TANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):151-157
Objective To investigate the characteristics of peripheral blood in the treatment of aplastic anemia(AA)with Bushen Shengxue Method and Yiqi Yangxue Method combined with Western medicine.Methods Totally 492 AA patients who were treated in 19 centers including Xiyuan Hospital China Academy of Chinese Medical Sciences from September 2018 to March 2021 were selected,and were randomized into three groups:161 cases in the Bushen Shengxue group,164 cases in the Yiqi Yangxue group,and 167 cases in the control group.All three groups were orally administered cyclosporine and androgens.Bushen Shengxue group was given Bushen Shengxue Granules,Yiqi Yangxue group was given Yiqi Yangxue Granules,and the control group was given placebo(half dosage of Bushen Shengxue granules).The general data,overall efficacy,and peripheral blood at the 1st month,the 4th month,and 6th month after treatment were analyzed.Results The total effective rate of Bushen Shengxue group was 98.8%(159/161),which was significantly higher than that of Yiqi Yangxue group(79.9%)and the control group(61.7%),with statistical significance(P<0.001);The total effective rate of Yiqi Yangxue group was significantly higher than that of the control group(P<0.001).Compared with before treatment,the hemoglobin(HGB)levels of all three groups of patients significantly increased after treatment(P<0.001,P<0.01),and the platelet levels of Bushen Shengxue group and the control group significantly increased after treatment(P<0.001);after treatment,the HGB levels in the three groups were ranked from high to low as the Bushen Shengxue group,Yiqi Yangxue group and the control group(P<0.01).25%of patients had HGB levels exceeding 20%of baseline values,Bushen Shengxue group took 1 month,while Yiqi Yangxue group and control group took 4 months;25%of patients had an increase in HGB levels exceeding 50%of the baseline value,Bushen Shengxue group took 6 months,while Yiqi Yangxue group and control group took more than 6 months.At 6 months,the number of patients with HGB elevation exceeding 20%and 50%of baseline values in Bushen Shengxue group was higher than that in Yiqi Yangxue group and the control group(P<0.05,P<0.001).25%of patients had white blood cell elevation exceeding 50%of the baseline value,Bushen Shengxue group took 4 months,Yiqi Yangxue group took 6 months,and the control group took more than 6 months.25%of patients showed an increase in platelet levels exceeding 100%of the baseline value,Bushen Shengxue group took 4 months,while Yiqi Yangxue group and control group took 6 months;at 6 months,the number of patients in Bushen Shengxue group and Yiqi Yangxue group with platelet elevation exceeding 20%of the baseline value was significantly higher than that in the control group(P<0.01,P<0.05).Conclusion Bushen Shengxue method combined with Western medicine intreating AA is better than the method of Yiqi Yangxue method combined with Western medicine.In terms of improving HGB,it is reflected in shortening the recovery time and increasing the number of beneficiaries,and the dosage can affect the recovery time and the number of beneficiaries at the same time;in terms of improving white blood cell and platelet,it is reflected in shortening the recovery time,and the dosage can affect the recovery time.
