Twelve-component pharmacokinetic study of rat plasma after oral administration of You-Gui-Wan in osteoporosis rats with kidney-yin deficiency and kidney-yang deficiency.

You-Gui-Wan is a widely used traditional Chinese medicine preparation for the treatment of osteoporosis with kidney-yang deficiency, and is composed of both yang-invigorating and kidney-tonifying herbs, and yin-nourishing and kidney essence-replenishing herbs. Considering that the pharmacokinetics of drugs might differ in different pathological conditions, it is necessary to study the pharmacokinetic characteristics of You-Gui-Wan under different osteoporotic conditions. In this study, the pharmacokinetic behaviors of You-Gui-Wan in osteoporosis rats with kidney-yin and kidney-yang deficiency were compared. The results showed that the absorption, metabolism, and disposition of You-Gui-Wan varied widely in animals with different types of osteoporosis. The active components belonging to the yang-invigorating herbs, such as aconitine, hypaconitine, mesaconitine, benzoylaconine, benzoylhypacoitine, benzoylmesaconine, chlorogenic acid and pinoresinol diglucoside, had a higher uptake and slower elimination in osteoporosis rats with kidney-yang deficiency, which corresponds to the opinion that You-Gui-Wan is used to treat kidney-yang deficiency syndrome, and indicates the scientific nature of Bian-Zheng-Lun-Zhi.

[Zuogui Pills and Yougui Pills in differential treatment of diminished ovarian reserve based on metabolomics].

Based on the metabolomics, this paper systematically analyzed the metabolic substance basis of Zuogui Pills and Yougui Pills in syndrome differentiation and treatment of diminished ovarian reserve(DOR), so as to provide a scientific basis for the traditional Chinese medicine(TCM) syndrome differentiation and treatment of DOR. Patients with DOR of kidney-Yin deficiency syndrome were collected from outpatient department of hospitals and treated with Zuogui Pills for 12 weeks. And kidney-Yang deficiency syndrome were treated with Yougui Pills for 12 weeks. Based on the non-targeted metabolomic research techniques, the potential biomarkers of Zuogui Pills and Yougui Pills in the treatment of DOR with kidney-Yin deficiency and kidney-Yang deficiency, respectively, were screened out, and metabolic pathways of biomarkers were analyzed. The pregnancy rate, basic serum hormone levels [basal follicle-stimulating hormone(bFSH), basal-luteinizing hormone(bLH), basal-estradiol(bE_2), and anti-Müllerian hormone(AMH)], TCM syndrome type score, and Kupperman score were recorded and statistically analyzed after treatment. The results showed that 23 patients with DOR of kidney-Yin deficiency syndrome and 25 patients of kidney-Yang deficiency syndrome were collected. Twenty-six differential metabolites, including L-carnitine, acetyl-CoA, coenzyme A, and coenzyme Q_(10)(CoQ10), were mapped to 12 metabolic pathways in patients with kidney-Yin deficiency treated with Zuogui Pills. Twenty-two differential metabolites, such as adipoyl-CoA, L-lysine, lysine arginine, and α-tocopherol, were mapped to 11 metabolic pathways in patients with kidney-Yang deficiency. After treatment, bFSH and bLH of patients with DOR were significantly lower than those before treatment(P<0.05). Although the comparison of bE_2 and AMH had no significant differences, there was a improvement trend. The TCM syndrome type score and Kupperman score of patients with DOR after TCM treatment were significantly lower than those before treatment(P<0.05).

[Anti-fatigue effect of Lubian on kidney Yin deficiency and kidney Yang deficiency mice and mechanism based on PI3K-Akt pathway].

This study aimed to investigate the anti-fatigue effect and mechanism of Lubian(Cervi Penis et Testis) on kidney Yin deficiency and kidney Yang deficiency mice. After one week of adaptive feeding, 88 healthy male Kunming mice were randomly divided into a blank group, a kidney Yin deficiency model group, a kidney Yin deficiency-Panacis Quinquefolii Radix(PQR) group, kidney Yin deficiency-Lubian treatment groups, a kidney Yang deficiency model group, a kidney Yang deficiency-Ginseng Radix et Rhizoma(GR) group, and kidney Yang deficiency-Lubian treatment groups, with eight mice in each group. The kidney Yin deficiency model and kidney Yang deficiency model were prepared by daily regular oral administration of dexamethasone acetate and hydrocortisone, respectively, and meanwhile, corresponding drugs were provided. The mice in the blank group received blank reagent. The treatment lasted 14 days. The exhaustive swimming time was measured 30 min after drug administration on the 14th day. On the 15th day, blood was collected from eyeballs and the serum was separated to determine the content of lactic acid(LD), blood urea nitrogen(BUN), lactate dehydrogenase(LDH), cyclic adenosine monophosphate(cAMP), and cyclic guanosine monophosphate(cGMP). The liver was dissected to determine the content of liver glycogen and the protein expression of phosphoinositide 3-kinase(PI3K) and protein kinase B(Akt). Compared with the kidney Yang deficiency model group, the kidney Yang deficiency-Lubian treatment groups showed increased body weight(P<0.05), relieved symptoms of Yang deficiency, decreased cGMP content(P<0.01), increased cAMP/cGMP(P<0.01), prolonged exhausted swimming time(P<0.01), reduced LD(P<0.01), elevated BUN content(P<0.01), increased liver glycogen content(P<0.01), and increased protein expression of PI3K and Akt in the liver(P<0.05). Compared with the kidney Yin deficiency model group, the kidney Yin deficiency-Lubian treatment groups showed increased body weight(P<0.01), relieved symptoms of Yin deficiency, increased content of cGMP(P<0.01), decreased cAMP/cGMP(P<0.01), prolonged exhausted swimming time(P<0.01), decreased LD(P<0.01), decreased BUN content(P<0.01), increased liver glycogen content(P<0.01), and increased protein expression of PI3K(P<0.05) and Akt in the liver(P<0.05). To sum up, Lubian can regulate Yin deficiency and Yang deficiency and increase glycogen synthesis by affecting the PI3K-Akt pathway, thereby exerting an anti-fatigue role.

