1.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
2.Formulation of expert consensus on clinical application of external ethnic medicine: taking Baimai Ointment as an example.
Ying-Jie GUAN ; Xiao-Qiao REN ; Hong-Sheng ZHAN ; Zhi-Xiu SHEN ; Kai-Lie LIU ; Wen-Jing CHANG ; Yun LI ; Wei CHEN
China Journal of Chinese Materia Medica 2023;48(3):847-852
The concept of ethnic medicine is divided into a broad sense and a narrow sense. The broad concept refers to the traditional medicine of the Chinese nation, and the narrow concept refers to the traditional medicine of Chinese ethnic minorities. The external medicine is one of the main forms of ethnic medicine, and it is also the important content of ethnic medicine for external use, which is widely used in clinical practice. As the theory of ethnic medicine is unique, the application methods have certain characteristics, which are the key technical parts of clinical practice. However, the existing traditional Chinese medicine consensus formulation me-thods cannot meet the needs of the consensus formulation of the external ethnic medicine. Therefore, the methods suitable for expert consensus on external ethnic medicine are required. This article took Expert opinion on clinical application of Baimai Ointment as an exa-mple, and explorde a reasonable, effective, multi-dimensional, and multi-stage method to formulate expert consensus on the external ethnic medicine. In this research, three-dimensional sources of information, including ancient classics, clinical research evidence, and expert application experiences, were systematically and scientifically collected. After organization and analysis, the information was formed into comprehensive evidence. In a formal consensus meeting, part of the recommendations reached consensus. As to the issues that did not reach agreement, in-depth interviews were used to explore the reasons for the differences and resolve the disagreements. Finally, unanimous recommendations were reached. There are common problems during the formulation process of Expert opinion on clinical application of Baimai Ointment. This study is expected to provide references for the formulation of expert consensus on other external ethnic medicine.
Humans
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Biological Products
;
Consensus
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Drugs, Chinese Herbal
3.Punicalagin inhibits hepatic lipid deposition in obese mice via AMPK/ACC pathway.
Re-Na JIENSI ; Zhan-Ying CHANG ; Ruo-Hui NIU ; Xiao-Li GAO
China Journal of Chinese Materia Medica 2023;48(7):1751-1759
Hepatic lipid deposition is one of the basic manifestations of obesity, and nowadays pharmacological treatment is the most important tool. Punicalagin(PU), a polyphenol derived from pomegranate peel, is a potential anti-obesity substance. In this study, 60 C57BL/6J mice were randomly divided into a normal group and a model group. After establishing a model of simple obesity with a high-fat diet for 12 weeks, the successfully established rat models of obesity were then regrouped into a model group, an orlistat group, a PU low-dose group, a PU medium-dose group, and a PU high-dose group. The normal group was kept on routine diet and other groups continued to feed the high-fat diet. The body weight and food intake were measured and recorded weekly. After 8 weeks, the levels of the four lipids in the serum of each group of mice were determined by an automatic biochemical instrument. Oral glucose tole-rance and intraperitoneal insulin sensitivity were tested. Hemoxylin-eosin(HE) staining was applied to observe the hepatic and adipose tissues. The mRNA expression levels of peroxisome proliferators-activated receptor γ(PPARγ) and C/EBPα were determined by real-time quantitative polymerase chain reaction(Q-PCR), and the mRNA and protein expression levels of adenosine 5'-monophosphate-activated protein kinase(AMPK), anterior cingulate cortex(ACC), and carnitine palmitoyltransferase 1A(CPT1A) were determined by Western blot. Finally, the body mass, Lee's index, serum total glyceride(TG), serum total cholesterol(TC), and low-density lipoprotein cholesterol(LDL-C) levels were significantly higher and high-density lipoprotein cholesterol(HDL-C) levels were significantly lower in the model group as compared with the normal group. The fat deposition in the liver was significantly increased. The mRNA expression levels of hepatic PPARγ and C/EBPα and the protein expression level of ACC were increased, while the mRNA and protein expression levels of CPT-1α(CPT1A) and AMPK were decreased. After PU treatment, the above indexes of obese mice were reversed. In conclusion, PU can decrease the body weight of obese mice and control their food intake. It also plays a role in the regulation of lipid metabolism and glycometabolism metabolism, which can significantly improve hepatic fat deposition. Mechanistically, PU may regulate liver lipid deposition in obese mice by down-regulating lipid synthesis and up-regulating lipolysis through activation of the AMPK/ACC pathway.
