1.Common failure analysis and maintenance management strategy for transcranial magnetic stimulator
Xing-Guang ZHU ; Li-Juan BAI ; Meng-Fan JIA ; Xiao-An WANG
Chinese Medical Equipment Journal 2023;44(9):110-113
The working principle and structural composition of the transcranial magnetic stimulator were introduced.The failures of the transcranial magnetic stimulator in some hospital were summarized from 2018 to 2022.The causes for common failures of the transcranial magnetic stimulator were analyzed with the fishbone diagram,and some suggestions were put forward on its daily utilization management.The maintenance thoughts for two common failures were described in detail including flow control alarm and no magnetic field output.References were provided for daily management and maintenance of the transcranial magnetic stimulator.[Chinese Medical Equipment Journal,2023,44(9):110-113]
2.Establishment of a Patient-Derived T-Cell Acute Lymphoblastic Leukemia Xenograft Model in Novel Immunodeficient NCG Mice.
Peng-Jun JIANG ; Xing-Bin DAI ; Xiang-Tu KONG ; Zu-Qiong XU ; Hui YU ; Jie PANG ; Wen XIA ; Ju-Hua YU ; Guang-Rong ZHU ; Fang TIAN ; Xue-Jun ZHU
Journal of Experimental Hematology 2023;31(2):311-318
OBJECTIVE:
The leukemia cells from patients with T-cell acute lymphoblastic leukemia (T-ALL) were inoculated into NCG mice to establish a stable human T-ALL leukemia animal model.
METHODS:
Leukemia cells from bone marrow of newly diagnosed T-ALL patients were isolated, and the leukemia cells were inoculated into NCG mice via tail vein. The proportion of hCD45 positive cells in peripheral blood of the mice was detected regularly by flow cytometry, and the infiltration of leukemia cells in bone marrow, liver, spleen and other organs of the mice was detected by pathology and immunohistochemistry. After the first generation mice model was successfully established, the spleen cells from the first generation mice were inoculated into the second generation mice, and after the second generation mice model was successfully established, the spleen cells from the second generation mice were further inoculated into the third generation mice, and the growth of leukemia cells in peripheral blood of the mice in each group was monitored by regular flow cytometry to evaluate the stability of this T-ALL leukemia animal model.
RESULTS:
On the 10th day after inoculation, hCD45+ leukemia cells could be successfully detected in the peripheral blood of the first generation mice, and the proportion of these cells was gradually increased. On average, the mice appeared listless 6 or 7 weeks after inoculation, and a large number of T lymphocyte leukemia cells were found in the peripheral blood and bone marrow smear of the mice. The spleen of the mice was obviously enlarged, and immunohistochemical examination showed that hCD3+ leukemia cells infiltrated into bone marrow, liver and spleen extensively. The second and third generation mice could stably develop leukemia, and the average survival time was 4-5 weeks.
CONCLUSION
Inoculating leukemia cells from bone marrow of patients with T-ALL into NCG mice via tail vein can successfully construct a patient-derived tumor xenografts (PDTX) model.
Humans
;
Animals
;
Mice
;
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
;
Heterografts
;
Bone Marrow
;
Disease Models, Animal
;
T-Lymphocytes
;
Mice, SCID
3.Inhibitory Effect of Cinobufotalin on Macrophage Inflammatory Factor Storm and Its Mechanism.
Xi-Xi LIU ; Chen-Cheng LI ; Jing YANG ; Wei-Guang ZHANG ; Re-Ai-La JIANATI ; Xiao-Li ZHANG ; Zu-Qiong XU ; Xing-Bin DAI ; Fang TIAN ; Bi-Qing CHEN ; Xue-Jun ZHU
Journal of Experimental Hematology 2023;31(3):880-888
OBJECTIVE:
To investigate the inflammatory effects of Cinobufotalin on monocytes in resting state and macrophages in activated state and its molecular mechanism.