[Pharmacoeconomic evaluation of Qidong Yixin Oral Liquid in treatment of viral myocarditis (Qi-Yin deficiency syndrome) with TreeAge Pro].

To evaluate the pharmacoeconomic value of Qidong Yixin Oral Liquid in the treatment of viral myocarditis(Qi-Yin deficiency syndrome) by supplementing Qi, nourishing the heart, calming the mind, and relieving palpitation, the present study performed the Meta-analysis based on the published papers on Qidong Yixin Oral Liquid by AMSTAR and carried out pharmacoeconomic evaluation using TreeAge Pro by the cost-effectiveness analysis. The results showed that the quality of the included papers was good. After four weeks of treatment, Qidong Yixin Oral Liquid combined with the conventional treatment regimen was superior to the conventional treatment in improving creatine kinase isoenzyme, and the difference was statistically significant. Furthermore, the treatment cost was also higher than that of conventional treatment, with an incremental cost-effectiveness ratio of CNY 95.89, accounting for 0.30% of per capita disposable income. The results of sensitivity analysis showed that the research results were robust. Therefore, based on the assumption that the per capita disposable income in 2020 was the threshold of patients' willingness to pay, it is more economical for patients with viral myocarditis to use Qidong Yixin Oral Liquid combined with conventional secondary prevention regimen than conventio-nal secondary prevention regimen alone. The economic evaluation of Qidong Yixin Oral Liquid in the treatment of viral myocarditis will help physicians and patients choose optimal treatment options, improve rational clinical medication, and provide references for the efficient allocation and utilization of medical resources in China.

[Priority ranking of Chinese patent medicine prescriptions for type 2 diabetes mellitus (syndrome of deficiency of both Qi and Yin): based on analytic hierarchy process (AHP)].

Clinical expertise, patient preference, and the best evidence are the three elements of evidence-based medicine. Based on high-level and high-quality evidence, qualitative and quantitative analysis of the prescribing decisions of physicians is beneficial to improving clinical efficacy. A mature methodological system is available for the retrieval, analysis, summary, evaluation, and recommendation of the evidence, but there are still few studies on physicians' prescribing decisions. How to analyze the trend of physicians' prescribing decisions based on the priority ranking in addition and subtraction of prescriptions? Analytic hierarchy process(AHP) is a method for decision making, which arranges the elements of the decision problem into overall goal, criteria, and operational sub-criteria, and uses the matrix eigenvector method to solve the problem. This study aims to analyze the priority of physicians' prescribing decisions for diabetes mellitus with deficiency of both Qi and Yin based on AHP. To be specific, a database of diabetes mellitus cases with deficiency of both Qi and Yin was established and AHP was used to yield the priority ranking of Chinese patent medicine prescriptions in specific clinical scenarios. In the selected cases of diabetes mellitus with deficiency of both Qi and Yin, Xiaoke Pills was the best prescription for the treatment of type 2 diabetes mellitus(deficiency of both Qi and Yin)(normalized=0.388), followed by Liuwei Dihuang Pills(normalized=0.269), Qishen Capsules(normalized=0.230), and Shengmai Injection(normalized=0.113). According to the analysis the available data, for type 2 diabetes mellitus(deficiency of both Qi and Yin), Xiaoke Pills was the most effective prescription in specific scenarios. When the physicians' prescribing decisions are consistent with the evidence, quantitative analysis of physicians' cognition will boost the evidence-based medical decision-making. However, the research results are also affected by the quality of literature, evidence level and priority, which are thus have some limitations. It is recommended that further small data research based on individual cases be carried out to lay a evidence-based basis for the clinical decision-making of type 2 diabetes mellitus.

[Effect of Dendrobium officinale on Yin deficiency constipation induced by warm-drying medicine in mice].