Rats
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Mice
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Animals
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Mice, Obese
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AMP-Activated Protein Kinases/metabolism*
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PPAR gamma/metabolism*
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Mice, Inbred C57BL
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Liver/metabolism*
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Obesity/genetics*
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Body Weight
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Lipid Metabolism
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Diet, High-Fat/adverse effects*
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Lipids
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Cholesterol
4.Clinical observation on acupuncture for symptom burden in gastric cancer patients undergoing adjuvant chemotherapy after gastrectomy.
Xue-Song CHANG ; Yan-Juan ZHU ; Jian-Jun PENG ; Xiao-Yu WU ; Wei WANG ; Yi-Hong LIU ; Dan-Dan ZHAN ; Ya-Dong CHEN ; Hai-Bo ZHANG
Chinese Acupuncture & Moxibustion 2022;42(11):1226-1232
OBJECTIVE:
To observe the efficacy of acupuncture on symptom burden in patients with gastric cancer during adjuvant chemotherapy after gastrectomy.
METHODS:
A total of 58 patients were randomized into a high-dose acupuncture group (19 cases, 5 cases dropped off), a low-dose acupuncture group (20 cases, 6 cases dropped off) and a control group (19 cases, 2 cases dropped off). Conventional chemotherapy and antiemetic treatment were adopted in the control group. On the basis of the treatment in the control group, acupuncture was applied 7 times each chemotherapy cycle for totally 21 times in the high-dose acupuncture group, and 3 times each chemotherapy cycle for totally 9 times in the low-dose acupuncture group. Baihui (GV 20), Zusanli (ST 36), Neiguan (PC 6), etc. were selected in the two acupuncture groups, as well as back-shu points selected by the meridian heat sensing technique. Electroacupuncture was connected to ipsilateral Zusanli (ST 36) and Neiguan (PC 6), with continuous wave, 2 Hz in frequency for 20 min. The Edmonton symptom assessment system (ESAS) score was observed on day 1-7, 14, and 21 of each cycle of chemotherapy respectively in the 3 groups.
RESULTS:
The symptom burden was worst within 7 days of each cycle of chemotherapy in the 3 groups. After the 3rd chemotherapy cycle, the total score of ESAS in the low-dose acupuncture group was lower than the control group (P<0.05), the total score and the scores of feeling of non-well being, pain and shortness of breath of ESAS in the acupuncture group (the high-dose acupuncture group combined with the low-dose acupuncture group) were lower than the control group (P<0.05).
CONCLUSION
Acupuncture shows promising effect in controlling symptom burden during adjuvant chemotherapy in gastric cancer patients after gastrectomy.
Humans
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Acupuncture Points
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Stomach Neoplasms/surgery*
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Acupuncture Therapy
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Gastrectomy/adverse effects*
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Chemotherapy, Adjuvant
5.The importance of intranasal trigeminal event-related potentials test for patients with olfactory dysfunction.
Jia LIU ; Xiao Jun ZHAN ; Lin Yi YAO ; Xing GAO ; Hong Bo XIE ; Feifan CHANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2022;57(8):974-979
Objective: To analyze the characteristics of trigeminal event-related potentials (tERPs) in different kinds of olfactory disorders (OD), and to evaluate the importance of tERPs for the patients with olfactory dysfunction. Methods: Clinical data of 314 patients with olfactory dysfunction from the Smell and Taste Clinics in Beijing Anzhen Hospital from 2015 to 2021 were retrospectively reviewed, including 158 males and 156 females, aging from 6 to 78 years. The control group consisted of healthy people from medical examination center, who were gender and age matched. The clinical characteristics of OD were analyzed using Sniffin' Sticks test, olfactory event-related potentials (oERPs), tERPs and acoustic rhinometry test. SPSS 17.0 software was used to compare the difference of tERPs between the two groups, and to analyze the related factors affecting trigeminal function. Results: The ratio of tERPs presence was different in OD caused by different reasons: head traumatic OD (54.9%), post-virus infection OD (63.6%), sinonasal inflammatory OD (68.4%) and OD due to other causes (56.9%). Compared with controls, tERPs signals in OD patients showed a significant lower amplitude in the N1 wave (all P<0.001), and lower amplitude in the P2 wave in most OD patients (head trauma t=-4.11, P<0.001; sinonasal inflammation t=-2.04, P=0.046; others t=-2.40, P=0.020) except in OD by post-virus infection (t=-1.98, P=0.052). tERPs signals in OD patients by sinonasal inflammation showed longer latency in the N1 wave (t=2.15, P=0.036), but this difference was not observed in other OD patients (all P>0.05). tERPs signals were significantly correlated with the Sniffin' Sticks score, deficiency of oERPs and nasal minimum cross-sectional area (all P<0.05). Conclusions: OD patients show neurophysiologic deficits in trigeminal function. The absence of tERPs or lower amplitude in N1 waves are the important characteristics of patients with OD.
