Evaluation of Clinical Efficacy of Shengmaisan Granules in Inhibiting Myocardial Fibrosis in Patients with Chronic Heart Failure with Qi-Yin Deficiency Syndrome Based on CMR / 中国实验方剂学杂志

ObjectiveTo evaluate the effect of Shengmaisan granules on myocardial fibrosis in chronic heart failure patients with Qi-Yin deficiency syndrome by cardiac magnetic resonance （CMR） imaging and serological indicators. MethodSixty-six chronic heart failure patients with Qi-Yin deficiency syndrome who visited the Affiliated Hospital of Integrated Traditional Chinese and Western Medicine， Nanjing University of Chinese Medicine from October 2021 to January 2023 were selected. The patients were assigned into a control group （33 cases） and an observation group （33 cases） by the minimization random method. Both groups received standardized Western medicine treatment for heart failure. In addition， the control group was treated with placebo granules， and the observation group with Shengmaisan granules for a course of 6 months. The baseline data， clinical efficacy， TCM symptom scores， serological indicators ［high-sensitivity C-reactive protein （hs-CRP）， soluble growth stimulation expressed gene 2 protein （sST2）， pro-collagen Ⅲ N-terminal peptide （PⅢNP）， interleukin （IL）-6， IL-11， transforming growth factor-β1 （TGF-β1）］， echocardiography ［Left atrial diameter （LAD）， left ventricular end systolic diameter （LVEDs）， left ventricular end diastolic diameter （LVEDd）］ and CMR indicators ［left ventricular ejection fraction （LVEF）， myocardial extracellular volume fraction （ECV）， and longitudinal relaxation time （T1）］ were compared between the two groups. ResultFinally， 31 patients in the control group and 30 patients in the observation group were included. There was no significant difference in baseline data or indicators between the two groups before treatment. Compared with those before treatment， the scores of TCM symptoms （shortness of breath， fatigue， palpitations， spontaneous or night sweats， thirst/dry throat， feverish feeling in palms and soles， and edema in lower limbs）， total score of TCM symptoms， ECV， T1， inflammation/fibrosis indicators （hs-CRP， sST2， PⅢNP， IL-6， IL-11， and TGF-β1） in observation group decreased （P<0.05， P<0.01）， and the scores of TCM symptoms （except feverish feeling in palms and soles）， T1， and inflammation/fibrosis indicators in the control group decreased （P<0.05， P<0.01）. After treatment， the observation group had lower scores of TCM symptoms （except feverish feeling in palms and soles and edema in lower limbs）， ECV， T1， and inflammation/fibrosis indicators than the control group （P<0.05， P<0.01）. After treatment， the total response rate in the observation group was 93.33% （28/30）， which was higher than that （80.65%， 25/31） in the control group （Z=2.976， P<0.01）. There was no significant difference in adverse reactions between the two groups during treatment. ConclusionFor patients with chronic heart failure with Qi-Yin deficiency syndrome， Shengmaisan Granules can alleviate the TCM symptoms， reduce inflammation， and inhibit myocardial fibrosis by regulating the TGF-β1/IL-11 signaling axis.

Clinical research on Shenqi Dihuang Decoction combined with conventional western medicine in the treatment of stage Ⅲ diabetic nephropathy / 国际中医中药杂志

Objective:To observe the clinical efficacy of Shenqi Dihuang Decoction combined with conventional western medicine in the treatment of stage Ⅲ Diabetic Nephropathy (DN).Methods:A total of 96 patients with stage Ⅲ diabetic nephropathy with syndrome of deficiency of qi and yin in our hospital, from January 2019 to January 2021, who met the inclusion criteria, were divided into 2 groups by random number table method, 48 in each group. The control group was given the conventional western treatment. The observation group was given Shenqi Dihuang Decoction on the basic of the control group treatment. Both groups treatment lasted for 3 months. Before and after the treatment, the changes of TCM Syndrome Scores were observed. The levels of soluble intercellular adhesion molecular-1 (sICAM-1) and monocyte chemoattractant protein-1 (MCP-1) were detected by double antibody sandwich ELISA. The levels of BUN, SCr, SOD and Hcy were detected by automatic biochemical analyzer, collect 24-hour urine, 24-hour urine total protein quantity (24 UTP) was detected by immunoturbidimetry, and eGFR was calculated by CKD-EPI formula to evaluate the clinical efficacy.Results:After the treatment, the total effective rate in the observation group was 83.3% (40/48), and the control group was 66.7% (32/40) and the difference was statistically significant ( χ2=3.56, P=0.049). After the treatment, TCM Syndrome Scores in the observation group was significantly better than that of the control group ( t=4.05, P<0.01). After treatment, the systolic blood pressure in the observation group was significantly lower than that of the control group ( t=4.29， P<0.01). After treatment, the levels of 24 hUTP [(1.43 ± 0.54) g vs. (1.86 ± 0.50) g, t=4.05], serum sICAM-1[(396.07 ± 50.61)μg/L vs. (480.11 ± 63.01)μg/L, t=7.20], Hcy [(27.41 ± 3.42) μmol/L vs. (29.76 ± 5.80) μmol/L, t=2.42] in the observation group were significantly lower than those in the control group ( P<0.05), and the levels of SOD [(168.32 ± 41.26) U/ml vs. (143.11 ± 37.02) U/ml, t=3.15] was significantly higher than that of the control group ( P<0.01). Conclusions:Shenqi Dihuang Decoction combined with conventional western medicine can reduce 24 hUTP quantity and kidney damage, delay the development of Ⅲ DN, improve clinical effect and protect the kidney function, and sICAM-1 for the Ⅲ DN patients with the syndrome of qi and yin deficiency combined with blood stasis.