METHODS:
THP-1 cells were stimulated with Phorbol 12-myristate 13-acetate to induce differentiation into macrophages. Lipopolysaccharides was added to activate macrophages in order to establish macrophage activation model. Cinobufotalin was added to the inflammatory cell model for 24 h as a treatment. CCK-8 was used to detect cell proliferation, Annexin V /PI double staining flow cytometry was used to detect cell apoptosis, flow cytometry was used to detect macrophage activation, and cytometric bead array was used to detect cytokines. Transcriptome sequencing was used to explore the gene expression profile regulated by Cinobufotalin. Changes in the significantly regulated molecules were verified by real-time quantitative polymerase chain reaction and Western blot.
RESULTS:
1∶25 concentration of Cinobufotalin significantly inhibited the proliferation of resting monocytes(P<0.01), and induced apoptosis(P<0.01), especially the activated macrophages(P<0.001, P<0.001). Cinobufotalin significantly inhibited the activation of macrophages, and significantly down-regulated the inflammatory cytokines(IL-6, TNF-α, IL-1β, IL-8) released by activated macrophages(P<0.001). Its mechanism was achieved by inhibiting TLR4/MYD88/P-IκBa signaling pathway.
CONCLUSION
Cinobufotalin can inhibit the inflammatory factors produced by the over-activation of macrophages through TLR4/MYD88/P-IκBa pathway, which is expected to be applied to the treatment and research of diseases related to the over-release of inflammatory factors.
Humans
;
Toll-Like Receptor 4/metabolism*
;
Myeloid Differentiation Factor 88/genetics*
;
Macrophages/metabolism*
;
Cytokines/metabolism*
;
Lipopolysaccharides/pharmacology*
;
NF-kappa B
4.Influence of visceral lipids obesity on the early postoperative complications after radical gastrectomy.
Guang Lin QIU ; Xiao Wen LI ; Hai Jiang WANG ; Pan Xing WANG ; Jia Huang LIU ; Meng Ke ZHU ; Xin Hua LIAO ; Lin FAN ; Xiang Ming CHE
Chinese Journal of Gastrointestinal Surgery 2022;25(7):596-603
Objective: To investigate the effect of visceral fat area (VFA) on the surgical efficacy and early postoperative complications of radical gastrectomy for gastric cancer. Methods: A retrospective cohort study method was used. Clinicopathological data and preoperative imaging data of 195 patients who underwent D2 radical gastric cancer surgery at the First Affiliated Hospital of Xi'an Jiaotong University from January 2014 to December 2017 were analyzed retrospectively. Inclusion criteria: (1) complete clinicopathological and imaging data; (2) malignant gastric tumor diagnosed by preoperative pathology, and gastric cancer confirmed by postoperative pathology; (3) no preoperative complications such as bleeding, obstruction or perforation, and no distant metastasis. Those who had a history of abdominal surgery, concurrent malignant tumors, poor basic conditions, emergency surgery, palliative resection, and preoperative neoadjuvant therapy were excluded. The VFA was calculated by software and VFA ≥ 100 cm2 was defined as visceral obesity according to the Japan Obesity Association criteria . The patients were divided into high VFA (VFA-H, VFA≥100 cm2, n=96) group and low VFA (VFA-L, VFA<100 cm2, n=99) group . The clinicopathological characteristics, surgical outcomes and early postoperative complications were compared between the two groups. Univariate and multivariate Logistic regression models were used to analyze the risk factors of early complications. Receiver operating characteristic (ROC) curve was used to analyze predictive values of VFA for early complications. Pearson's χ2 test was used to analyze the correlation between BMI and VFA. Results: There were no significant differences in terms of gender, age, American Society of Anesthesiologists physical status classification, preoperative comorbidities, preoperative anemia, tumor TNM staging, N staging, T staging and tumor differentiation, surgical method, extent of resection, and tumor location between the VFA-L group and the VFA-H group (all P>0.05). However, patients in the VFA-H group had higher BMI, larger tumor, lower rate of hypoalbuminemia and greater subcutaneous fat area (SFA) (all P<0.05). The VFA-H group presented significantly longer operation time and significantly less number of harvested lymph nodes as compared to the VFA-L group (both P<0.05). However, there were no significant differences in intraoperative blood loss, conversion to laparotomy and postoperative hospital stay (all P>0.05). Complications of Clavien-Dindo