Dendrobium officinale is a sacred product for nourishing Yin and has a clear "thick gastrointestinal" effect. Modern pharmacological studies had found that it could improve gastrointestinal function. This study observed the improvement effect of D. officinale on constipation model mice with Yin deficiency caused by warm-drying medicine. It provided experimental basis for the treatment of Yin deficiency constipation. The male and female ICR mice were randomly divided into normal group, model group, D. officinale high, medium and low dose groups(0.6, 0.4, 0.2 g·kg~(-1)), and phenolphthalein tablets group. The model mice of Yin deficiency constipation were established by gavage with warm-drying medicine. The overall state and body temperature of the mice were observed and recorded. The number of feces, feces weight, fecal moisture content and intestinal propulsion were measured. The morphological damage of colon tissue was observed by hematoxylin-eosin(HE) staining. The expression of inducible nitric oxide synthase(iNOS) in the colon was detected by Western blot and immunohistochemical method. The expression of iNOS mRNA in the colon was detected by Real-time fluorescence quantitative PCR, and the serum cyclic guanosine phosphate(cGMP) level was detected the enzyme-linked immunosorbent assay(ELISA). The results showed that D. candidum could reduce the body temperature of mice with Yin deficiency constipation, increase the number of feces, wet feces, dry feces and intestinal propulsion ability, reduce the expression of iNOS protein and mRNA in the colon, and reduce the content of cGMP in the serum. It showed that D. candidum could improve the symptoms of Yin deficiency constipation mice caused by warm-drying medicine, and the mechanism may be related to reducing the expression of iNOS in the colon and increasing intestinal motility.

[Therapeutic effect and mechanism of three kinds of Dendrobium on constipation in rats with spleen Yin deficiency].

Books on Chinese herbal medicines have shown that Dendrobium has the effect of nourishing Yin and reinforcing Yin,usually used for constipation induced by spleen Yin deficiency in clinical application. D. huoshanense,as an independent species among many species of Dendrobium,has no experimental studies about its effects on spleen Yin deficiency-type constipation. The purpose of this experiment was to illustrate the therapeutic effect of D. huoshanense on the constipation of spleen Yin deficiency type in rats,investigate its preliminary mechanism,and compare it with the D. officinale and D. nobile contained in the Chinese Pharmacopoeia to clarify its characteristics. The spleen Yin deficiency model was replicated in 70 rats by the composite factor method,and then the model rats were randomly divided into 7 groups: model group,Liuwei Dihuang Pills group( LWDHP),D. huoshanense high( DHS-H),medium( DHS-M),low( DHS-L) dose groups,D. nobile group( DNS),and D. officinale group( DOS),and another 10 rats were used as normal group( Normal). After 7 continuous days of administration,the fecal water content and intestine propulsion rate of each group were detected. HE staining was used to observe the pathological damage of ileum and colon in each group. Immunohistochemistry and Western blot were used to detect aquaporin 3( AQP3) expressions,while the expression levels of the somatostatin( SS) and motilin( MTL) in the ileum of each group were detected by enzyme-linked immunosorbent assay. The results showed that as compared with the model group,the rats in each drug-administered group had increased number of fecal pellets,increased fecal water content,and the increased intestinal propulsion rate( P<0. 01),while the pathological damage of the ileum and colon was significantly reduced; the expression of AQP3 protein was significantly decreased( P<0. 01); the level of MTL was significantly increased and the level of SS was decreased( P<0. 01). All DHS groups showed a good dose-effect relationship,and the same dose treatment effect was equivalent to that of DOS,but it was superior to DNS. Therefore,DHS has a significant therapeutic effect on constipation of spleen Yin deficiency type,and its mechanism may be related to intestinal motility and water-liquid metabolism,with a good therapeutic effect.

[Effects and mechanism of Angelicae Sinensis Radix on Th1/Th2 and Th17/Treg in mice with asthma and Yin deficiency syndrome].

Angelicae Sinensis Radix, with nourishing Yin, promoting blood circulation, and moisturizing dryness functions, is commonly used in clinical medicine. In order to investigate the effects and mechanism of Angelica sinensis(AS) on Th1/Th2 and Th17/Treg in mice with asthma and Yin deficiency syndrome, asthmatic and Yin deficiency syndrome Balb/c mice models were established by injecting and inhaling ovalbumin(OVA) and thyroxin. The models were treated with dexamethasone(DXM), AS extract and AS extract+DXM, respectively. Pathological examination of lung tissues was conducted by HE staining, and ELISA was used to detect the levels of IL-4, IL-17, IFN-γ, TGF-ß as well as retinoic acid receptor-related orphan receptor (RORγt). Results showed that AS could significantly improve the situation of inflammation infiltration, increase ratios of IFN-γ/IL-4 and TGF-ß/IL-17, decrease the levels of RORγt in lung tissues. The AS+DXM group showed a best treatment effect. The results indicated that AS played a therapeutic role for asthma with Yin deficiency syndrome and improved airway inflammation by inhibiting the expression of RORγt in lung tissues and regulating the balance of Th1/Th2 and Th17/Treg.