4.Clinical Study on the Huoxue Jiedu Prescription for the Treatment of Polycythemia Vera with Heat Toxicity and Blood Stasis Syndrome
Yumin ZHAO ; Yuliang ZHANG ; Guozi WANG ; Pengmin ZHAO ; Mengjun ZHAO ; Xizan LIU ; Zhaoxia LI ; Haixia DI
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(4):141-145
Objective To evaluate the clinical efficacy and safety of Huoxue Jiedu Prescription in the treatment of polycythemia vera with heat toxicity and blood stasis syndrome.Methods Totally 155 patients of polycythemia vera with heat toxicity and blood stasis syndrome from 5 hospitals including Langfang Traditional Chinese Medicine Hospital from October 2022 to March 2024 were collected.Patients were divided into an observation group(79 cases)and control group(76 cases)using a random number table method.Both groups received conventional Western medicine treatment.The observation group was given Huoxue Jiedu Prescription,one dosage per day,taken orally twice a day;both groups received one treatment course of one month,and three treatment courses were observed.The efficacy of Western medicine and TCM syndromes was observed,and the total symptom assessment scale of myeloproliferative neoplasms(MPN-10)scores,hematological indicators,coagulation function before and after treatment were compared.The safety indicators of the two groups were monitored.Results The control group and observation group lost 2 and 4 cases,respectively.The total effective rate of Western medicine in the observation group was 90.67%(68/75),while the control group was 67.57%(50/74),with statistical significance(P<0.01).The total effective rate of TCM syndromes in the observation group was 94.67%(71/75),while in the control group was 71.62%(53/74),with statistical significance(P<0.01).Compared with before treatment,the total score of MPN-10 in both groups significantly decreased(P<0.05);after treatment,the total score of MPN-10 in the observation group was lower than that in the control group(P<0.05).Compared with before treatment,both groups showed significant reductions in hemoglobin,white blood cell count,hematocrit and platelet count after treatment(P<0.05);after treatment,the above hematological indicators in the observation group were better than those in the control group(P<0.05).Compared with before treatment,the levels of D-dimer and fibrinogen in both groups significantly decreased after treatment,and the activated partial thromboplastin time and prothrombin time were significantly shortened(P<0.05);after treatment,the observation group showed better improvement in the coagulation function indicators compared to the control group(P<0.05).There were no significant adverse reactions in the two groups.Conclusion Huoxue Jiedu Prescription can improve clinical efficacy of polycythemia vera with heat toxicity and blood stasis syndrome,improve hematological indexes,reduce coagulation indexes,and has good safety.
5.Clinical Study on the Huoxue Jiedu Prescription for the Treatment of Polycythemia Vera with Heat Toxicity and Blood Stasis Syndrome
Yumin ZHAO ; Yuliang ZHANG ; Guozi WANG ; Pengmin ZHAO ; Mengjun ZHAO ; Xizan LIU ; Zhaoxia LI ; Haixia DI
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(4):141-145
Objective To evaluate the clinical efficacy and safety of Huoxue Jiedu Prescription in the treatment of polycythemia vera with heat toxicity and blood stasis syndrome.Methods Totally 155 patients of polycythemia vera with heat toxicity and blood stasis syndrome from 5 hospitals including Langfang Traditional Chinese Medicine Hospital from October 2022 to March 2024 were collected.Patients were divided into an observation group(79 cases)and control group(76 cases)using a random number table method.Both groups received conventional Western medicine treatment.The observation group was given Huoxue Jiedu Prescription,one dosage per day,taken orally twice a day;both groups received one treatment course of one month,and three treatment courses were observed.The efficacy of Western medicine and TCM syndromes was observed,and the total symptom assessment scale of myeloproliferative neoplasms(MPN-10)scores,hematological indicators,coagulation function before and after treatment were compared.The safety indicators of the two groups were monitored.Results The control group and observation group lost 2 and 4 cases,respectively.The total effective rate of Western medicine in the observation group was 90.67%(68/75),while the control group was 67.57%(50/74),with statistical significance(P<0.01).The total effective rate of TCM syndromes in the observation group was 94.67%(71/75),while in the control group was 71.62%(53/74),with statistical significance(P<0.01).Compared with before treatment,the total score of MPN-10 in both groups significantly decreased(P<0.05);after treatment,the total score of MPN-10 in the observation group was lower than that in the control group(P<0.05).Compared with before treatment,both groups showed significant reductions in hemoglobin,white blood cell count,hematocrit and platelet count after treatment(P<0.05);after treatment,the above hematological indicators in the observation group were better than those in the control group(P<0.05).Compared with before treatment,the levels of D-dimer and fibrinogen in both groups significantly decreased after treatment,and the activated partial thromboplastin time and prothrombin time were significantly shortened(P<0.05);after treatment,the observation group showed better improvement in the coagulation function indicators compared to the control group(P<0.05).There were no significant adverse reactions in the two groups.Conclusion Huoxue Jiedu Prescription can improve clinical efficacy of polycythemia vera with heat toxicity and blood stasis syndrome,improve hematological indexes,reduce coagulation indexes,and has good safety.