grade II and above within 30 days after operation were mainly anastomosis-related complications (leakage, bleeding, infection and stricture), intestinal obstruction and incision infection. The VFA-H group had a higher morbidity of early complications compared to the VFA-L group [24.0% (23/96) vs 10.1% (10/99), χ2=6.657, P=0.010], and the rates of anastomotic complications and incision infection were also higher in the VFA group [10.4% (10/96) vs. 3.0% (3/99), χ2=4.274, P=0.039; 7.3% (7/96) vs. 1.0% (1/99), P=0.033]. Multivariate logistic analysis showed that high BMI (OR=3.688, 95%CI: 1.685-8.072, P=0.001) and high VFA (OR=2.526, 95%CI: 1.148-5.559,P=0.021) were independent risk factors for early complications. The area under the ROC curve (AUC) of VFA for predicting early complications was 0.645, which was higher than that of body weight (0.591), BMI (0.624) and SFA (0.626). Correlation analysis indicated that there was a significantly positive correlation between BMI and VFA (r=0.640, P<0.001). Conclusion: VFA ≥ 100 cm2 is an independent risk factor for early complications after radical gastrectomy for gastric cancer.It can better predict the occurrence of above early postoperative complications.
Gastrectomy/methods*
;
Humans
;
Laparoscopy/methods*
;
Lipids
;
Obesity/surgery*
;
Obesity, Abdominal/surgery*
;
Postoperative Complications/epidemiology*
;
Retrospective Studies
;
Stomach Neoplasms/pathology*
5.Comparative study of the effects between second toe tibial dorsal artery flap and second toe tibial plantar proper artery flap in repairing finger skin and soft tissue defects.
Jin LI ; Hai Bo WU ; Guang Zhe JIN ; Cong Kun ZHU ; Kai WANG ; Qiang WANG ; Ji Hui JU ; Rui Xing HOU
Chinese Journal of Burns 2022;38(10):937-943
Objective: To compare the effects between second toe tibial dorsal artery flap (2-TDAF) and second toe tibial plantar proper artery flap (2-TPPAF) in repairing finger skin and soft tissue defects. Methods: A retrospective cohort study was conducted. From January 2019 to June 2020, 27 patients with skin and soft tissue defects at the fingertips with area of 1.5 cm×1.2 cm-2.6 cm×1.8 cm after debridement who met the inclusion criteria were admitted to Suzhou Ruihua Orthopaedic Hospital, including 21 males and 6 females, aged 19-59 (37±10) years. According to flap repair methods used in the defective fingers, the patients were divided into 2-TDAF group (12 cases) and 2-TPPAF group (15 cases). The area of 2-TDAF ranged from 1.5 cm×1.2 cm to 2.5 cm×1.6 cm, and the area of 2-TPPAF ranged from 1.7 cm×1.3 cm to 2.6 cm×1.8 cm. Full-thickness skin grafts from the medial side of the ipsilateral leg were grafted to the wounds in donor sites, and the wounds in donor sites of skin grafts were directly sutured. Flap arterial diameter, flap excision time, flap survival situation of patients in 2 weeks after operation, and follow-up time were recorded. At the last follow-up, the two-point discrimination distance of flap graft site, total action motion (TAM) of the finger joints, and wound healing of the flap donor site were recorded; the Vancouver scar scale (VSS) was used to score the scar in donor area of the second toe and the recipient area of fingers; the appearance and self-satisfaction subscales of the Michigan hand outcomes questionnaire (MHQ) were used to evaluate the affected finger. Data were statistically analyzed with independent sample t test or Fisher's exact probability test. Results: The flap artery diameter of patients in 2-TDAF group was 0.35-0.80 (0.56±0.14) mm and the flap cutting time was (14.0±2.7) min, which were significantly shorter than 0.80-1.35 (1.02±0.16) mm and (19.7±3.4) min in 2-TPPAF group (with t values of 7.81 and 4.79, respectively, P<0.01). The flaps of patients in the 2 groups in recipient areas survived well in 2 weeks after operation, and the wounds in donor areas of flaps of patients in the 2 groups healed well at the last follow-up. There was no statistically significant difference in the postoperative follow-up time, and two-point discrimination distance of flap graft site, TAM of the finger joints, VSS score of scar in the second toe donor site and the finger recipient site, and the appearance and self-satisfaction of MHQ scores of the affected finger at the last follow-up (P>0.05). Conclusions: Compared with 2-TPPAF, 2-TDAF has a shallower anatomical layer and shorter time for surgical flap removal, which can preserve the proper arteries and nerves at the base of the toes and reduce the damage to the donor site.