Characteristics and Functional Differences of Intestinal Flora in Type 2 Diabetes Mellitus Patients with Dampness Heat Trapping Spleen Syndrome and Qi-Yin Deficiency Syndrome： An Analysis Based on High-throughput Sequencing Technology / 中国实验方剂学杂志

ObjectiveTo explore the structural characteristics and functional differences of intestinal flora in patients with type 2 diabetes mellitus （T2DM） of dampness heat trapping spleen（DHTS） syndrome and Qi-Yin deficiency（QYD） syndrome. MethodFrom June 2018 to January 2020，62 T2DM patients with DHTS syndrome and 60 with QYD syndrome were selected from Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine. Serum and fecal samples were collected to compare body mass index（BMI），glucose and lipid metabolism，fasting insulin （FINS） and fasting C-peptide （FCP） levels，and homeostasis model assessment of insulin resistance（HOMA-IR） of the two syndrome types. Fecal samples were extracted for DNA database construction，and 16S rDNA high-throughput sequencing was used to analyze and compare the intestinal flora and metabolic pathways. Result① The BMI，fasting plasma glucose（FPG），2-hour postprandial blood glucose （2 h PBG），total cholesterol（TC），triglyceride（TG），low density lipoprotein（LDL），FINS，FCP，and HOMA-IR were higher in patients with DHTS syndrome than in patients with QYD syndrome，and the high density lipoprotein（HDL） of the former was lower than that of the latter，（P<0.05，P<0.01）. ② In terms of species composition and differences，Bacteroidetes， Clostridia and Gammaproteobacteria were dominant at the class level，and the relative abundance of Clostridia，Mollicutes and Verrucomicrobiae in QYD syndrome group was higher than that in DHTS syndrome group. At the order level，Bacteroidales，Clostridiales and Enterobacteriales were mainly found. The relative abundance of Clostridiales，Erysipelotrichales and Verrucomicrobiales in QYD syndrome group was obviously higher than that in DHTS syndrome group，while Aeromonadales in the former was lower than that in the latter （P<0.05）. At the family level，Bacteroidaceae，Prevotellaceae and Ruminococcaceae were predominant. The relative abundance of Ruminococcaceae，Porphyromonadaceae and Erysipelotrichaceae in QYD syndrome group was higher than that in DHTS syndrome group（P<0.05）. At the genus level，Bacteroides，Prevotella and Parabacteroides were mainly found. The relative abundance of Parabacteroides，Butyrivibrio and Ruminiclostridium in QYD syndrome group was higher than that in DHTS syndrome group，while that of Klebsiella and Megasphaera in DHTS syndrome group was higher than that in QYD syndrome group（P<0.05）. ③ Through Venn analysis of operational taxonomic units（OTU），it was found that there were 49 OTUs in patients with DHTS syndrome patients and 47 OTUs in QYD syndrome patients. ④ The results of OTU β diversity and α analysis showed that Shannon and Simpson indexes had statistical differences，while Ace and Chao indexes had no statistical differences. The intestinal microbial diversity of patients with QYD syndrome was higher than that of patients with DHTS syndrome（P<0.05）. The analysis of similarities （ANOSIM） showed that the difference of β diversity between the two groups was significant（P<0.05）. ⑤ Linear discriminant analysis Effect Size（LEfSe） results demonstrated that Klebsiella，Megasphaera and Aeromonadales could be selected as the key biomarkers for DHTS syndrome； 14 bacteria such as Ruminiclostridium，Burkholderiaceae，Lautropia，Butyrivibrio，Erysipelotrichales can be selected as the key biomarkers for QYD syndrome. ⑥Functional annotation and analysis showed that the DHTS syndrome involved 9 metabolic pathways，including arginine and proline metabolism，lipopolysaccharide biosynthesis，nicotinic acid and nicotinamide metabolism，while the QYD syndrome involved 10 metabolic pathways，including acarbose and valinomycin biosynthesis，glucagon signaling pathway and NOD-like receptor signaling pathway. ConclusionThere are obvious differences in intestinal flora and functions in T2DM patients of DHTS syndrome and QYD syndrome，which can be used as reference for traditional Chinese medicine （TCM） syndrome differentiation and the target of TCM treatment.

Clinical study of acupuncture using the principle of invigorating viscera and purging fu, replenishing qi and nourishing yin for the type 2 diabetes mellitus patients with qi and yin deficiency / 国际中医中药杂志

