OBJECTIVE: To evaluate the efficacy and safety of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with wind-warm syndrome. METHODS: The multiple center, double-blinded, double-dummy and randomized controlled method was conducted. Three hundred and sixty patients were randomly divided into the treatment group A (n=120, treated with Yiqing Shuangjie Capsule and Chaihuang analogues), treatment group B (n=120, treated with Yiqing Shuangjie Tablet and Chaihuang analogues) and the control group (n=120, treated with Chaihuang Tablet and Yiqing Shuangjie Capsule analogues). Every drug was administered 3 pills each time. Patients in the three groups were all treated for 5 days and three times daily. The accumulated scores of syndrome, clinical symptoms, adverse effect and body temperature were recorded before and after the treatment. The safety indexes, such as routine tests of blood, urine and stool, hepatic and renal function tests and electrocardiogram (ECG) were taken before and after the treatment. RESULTS: Three cases were excluded and eighteen cases lost to follow-up. There were 343 patients who entered to the intention-to-treat (ITT) analysis and 339 patients fitted in the per-protocol population set (PPS) analysis. After treatment, the therapeutic effects of respiratory tract infection were calculated by ITT and PPS analysis respectively. The rates of total obvious effect were 84.96% and 87.27% respectively in the treatment group A, and the total response rates were 96.46% and 97.27% respectively. The rates of total obvious effect were 85.47% and 86.20% respectively in the treatment group B, and the total response rates were 97.45% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and the total response rates both were 99.12%. There was significant difference among the three groups (P<0.05). The effects of traditional Chinese medicine syndrome were also detected by ITT and PPS analysis respectively. In the treatment group A, the total obvious effect rates were 84.07% and 85.46% respectively, and the total response rates were 96.46% and 97.27% respectively. In the treatment group B, the rates of total obvious effect were 88.89% and 89.65% respectively, and the total response rates were 97.44% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and total response rates both were 99.12%. There was also statistical significant difference among the three groups (P<0.05). ITT and PPS analysis had the same results. No adverse effect was found in the trial. CONCLUSION: Yiqing Shuangjie Capsule and Tablet are effective and safe in treating acute upper respiratory tract infection of wind heat syndrome without obvious adverse effect.

The corn germ protein tested was a by-product from, corn starch plant and it contained more lysine (average 5.7%) and a relatively ideal proportion of eight essential amino acids similar to the 1973 FAO/WHO provisional amino acid pattern. A 5-week rat growth experiment was conducted to evaluate the nutritive value of corn germ protein by using body weight gain, nitrogen balance and apparent net protein utilization as assessment criteria.The feed of the experimental group was made of wheat protein supplemented with 17.3% germ protein and that of the control with 2.4% wheat glu- ten to made the final protein level of both feeds equivalent to 10%.These results showed that the body weight gain of rat in the experimental group was higher than that of the control group regardless of female or male, the body weight gain per 100g feed consumed in two groups of female was 19.0g and 12.2g and that of male was 17.6g and 10.4g respectively (p

OBJECTIVETo explore the significance of pelvic hemodynamics as an index in evaluating efficacy of TCM treatment for chronic pelvic inflammation (CPI).

METHODSSixty patients with CPI received treatment with Penyanping, a self-formulated TCM recipe, for 30 days, and the changes of pelvic hemodynamic indexes in them were measured before and after treatment within the 3 - 7 days after menstruation using color Doppler.

RESULTSImprovement of pelvic hemodynamics indexes were shown after treatment in ovarian left arteriopalmus index, bilateral resistance index, maximal speed of left arterial blood flow and score of time-velocity, as compared with those before treatment, the difference was significant respectively (P < 0.05).

CONCLUSIONPelvic hemodynamic indexes could be taken as one of the objective parameters for evaluating efficacy of TCM treatment of CPI according to principle of activating blood circulation to remove stasis, clearing heat and detoxifying.