Male
;
Female
;
Humans
;
Soft Tissue Injuries/surgery*
;
Finger Injuries/surgery*
;
Cicatrix/surgery*
;
Plastic Surgery Procedures
;
Retrospective Studies
;
Treatment Outcome
;
Surgical Flaps
;
Skin Transplantation
;
Toes/surgery*
;
Arteries
;
Perforator Flap
6.Clinical analysis of 5 cases of dermatomyositis complicated with macrophage activation syndrome.
Xiao Yan XING ; Jun Xiao ZHANG ; Fen Yun Zhi ZHU ; Yi Fan WANG ; Xin Yao ZHOU ; Yu Hui LI
Journal of Peking University(Health Sciences) 2022;54(6):1214-1218
To investigate the clinical and immunological features of dermatomyositis (DM) complicated with macrophage activation syndrome (MAS). The demographic and clinical characteristics of five patients diagnosed with DM complicated with MAS hospitalized in the Department of Rheumatology and Immunology, Peking University People ' s Hospital from 2011 to 2021 were collected. The results of clinical manifestations, laboratory tests, immunological features, treatments and prognosis were analyzed and summarized. In this study, five female patients in Peking University People's Hospital with an average age of 63.8 (44.0-83.0) years and an average disease duration of 16.1 (1.5-48.0) months. All the patients had typical DM rash (such as heliotrope sign, V/shawl sign or Gottron's sign/papules). They all had muscle involvement (including myalgia or muscle weakness). Two patients had positive myositis-specific antibodies (MSAs), in which case 1 had anti-TIF1-γ antibody and case 5 had anti-NXP-2 antibody. Four patients had interstitial lung disease except case 3. All of the cases developed MAS in the active stage of DM. Common manifestations of MAS in these five patients included high-grade fever, cytopenia, decreased fibrinogen, elevated ferritin and increased soluble CD25. Case 1 presented with neutropenia (0.6×109 /L), thrombocytopenia (26.0×109 /L), hypofibrinogenemia (0.9 g/L), markedly elevated ferritin (26 331.0 μg/L), decreased NK cell activity. Case 2 had anaemia (hemoglobin 81.0 g/L), thrombocytopenia (55.0×109 /L), hypertriglyceridemia (4.7 mmol/L), hypofibrinogenemia (1.2 g/L), elevated ferritin (>100 000.0 μg/L), hemophagocytosis in bone marrow. Case 3 had anaemia (hemoglobin 88 g/L), decreased fibrinogen (1.9 g/L), increased ferritin (>27 759.0 μg/L), splenomegaly, hemophagocytosis in bone marrow. Case 4 suffered from neutropenia(0.3×109 /L), anaemia(hemoglobin 78 g/L), hypertriglyceridemia (4.2 mmol/L), hypofibrinogenemia (0.9 g/L), increased ferritin (>100 000.0 μg/L), and decreased NK cell activity. Case 5 presented anaemia (hemoglobin 60.0 g/L), thrombocytopenia (67.0×109 /L), hypertriglyceridemia (12.7 mmol/L), decreased fibrinogen (1.1 g/L), and elevated ferritin (>923.0 μg/L). All the patients were treated with methylprednisone pulse therapy (200-500 mg) combined