1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
;
Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome
2.Phenylethanoid glycosides from Verbenae Herba
Jie LI ; Dan-Yang DONG ; Cai-Ying PENG ; Qin YANG ; Jian-Qun LIU ; Ji-Cheng SHU
Chinese Traditional Patent Medicine 2024;46(1):137-142
AIM To study the phenylethanoid glycosides from Verbenae Herba.METHODS The 80%ethanol extract from Verbenae Herba was isolated and purified by silica gel,Sephadex LH-20,TLC and semi-preparative HPLC,then the structures of obtained compounds were identified by physicochemical properties and spectral data.RESULTS Nine compounds were isolated and identified as verbofficoside A(1),cistanoside D(2),epimeredinoside A(3),verbascoside(4),isoverbascoside(5),cistanoside C(6),cistanoside F(7),decaffeoylacteoside(8),jionoside C(9).CONCLUSION Compound 1 is a new compound.Compounds 3 and 6-9 are isolated from this plant for the first time.
3.Low-dose chloroquine treatment extends the lifespan of aged rats.
Wei LI ; Zhiran ZOU ; Yusheng CAI ; Kuan YANG ; Si WANG ; Zunpeng LIU ; Lingling GENG ; Qun CHU ; Zhejun JI ; Piu CHAN ; Guang-Hui LIU ; Moshi SONG ; Jing QU ; Weiqi ZHANG
Protein & Cell 2022;13(6):454-461
4.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.
5.Chemical constituents from the fruits of Psidum littorale
qing Hang CUI ; ying Cai PENG ; zheng Ying HUANG ; Ying GAO ; qun Jian LIU ; Rui ZHANG ; cheng Ji SHU
Chinese Traditional Patent Medicine 2017;39(12):2538-2542
AIM To study the chemical constituents from the fruits of Psidum littorale Raddi.METHODS The ethyl acetate and methanol fractions of 90% ethanol extract from P.littorale were isolated and purified by silica,Sephadex LH-20,D-101 macroporous resin and preparative HPLC column,then the structures of obtained compounds were identified by spectral data.RESULTS Twelve compounds were isolated and identified as lupeol (1),betulin (2),nigaichigoside F1 (3),2oα-hydroxybetulinic acid (4),(-)-episyringaresinol (5),(+)-syringaresinol (6),(+)-isolariciresinol-9'-O-β-glucopyranoside (7),(7S,8R)-urolignoside (8),benzyl-β-D-glucopyranoside (9),butanedioic acid (10),β-sitosterol (11),daucosterol (12).CONCLUSION Compounds 1-9 are isolated from genus Psidium for the first time.
6.A new triterpenoid from roots of Psidium guajava
Cai-ying PENG ; Ying-zheng HUANG ; Jian-qun LIU ; Hui-lian HUANG ; Ji-cheng SHU
Acta Pharmaceutica Sinica 2017;52(11):1731-1736
To investigated the chemical constituents of the roots of Psidium guajava,we isolated seven compounds by silica gel column chromatography.These include oleanane derivatives,2 α,3β,6β,23-tetrahydroxylurs-12,20(30)-dien-28-oic acid β-D-glucopyranoside (1),2α,3β,6β,23-tetrahydroxylurs-12,18-dien-28-oic acid β-D-glucopyranoside (2),2α,3β,23-trihydroxylurs-12,18-dien-28-oic acid β-D-glucopyranoside (3), nigaichigoside F1(4),asiaticoside C (5),2α,3β,6β,19α,23-pentahydroxylurs-12,18-dien-28-oic acid β-Dglucopyranoside (6) and 2α,3β,19α,23-tetrahydroxylurs-12-en-28-oic acid (7).Their structures were elucidated on the basis of spectral analysis with reference to the published data.Compound 1 is brand new,compounds 2-6 were first isolated from this plant.The new compound was evaluated for their cytotoxic activity against human hepatoma Bel 7402 in vitro.The results were expressed as the ratio of inhibiting Bel 7402 cells growth by comparing to untreated cells.The new compound (concentration:25 μmol·L-1) showed the ratio values of 52.5%.