Curative effect of Maimendong decoction in treating advanced lung cancer with Qi-Yin deficiency cough.

The objective of this paper is to analyze the curative effect of Maimendong Decoction in treating advanced lung cancer with Qi-Yin deficiency cough. 60 patients with advanced lung cancer with Qi-Yin deficiency cough admitted to our hospital were selected and randomly divided into two groups, among which 30 cases treated with Maimendong Decoction were experimental group, and another 30 cases treated with ambroxol hydrochloride oral solution were control group. After treatment, the clinical therapeutic effects of the two groups were compared and analyzed. After 40 d treatment, the total effective rate of the treatment group was significantly higher than that of control group, with statistical significance (P<0.05). There is a definitive therapeutic effect of Maimendong Decoction in the treatment of advanced lung cancer with Qi-Yin deficiency cough, which is worthy of application and promotion in clinic.

[Modified Shengma Biejia Decoction Combined with CAG Program for Elderly Acute Myeloid Leuke- mia Patients with Yin Deficiency Toxin Stasis Syndrome].

OBJECTIVE: To observe the efficacy and safety of modified Shengma Biejia Decoction (MSBD) combined with CAG program in treating elderly acute myeloid leukemia (AML) patients with yin deficiency toxin stasis syndrome (YDTSS). METHODS: Totally 46 elderly AML patients were assigned to the treatment group (24 cases; treated with MSBD + CAG) and the control group (22 cases; treated with CAG + placebos of Chinese medicine) according to random digit table. The therapeutic course of CM placebo or MSBD was 21 days. The clinical efficacy and adverse reactions were observed. Meanwhile, physical state (ECOG Score), transfusion dependency, and TCM syndrome score were compared before and after treatment. RESULTS: (1) The complete remission rate was 54% (13/24) and the objective response rate (ORR) was 71% (17/24) in the treatment group, obviously higher than those of the control group [36% (8/22); 54% (13/24)], with statistical difference (P = 0.036, 0.042). When comparing the efficacy based on risk level, the moderate and poor ORR was 71% (10/14) and 67% (6/9) in the treatment group, and 57% (8/14) and 33% (2/6) in the control group, with statistical difference between the two groups (P = 0.048; P = 0.010). (2) Compared with before treatment in the same group, the ECOG score significantly decreased, the average infusion time of red cells and platelets were markedly prolonged in the treatment group after treatment (P < 0.05). ECOG score, the average infusion time of red cells and platelets were significantly better in the treatment group than in the control group after treatment (P < 0.05). (3) Compared with before treatment in the same group, scores of fever, hemorrhage, and bone pain were markedly reduced in the control group (P < 0.05); scores of fever, fatigue, hemorrhage, dry mouth, and bone pain were markedly reduced in the treatment group (P < 0.05). Better effect in relief of fever, fatigue, hemorrhage, dry mouth, and so on was obtained in the treatment group than in the control group (P < 0.05). (4) In aspect of hematotoxicity, the incidence of neutropenia, anemia, thrombocytopenia was obviously lower in the treatment group than in the control group [29.2% (7/24) vs 54.5% (12/22); 16.7% (4/ 24) vs 45.5% (10/22); 33.3% (8/24) vs 63.6% (14/22); P < 0.05]. The incidence of fatigue and anorexia was obviously lower in the treatment group than in the control group [37.5% (9/24) vs 63.6% (14/22), 37.5% (9/24) vs 81.8% (18/22); P < 0.05]. CONCLUSION: MSBD combined with CAG program in treating elderly AML patients with YDTSS, with efficacy enhancing toxicity reducing effect, had distinct advantages in improving physical condition and clinical symptoms, and reducing transfusion dependency.

[Clinical characteristics of traditional Chinese medicine and 40 cases of infertility patients].

In order to understand the characteristics of traditional Chinese medicine（TCM） syndrome types, the typical symptoms of different patients and the analysis of professor MA's medication characteristics of the treatment for infertility patients were analyzed. Totally 40 cases of infertile women treated in Xiyuan hospital and TCM out-patient department of China Academy of Chinese Medical Sciences in the past five years were randomly selected to classify their symptoms, signs and the four diagnostic situations in the first diagnosis, summarize syndromes and typical symptoms and analyze the characteristics of medication with Ma. Randomly selected nearly five years in 40 cases of infertile women with China Academy of Chinese Medical Sciences Xiyuan hospital and Chinese medicine out-patient department treatment, first diagnosed by symptoms, signs and the four diagnostic situation. According to the results, kidney yang deficiency： 10 cases (25%), kidney yin deficiency： 6 cases (15%), phlegm dampness： 3 cases (7.5%), liver qi stagnation： 3 cases (7.5%), blood stasis in the uterus： 7 cases (17.5%), deficiency of kidney yin deficiency and phlegm dampness： 1 cases (2.5%), kidney yin deficiency syndrome of liver qi stagnation： 2 cases (accounted for 5%), deficiency of kidney yang deficiency syndrome of liver qi stagnation： 1 cases (2.5%), phlegm dampness syndrome of liver qi stagnation：1 cases (2.5%), kidney yin deficiency syndrome, blood stasis and stagnation in the uterus 2 cases (accounted for 5%), liver qi stagnation syndrome and blood stasis in the uterus 2 cases (accounted for 5%), deficiency of kidney yang deficiency syndrome of liver qi stagnation syndrome and blood stasis in the uterus, 1 cases (2.5%). Typical symptoms were dominated by backache, pain and cold in the lower abdomen, followed by thirst, dry throat, more menstrual blood clots, more petechial hemorrhages at tongue, dysphoria, premenstrual breast pain, irritability, chest distress and greasy in mouth, leucorrhea, semiliquid stool or coprostasis. 40 cases of infertility patients showed obvious curative effect after the treatment of professor Ma's medication.