with cyclosporine while case 5 received rituximab after methylprednisone pulses. In addition, case 3 also received the combination of mycophenolate mofetil. Case 1 was given etoposide while case 4 was treated with cyclophosphamide and repeated plasmapheresis at the same time. Moreover, intravenous immunoglobulin was added meantime apart from case 3. The condition of four patients improved significantly, nevertheless case 4 experienced recurred pulmonary symptoms and died of respiratory failure. As for complications about infection, case 2 had bacterial infection with high level procalcitonin (PCT) before MAS treatment and condition was improved after empiric antibacterial therapy. Case 3 had cytomegalovirus DNAemia before diagnosis of MAS and viral titer turned negative after ganciclovir therapy. After treatment of MAS, four patients developed cytomegalovirus DNAemia except case 3, in which case 5 was co-infected with bacteria. To sum, DM complicated with MAS is relatively rare, and its patients are of ten in life-threatening condition. Early detection, treatment and prevention of infection during treatment are critical to improve the prognosis.
Humans
;
Female
;
Middle Aged
;
Dermatomyositis/complications*
;
Macrophage Activation Syndrome/complications*
;
Afibrinogenemia/complications*
;
Autoantibodies
;
Neutropenia
;
Thrombocytopenia/complications*
;
Ferritins/therapeutic use*
;
Hypertriglyceridemia/complications*
;
Fibrinogen/therapeutic use*
7.Analysis of the usage of post-exposure prophylaxis and related factors among men who have sex with men.
Lian Zheng HAO ; Lei HAN ; Xiao Yan ZHU ; Xing Guang YANG ; Ling LI ; Bin LIN ; Lin LIN ; Jin Hai LI ; Na ZHANG ; Guo Yong WANG ; Dian Min KANG
Chinese Journal of Preventive Medicine 2022;56(12):1868-1871
A survey was conduct to analyze the usage situation of post-exposure prophylaxis(PEP) and related factors among men who have sex with men(MSM) in 6 cities of Shandong Province. Total of 2 620 subjects, the use ratio was 2.98% (78/2 620). Compared with age≤24 years,monthly income<5 000 yuan,non-commercial sex, non-DU,non-STD,role for being insert in the anal intercourse,MSM was more likely to use PEP with age≥45 years(OR=3.87, 95%CI:1.12-13.36),monthly income≥5 000 yuan(OR=1.87, 95%CI:1.07-3.28),commercial sex (OR=3.13, 95%CI:1.56-6.28), drug users (DUs) (OR=4.63, 95%CI:2.51-8.52),STD patient (OR=2.35,95%CI:1.05-5.27),the mixed sex role group(OR=2.25,95%CI:1.10-4.62).
Male
;
Humans
;
Young Adult
;
Adult
;
Middle Aged
;
Homosexuality, Male
;
HIV Infections/prevention & control*
;
Post-Exposure Prophylaxis
;
Sexual and Gender Minorities
;
Sexual Behavior
8.Efficacy of laparoscopic proximal gastrectomy with double-tract reconstruction versus laparoscopic total gastrectomy with Roux-en-Y reconstruction for early upper gastric cancer.