6.Population Characteristics of Arsenic-containing TCM Compounds in the Treatment of Platelets in Myelodysplastic Syndrome
Jian LIU ; Wenru WANG ; Peizhen JIANG ; Kaizhi LU ; Qinlong ZHENG ; Haixia DI ; Lijuan YAO ; Bing WU ; Jiangwei WAN ; Qifeng LIU ; Ruibai LI ; Xudong TANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(9):154-160
Objective To compare the differences of baseline characteristics of patients with myelodysplastic syndrome(MDS)who achieved platelet(PLT)response after arsenic-containing TCM compounds combined with Western medicine treatment.Methods Totally 72 MDS patients were selected from 12 outpatient departments and wards,such as Xiyuan Hospital,China Academy of Chinese Medical Sciences,Dongfang Hospital,Beijing University of Chinese Medicine from October 2021 to October 2024.Among them,45 patients received arsenic-containing TCM compounds combined with Western medicine treatment,27 patients received Western medicine treatment.The blood routine[white blood cell(WBC)count,hemoglobin,PLT,neutrophil count],TCM syndrome scores,safety indicators,and adverse events were observed before and after three courses of treatment.The efficacy of all patients was evaluated,and the baseline characteristics of patients who achieved PLT response in the arsenic-containing TCM compounds group and the Western medicine treatment group were compared.Results Comparing the differences of baseline characteristics of the two groups,it was found that the patients who achieved PLT response in the arsenic-containing TCM compounds group were compared with those in the Western medicine treatment group:Age<60 years old(P=0.038),longer disease duration(P=0.012),lower WBC(P=0.017),lower reticulocyte percentage(P=0.037),lower blood urea nitrogen(P=0.046),lower high-density lipoprotein cholesterol(P=0.014),and lower N-terminal pro-B-type natriuretic peptide(P=0.034),abnormal electrocardiogram(P=0.013),high blasts(P=0.009),grade 0 reticular fiber staining(P<0.01),normal chromosome karyotype(P<0.01),gene mutation(P<0.01)and high TCM syndrome scores(P=0.013)were found.Conclusion Arsenic-containing TCM compounds consisting of Qinghuang Powder and Bushen Jianpi Decoction combined with Western medicine is used to treat MDS.Patients with age<60 years old,long disease duration,low WBC count,low reticulocyte percentage,low blood urea nitrogen,low high-density lipoprotein cholesterol,low N-terminal pro-B-type natriuretic peptide,abnormal electrocardiogram,high blasts,grade 0 reticular fiber staining,normal chromosome karyotype,gene mutation and high TCM syndrome score are more likely to obtain PLT response.
7.Analysis on Characteristics of Peripheral Blood Recovery in Treatment of Aplastic Anemia with Bushen Shengxue Method and Yiqi Yangxue Method Combined with Western Medicine
Yaoyin ZHANG ; Jiaqi HE ; Chaochang ZHANG ; Wenru WANG ; Yubin DING ; Jinhuan WANG ; Ruirong XU ; Haixia DI ; Jiangwei WAN ; Qifeng LIU ; Haixia WANG ; Antao SUN ; Xudong TANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):151-157
Objective To investigate the characteristics of peripheral blood in the treatment of aplastic anemia(AA)with Bushen Shengxue Method and Yiqi Yangxue Method combined with Western medicine.Methods Totally 492 AA patients who were treated in 19 centers including Xiyuan Hospital China Academy of Chinese Medical Sciences from September 2018 to March 2021 were selected,and were randomized into three groups:161 cases in the Bushen Shengxue group,164 cases in the Yiqi Yangxue group,and 167 cases in the control group.All three groups were orally administered cyclosporine and androgens.Bushen Shengxue group was given Bushen Shengxue Granules,Yiqi Yangxue group was given Yiqi Yangxue Granules,and the control group was given placebo(half dosage of Bushen Shengxue granules).The general data,overall efficacy,and peripheral blood at the 1st month,the 4th month,and 6th month after treatment were analyzed.Results The total effective rate of Bushen Shengxue group was 