Objective:To evaluate the effect of acupuncture with invigorating viscera and purging fu, replenishing qi and nourishing yin for the T2DM patients with qi and yin deficiency syndrome.Methods:A total of 59 patients who met the inclusion criteria from January 1, 2019 to December 31, 2020 in the Endocrinology Department of the Second Affiliated Hospital of Anhui University of Chinese Medicine were divided into the acupuncture group with 30 cases and a control group with 29 cases, according to the random number table method. The control group received conventional hypoglycemic treatment. And the acupuncture group was treated with acupuncture on the basis of the control group treatment. Both groups were treated for 4 weeks. TCM syndrome scores were performed before and after treatment, respectively. Serum IL-6 was measured by ELISA, serum CRP by immunoturbidimetry, and serum fasting blood glucose (FPG), 2 hPG, HbAlc, TC, TG, HDL-C, LDL-C levels by spectrophotometry. The BMI, clinical effect rates were calculated.Results:The total effective rate was 96.7% (29/30) in acupuncture group and 75.9% (22/29) in control group, and the difference was statistically significant ( χ2=5.96, P<0.01). After treatment, the scores of fatigue, dryness of mouth and pharynx, spontaneous sweating and night sweating, shortness of breath and lazy speech in acupuncture group were significantly lower than those in the control group ( t values were 6.02, 4.31, 4.34, 3.63, respectively, all Ps<0.01). The serum CRP level in acupuncture group was significantly lower than that of the control group at 21, 48 d after treatment ( t values were -4.36, -3.75, respectively, all Ps<0.01), and IL-6 level was significantly lower than that of the control group at 14, 21, 28 d after treatment ( t values were -2.92, -5.35, -8.71, respectively, all Ps<0.01). After treatment, the serum TC [(4.62±0.68) mmol/L vs. (5.56±0.72) mmol/L, t=5.16], TG [(1.48±0.42) mmol/L vs. (2.12±0.89) mmol/L, t=3.55], LDL-C [(2.48±0.84) mmol/L vs.(3.02±0.95) mmol/L, t=2.32] in the acupuncture group were significantly lower than those in the control group ( P<0.05), HDL-C [(1.39±0.27) mmol/L vs. (1.26±0.22) mmol/L, t=-2.02] in the acupuncture group was significantly higher than that of the control group ( P<0.05). The serum FPG level at 21 d [(6.12±0.67) mmol/L vs. (6.57±0.61) mmol/L, t=-4.96], 28 d [(5.78±0.52) mmol/L vs. (6.49±0.58) mmol/L, t=-2.70] in acupuncture group were significantly lower than those in the control group ( P<0.01). The 2h PG level at 14 d after treatment [(10.23±1.06) mmol/L vs. (11.76±1.34) mmol/L, t=-4.87], 21 d [(9.05±0.98) mmol/L vs. (10.53±1.24) mmol/L, t=-5.10], 28 d [(7.45±0.69) mmol/L vs. (9.31±0.78) mmol/L, t=-9.71] in the acupuncture group were significantly lower than those in the control group ( P<0.01), and HbA1c level were decreased 14 d [(7.93±0.86)% vs. (8.52±0.97)%, t=-2.47], 21 d [(7.63±0.85)% vs. (8.15±0.92)%, t=-2.26], 28 d [(6.47±0.51)% vs. (7.51±0.62)%, t=-7.05] significantly lower than those in the control group ( P<0.01), BMI [(22.13±1.57) kg/m 2vs. (24.16±1.82) kg/m 2, t=-4.59] 28 d after treatment was significantly lower than that of the control group ( P<0.01). Conclusion:Acupuncture therapy of nourishing viscera and purging fu, nourishing qi and nourishing yin can regulate the disorder of glucose and lipid metabolism in patients with T2DM and syndrome of qi and yin deficiency.

Clinical study of Yiqi Dihuang Decoction combined with conventional therapy for the patients with early stage diabetic nephropathy and deficiency of qi and yin / 国际中医中药杂志

Objective:To investigate the effect of Yiqi Dihuang Decoction assisting conventional western medicine therapy in the treatment of early diabetic nephropathy (DN) with deficiency of qi and yin.Methods:A total of 117 patients with early DN who met the inclusion criteria from June 2018 to December 2020 in Beijing Hospital of Traditional Chinese Medicine Shunyi Branch were divided into a control group of 58 patients and a treatment group of 59 patients according to the random number table method. The control group was treated with conventional western medicine therapy, and the treatment group was additionally treated with Yiqi Dihuang Decoction on the basis of the control group. Both groups were treated for 1 month. Serum levels of IL-1, macrophage scavenger receptor A (SR-A), TNF-α, C-C motif chemokine 2 (CCL2), GSH-Px and SOD were detected by ELISA before and after treatment. Cystatin C (Cys C) and SCr levels were detected by automatic biochemical analyzer. The urinary albumin was determined by radioimmunoassay, urinary creatinine determined by rate method, and urinary albumin/creatinine ratio (UACR) and glomerular filtration rate (eGFR) were calculated. The adverse events during treatment and clinical efficacy were evaluated.Results:The total effective rate was 94.92% (56/59) in the treatment group and 81.03% (47/58) in the control group, and the difference between the two groups was statistically significant ( χ2=5.35, P=0.021). After treatment, UACR [(92.28±15.42) mg/g vs. (108.42±20.76)mg/g, t=4.78], eGFR [(91.42±13.18) m·min -1·1.73m -2vs. (95.30±15.94) m·min -1·1.73m -2, t=2.02], SCr [(65.30±9.54) μmol/L vs. (70.18±12.53) μmol/L, t=5.42], Cys C [(0.65±0.12)mg/L vs. (1.07±0.26)mg/L, t=11.25] in the treatment group were significantly lower than those in the control group ( P<0.05). Serum SR-A [(37.18±6.10) μg/L vs. (51.51±7.12) μg/L, t=11.70], CCL2 [(13.12±1.63) μg/L vs. (19.68±2.90) μg/L, t=15.12], TNF-α [(20.57±3.50) ng/L vs. (29.68±4.17) ng/L, t=12.81], IL-1 [(8.47±0.97) ng/L vs. (13.12±1.57) ng/L, t=19.31] levels in the treatment group were significantly lower than those in the control group ( P<0.01); serum SOD [(24.09±3.12) mg/L vs. (18.72±2.76) mg/L, t=9.85] activity and GSH-Px [(231.57±25.38) mg/L vs. (174.58±22.96) mg/L, t=12.73] in the treatment group were significantly higher than those in the control group ( P<0.01). During the treatment period, the incidence of adverse events was 10.34% (6/58) in the control group and 6.78% (4/59) in the treatment group, and there was no significant difference between the two groups ( χ2=0.48, P=0.490). Conclusion:Yiqi Dihuang Decoction assisted with conventional western medicine can effectively improve the renal function of patients with early DN syndrome of qi and yin deficiency, inhibit the body's inflammatory response and oxidative stress response, and improve clinical efficacy.