Guang Lin QIU ; Chao WEI ; Meng Ke ZHU ; Shao Ning HAN ; Xiao Wen LI ; Hai Jiang WANG ; Pan Xing WANG ; Jia Huang LIU ; Hua You ZHOU ; Xin Hua LIAO ; Xiang Ming CHE ; Lin FAN
Chinese Journal of Gastrointestinal Surgery 2022;25(5):412-420
Objective: To compare clinical efficacy between laparoscopic radical proximal gastrectomy with double-tract reconstruction (LPG-DTR) and laparoscopic radical total gastrectomy with Roux-en-Y reconstruction (LTG-RY) in patients with early upper gastric cancer, and to provide a reference for the selection of surgical methods in early upper gastric cancer. Methods: A retrospective cohort study method was carried out. Clinical data of 80 patients with early upper gastric cancer who underwent LPG-DTR or LTG-RY by the same surgical team at the Department of General Surgery, the First Affiliated Hospital of Xi'an Jiaotong University from January 2018 to January 2021 were retrospectively analyzed. Patients were divided into the DTR group (32 cases) and R-Y group (48 cases) according to surgical procedures and digestive tract reconstruction methods. Surgical and pathological characteristics, postoperative complications (short-term complications within 30 days after surgery and long-term complications after postoperative 30 days), survival time and nutritinal status were compared between the two groups. For nutritional status, reduction rate was used to represent the changes in total protein, albumin, total cholesterol, body mass, hemoglobin and vitamin B12 levels at postoperative 1-year and 2-year. Non-normally distributed continuous data were presented as median (interquartile range), and the Mann-Whitney U test was used for comparison between groups. The χ(2) test or Fisher's exact test was used for comparison of data between groups. The Mann-Whitney U test was used to compare the ranked data between groups. The survival rate was calculated by Kaplan-Meier method categorical, and compared by using the log-rank test. Results: There were no statistically significant differences in baseline data betweeen the two groups, except that patients in the R-Y group were oldere and had larger tumor. Patients of both groups successfully completed the operation without conversion to laparotomy, combined organ resection, or perioperative death. There were no significant differences in the distance from proximal resection margin to superior margin of tumor, postoperative hospital stay, time to flatus and food-taking, hospitalization cost, short- and long-term complications between the two groups (all P>0.05). Compared with the R-Y group, the DTR group had shorter distal margins [(3.2±0.5) cm vs. (11.7±2.0) cm, t=-23.033, P<0.001], longer surgery time [232.5 (63.7) minutes vs. 185.0 (63.0) minutes, Z=-3.238, P=0.001], longer anastomosis time [62.5 (17.5) minutes vs. 40.0 (10.0) minutes, Z=-6.321, P<0.001], less intraoperative blood loss [(138.1±51.6) ml vs. (184.3±62.1) ml, t=-3.477, P=0.001], with significant differences (all P<0.05). The median follow-up of the whole group was 18 months, and the 2-year cancer-specific survival rate was 97.5%, with 100% in the DTR group and 95.8% in the R-Y group (P=0.373). Compared with R-Y group at postoperative 1 year, the reduction rate of weight, hemoglobin and vitamin B12 were lower in DTR group with significant differences (all P<0.05); at postoperative 2-year, the reduction rate of vitamin B12 was still lower with significant differences (P<0.001), but the reduction rates of total protein, albumin, total cholesterol, body weight and hemoglobin were similar between the two groups (all P>0.05). Conclusions: LPG-DTR is safe and feasible in the treatment of early upper gastric cancer. The short-term postoperative nutritional status and long-term vitamin B12 levels of patients undergoing LPG-DTR are superior to those undergoing LTG-RY.
Albumins
;
Anastomosis, Roux-en-Y/adverse effects*
;
Cholesterol
;
Gastrectomy/methods*
;
Hemoglobins
;
Humans
;
Laparoscopy/methods*
;
Postoperative Complications/etiology*
;
Retrospective Studies
;
Stomach Neoplasms/pathology*
;
Treatment Outcome
;
Vitamin B 12
9.Characteristics and depressive symptoms among self-reported HIV infection through heterosexual transmission men who have sex with men.