98.8%(159/161),which was significantly higher than that of Yiqi Yangxue group(79.9%)and the control group(61.7%),with statistical significance(P<0.001);The total effective rate of Yiqi Yangxue group was significantly higher than that of the control group(P<0.001).Compared with before treatment,the hemoglobin(HGB)levels of all three groups of patients significantly increased after treatment(P<0.001,P<0.01),and the platelet levels of Bushen Shengxue group and the control group significantly increased after treatment(P<0.001);after treatment,the HGB levels in the three groups were ranked from high to low as the Bushen Shengxue group,Yiqi Yangxue group and the control group(P<0.01).25%of patients had HGB levels exceeding 20%of baseline values,Bushen Shengxue group took 1 month,while Yiqi Yangxue group and control group took 4 months;25%of patients had an increase in HGB levels exceeding 50%of the baseline value,Bushen Shengxue group took 6 months,while Yiqi Yangxue group and control group took more than 6 months.At 6 months,the number of patients with HGB elevation exceeding 20%and 50%of baseline values in Bushen Shengxue group was higher than that in Yiqi Yangxue group and the control group(P<0.05,P<0.001).25%of patients had white blood cell elevation exceeding 50%of the baseline value,Bushen Shengxue group took 4 months,Yiqi Yangxue group took 6 months,and the control group took more than 6 months.25%of patients showed an increase in platelet levels exceeding 100%of the baseline value,Bushen Shengxue group took 4 months,while Yiqi Yangxue group and control group took 6 months;at 6 months,the number of patients in Bushen Shengxue group and Yiqi Yangxue group with platelet elevation exceeding 20%of the baseline value was significantly higher than that in the control group(P<0.01,P<0.05).Conclusion Bushen Shengxue method combined with Western medicine intreating AA is better than the method of Yiqi Yangxue method combined with Western medicine.In terms of improving HGB,it is reflected in shortening the recovery time and increasing the number of beneficiaries,and the dosage can affect the recovery time and the number of beneficiaries at the same time;in terms of improving white blood cell and platelet,it is reflected in shortening the recovery time,and the dosage can affect the recovery time.
8.Changes of Immunological Indexes and Blood Routine in Treatment of Aplastic Anemia by Yiqi Yangxue Prescription
Yaoyin ZHANG ; Chaochang ZHANG ; Jiaqi HE ; Wenru WANG ; Yubin DING ; Jinhuan WANG ; Ruirong XU ; Haixia DI ; Jiangwei WAN ; Qifeng LIU ; Haixia WANG ; Antao SUN ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(12):97-104
ObjectiveTo investigate the immunological characteristics of the patients with aplastic anemia (AA) and elevated hemogram parameters treated with Yiqi Yangxue prescription combined with Western medicine and the predictive effects of immunological indexes on elevated hemogram parameters, thus providing a reference for the prediction of the treatment efficacy and the adjustment of the treatment regimen. MethodA retrospective study was conducted, involving 77 AA patients treated with Yiqi Yangxue prescription combined with Western medicine for 6 months in 19 medical institutions including Xiyuan Hospital, China Academy of Chinese Medical Sciences from September 2018 to March 2021. The patients were assigned into two groups according to the elevations in hemogram parameters [including hemoglobin (HGB), white blood cell count (WBC), platelet (PLT), and absolute neutrophil count (ANC)] after 6 months of treatment. One group had the elevation <50%, and the other group had the elevation ≥50% compared with the baseline. The clinical and immunological characteristics were compared between the two groups. Result① Compared with the group with HGB elevation<50%, the group with HGB elevation≥50% showed elevated level of CD3+ human leukocyte antigen-DR (HLA-DR)+ and increased proportion of patients with T-helper cell type 2 (Th2)<5%, CD8+≥50%, and CD3+HLA-DR+≥9% before treatment (P<0.05, P<0.01). The multivariate Logistic regression analysis showed that CD8+≥50% before treatment was the independent influencing factor for HGB elevation ≥50% [odds ratio (OR)=12.000, 95% confidence interval (CI) 2.218, 64.928, P<0.01]. ② Compared with the group with WBC elevation<50%, the group with WBC elevation≥50% showed increased proportion of patients with CD3+HLA-DR+<6% and T-box transcription factor (T-bet)≥200% before treatment (P<0.05). The multivariate Logistic regression analysis showed that CD3+HLA-DR+<6% (OR=2.998, 95%CI 1.036, 8.680, P<0.05) and T-bet≥200% (OR=3.634, 95%CI 1.076, 12.273, P<0.05) before treatment were independent influencing factors for WBC elevation≥50%. ③ Compared with the group with PLT elevation<50%, the group with PLT elevation≥50% presented lowered Th1 and CD3+HLA-DR+ levels and increased proportion of patients with Th1<12%, CD4+≥6%, and CD3+HLA-DR+<5% before treatment (P<0.05, P<0.01). The multivariate Logistic regression analysis showed that CD3+HLA-DR+<5% before treatment was the independent influencing factor for PLT elevation≥50% (OR=16.190, 95%CI of 3.430 to 76.434, P<0.01). ④ Compared with the group with ANC elevation<50%, the group with ANC elevation≥50% showed no significant changes in the hemogram parameters before treatment. ConclusionAs for the AA patients with rapid elevation in HGB, Yiqi Yangxue prescription combined with Western medicine demonstrate significant effects in the patients with Th2<5% and CD3+HLA-DR+≥9%, especially those with CD8+≥50%. As for the AA patients with rapid elevation in WBC, the therapy was particularly effective in the patients with CD3+HLA-DR+<6% and T-bet≥200%. As for the AA patients with rapid growth in PLT, the therapy was particularly effective in the patients with Th1<12% and CD4+≥6%, especially those with CD3+HLA-DR+<5%.
9.Multimodal ultrasound and ultrasound-guided fine-needle aspiration biopsy for distinguishing benign and malignant thyroid nodules of C-TIRADS grade 4
Di ZHONG ; Di TANG ; Xiaoqiang GAO ; Haixia LI ; Hongbo WANG ; Ying LIU
Chinese Journal of Medical Imaging Technology 2024;40(2):182-185
Objective To compare the value of multimodal ultrasound and ultrasound-guided fine-needle aspiration biopsy(US-FNAB)for distinguishing benign and malignant thyroid nodules of Chinese thyroid imaging reporting and data system(C-TIRADS)grade 4.Methods Data of 247 thyroid nodules in 201 patients were retrospectively analyzed,including 193 malignant and 54 benign noes.Taken postoperative pathology as the gold standards,the value of multimodal ultrasound,i.e.the combination of conventional ultrasound,shear wave elastography(SWE)and contrast-enhanced ultrasound(CEUS)and US-FNAB for distinguishing benign and malignant thyroid nodules were compared.Results The sensitivity,specificity,accuracy,misdiagnosis rate and rate of missed diagnosis of conventional ultrasound for diagnosing malignant thyroid nodules was 86.53%,59.26%,80.57%,40.74%and 13.47%,respectively,of SWE was 78.76%,74.07%,77.73%,25.93%and 21.24%,respectively,of CEUS was 90.16%,77.78%,87.45%,22.22%and 9.84%,respectively,while of multimodal ultrasound was 97.93%,88.89%,95.95%,11.11%and 2.07%,respectively,and of US-FNAB was 89.64%,96.30%,91.09%,3.70%and 10.36%,respectively.The sensitivity,specificity and accuracy of multimodal ultrasound for distinguishing benign and malignant thyroid nodules were higher,while the misdiagnosis rate and missed diagnosis rate were lower than those of conventional ultrasound,SWE and CEUS alone.The sensitivity,accuracy and misdiagnosis rate of multimodal ultrasound were higher,while its specificity and missed diagnosis rate were both lower than those of US-FNAB(all P<0.05).Conclusion For distinguishing benign and malignant thyroid nodules of C-TIRADS grade 4,multimodal ultrasound had higher sensitivity and accuracy but higher misdiagnosis rate,while US-FNAB had higher specificity but also higher missed diagnosis rate.