Efficacy of addition and subtraction of Buyang Huanwu decoction in the adjuvant treatment of non-proliferative diabetic retinopathy of Qi-Yin deficiency and blood stasis / 国际眼科杂志(Guoji Yanke Zazhi)

@#AIM: To observe the efficacy of addition and subtraction of Buyang Huanwu decoction in the adjuvant treatment of non-proliferative diabetic retinopathy of Qi-Yin deficiency and blood stasis and its effects on traditional Chinese medicine(TCM)syndromes and visual function level. <p>METHODS: A total of 110 patients with non-proliferative diabetic retinopathy of Qi-Yin deficiency and blood stasis in our hospital between January 2017 and December 2019 were selected and divided into observation group(55 cases, 110 eyes)and control group(55 cases, 110 eyes). Patients in control group received conventional treatment according to the condition of patients with reference to relevant guidelines, and patients in observation group were combined with addition and subtraction of Buyang Huanwu decoction adjuvant therapy on this basis. The clinical efficacy after 3mo of treatment, and TCM syndromes scores, clinical indicators(macular edema score, macular retinal volume, macular foveal retinal thickness), visual function(best corrected visual acuity, average visual field sensitivity)and serum biochemical indicators \〖vascular endothelial growth factor(VEGF), hypoxia-inducible factor-1(HIF-1)\〗 before treatment and 3mo after treatment were compared between the two groups.<p>RESULTS: After 3mo of treatment, the total effective rate of treatment in observation group was significantly higher than that in control group(<i>P</i><0.05). After 3mo of treatment, the TCM syndromes scores in the two groups were decreased compared with those before treatment, and the scores in observation group were lower than those in control group(<i>P</i><0.05). After 3mo of treatment, the macular edema score, macular retinal volume and macular foveal retinal thickness in the two groups were reduced compared with those before treatment, and the indexes in observation group were smaller than those in control group(<i>P</i><0.05). After 3mo of treatment, the best corrected visual acuity and average visual field sensitivity in the two groups were improved compared with those before treatment, and the indexes in observation group were higher than those in control group(<i>P</i><0.05). After 3mo of treatment, the levels of serum VEGF and HIF-1 in the two groups were decreased compared with those before treatment, and the levels in observation group were lower than those in control group(<i>P</i><0.05). <p>CONCLUSION: Addition and subtraction of Buyang Huanwu decoction has an exact efficacy in the adjuvant treatment of non-proliferative diabetic retinopathy of Qi-Yin deficiency and blood stasis, and it can improve symptoms and promote visual function recovery by reducing the expressions of VEGF and HIF-1.

Efficacy of Yangyin Yiqi Huoxue Granule () in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule (, YYHG) in the treatment of ischemic stroke (IS) patients with qi-yin deficiency and blood stasis syndrome (QYDBSS), and to explore its effective dosage.@*METHODS@#The total of 288 patients were randomly assigned to the YYHG high-dose, YYHG low-dose, positive control (administered Xiaoshuantong Granule, XSTG, ), or placebo control (administered inert granule) groups (72 cases per group) by software-drived competitive block randomization. The trial was conducted for a 28-day period, with a 180-day follow-up period. The primary outcome was the comprehensive curative evaluation, and secondary outcomes were the National Institute of Health Stroke Scale (NIHSS) score, Barthel activities of daily living (ADL) index score, the quality of life index (QLI) score, and the Chinese medicine syndrome (CMS) score. All analyses were done on an intention-to-treat basis. The clinical safety was also assessed.@*RESULTS@#The total of 288 participants were recruited between June 1, 2008 and September 30, 2009, and 287 patients received intervention; the treatment groups were well balanced at baseline. The comprehensive cure rates of YYHG high-dose, low-dose, positive and placebo control groups were 63.38%, 31.94%, 36.11% and 6.14%, respectively; there was a statistical difference between the two groups (P<0.01), while the high-dose YYHG treatment group was significantly higher than the other 3 groups (P<0.01). The improvement of NIHSS, ADL, QLI and CMS scores of the YYHG high-dose and low-dose groups was significantly better than that of the positive control group and the placebo control group (P<0.05). In terms of improving the classification of the NIHSS scale and the assessment of the ADL scale, the YYHG high-dose group was significantly better than the other three groups (P<0.05), and the YYHG low-dose group was better than the placebo control group (P<0.01). At the same time, except for the QLI score, the high-dose group was better than the low-dose group (P<0.05). In terms of safety, adverse reactions after YYHG treatment were generally mild (3.78%), and no serious adverse reactions have been reported.@*CONCLUSION@#YYHG is safe and effective in the treatment of IS patients with QYDBSS.

Effect of Modified Huangqi Biejiatang Combined with Auricular Acupressure on Diabetic Peripheral Neuropathy of Qi-Yin Deficiency Syndrome and Serum MyD88/IκB Signaling Pathway / 中国实验方剂学杂志

Objective:To observe the effects of modified Huangqi Biejiatang combined with auricular acupressure on diabetic peripheral neuropathy （DPN） due to Qi and Yin deficiency and serum myeloid differentiation factor 88/inhibitor of nuclear factor-<italic>κ</italic>B （MyD88/I<italic>κ</italic>B） signaling pathway. Method:One hundred and forty cases were randomly divided into an observation group （<italic>n</italic>=70） and a control group （<italic>n</italic>=70）. In addition to routine treatments like dietary intervention and the regulation of fasting blood glucose （FBG） and blood pressure， the modified Huangqi Biejiatang combined with auricular acupressure was further provided in the observation group， while mecobalamine was administered in the control group. After four-week intervention， the toronto clinical scoring system （TCSS） score， traditional Chinese medicine （TCM） syndrome score， the conduction velocities of motor and sensory nerves （median nerve， common peroneal nerve， tibial nerve， and ulnar nerve）， glucose metabolism indexes ［fasting plasma glucose （FPG）， 2 h postprandial blood glucose （2 h PG）， and hemoglobin A1c （HbA1c）］， intestinal genera （<italic>Clostridium</italic>， <italic>Prauserella</italic>， <italic>Bacteroides</italic>， and <italic>Faecalibacterium</italic>）， as well as the serum MyD88， I<italic>κ</italic>B<italic>α</italic>， and phosphorylated I<italic>κ</italic>B<italic>α </italic>（p-I<italic>κ</italic>B<italic>α</italic>） levels in the MyD88/I<italic>κ</italic>B signaling pathway before and after treatment were observed in the two groups， for comparing their clinical efficacy and safety. Result:The total effective rate of the observation group was 85.3% （58/68）， which was higher than 48.5% （32/66） of the control group （<italic>χ</italic>²=6.143， <italic>P</italic><0.05）. The comparison with the control group revealed that the scores of TCSS and TCM syndrome， the levels of FPG， 2 h PG， HbA1c， MyD88， and p-I<italic>κ</italic>B<italic>α</italic>， as well as the abundances of <italic>Clostridium</italic> and <italic>Prauserella</italic> in the observation group were decreased （<italic>P</italic><0.05）， while the conduction velocities of motor and sensory nerves （median nerve， common peroneal nerve， tibial nerve， and ulnar nerve） were significantly accelerated （<italic>P</italic><0.05）. Besides， the abundances of <italic>Bacteroides</italic> and <italic>Faecalibacterium</italic> and I<italic>κ</italic>B<italic>α</italic> level were significantly elevated （<italic>P</italic><0.05）. The incidence of adverse reactions in the observation group was 1.5% （1/68）， lower than 12.1% （8/66） in the control group （<italic>χ</italic>²=4.328， <italic>P</italic><0.05）. Conclusion:The modified Huangqi Biejiatang combined with auricular acupressure alleviates DPN due to Qi and Yin deficiency， which may be attributed to the regulation of serum MyD88/I<italic>κ</italic>B signaling pathway.