Adolescent ; Adult ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Hemodynamics ; drug effects ; Humans ; Medicine, Chinese Traditional ; Middle Aged ; Pelvic Inflammatory Disease ; drug therapy ; physiopathology ; Pelvis ; blood supply ; diagnostic imaging ; Phytotherapy ; Time Factors ; Ultrasonography, Doppler, Color

ObjectiveTo analyse the current implementation status of Chinese herbal medicine （CHM） placebo and systematically evaluate the placebo effect in randomised controlled trials （RCTs） of traditional Chinese medicine （TCM） for the treatment of functional dyspepsia （FD）. MethodsA combination of medical subject terms and free words was used to search six databases， including PubMed， EMBASE， Cochrane Library， Web of Science， China National Knowledge Infrastructure， and Wanfang， for RCTs with CHM placebo group for FD published from January 31st， 1994 to September 30th， 2023. The dosage forms， composition， and methodological quality were collected and evaluated. The quality of the included articles was evaluated by Cochrane risk of bias assessment tool， and meta-analysis was performed on the CHM placebo response rate of patients with FD， and subgroup analysis and meta-regression was performed according to diagnostic criteria， efficacy criteria， duration of treatment， type of placebo， whether it contained active ingredient， and whether it evaluated placebo effects. ResultsA total of 34 publications were included involving 5046 participants， of which 2221 FD patients received CHM placebo treatment. Granules were the predominant placebo preparation， accounting for 71% （24/34）； 32.35% （11/34） of the studies added real CHM to the placebo， and only 12 （35%） of the studies described appearance， odour， and taste. The placebo response rate in FD patients in the placebo group was 41% （95% CI： 0.35 to 0.47； P＜0.01， I² = 87%）； there was significant difference between groups with different diagnostic criteria and different treatment durations （P＜0.05 or P＜0.01）， but there was no significant difference between the different efficacy evaluation criteria， the different placebo preparation， the presence of a low-dose active ingredient， and the presence or absence of placebo assessment （P＞0.05）. ConclusionThere was a significant CHM placebo effect in patients with FD， with granules as the main preparation of placebop. Different diagnostic criteria and different treatment times may affect the response rate of patients， and the addition of low-dose real medicine to the CHM placebos has not been seen to have an effect on the response rate. Clinical investigators have not paid enough attention to placebos， and there is a lack of uniform standards and norms for the preparation and evaluation of CHM placebos.

OBJECTIVE: To study the pharmacological mechanism of Guanxin II formula (II) for treatment of coronary heart disease (CHD). METHODS: A network pharmacology-based method was utilized. First candidate compounds, targets of GX II were collected using PharmMapper, BATMAN-TCM, DrugBank and SwissTargetPrediction, and targets on CHD were mined from GeneCards, DisGenet, DrugBank and GEO. Afterwards, the big hub compounds and targets were chosen in the candidate compounds-direct therapeutic targets on the CHD (C-T) network and the direct therapeutic targets on the CHD (T-D) network. Furthermore, the Gene Ontology and Kyoto Encyclopedia of Genes and Genomes analysis were performed to identify the enriched terms. Finally, a molecular docking simulation strategy was adopted to verify the binding capacity between the big hub compounds and big hub targets on CHD. RESULTS: First, 114 candidate compounds were selected with the following criteria: OB⩾30%, DL⩾0.18, and HL ⩾4 h. Then, 1,035 targets of GX II were gathered, while 928 targets on CHD were collected. Afterwards, 196 common targets of compound targets and therapeutic targets on CHD were defined as direct therapeutic targets acting on CHD. In addition, the contribution index (CI) in the C-T network was calculated, and 4 centrality properties, including degree, betweenness, closeness and coreness, in the T-D network, 4 big hub compounds, and 6 big hub targets were eventually chosen. Furthermore, the GO and KEGG analysis indicated that GX II acted on CHD by regulating the reactive oxygen species metabolism, steroid metabolism, lipid metabolism, inflammatory response, proliferation, differentiation and apoptosis. The docking results manifested excellent binding capacity between the 4 big hub compounds and 6 big hub targets on CHD. CONCLUSION This network pharmacology-based exploration revealed that GX II might prevent and inhibit the primary pathological processes of CHD.