10.Analysis of Predictive Factors for Efficacy of Yiqi Yangxue Prescription Combined with Western Medicine in Treatment of Aplastic Anemia in Non-elderly Adults
Chaochang ZHANG ; Rui LI ; Jian LIU ; Yubin DING ; Jinhuan WANG ; Qifeng LIU ; Ruirong XU ; Haixia WANG ; Haixia DI ; Antao SUN ; Yonggang XU ; Xiupeng YANG ; Feng LIU ; Rou MA ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(20):88-98
ObjectiveTo explore the predictive factors for the efficacy of Yiqi Yangxue prescription combined with western medicine in treating aplastic anemia (AA) in non-elderly adults, so as to provide a reference for predicting the prognosis of this therapy. MethodA retrospective study was conducted with the clinical data of non-elderly adult AA patients who visited 19 hospitals including Xiyuan Hospital of the China Academy of Chinese Medical Sciences from September 2018 to March 2021 and were treated with Yiqi Yangxue Prescription combined with western medicine. According to the efficacy evaluation results at the 6th month of treatment, the patients were assigned into effective and ineffective groups. The two groups were compared in terms of the gender, age, disease classification [non-severe aplastic anemia (NSAA)/severe aplastic anemia (SAA)], course of disease, family history, complications, history of drug allergy, baseline blood routine examination [hemoglobin (HGB), white blood cell (WBC), neutrophil (ANC), platelet (PLT), and reticulocyte (Ret)], T lymphocyte subsets, degree of proliferation of nucleated cells in bone marrow, and expression of T-bet and GATA-3. ResultA total of 101 non-elderly adult AA patients were enrolled in this study, including 81 in the effective group and 20 in the ineffective group. The effective group had a higher proportion of the patients without a history of drug allergy than the ineffective group (P<0.05). The body height, body weight, gender, age, disease classification, course of disease, family history, and complications showed no significant differences between two groups. The effective group had higher levels of ANC and PLT before treatment (P<0.05) and higher proportion of patients with ANC≥1.6×109/L and PLT≥25×109/L (P<0.05, P<0.01) than the ineffective group. The baseline levels of WBC, HGB, and Ret showed no significant statistical differences between two groups. The levels of CD3+HLA-DR+T cells in the effective group before treatment was higher than that in the ineffective group (P<0.05). The levels of CD3+CD19-T cells, CD4+T cells, CD8+T cells, Th1 cells, Th2 cells, and CD3+CD25+T cells showed no significant statistical differences between two groups before treatment. The proportion of patients with active bone marrow nucleated cells proliferation in the effective group before treatment were significantly higher than that in the ineffective group, while the proportion of patients with reduced or extremely reduced proliferation were significantly lower than that in the ineffective group (P<0.05). The expression levels of T-bet and GATA-3 genes had no significant differences between two groups before treatment. The multivariate binary logistic regression analysis showed that the ANC level before treatment and history of drug allergy were independent influencing factors for efficacy (P<0.05, P<0.01), while other indicators were not influencing factors for efficacy. The receiver operating characteristic (ROC) curve was applied to analyze the predictive value of the ANC level before treatment in the treatment of AA in non-elderly adults with Yiqi Yangxue prescription combined with western medicine. The area under the curve was 0.679 (P<0.05), with the critical value of 1.595×109/L, the sensitivity of 0.42, and the specificity of 0.95. ConclusionThe history of drug allergy, pre-treatment ANC, PLT, CD3+HLA-DR+ T cell levels, and proliferation of nucleated cells in bone marrow before treatment are predictive factors for the efficacy of Yiqi Yangxue prescription combined with western medicine in treating AA in non-elderly adults. This therapy tends to be more effective for the patients with no history of drug allergy, higher ANC and PLT levels before treatment, especially those with ANC≥1.6×109/L, PLT≥25×109/L, and higher CD3+ HLA-DR+T cell levels and the more active proliferation of nucleated cells in bone marrow before treatment.

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