Clinical Efficacy of Modified Zengyetang Against Slow Transit Constipation Due to Qi-Yin Deficiency and Its Effect on Gastrointestinal Function / 中国实验方剂学杂志

Objective:To observe the clinical effect of modified Zengyetang in treating slow transit constipation （STC） due to Qi-Yin deficiency and its effect on gastrointestinal function. Method:One hundred and thirty eligible patients were randomly divided into a control group （<italic>n</italic>=65， 6 cases dropped out or were lost to follow-up and 59 completed the trial） and a treatment group （<italic>n</italic>=65， 3 cases dropped out or were lost to follow-up and 62 completed the trial）. Patients in the control group received oral mosapride citrate dispersible tablets， 5 mg per time， three times per day， while those in the treatment group were treated with modified Zengye Tang， one bag per day， for four successive weeks. The main symptom constipation， the Patient Assessment of Constipation Symptoms （PAC-SYM）， and traditional Chinese medicine （TCM） syndrome scores， colonic transit， as well as motilin （MTL）， vasoactive intestinal peptide （VIP）， and substance P （SP） levels before and after treatment were recorded， together with the frequency of spontaneous complete bowel movements （SCBMs） per week and STC recurrence during treatment. Result:The clinical efficacy （95.16%） of the treatment group was higher than that （81.36%） of the control group （<italic>χ</italic>²=5.631 4， <italic>P</italic><0.05）， whereas the recurrence rate （30.65%） of the treatment group was significantly lower than that （57.63%） of the control group （<italic>χ</italic>²=8.941 1， <italic>P</italic><0.01）. After treatment， the main symptom constipation， three sub-scale and total PAC-SYM， and TCM syndrome scores in the treatment group were obviously decreased as compared with those in the control group （<italic>P</italic><0.01）. The proportions of residual markers at 24， 48， and 72 h in the treatment group declined in contrast to those in the control group （<italic>P</italic><0.01）. The frequency of SCBMs per week in the 2^nd， 3^rd， and 4^th weeks of the treatment group was higher than that in the control group （<italic>P</italic><0.01）. Compared with the control group after treatment， the treatment group exhibited significantly elevated MTL and SP but lowered VIP （<italic>P</italic><0.01）. Conclusion:Modified Zengyetang relieves the clinical symptoms， regulates gastrointestinal hormone secretion， increases the frequency of SCBMs， enhances colonic transit， and decreases the recurrence of patients with STC due to Qi-Yin deficiency.

Clinical Observation of Modified Zhizhutang in Treatment of Senile Primary Constipation Due to Qi-Yin Deficiency / 中国实验方剂学杂志

Objective:To explore the clinical efficacy of modified Zhizhutang in treating senile primary constipation due to Qi-Yin deficiency and its influences on gastrointestinal neurotransmitters and gastrointestinal motility. Method:One hundred and twenty-one eligible patients were randomly divided into a control group （<italic>n</italic>=60） and an observation group （<italic>n</italic>=61）. On the basis of lifestyle adjustments， patients in the control group further received oral Qihuang Tongmi soft capsule，three capsules per time，three times per day， whereas those in the observation group were further treated with modified Zhizhutang，one bag per day， for eight successive weeks. The number of complete spontaneous bowel movements （CSBM， normal defecation was considered if CSBM ≥ three times per week） before and after treatment was recorded. The main symptoms of constipation，the patient assessment of constipation quality of life （PAC-QOL）， and the traditional Chinese medicine （TCM） syndrome before and after treatment were scored， followed by the anorectal pressure measurement and colonic transit test before and after treatment. The levels of somatostatin （SS），motilin （MTL），substance P （SP） and vasoactive intestinal peptide （VIP） before and after treatment were detected. Result:The weekly average number of CSBM in the observation group was greater than that of the control group （<italic>P</italic><0.01）， but the TCM syndrome score was lower than that of the control group （<italic>P</italic><0.01）. The normal defecation rate in the observation group was 57.38% （35/61），which was higher than 35% （21/60） of the control group （<italic>χ</italic>²=6.092，<italic>P</italic><0.05）. The scores of the main symptoms of constipation in the observation group were significantly lower than those in the control group （<italic>P</italic><0.01）. The PAC-QOL subscale scores and the total score of the observation group significantly declined as compared with those of the control group （<italic>P</italic><0.01）. The anal resting pressure and anal maximum systolic pressure of the observation group were higher than those of the control group （<italic>P</italic><0.01），while the first sensation volume， urge sensation volume and maximum tolerable volume were lower （<italic>P</italic><0.01）. The excretion rates of markers in the observation group at 24 h，48 h and 72 h were significantly elevated in comparison with those in the control group （<italic>P</italic><0.01）. Compared with the control group， the observation group also exhibited increased serum MTL and SP （<italic>P</italic><0.01） and decreased SS and VIP （<italic>P</italic><0.01）. The recurrence rate in the observation group was 34.29% （12/35），obviously lower than 61.90% （13/21） in the control group （<italic>χ</italic>²=5.051，<italic>P</italic><0.05）. The total effective rates in the observation group and the control group were 95.08% （58/61） and 81.67% （49/60） ， implying a significant difference （<italic>χ</italic>²=5.321，<italic>P</italic><0.01）. Conclusion:For the elderly with primary constipation due to Qi-Yin deficiency， oral administration of modified Zhizhutang helps to regulate gastrointestinal neurotransmitters，improve gastrointestinal motility and gastrointestinal emptying rate， alleviate the symptoms of constipation， restore spontaneous bowel movements， improve their quality of life， and lower the recurrence rate. Its clinical effects were better than those of Qihuang Tongmi soft capsule.