[Effect of protein intervention on amino acid metabolism spectrum of Qi and Yin deficiency type 2 diabetic rats].

To study the effect of plant protein and animal protein on amino acid metabolism spectrum of Qi and Yin deficiency type 2 diabetic rats. 110 male SD rats were randomly divided into blank group (n=10), diabetic model group (n=20), disease-symptoms group (n=80). The rats of blank group received ordinary feeding, while other groups were fed with high sugar and fat diets. During the whole process of feeding, rats of disease-symptoms group were given with Qingpi-Fuzi (15.75 g•kg⁻¹) once a day through oral administration. Five weeks later, the rats were given with a low dose of STZ (40 mg•kg⁻¹) by intraperitoneal injection to establish experimental diabetic models. Then the models were randomly divided into disease-symptoms group 1 (Qi and Yin deficiency diabetic group, 15.75 g•kg⁻¹), disease-symptoms group 2 (plant protein group, 0.5 g•kg⁻¹), disease-symptoms group 3 (animal protein group, 0.5 g•kg⁻¹), disease-symptoms group 4 (berberine group, 0.1 g•kg⁻¹). The drugs were given for 4 weeks by gavage administration. After 4 weeks of protein intervention, the abdominal aortic blood was collected and serum was isolated to analyze its free amino acid by using AQC pre-column derivatization HPLC and fluorescence detector. Four weeks after the protein intervention, plant protein, animal protein and berberine had no obvious effect on body weight and blood sugar in type 2 diabetic rats. As compared with animal protein group, histidine and proline（P<0.01）, serine, glycine, threonine, alanine, tyrosine, valine, methionine, bright+isoleucine, phenylalanine and lysine（P<0.05）changed a lot in rats serum of plant protein group.The results showed that gavage administration of protein would produce effects on amino acid metabolism of Qi and Yin deficiency type 2 diabetic SD rats. Symbolic differential compounds could be found through metabonomics technology, providing experimental basis for early warning of type 2 diabetes and diagnosis of Qi and Yin deficiency syndrome.

Effect of Huqian Wan on liver-Yin and kidney-Yin deficiency patterns in patients with knee osteoarthritis.

OBJECTIVE: To observe the curative effect of Huqian Wan on liver and kidney-Yin deficiency knee osteoarthritis (KOA). METHODS: One hundred patients were randomly divided, into a treatment (50 patients) and control group (50 patients). In the treatment group, patients orally took the Chinese medicine Huqian Wan. Control group patients orally took Votalin, 75 mg, once a day, for 8 weeks. The visual analog scale (VAS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and Medical Outcomes Study Short Form 36-Item Health Survey (SF 36) were used to evaluate the curative effect before treatment and after 8 and 16 weeks of treatment. RESULTS: VAS and WOMAC scores significantly decreased and SF 36 scores significantly increased after treatment in both groups compared with before treatment (P < 0.05). There were significant differences in VAS, WOMAC, and SF 36 score changes between the two groups at week 16 (P < 0.05). There was a significant increase in VAS and WOMAC scores in the control groups (P < 0.05) between weeks 8 and 16, but no significant difference was found in the treatment group (P > 0.05). CONCLUSION: Huqian Wan could effectively improve the clinical symptoms and quality of life in patients with KOA. It could also have a better and longer lasting curative effect without obvious adverse events compared with Votalin.

Alzheimer's disease treated with combined therapy based on nourishing marrow and reinforcing Qi.