ObjectiveTo explore the possible mechanism of Modified Gegen Qinlian Decoction （加味葛根芩连汤， MGQD） in the treatment of ulcerative colitis （UC） based on intestinal mucus barrier. MethodsThirty C57BL/6 mice were randomly divided into a control group， a model group and a MGQD group with 10 mice in each. Dextran Sulfate Sodium Salt （DSS） was used to construct the UC model in all groups except for the control group. Meanwhile， mice in the MGQD group were given 20 g/kg of MGQD decoction by gavage according to their body weight， while those in the control group and model group were given 0.2 ml/20 g of pure water by gavage， once a day for 7 consecutive days. On the day following the last gavage， the body weight， disease activity index （DAI） score， spleen weight， and colon length were compared. The pathological changes of the intestinal mucosal tissues were observed by HE staining； the protein expression levels of mucin 2 （MUC2） and leucine-rich repeat G protein-coupled receptor 5 （Lgr5） in the intestinal mucosal tissues were detected by immunofluorescence； the cuprocytes in the intestinal mucosal tissues were detected by AB/PAS staining； and the expression level of Ki67 in the intestinal mucosal tissues was detected by immunohistochemistry. ResultsHE staining showed that the colon mucosal tissue of the mice in the control group was intact. In the model group， the colon mucosal epithelial structure was severely damaged， with a large amount of inflammatory cell infiltration in the mucosal propria. In the MGQD group， the mucosal tissue structure was partially lost， with a small amount of inflammatory cell infiltration.The body weight and colon length of mice in the model group decreased significantly compared to those in the control group， while DAI scores and spleen weight increased， and the levels of MUC2， Ki67， Lgr5 proteins， and the number of goblet cells were significantly reduced （P＜0.01）. Compared to the model group， the MGQD group had increased body weight of mice， colon length， and decreased DAI scores and spleen weight； the levels of MUC2， Ki67， Lgr5 proteins， and the number of goblet cells were increased （P＜0.05 or P＜0.01）. ConclusionMGQD has a favorable ameliorative effect on UC-related symptoms and pathological tissue damage， and its mechanism of action may be related to the restoration of the prolife-ration and differentiation of intestinal stem cells into goblet cells， thereby promoting the repair of the intestinal mucus barrier.

OBJECTIVETo evaluate the effectiveness and safety of lyophilized Salvia salt of lithospermic acid powder for injection (SSLA) in treating coronary heart diseases angina pectoris (CHD-AP) of Xin-blood stasis syndrome type, and to conduct the non-inferiority trial with Danshen injection (DSI) as positive control.

METHODSAn non-inferiority clinical layered, segmented, randomized, and blinded trial on three parallel and multiple centered groups was conducted in 480 patients with stable effort angina grade I, II and III, who had two or more times of attack every week. The 240 patients in test group A were treated with SSLA 200 mg added in 250 ml of 5% glucose solution for intravenous dripping every day; the 120 patients in test group B were treated with SSLA but the dosage doubled; and the 120 patients in the control group were treated with DSI 20 ml daily in the same method as SSLA was given. The clinical effectiveness and safety were evaluated after the patients were treated for 14 days.

RESULTSThe results showed that the markedly effective rate in test groups A, B and control group was 37.45%, 36.75% and 30.09% respectively, while the total effective rate in them was 88.09%, 89.74% and 67.26% respectively. Statistical significance was shown in comparisons of the therapeutic effect between control group with test group A and test group B, with that in the two test groups superior to that in the control group, and non-inferiority trial showed eligibility (P < 0.01). Adverse reaction appeared in 8 patients in the test groups and 2 in the control group.

CONCLUSIONSSLA has definite therapeutic effect in treating patients with CHD-AP, with its effect not inferior to that of DSI, and no evident toxic-adverse reaction.