Clinical effect of Shenqi-Gushen Decoction combined with routine western medicine in the treatment of chronic renal failure of qi-yin deficiency syndrome / 国际中医中药杂志

Objective:To evaluate the clinical curative effect of Shenqi-Gushen Decoction on patients with chronic renal failure (CRF) of qi-yin deficiency syndrome. Methods:A total of 82 patients with CRF meeting inclusion criteria in the hospital were enrolled between June 2018 and January 2021. According to random number table method, they were divided into control group and observation group, 41 in each group. The control group was treated with routine western medicine, while the observation group was treated with Shenqi-Gushen Decoction on basis of control group. All were treated for 2 months. Before and after treatment, Traditional Chinese Medicine (TCM) symptoms were scored. The serum creatinine (SCr) and blood urea nitrogen (BUN) were detected by full-automatic biochemical analyzer. The levels of IL-6, TNF-α and hypersensitive C-reactive protein (hs-CRP) were detected by ELISA. The levels of hemoglobin (Hb), serum albumin (Alb) and prealbumin (PA) were detected by immune scatter turbidity. And clinical curative effect was evaluated. Results:The total response rate [80.5% (33/41) vs. 46.3% (19/41); χ2=5.861, P=0.015] in the observation group was significantly higher than that of the control group. After treatment, scores of TCM symptoms in observation group was significantly lower than that of the control group ( t=23.468, P<0.01), levels of serum SCr [(421.19 ± 43.82) μmol/L vs. (488.71 ± 48.39) μmol/L, t=6.623] and BUN [(19.54 ± 1.26) mmol/L vs. (24.12 ± 2.42) mmol/L, t=10.749] were significantly lower than those in the control group ( P<0.01), and eGFR [(47.71 ± 4.68) ml/min vs. (42.51 ± 4.55) ml/min, t=5.101] was significantly higher than that of control group ( P<0.01). After treatment, levels of serum IL-6, TNF-α and hs-CRP in observation group were significantly lower than those in the control group ( t=3.412, 3.714, 2.466, P<0.01 or P<0.05), while levels of Hb, Alb and PA were significantly higher than those in the control group ( t=4.462, 5.807, 2.256, P<0.01 or P<0.05). Conclusion:Shenqi-Gushen Decoction combined with routine western medicine can improve clinical syndromes, renal function, micro-inflammation response, nutrition status and curative effect in patients with CRF of qi-yin deficiency syndrome.

Effects of Tangzhiping Prescription on Non-proliferative Diabetic Retinopathy Damage / 中国中医药信息杂志

Objective To observe the clinical efficacy of Tangzhiping Prescription on non-proliferative diabetic retinopathy (NPDR) and the effects on serum vascular epithelial growth factor (VEGF) and pigment epithelium derived factor (PEDF). Methods Totally 86 NPDR patients were randomly divided into treatment group (43 cases) and control group (43 cases). Both groups were given hypoglycemic, anti hypertensive and lipid-regulatory basic therapy. The control group was given calcium distillate capsules, 0.5 g per time, 3 times a day, orally; the treatment group was treated with Tangzhiping Prescription based on the control group, 1 dosage per day, twice a day, orally. Four weeks were set as one treatment course. Treatment for both groups lasted for three courses. Clinical efficacy and fundus efficacy of both groups were evaluated. TCM symptom scores, fundus scores, and visual condition were observed; FPG, 2 h PG, Hb A1 C, TC, TG, HDL-C and LDL-C and changes in the contents of VEGF and PEDF were detected. Results The control group and the treatment group lost 2 and 3 cases respectively. The total effective rate of clinical efficacy and total fundus efficiency of the control group were 65.00％ and 68.35％, respectively, and the treatment group were 87.50％ and 84.62％ respectively, with statistical significance (P＜0.05). Compared with before treatment, TCM symptom scores and fundus scores decreased significantly after treatment in both groups (P＜0.01); After treatment, the TCM symptom scores and fundus scores in the treatment group were lower than those in the control group (P＜0.05, P＜0.01). Compared with before treatment, visual acuity improved significantly after treatment in both groups (P＜0.05, P＜0.01). Compared with before treatment, levels of FPG, 2 h PG, Hb A1 c, TC, TG, and LDL-C decreased significantly in both groups after treatment (P＜0.01). After treatment, the levels of 2 h PG, Hb A1 c, TC, TG, and LDL-C in the treatment group were significantly lower than the control group (P＜0.05, P＜0.01). Compared with before treatment, the levels of VEGF decreased and PEDF levels increased in both groups, with statistical significance (P＜0.01). After treatment, the improvement of VEGF and PEDF in the treatment group was better than that in the control group (P＜0.05, P＜0.01); negative correlation was found between VEGF and PEDF (r=-0.320, P＜0.01). Conclusion Tangzhiping Prescription can effectively improve the clinical symptoms of patients with NPDR and slow down the progress of NPDR via reducing the blood glucose and blood lipids, and regulating the contents of VEGF and PEDF.