Xiao Yan ZHU ; Guo Yong WANG ; Mei Zhen LIAO ; Ya Jun LI ; Na ZHANG ; Ling LI ; Xing Guang YANG ; Peng Xiang HUANG ; Tao HUANG ; Dian Min KANG
Chinese Journal of Epidemiology 2022;43(10):1639-1644
Objective: To understand the characteristics and depressive status of men who have sex with men (MSM) who self-reported HIV infection through heterosexual transmission and to provide evidence for personalized management of HIV infected people. Methods: A cross-sectional survey was carried out in Shandong province from September to December in 2019. Male HIV patients aged ≥15 years who self-reported HIV infection through heterosexual transmission were selected to verify the route of infection by one-to-one interview in Ji'nan, Qingdao, Weifang and Linyi cities of Shangdong province. According to the 1∶1 ratio, local HIV patients with age difference ≤3 years who self-reported MSM were selected as controls. A questionnaire survey was conducted, including data on demographic characteristics, behavior status, CES-D and PSSS. The related factors of the depressive symptoms and characteristics were analyzed. Results: A total of 373 male HIV patients were interviewed, and 39.7%(148/373) were confirmed as MSM after reexamination. The interviewers were: aged (40.3±12.0) years old, 41.9% (62/148) married/cohabiting. 27.0% (40/148) had been tested before HIV diagnosis, 71.6% (106/148) had homosexual partners ≥2 and 55.4% (82/148) had depressive symptom. Multivariate analysis showed that the MSM without HIV testings before diagnosis, had homosexual partners ≥2 before diagnosis, had first homosexual behavior at the age >30 years old and with depressive symptoms were more likely to conceal the true infection route. The incidence of depression among MSM who self-reported HIV infection through heterosexual transmission was related to physical health status social support and occupational stability. Conclusions: Some male HIV persons self-reported as being heterosexually transmitted were really transmitted through homosexual behavior. There were high-risk behaviors such as multiple partners and intersex among this group, and with high incidence of depression. It is necessary to encourage the reexamination program during follow-up and target on psychological and behavioral interventions, continuously.
Male
;
Humans
;
Adult
;
Middle Aged
;
Heterosexuality
;
Depression/epidemiology*
;
HIV Infections/epidemiology*
;
Self Report
;
Homosexuality, Male
;
Cross-Sectional Studies
;
Sexual and Gender Minorities
10.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.
Jie WU ; Shu-Wei DUAN ; Hong-Tao YANG ; Yue-Yi DENG ; Wei LI ; Ya-Ni HE ; Zhao-Hui NI ; Yong-Li ZHAN ; Shan LIN ; Zhi-Yong GUO ; Jun ZHU ; Jing-Ai FANG ; Xu-Sheng LIU ; Li-Hua WANG ; Rong WANG ; Nian-Song WANG ; Xiao-Hong CHENG ; Li-Qun HE ; Ping LUO ; Shi-Ren SUN ; Ji-Feng SUN ; Ai-Ping YIN ; Geng-Ru JIANG ; Hong-Yu CHEN ; Wen-Hu LIU ; Hong-Li LIN ; Meng LIANG ; Lu MA ; Ming CHEN ; Li-Qun SONG ; Jian CHEN ; Qing ZHU ; Chang-Ying XING ; Yun LI ; Ji-Ning GAO ; Rong-Shan LI ; Ying LI ; Hao ZHANG ; Ying LU ; Qiao-Ling ZHOU ; Jun-Zhou FU ; Qiang HE ; Guang-Yan CAI ; Xiang-Mei CHEN
Journal of Integrative Medicine 2021;19(2):111-119
BACKGROUND:
Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
OBJECTIVE:
This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION:
This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m
MAIN OUTCOME MEASURES:
The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
RESULTS:
A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
CONCLUSION:
SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
TRIAL REGISTRATION NUMBER
NCT02063100 on ClinicalTrials.gov.

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