OBJECTIVE: To study the efficacy and safety of combined Traditional Chinese Medicine (TCM) therapy based on nourishing marrow to improve intellect and reinforcing Qi to activate bloodon mild to moderate Alzheimer's disease (AD). METHODS: Sixty-six patients with AD, whose Mini-Mental State Examination (MMSE) score were from 10-24, were randomized equally into an intervention group and a control group. The control group was given Aricept (5 mg, once daily). The intervention group was further divided into Yang-Qi deficiency (n = 18) and of Yin-Qi deficiency (n = 15) subgroups. Patients in the Yang-Qi deficiency group were intravenously administered shenfu injection, 60 mL, and deproteinized calf blood injection (DCBI), 1.2 g, once daily. The Yin-Qi deficiency group was given shenmai injection, 60 mL, and DCBI, 1.2 g, once daily. Each course lasted 21 days. RESULTS: Compared with the control group and with pre-treatment in the same group, MMSE, clinical dementia rating, and activities of daily living scale scores in the intervention group were significantly improved (all P < 0.05). These metrics mildly improved in the control group compared with before treatment (P > 0.05). No adverse effects were observed in any group during treatment. CONCLUSION: We found that combined TCM therapy is effective and safe for managing mild to moderate AD.

[Treatment of Recurrent Oral Ulceration (Yin Deficiency Fire Excess Type) by Qianjin Kouchuang Jiawei Granule: a Clinical Observation].

OBJECTIVE: To observe the curative effect of Qianjin Kouchuang Jiawei Granule (QKJG) on recurrent oral ulceration [yin deficiency fire excess type (YDFET)]. METHODS: Totally 120 patients who suffered from recurrent oral ulceration (YDFET) were randomly assigned to two groups, the experiment group and the control group, 60 in each group. Patients in the experiment group took QKJG, 20 g each time, twice per day, while those in the control group took Kouyanqing Granule (KG) , 20 g each time, twice per day. Fourteen days consisted of one therapeutic course, two for all. Scores for patients' symptoms and signs (ulcer area, exudation, hyperaemia, edema, the number of ulceration, burning sensation, and pain degrees) were assessed before treatment, at day 3 and 7 after treatment. Short-term efficacy was assessed by visual analogue scale (VAS). The total paralysis time and the total number of ulceration at month 12 after treatment were taken as judgment for long-term efficacy. Results Compared with before treatment in the same group, symptoms and signs were obviously improved at day 3 and 7 after treatment in the two groups (P < 0.05). Compared with the control group at day 3 after treatment, the improvement of edema, exudation, pain degree, and burning sensation was more obvious in the experiment group (P < 0.05, P < 0.01). The improvement of edema, pain degree, and burning sensation at day 7 after treatment was more obvious in the experiment group than in the control group (P < 0.05). As for short-term efficacy, the total effective rate was 86.67% (52/60 cases) in the experiment group and 83.33% (50/60 cases) in the control group, with no statistical difference between the two groups (P > 0.05). As for long-term efficacy, the total effective rate was 90.00% (54/60 cases) in the experiment group, significantly higher than that of the control group with statistical difference [81.67% (49/60 cases), P < 0.05]. At month 12 after treatment, the total number of ulceration was reduced and the paralysis time of ulcer attack prolonged in the experiment group, with statistical difference when compared with the control group (P < 0.05). CONCLUSION: QKJG showed better long-term efficacy than that of KG in treating recurrent oral ulceration (YDFET).

[Effect of extracts from Dendrobii ifficinalis flos on hyperthyroidism Yin deficiency mice].

Some unhealthy life habits, such as long-term smoking, heavy drinking, sexual overstrain and frequent stay-up could induce the Yin deficiency symptoms of zygomatic red and dysphoria. Stems of Dendrobii officinalis flos (DOF) showed the efficacy of nourishing Yin. In this study, the hyperthyroidism Yin deficiency model was set up to study the yin nourishing effect and action mechanism of DOF, in order to provide the pharmacological basis for developing DOF resources and decreasing resource wastes. ICR mice were divided into five groups: the normal control group, the model control group, the positive control group and DOF extract groups (6.4 g · kg(-1)). Except for the normal group, the other groups were administrated with thyroxine for 30 d to set up the hyperthyroidism yin deficiency model. At the same time, the other groups were administrated with the corresponding drugs for 30 d. After administration for 4 weeks, the signs (facial temperature, pain domain, heart rate and autonomic activity) in mice were measured, and the facial and ear micro-circulation blood flow were detected by laser Doppler technology. After the last administration, all mice were fasted for 12 hours, blood were collected from their orbits, and serum were separated to detect AST, ALT, TG and TP by the automatic biochemistry analyzer and test T3, T4 and TSH levels by ELISA. (1) Compared with the normal control group, the model control group showed significant increases in facial and ear micro-circulation blood flow, facial temperature and heart rate (P < 0.05, P < 0.01), serum AST, ALT (P < 0.01), T3 level (P < 0.05), TSH level (P < 0.05) and notable deceases in pain domain (P < 0.01), TG level (P < 0.01). (2) Compared with the model control group, extracts from DOF (6 g · kg(-1)) could notably reduce facial and ear micro-circulation blood flow, facial temperature and heart rate (P < 0.05, P < 0.01) and AST (P < 0.05) and enhance pain domain (P < 0.01) and TG (P < 0.01). Extracts from DOF (4 g · kg(-1)) could remarkably reduce AST and ALT levels (P < 0.01, 0.05). Extracts from DOF (6 g · kg(-1) 4 g · kg(-1)) could significantly reduce T3 and increase serum TSH level (P < 0.05). DOF could improve Yin deficiency symptoms of zygomatic red and dysphoria in mice as well as liver function injury caused by overactive thyroid axis. According to its action mechanism, DOF may show yin nourishing and hepatic protective effects by impacting thyroxin substance metabolism, improving micro-circulation and reducing heart rate.