Visualization Analysis on Diagnostic Criteria Research of Qi-yin Deficiency Based on Knowledge Mapping Function of CiteSpace / 世界科学技术-中医药现代化

Objective: To analyze the status and existing problems of the diagnostic criteria of qi and yin deficiencysyndrome by applying the knowledge mapping method. Methods: In the China Knowledge Network Database (CNKI), wesearched the relevant journal articles on the diagnostic criteria of qi and yin deficiency syndrome, exported andtransformed the literature data, and used CiteSpace software to draw co-occurrence map of authors, institutions and keywords of research on the diagnosis criteria of qi and yin deficiency syndrome for analysis.Results:A total of 378research papers were included, and the main researchers and teams represented by Li Jiansheng were found.The research institute was mainly the Institute of Geriatrics of Henan University of Traditional Chinese Medicine.Diabetes was the most concerned research direction in this field.Conclusion:Although the research on the diagnostic criteria of qi and yin deficiency syndrome is currently facing great difficulties, the research institutions in this field have cooperat extensively.The wisdom collision brought by such cooperation foundation will provide solutions to these problems, an the output of excellent results was expected.Based on diabetes, IGA nephropathy, coronary heart disease, and clinic research as the method, the relevant research is the main direction, which will be the main trend of the research on t diagnostic criteria of qi and yin deficiency syndrome.

Clinical efficacy of Liuweidihuang Pill combined with Metformin in treatment of type 2 diabetes with Qi-Yin deficiency / 药物评价研究

Objective To discuss the efficacy of six ingredient rehmannia pill combined with metformin in treatment of type 2 diabetes with Qi-Yin deficiency.Methods 120 cases with type 2 diabetes were selected.They were divided into two groups randomly.The observation group (60 cases) took six ingredient rehmannia pill combined with metformin.The control group (60 cases) took metformin.The efficacy of interlocking intramedullary nail and fracture contusion capsule in treatment of open tibial fracutre was evaluated by fasting blood glucose,postprandial 2 h blood glucose,total symptom scores before and after treatment,adverse reaction during treatment.Results The effective rate of observation group was significantly higher than that of the control group (P ＜ 0.05).Before treatment,fasting blood glucose and postprandial 2 h blood glucose level had no significant difference between two groups.After treatment,the blood glucose of two groups were decreased (P ＜ 0.05).The fasting blood glucose and blood glucose 2 h after meal of observation group were lower than that of the control group (P ＜ 0.05).Before treatment,total symptom scores had no significant difference.After treatment,the two groups of the total symptom scores were decreased significantly (P ＜ 0.05),and the observation group the total symptom score lower than that of the control group (P ＜ 0.05).During the treatment,the control group of 1 cases of hypoglycemia,the observation group of 1 cases of hypoglycemia,1 cases of mild nausea.The adverse reactions of two groups had no significant difference.Conclusion Six ingredient rehmannia pill combined with metformin had good effect on type 2 diabetes.It could significantly improve the symptoms of diabetes diagnosed by traditional Chinese medicine.The hypoglycemic effect was obvious with high drugy safety.It was worthy of clinical application.

Clinical efficacy of Liuweidihuang Pill combined with Metformin in treatment of type 2 diabetes with Qi-Yin deficiency / 药物评价研究

Objective To discuss the efficacy of six ingredient rehmannia pill combined with metformin in treatment of type 2 diabetes with Qi-Yin deficiency.Methods 120 cases with type 2 diabetes were selected.They were divided into two groups randomly.The observation group (60 cases) took six ingredient rehmannia pill combined with metformin.The control group (60 cases) took metformin.The efficacy of interlocking intramedullary nail and fracture contusion capsule in treatment of open tibial fracutre was evaluated by fasting blood glucose,postprandial 2 h blood glucose,total symptom scores before and after treatment,adverse reaction during treatment.Results The effective rate of observation group was significantly higher than that of the control group (P ＜ 0.05).Before treatment,fasting blood glucose and postprandial 2 h blood glucose level had no significant difference between two groups.After treatment,the blood glucose of two groups were decreased (P ＜ 0.05).The fasting blood glucose and blood glucose 2 h after meal of observation group were lower than that of the control group (P ＜ 0.05).Before treatment,total symptom scores had no significant difference.After treatment,the two groups of the total symptom scores were decreased significantly (P ＜ 0.05),and the observation group the total symptom score lower than that of the control group (P ＜ 0.05).During the treatment,the control group of 1 cases of hypoglycemia,the observation group of 1 cases of hypoglycemia,1 cases of mild nausea.The adverse reactions of two groups had no significant difference.Conclusion Six ingredient rehmannia pill combined with metformin had good effect on type 2 diabetes.It could significantly improve the symptoms of diabetes diagnosed by traditional Chinese medicine.The hypoglycemic effect was obvious with high drugy safety.It was worthy of clinical application.

Relationship between prescription and syndrome on mini-swine phlegm-stasis syndrome of coronary heart disease / 药学学报

This study was conducted to investigate the effects of Danlou (correspondence between prescription and syndrome) tablet and Shengmai capsule (non-correspondence between prescription and syndrome) on mini-swine phlegm-stasis syndrome of coronary heart disease (CHD). 24 mini-swines were randomly divided into normal control group, model group, Danlou tablet group (0.24 g·kg-1) and Shengmai capsule group (0.14 g·kg-1). Phlegm-stasis syndrome of coronary heart disease was established by high-fat feeding and coronary intervention balloon injury. After 8 weeks of administration, blood lipid levels and blood rheology was detected. Echocardiography was used to examine the changes in heart function, and the extent of infarction was determined by nitro blue tetrazolium (NBT) staining method. The main symptoms, accompanied symptoms, tongue and pulse signs of the coronary heart disease mini-swine with phlegm-stasis syndrome were observed according to the symptom-graded scoring method. The results showed that Danlou tablet decreased serum total cholesterol (TC), triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C) (P P P P P P P P P P P P < 0.05). However, Shengmai capsule failed to show therapeutic effects on blood lipid metabolism, the myocardial infarction area and primary symptom and syndrome score. The results suggest that as a drug for the treatment of Qi and Yin deficiency syndrome of CHD, Danlou tablet has limited therapeutic effects on phlegm-stasis syndrome of CHD. Only by the prescription correspondence with syndrome, using drug for the treatment of phlegm-stasis syndrome of CHD to treat phlegm-stasis syndrome of CHD, the prescription has a comprehensive therapeutic effect.