7.Flavonoids from leaves of Psidum littorale
Hang-qing CUI ; Cai-ying PENG ; Ying-zheng HUANG ; Ying GAO ; Jian-qun LIU ; Rui ZHANG ; Ji-cheng SHU
Acta Pharmaceutica Sinica 2016;51(11):1745-
We investigated the chemical constituents of the leaves of Psidum littorale, which include 16 flavonoids, including seven flavonols, six flavonoid glycosides and three flavonones. The compounds were isolated by silica gel column chromatography. Their structures were elucidated on the basis of spectral analysis and by comparison with published data. Seven flavonols were kaempferol (1), isorhamnetin (2), myricetin-3,7,3'-trimethyl ether (3), laricitrin (4), quercetin (5), myricetin (6) and quercein-3,4'-dimethyl ether (7), six flavonoid glycosides were guaijaverin (8), hyperoside (9), 5,4'-dyhydroxy-3,7,5'-methoxyflavone-3'-O-β-D-glucoside (10), laricitrin-3-O-xyloside (11), myricetin-3-O-α-L-rhamnopyranoside (12) and myricetin-3-O-β-D-xyloside (13). Three flavonones were 4'-O-methyldihydroquercetin (14), dihydroapigenin (15) and ampelopsin 4'-O-β-D-glucopyranoside (16). Compound 10 is a new chemical, compounds 2-4, 7, 10-16 were first isolated from this plant. 1H NMR and 13C NMR data of compound 11 were not reported in literature.
8.The Correlation between Blood Uric Acid and Goldstein Grading in Hepatolenticular Degeneration Patients with Different Chinese Medical Syndrome Types.
Ji-yuan HU ; Yong-zhu HAN ; Qun-rong YE ; Ming-fan HONG ; Yong-liang CAI ; Ming-shan REN ; Fa-ming PAN ; Xun WANG ; Ren-ming YANG
Chinese Journal of Integrated Traditional and Western Medicine 2015;35(11):1335-1339
OBJECTIVETo observe blood uric acid levels and Goldstein grading, as well as their correlation in Wilson's disease (WD) patients with different Chinese medical syndrome types.
METHODSTotally 906 WD patients in line with inclusive criteria were assigned to 6 groups, i.e., the heart spirit confused by phlegm group (HSCP, 26 cases), the phlegm-fire disturbing heart group (PFDH, 90 cases), the retention of damp-heat group (RDH, 113 cases), deficiency of qi and blood group (DQB, 168 cases), the deficiency of Gan-yin and Shen-yin group (DGYSY, 327 cases), the deficiency of Gan and Shen group (DGS, 182 cases) due to different Chinese medical syndrome types. Recruited were another 160 healthy subjects having similar ages and diet structures, who came for medical examinations, as the healthy control group. Venous blood was collected from the medial cubital vein of each-patient on an empty stomach in early mornings to detect blood uric acid levels. Results Blood uric acid levels were lower in each syndrome type group than in the healthy control group (146.08 +/- 67.24 micromol/L in the HSCP group; 157.08 +/- 69.77 micromol/L in the PFDH group; 162.58 +/- 97.72 micromol/L in the RDH group; 156.20 +/- 62.63 micromol/L in the DQB group; 161.83 +/- 111.23 micromol/L in the DGYSY group; 194.41 +/- 90.01 micromol/L in the DGS group; 242.39 +/- 87.55 micromol/L in the healthy control group, P < 0.01). Blood uric acid levels were higher in the DGYSY group than in the other 5 syndrome groups (P < 0.01). Correlation analyses between Goldstein grading and blood uric acid showed that, along with increased Goldstein grade (that was aggravating disease conditions), WD patients' blood uric acid levels decreased (P < 0.01).