[Treatment of type 2 diabetes mellitus patients of qi-yin deficiency phlegm-stasis inter-obstruction syndrome by jiangtang xiaozhi capsule and pioglitazone tablet: a non-inferiority randomized controlled trial].

UNLABELLED: OBJECTIVE; To evaluate the efficacy and safety of Jiangtang Xiaozhi Capsule (JTXZC) in treating type 2 diabetes mellitus (T2DM) of qi-yin deficiency phlegm-stasis inter-obstruction syndrome (QYDPSIOS), and to observe its effect on inflammatory factors and fibrinolytic factors. METHODS: By adopting a randomization grouping, parallel control, and prospective study, 73 T2DM patients of QYDPSIOS were assigned to two groups by random digit table, the Pioglitazone Tablet group (36 cases, as the control) and the JTXZC group (37 cases). All patients maintained their basic therapies and lifestyle as previous after recruitment. Patients in the JTXZC group took JTXZC, 4 pills each time, three times per day, while those in control group took Pioglitazone Tablet, 15 mg each time, once daily. The therapeutic course for all was 8 weeks. The body weight (BW), the height, body mass index (BMI), waist circumference (WC), hip circumference, waist-to-hip ratio (WHR), and scoring of Chinese medicine (TCM) symptoms were observed. Levels of fasting blood glucose (FBG), 2 h postprandial blood glucose (2 h PBG), glycated hemoglobin (HbA1c), tumor necrosis factor alpha (TNF-alpha), nuclear factor kappaB (NF-kappaB), and plasminogen activator inhibitor 1 (PAL-1) were detected. The safety indices such as liver and renal functions and adverse reactions were also observed. RESULTS: Compared with before treatment, BW, BMI, HbA1c, and PBG were obviously lower after 8-week treatment than before treatment in the JTXZC group (P < 0.05). There was no statistical difference in post-treatment BW, BMI, HbA1c, or 2 h PBG between the two groups (P < 0.05). Compared with before treatment, levels of TNF-alpha and PAI-1 were lowered after 8 weeks of treatment in both groups (P < 0.01). The level of NF-kappaB was obviously lowered after 8 weeks of treatment in the control groups (P < 0.05), but it also decreased in the JTXZC group with no statistical difference. The scorings of CM symptoms were somewhat improved after treatment in the two groups (P < 0.01). Besides, better effects were obtained in the JTXZC group (P < 0.05). No severe adverse event occurred in either group during the whole therapeutic course. CONCLUSIONS: JTXZC showed similar therapeutic effect to pioglitazone. Both of them could effectively improve patients' clinical symptoms, the inflammation and fibrinolytic activities in different pathways, with no severe adverse reaction.

[Therapeutic effect of Astragalus and Angelica mixture on the renal function and TCM syndrome factors in treating stage 3 and 4 chronic kidney disease patients].

OBJECTIVE: To compare the therapeutic effect of Astragalus and Angelica Mixture (AAM) on treating CKD patients according to different CKD primary diseases, staging and TCM syndromes. METHODS: A multicentre, open-label, and self control clinical design was used, and thirty-two patients in line with inclusive criteria were recruited. Based on maintaining their previous basic CKD treatment, patients additionally took AAM (Astragalus and Angelica each 30 g), once a day, three months consisted of one therapeutic course. Serum creatinine (SCr), estimated glomerular filtration rate (eG- FR), 24 h urinary total protein (UTP), plasma albumin (ALB), hemoglobin (Hb), and changes of TCM syndrome factor integrals were compared before treatment, at the end of month 1, 2, and 3. The differences in the aforesaid indices were compared between CKD patients with different CKD primary diseases (chronic glomerulonephritis, chronic renal tubulointerstitial disease, hypertensive renal damage), different CKD stages (CKD 3 and CKD 4), and patients of qi-blood deficiency syndrome (QBDS) and non-QBDS. RESULTS: AAM could improve 78.12% (25/32) patients' renal function. Compared with before treatment, SCr decreased (12.08% +/- 10.11%), eGFR increased (21.14% +/- 18.55%), and ALB increased (2.76% +/- 1.97%) at the end of 3-month treatment (all P < 0.05). As for TCM syndrome factor integrals, compared with before treatment, the integrals for qi deficiency syndrome, blood deficiency syndrome, and yin deficiency syndrome decreased, while the integrals for dampness heat syndrome and turbid-toxin syndrome increased (all P < 0.05). There was no obvious difference in all indices except the integral for hypertensive renal damage patients of yin deficiency syndrome (P > 0.05). The SCr decreasing percent was 19.82% +/- 8.30% for patients of non-QBDS and 5.24% +/- 10.75% for patients of QBDS. The latter was higher with statistical difference (P < 0.05). As for TCM syndrome factor integrals, the integral differences of qi deficiency and blood deficiency were obviously higher in patients of QBDS, when compared with patients of non-QBDS (P < 0.05). CONCLUSION: AAM could improve the renal function of CKD patients, elevate their ALB levels, and ameliorate associated qi deficiency syndrome, blood deficiency syndrome, and yin deficiency syndrome, especially for CKD patients of QBDS.