Evoked Potentials/physiology*
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Female
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Humans
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Inflammation
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Male
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Olfaction Disorders/etiology*
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Retrospective Studies
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Smell/physiology*
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Virus Diseases/complications*
6.Curcumin improves cardiac fibrosis by inhibiting endothelial-mesenchymal transition through NRF2-DDAH-ADMA-NO pathway.
Xiao CHEN ; Chang-Xi CHEN ; Zhan GAO ; Xing-Xing CHEN ; Jie HU ; Hao ZHOU
China Journal of Chinese Materia Medica 2022;47(3):745-752
The present study analyzed the correlations between curcumin(Cur), nuclear factor E2 related factor 2(NRF2)-dimethylarginine dimethylaminohydrolase(DDAH)-asymmetric dimethylarginine(ADMA)-nitric oxide(NO) pathway, and endothelial-mesenchymal transition(EndMT) based on SD rats with cardiac fibrosis, and explored the effect and mechanism of Cur in resisting cardiac fibrosis to provide an in-depth theoretical basis for its clinical application in the treatment of heart failure. The cardiac fibrosis model was induced by subcutaneous injection of isoprenaline(Iso) in rats. Thirty-two rats were randomly divided into a control group, a model group, a low-dose Cur group(100 mg·kg~(-1)·d~(-1)), and a high-dose Cur group(200 mg·kg~(-1)·d~(-1)), with eight in each group. After 21 days of treatment, cardiac function was detected by echocardiography, degree of cardiac fibrosis by Masson staining, expression of CD31 and α-SMA by pathological staining, expression of VE-cadherin, vimentin, NRF2, and DDAH by Western blot, and ADMA level by HPLC. Compared with the model group, the Cur groups showed alleviated cardiac fibrosis, accompanied by increased CD31 and VE-cadherin expression and decreased α-SMA and vimentin expression, indicating relieved EndMT. Additionally, DDAH and NRF2 levels were elevated and ADMA and NO expression declined. Cur improves cardiac fibrosis by inhibiting EndMT presumedly through the NRF2-DDAH-ADMA-NO pathway.
Amidohydrolases/metabolism*
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Animals
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Curcumin
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Fibrosis
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NF-E2-Related Factor 2/genetics*
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Nitric Oxide/metabolism*
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Rats
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Rats, Sprague-Dawley
7. The Crystal Structure and Molecular Docking of CYP76AH3 in the Tanshinone Biosynthesis Pathway
Zhang-Xin CHEN ; Ke HE ; Chao SHI ; Li-Xin HUANG ; Zhen-Zhan CHANG ; Cheng-Liang XIAO
Chinese Journal of Biochemistry and Molecular Biology 2022;38(4):488-494
Salvia miltiorrhiza is widely used in the treatment of the angina pectoris, coronary heart disease and myocardial infarction. CYP76AH3 is the key P450 enzyme, locating at the branch point of the tanshinone synthesis pathway. The crystal structural study and key amino acid analysis are of great significance for synthetic biology study on tanshinone. But it is always a challenge for scientists to carry out protein purification, crystallization and crystal structural studies on transmembrane type Ⅱ P450 enzymes. In this study, the prokaryotic expression plasmid was generated, and the high-purity target protein was purified. CYP76AH3 was successfully crystallized, and the crystal structure was solved.After docking range was determined by Cavityplus analysis, molecular docking with Discovery Studio was conducted. The docking result indicated that Gly298 and Asp294 had hydrogen bond interaction with the substrate, while Phe479, Leu367 and Leu293 had hydrophobic interaction with the substrate.In addition, the effect of mutations at the key amino acids on the protein structure stability was predicted throung point mutation simulation. This study would provide a target for protein engineering of CYP76AH3 and lay a foundation for the study of synthesis biology on tanshinones.