Zishendecoction combined with standard treatment of western medicine for stage IV diabetic nephropathy with Qi and Yin deficiency / 国际中医中药杂志

ObjectiveTo evaluate the therapeutic effect ofZishen decoction combined with standard treatment of western medicine for for stage IV diabetic nephropathy with Qi and Yin deficiency.MethodsA total of 112 patients with stage IV diabetic nephropathy and Qi and Yin deficiency were randomized to thestandard treatment and the combined treatment groups, 56 in each. The standard treatment group received conventional treatment, including blood glucose controlling, antihypertensive, blood lipid regulating and diet controlling. The combined treatment group receivedZishen decoction on the basis of conventional treatment. All the patients were treated for 3 months. The blood urea nitrogen (BUN), serum creatinine (SCr), total cholesterol (TG), triacylglycerol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and glycated hemoglobin (HbA1c) were measured by an automatic chemistry analyzer. The urinary albumin excretion rate (UAER) was measured by the enzyme-linked immunosorbent assay.ResultsCompared with the standard treatment group, the SCr (53.51 ± 18.12μmol/Lvs. 62.66 ± 21.14μmol/L;t=2.459,P<0.05), UAER(100.73±84.24μg/minvs. 156.24 ± 96.38μg/min;t=3.245,P<0.05), TG(1.73±0.22 mmol/Lvs. 2.06 ± 0.21 mmol/L;t=8.112,P<0.01), TC(4.56 ± 0.62 mmol/Lvs. 5.10 ±0.31 mmol/L;t=5.830, P<0.01), LDL-C (2.42 ± 1.05 mmol/Lvs. 3.31 ± 0.81 mmol/L;t=5.022,P<0.01) in the combined treatment group decreased significantly, and the HDL-C (1.67 ± 0.33 mmol/Lvs. 1.36 ± 0.41 mmol/L;t=4.460,P<0.01) increased significantly. ConclusionZishen decoction on the basis of conventional treatment can improve the SCr and UAER, and regulate the blood lipid in the patients with stage IV diabetic nephropathy and Qi-Yin deficiency.

Empirical Study on Qi-yin Deficiency Syndrome of Type 2 Diabetes Based on Structural Equation Model / 中国中医药信息杂志

Objective To verify the relationship between qi-yin deficiency syndrome and the etiology and diagnostic information on type 2 diabetes mellitus.Methods Data of 185 cases of qi-yin deficiency syndrome of type 2 diabetes and 351 cases of other syndromes at TCM Hospital of Hongqiao District in Tianjin and Metabolic Disease Hospital of Tianjin Medical University were randomly collected. Etiology and diagnostic information of qi-yin deficiency syndrome were screened by the likelihood radio of forward step method by using Logistic regression analysis. On this basis, the relationship between qi-yin deficiency syndrome and the etiology and diagnostic information was verified by using maximum likelihood estimation method of the structural equation model.Results The goodness of fit index of the model (GFI) was 0.909; root mean square residual (RMR) of that was 0.071; comparative fit index (CFI) of that was 0.942, which suggested that the fitting effect of the model was good. The reasonable interpretation of the relationship between qi-yin deficiency syndrome and the etiology and diagnostic information was given. Conclusion From the aspect of single syndrome factors, the relationship between qi-yin deficiency syndrome and the etiology and diagnostic information on type 2 diabetes mellitus is verified.

Clinical Observation of Modified Xiaoshengliu Decoction for Intervention of Sub-health Population / 广州中医药大学学报

Objective To observe the intervention of sub-health population with modified Xiaoshengliu Decoction, a Chinese herbal recipe with the actions of strengthening Qi and nourishing yin, soothing liver and relieving stagnation, tonifying liver and kidney. Methods The clients of professor LUO Ren from Dept. of Traditional Chinese Medicine, Nanfang Hospital Affiliated to Southern Medical University, were chosen as the studying objects. Sub-health outpatient cases were defined according to the data of four diagnostic methods together with Sub-health Questionnaire developed by the sub-health program of Southern Medical University, and then were given modified Xiaoshengliu Decoction (mainly composed of Radix Bupleuri, Radix Scutellariae, Rhizoma Pinelliae Preparata, Radix Codonopsis, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Fructus Corni, Cortex Moutan, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Glycyrrhizae Preparata, etc.) for intervention. The symptoms of the subjects were followed up before and after treatment for the evaluation of therapeutic effect with Sub-health State Symptom Checklist. Results (1) The results showed that the total effective rate was 92.03%at first follow -up, and was 100% at the last follow-up, the difference being significant between the two periods of follow-up (P<0.01) . (2) The results of single-factor variance analysis showed that the differences of symptoms scores before treatment, at the first and the last follow-up were statistically significant (P<0.01) . The symptoms scores before treatment, at the first follow-up and at the last follow-up were in decreasing sequence (P<0.01) . Conclusion Modified Xiaoshengliu Decoction shows certain effect on the intervention of sub-health population with the syndrome of Qi-yin deficiency .

Clinical Observation on Yin-nourishing and Qi-strengthening Therapy Combined with Insulin Pumps for Type 2 Diabetes Mellitus with Qi-yin Deficiency / 广州中医药大学学报

0.05).The effect on traditional Chinese medical syndrome in the treatment group was superior to that in the control group(P 0.05).The average insulin dosage and hypoglycemia incidence were reduced,and the time for blood glucose becoming normal was shortened in the treatment group(P