[Treatment of type 2 diabetic peripheral neuropathy patients of qi-yin deficiency complicated phlegm-dampness blocking collaterals syndrome by internal application of qigui mixture and external application of qigui huoxue lotion: a clinical study].

OBJECTIVE: To evaluate the efficacy of internal application of Qigui Mixture (QM) and external application of Qigui Huoxue Lotion (QHL) in treating type 2 diabetic peripheral neuropathy (DNP) patients of qi-yin deficiency complicated phlegm-dampness blocking collaterals syndrome (QYD-PDBCS), and to primarily discuss its mechanism. METHODS: Totally 62 DPN patients of QYD-PDBCS were randomly assigned to the treatment group (31 cases) and the control group (31 cases). All patients received routine comprehensive therapy. Patients in the control group took Mecobalamine Tablet, 500 microg each time, 3 times per day. Patients in the treatment group additionally took QM, 200 mL per day, twice daily. Besides, they had foot bath in QHL 10 - 15 min every evening for 3 months. The efficacy was assessed by Chinese medical symptom integrals and Toronto clinical scoring system (TCSS) before treatment, 2 and 3 months after treatment. The nerve conduction velocity was determined; the serum levels of total antioxidant capacity (T- AOC), malondialdehyde (MDA), and superoxide dismutase (SOD) were detected 2 and 3 months after treatment. RESULTS: The total effective rates of Chinese medical symptom integrals and TCSS score were obviously higher in the treatment group than in the control group (P < 0.05). The nerve conduction velocity was significantly improved in the treatment group, when compared with before treatment (P < 0.01). There was statistical difference in the nerve conduction velocity difference of right median nerve motor branch, bilateral tibial nerve motor branches, bilateral common peroneal nerve motor branches, bilateral ulnar nerve sensory branches, and left tibial nerve sensory branch (P < 0.05). Compared with before treatment, serum levels of T-AOC and SOD significantly increased, and the level of MDA decreased significantly in the treatment group after 2 and 3 months of treatment (P < 0.01). But only the SOD level increased significantly in the control group (P < 0.01). There was no statistical difference in increased T-AOC level between the two groups after 2 months of treatment (P > 0.05), but there was statistical difference in increased SOD level and decreased MDA level (P < 0.05). There was statistical difference in increased T-AOC and SOD levels and decreased MDA level between the two groups after 3 months of treatment (P < 0.05). No adverse reaction occurred during the therapeutic course. CONCLUSIONS: The internal application of QM and external application of QHL combined with Mecobalamine in treating DPN was safe and effective, with more significant efficacy than using Mecobalamine alone. Its mechanism might be associated with resistance to oxidative stress.

[Efficacy assessment of treating post-stroke shoulder-hand syndrome patients of yin deficiency yang hyperactivity with blood stasis stagnation collaterals syndrome by yishen tongluo decoction].

OBJECTIVE: To assess the efficacy of Yishen Jiejing Decoction (YJD) in treating poststroke shoulder-hand syndrome (SHS) patients of yin deficiency yang hyperactivity with blood stasis stagnation collaterals syndrome. METHODS: Totally 60 SHS patients of yin deficiency yang hyperactivity with blood stasis stagnation collaterals syndrome were randomly assigned to two groups, the treatment group and the control group, 30 cases in each group. Conventional rehabilitation training and therapeutics were applied in all patients. Besides, patients in the treatment group took 50 mL YJD, twice a day. One month without interruption consisted of one course of treatment. The curative effects of each group were evaluated respectively before treatment and at one month after treatment. The neurologic impairment, TCM syndrome, and the improvement of upper limbs movement were assessed by the neurologic impairment integral, scoring for TCM syndrome diagnostics, Fugl-Meyer Assessment (U-FMA). Adverse reactions were observed at the same time. RESULTS: The effective rate of stroke was 86.67% and the effective rate of SHS was 90.00% in the treatment group, higher than those of the control group (P < 0.05). Both groups got improvement in neurologic impairment, stroke induced blood stasis syndrome, yin deficiency yang hyperactivity syndrome, and the improvement of upper limbs movement after treatment (all P < 0.05). Besides, all the improvement was obviously superior in the treatment group (P < 0. 05). No adverse reaction occurred during the course of treatment. CONCLUSION: The curative effect of YJD combined with conventional rehabilitation training was confirmative and superior to the control group.