8.Effect of Astragaloside Ⅳ Combined with Notoginseng Total Saponins on Angiogenesis After Transplantation of BMSCs in Rats with Cerebral Ischemia
Yan-ling LI ; Huang DING ; Fu-rong YANG ; Zhan-hui LU ; Yu-wen LI ; Xiao-dan LIU ; Chang-qing DENG
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(21):73-79
Objective:To investigate the effect of astragaloside Ⅳ(AST Ⅳ)and Notoginseng total saponins (NTS) combined with bone marrow mesenchymal stem cell (BMSC) transplantation on neural repair and angiogenesis in rats with cerebral ischemia. Method:The rats were randomly divided into a sham operation group, a model group, low- and high-dose AST Ⅳ + NTS groups, a BMSC infusion group, and low- and high-dose BMSC infusion+AST Ⅳ (10 and 20 mg·kg-1) + NTS group (25, 50 mg·kg-1). BMSCs were isolated and purified by whole bone marrow adherent culture. The positive expression of surface markers of BMSCs (CD29, CD90, CD34, and CD45) was detected by flow cytometry. The focal cerebral ischemia model was established by middle cerebral artery occlusion (MCAO). The PKH26-labeled BMSCs were injected into the tail vein of rats in the BMSC infusion group, once a day. The rats in the combination groups received BMSC injection once a day and intragastric administration of drugs twice a day. Other groups were administered twice a day by gavage. The sham operation group and the model group received the same amount of normal saline. Symptoms and signs of neurological deficits were assessed by the Longa method and the cerebral infarction rate was determined by TTC staining. The survival and vascularization [double positive expression of PKH26/vascular endothelial growth factor (VEGF)] after transplantation of BMSCs were observed by the immunofluorescence method. The protein expression of Ang1 and TGF-
9.China experts' consensus on preventive and interceptive orthodontic treatments of malocclusions of children.
Xiao-Bing LI ; Quan-Fu YE ; Hong HE ; Hai-Ping LU ; Min ZHU ; Ruo-Ping JIANG ; Shu-Juan ZOU ; Xiang-Long HAN ; Li ZHOU ; Ke CHEN ; Xiao YUAN ; Jun-Mei ZHANG ; Li-Jun TAN ; Chang YIN ; Zhou HE ; Ang LI ; Bin CHENG ; Wen-Hua RUAN ; Fang HUANG ; Juan LIU ; Lan MA ; Rui ZOU ; Fang YANG ; Wei-Bing ZHANG ; Yu-Lou TIAN ; Bei-Zhan JIANG ; Lin-Qin SHAO ; Yang HUANG ; Li-Qin TANG ; Li GAO ; Chen-Chen ZHOU
West China Journal of Stomatology 2021;39(4):369-376
Malocclusion is one of the three most common oral diseases reported by World Health Organization(WHO). In China, its incidence rate is rising. Malocclusion seriously affects the dental and maxillofacial function, facial appearance and growth development of nearly 260 million children in China, and what is more, it affects their physical and mental health development. Malocclusion occurrence is related to genetic and environmental factors. Early treatment of malocclusion can create a good dental and maxillofacial development environment, correct abnormal growth and control the adverse effects of abnormal genetic factors. It can effectively reduce the prevalence of children's malocclusion and enhance their physical and mental health. This is an urgent need from the economic perspective of our society, so it has great practical and social significance. Experts from the project group "standard diagnose and treatment protocols for early orthodontic intervention of malocclusions of children" which initiated by China National Health Institute of Hospital Administration wrote the "China Experts' Consensus on Preventive and Interceptive Orthodontic Treatments of Malocclusions of Children", which aims to guide and popularize the clinical practice, improve the clinical theory and practice level, and accelerate the disciplinary development of early treatment of children's malocclusion in China. The consensus elaborates the harmfulness of malocclusion and the necessity of early treatment, and brings up the principles and fundamental contents. Based on the law of dental and maxillofacial development, this paper puts forward the guiding suggestions of preventive and interceptive treatments in different stages of dental development ranging from fetus to early permanent dentition. It is a systematic project to promote and standardize the early treatment of malocclusion. Through scientific and comprehensive stratified clinical practice and professional training, the clinical system of early treatment of malocclusion in China will eventually be perfected, so as to comprehensively care for children's dental and maxillofacial health, and improve their oral and physical health in China.
Child
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China/epidemiology*
;
Consensus
;
Dental Care
;
Humans
;
Malocclusion/prevention & control*
;
Orthodontics, Interceptive
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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