CONCLUSIONSWD patient's blood uric acid levels decreased more. Blood uric acid levels and Goldstein grading were different in various Chinese medical syndrome types. Blood uric acid levels had certain value in assessing the severity of WD.
Asian Continental Ancestry Group ; Heart ; Hepatolenticular Degeneration ; blood ; classification ; diagnosis ; Humans ; Medicine, Chinese Traditional ; Syndrome ; Uric Acid ; blood
9.Roles of targeting Ras/Raf/MEK/ERK signaling pathways in the treatment of esophageal carcinoma.
Yu-Sui CHANG ; Ji-Chun LIU ; Hua-Qun FU ; Ben-Tong YU ; Shu-Bing ZOU ; Qi-Cai WU ; Li WAN
Acta Pharmaceutica Sinica 2013;48(5):635-641
Ras is best known for its ability to regulate cell growth, proliferation and differentiation. Mutations in Ras are associated with the abnormal cell proliferation which can result in incidence of all human cancers. Extracellular signal-regulated kinase (ERK) is a downstream effector of Ras and plays important roles in prognosis of tumors. Recently, evidence has gradually accumulated to demonstrate that there are other effectors between Ras and ERK, these proteins interact each other and constitute the thorough Ras/Raf/MEK/ERK signaling pathway. The pathway has profound effects on incidence of esophageal carcinoma and clinical applications of some chemotherapeutic drugs targeting the pathway. Further understanding of the relevant molecular mechanisms of Ras/Raf/MEK/ERK signaling pathway can be helpful for the development of efficient targeting therapeutic approaches which contribute to the treatment of esophageal cancer. In this article, roles of Ras/Raf/MEK/ERK signaling pathway in esophageal carcinoma as well as pharmacological targeting point in the pathway are reviewed.
Animals
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Antineoplastic Agents
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pharmacology
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therapeutic use
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Carcinoma, Squamous Cell
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drug therapy
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enzymology
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pathology
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Cell Line, Tumor
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Enzyme Activation
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drug effects
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Esophageal Neoplasms
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drug therapy
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enzymology
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pathology
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Extracellular Signal-Regulated MAP Kinases
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antagonists & inhibitors
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metabolism
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Humans
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Mitogen-Activated Protein Kinase Kinases
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antagonists & inhibitors
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metabolism
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Proto-Oncogene Proteins c-raf
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antagonists & inhibitors
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metabolism
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Signal Transduction
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drug effects
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ras Proteins
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antagonists & inhibitors
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metabolism
10.Application of inversion-table in the treatment of lower pole renal stones.
Xiao YU ; Zhi-Qiang CHEN ; Wei-Min YANG ; Ji-Hong LIU ; Xi-Cai ZHOU ; Shao-Gang WANG ; Hui GUO ; Zhang-Qun YE
Chinese Journal of Surgery 2009;47(4):255-257
OBJECTIVETo investigate the effect of inversion-table in the treatment of lower pole renal stones.
METHODSFrom March 2006 to September 2008, 36 patients with lower pole renal calculi were treated by inversion-table, 13 cases with stone diameter from 4 mm to 20 mm received extracorporeal shock wave lithotripsy (ESWL) combined with inversion-table treatment and other 23 cases with stone diameter from 2 mm to 4mm received inversion-table treatment alone.
RESULTSAll of 36 cases underwent inversion-table treatment successfully and no one had cardio-cerebral accident. After following up 3 months, the radiologically documented complete stone clearance rate at 3 months group was 83.3%.
CONCLUSIONInversion-table treatment is a safe and valuable adjunct in assisting passage of lower pole renal stone fragments after mini-invasive treatment of stone and can improve stone-free rate.
Adult ; Female ; Follow-Up Studies ; Humans ; Kidney Calculi ; therapy ; Lithotripsy ; Male ; Middle Aged ; Posture ; Treatment Outcome ; Vibration ; therapeutic use

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