Adolescent ; Adult ; Aged ; Angina Pectoris ; drug therapy ; Benzofurans ; adverse effects ; therapeutic use ; Depsides ; Double-Blind Method ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Freeze Drying ; Humans ; Infusions, Intravenous ; Lithospermum ; Male ; Middle Aged ; Phytotherapy ; Salvia ; Salvia miltiorrhiza ; adverse effects

Objective To investigate the clinical,biochemical and genetic findings in patients with isolated methylmalonic aciduria. Methods From January 2001 to December 2014,a total of 126 patients with isolated methyl-malonic aciduria from Peking University First Hospital were enrolled in this study. In 60 patients,gene analysis was per-formed. The clinical characteristics,laboratory findings,treatment and outcomes were retrospectively analyzed. Results Among the 126 patients,only 3 cases(2. 4% )were detected through newborn screening and treated with dietary in-tervention,cobalamin and L - camitine. The age at onset of 123 cases(97. 6% )varied from a few hours after birth to 7 years and 11 months old. The common presentations were recurrent vomiting,mental retardation,poor feeding,lethargy, respiratory distress,coma,seizures,cutaneous lesion and jaundice with 11 patients(8. 73% )dead. Abnormal family his-tory was found in 27(21. 4% )patients. Metabolic acidosis and anemia were frequent laboratory findings. Basal ganglia damage and white matter changes were observed in most patients. Sixty patients got genetic analysis,and 58 cases of them had MUT gene mutations. One case had MMAA defect. One case had MMAB defect. In MUT gene,12 novel muta-tions were identified. After treatment,mild to severe psychomotor retardation was observed in 112 patients with isolated methylmalonic aciduria. Conclusions The clinical manifestation of patients with isolated methylmalonic aciduria is complex,and prone to appear metabolic crisis. MUT defect is the main cause. Early metabolic investigation is very im-portant to reach diagnosis. Newborn screening,early diagnosis and adequate therapy are key points to reduce the morta-lity and handicap.

OBJECTIVETo evaluate the efficacy and safety of Fulu Baoxinping (FLBXP) oral liquid in the treatment of coronary heart disease patients with premature ventricular beat (PVB), differentiated as qi-yin deficiency with phlegm-stasis syndrome type.

METHODSAdopting randomized, double-blinded, double-simulated, positive drug parallel controlled and multi-centered clinical research method, 240 patients enrolled were randomly assigned equally to the treatment group treated with FLBXP 10 mL (containing 13.33 g of crude drug) thrice a day and the control group treated with Wenxin Granule 9 g thrice a day. Meanwhile, simulator of the test or positive control drug was given to them all correspondingly. The therapeutic course for them all was 28 days. Efficacy on PVB and TCM syndrome was observed.

RESULTSThe markedly effective rate and total effective rate on PVB were 55.0% and 78.4% in the treatment group, and 37.2% and 53.1% in the control group, significant difference between groups was shown in comparison of both indexes (P < 0.05). Dynamic ECG showed the total number of PVB decreased for 3460.59 +/- 6516.56 beats/24 h in the treatment group, and for 2148.36 +/- 5129.47 beats/24 h in the control group, difference between them showed no statistical significance (P > 0.05). The TCM syndrome score in both groups was markedly decreased after treatment when compared with before treatment (P < 0.01); the differences of the treated and the control groups were -9.34 +/- 4.21 and -8.08 +/- 4.33 respectively, showing sigificant difference (P < 0.05).

CONCLUSIONFLBXP oral liquid has certain effect on PVB in CHD patients of qi-yin deficiency with phlegm-stasis syndrome type, no obvious adverse reaction was found in the clinical trial.

Administration, Oral ; Adult ; Aged ; Coronary Disease ; complications ; drug therapy ; physiopathology ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Electrocardiography ; Female ; Humans ; Male ; Middle Aged ; Treatment Outcome ; Ventricular Premature Complexes ; complications ; drug therapy ; physiopathology

It is believed that retention due to deficient qi is an important pathogenesis of endometriosis （EMs）. Deficient qi is the root of the disease， mainly manifested as spleen deficiency， while retention is the branch pathogenesis of the disease， mainly with blood stasis， complicated with constraint， phlegm， heat， toxin and other pathological factors. Therefore， it is proposed to follow the treatment principle of supplementing deficiency and unblocking stagnation， and take the methods of replenishing qi and fortifying the spleen， removing stasis and eliminating concretions. Self-made Fuzheng Huayu Formula （扶正化瘀方） is taken as the basic formula， and can be modified with the symptoms in menstrual and non-menstrual periods. Additionally， the methods of moving qi， dispelling phlegm， clearing heat， relieving toxin and others can be combined， and it is recommended to treat the root and the branch simultaneously.