China rheumatoid arthritis registry of patients with Chinese medicine (CERTAIN): Rationale, design, and baseline characteristics of the first 11,764 enrollees.

BACKGROUND: Chinese medicine (CM) has become a popular interventional treatment for rheumatoid arthritis (RA). However, limited knowledge about general characteristics and long-term clinical outcomes hampers the development of CM for RA. PURPOSE: The main objectives of the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) were to describe the population of RA patients receiving CM treatment in multiple centers in China using different variables and compare these findings with internationally reported data. STUDY DESIGN: The CERTAIN is a prospective, multicenter, observational disease registry. METHODS: Adult RA patients who fulfilled the 2010 American College of Rheumatology/ European League Against Rheumatism classification criteria for RA and received CM treatment were recruited into the CERTAIN by rheumatologists from 145 hospitals across 30 provinces in China. Data on demographics, disease characteristics, comorbidities, treatments, and adverse events, with a 2-year follow-up, were collected and documented using a predefined protocol. RESULTS: In the 2 years since the study began in September 2019, 11,764 patients have been enrolled (enrolment is ongoing), and 13.10% of participants have completed the 6-month follow-up. We present the baseline characteristics of the first 11,764 enrollees. CONCLUSIONS: The CERTAIN is the first nationwide registry to document comprehensive data on CM treatment in patients with RA. The development of the CERTAIN resource is a significant step forward for Chinese RA patients, herbal medicine users, and research communities and will deepen our understanding of CM for RA. REGISTRATION: The study was registered at ClinicalTrials.gov (NCT05219214).

Chemical composition, antioxidant and antimicrobial activity of the essential oil from the leaves of Macleaya cordata (Willd) R. Br.

The essential oil from the leaves of Macleaya cordata R.Br. obtained by hydrodistillation was analysed by gas chromatography/mass spectrometry. Sixty-eight compounds consisting of up to 92.53% of the essential oil were identified. Antioxidant activities of the essential oil were evaluated by using DPPH radical scavenging and ß-carotene-linoleic acid assays. The essential oil showed moderate antioxidant activity. In addition, the essential oil exhibited potential antimicrobial activity against all tested microorganisms, with diameters of inhibition zones ranging from 8.7 ± 0.5 to 17.2 ± 1.2 mm and minimum inhibitory concentration values from 125 to 500 µg/mL. We selected the most sensitive bacterium Staphylococcus aureus as model to observe of the action of essential oils of M. cordata on the membrane structure by scanning electron microscopy. The treated cell membranes were damaged severely. The results presented here indicate that the essential oil of M. cordata may be potential sources of antioxidant and antimicrobial agents in the future.

Indole alkaloids from Ervatamia chinensis.

Four vobasinyl-ibogan type bisindole alkaloids, ervachinines A-D (1-4), along with 12 known terpenoid indole alkaloids, were isolated from the whole plant of Ervatamia chinensis. Their structures were elucidated by analysis of spectroscopic data, including 1D and 2D NMR, and the absolute configurations of 1-4 were determined by CD exciton chirality method. All of the compounds were evaluated for in vitro cytotoxicity against five human cancer cell lines: HL-60, SMMC-7721, A-549, MCF-7 and SW480. Bisindole alkaloids 1-6 exhibited inhibitory effects, with IC(50) values comparable to those of cisplatin.

[Spatial distribution characteristics of surface sediments nutrients in Lake Hongze and their pollution status evaluation].

In order to illuminate nutrient spatial distribution characteristics in surface sediment of Lake Hongze, sediment samples at 10 representative sampling stations were collected in June of 2008, and concentrations of organic matter, total nitrogen, organic nitrogen, ammonia nitrogen, nitrate, total phosphorus, inorganic phosphorus, Al-Phosphorus, and calcium-Phosphorus in sediment of each station were measured. Analyze showed that: organic matter and total nitrogen are significantly correlated, and organic nitrogen occupies 90% of total nitrogen, which means that carbon and nitrogen were from the same source; Inorganic phosphorus is the majority (70%) of total phosphorus, and the calcium-Phosphorus accounts for a large percentage of inorganic phosphorus; The spatial distribution pattern of organic matter in the lake is very similar with that of total nitrogen, organic nitrogen and total phosphorus, which belongs to a typical sediment distribution pattern called Turbidity Flood Model. The C/N analysis showed that the main sources of organic matter in surface sediments are from the sedimentation of biomass in its water column. By organic matter index evaluation standards and organic nitrogen evaluation standards, the pollution levels of sediment at each sampling stations in the lake were evaluated at clean category, except that at north part of Longji, which was polluted by organic nitrogen.

[Principal factor analysis of symptoms of rheumatoid arthritis and their correlations with efficacy of traditional Chinese medicine and Western medicine].

OBJECTIVE: To explore the correlations between symptom-based principal factors of rheumatoid arthritis (RA) and the effect of traditional Chinese medicine or Western medicine on RA after factor analysis of RA symptoms. METHODS: Four hundred and thirteen RA patients from 9 clinical centers were included in the clinical trial. They were randomly divided into Western medicine (WM) treated group with 204 cases and traditional Chinese medicine (CM) treated group with 209 cases. A complete physical examination and 18 common clinical manifestations were recorded before the randomization and after the treatment. The WM therapy included voltaren extended action tablet, methotrexate and sulfasalazine. The CM therapy included glucosidorum Tripterygll totorum tablet and Yishen Juanbi Tablet. The American College of Rheumatology 20 (ACR20) was used for efficacy evaluation. All data were analyzed on SAS 8.2 statistical package. Eighteen symptoms in the RA patients were analyzed by factor analysis and the relationships between the factors and effects were analyzed with Chi-Square test. RESULTS: Four principal factors were obtained from the analysis results of the 18 symptoms. The factors could represent the symptoms related to joints, cold-syndrome, deficiency syndrome and heat-syndrome in traditional Chinese medicine (TCM), respectively. The effect of WM therapy was better than CM therapy. After 12 weeks of treatment, the effect of CM on patients without deficiency-syndrome was better than the patients with deficiency-syndrome. After 24 weeks of treatment, WM therapy showed better effect on patients with cold syndrome than patients without cold syndrome. CONCLUSION: The results based on the factor analysis of RA symptoms are similar to the results of syndrome differentiation of TCM, and the factor-related different categories of symptoms are associated with the curative effect, thus further research on the symptoms is necessary.

[Study on separation and purification of total alkaloids from Macleaya cordata].

A method for separation and purification of total alkaloids from Macleaya cordata with macroporous resin was studied, with the content and recovery rate of total alkaloids as indexes. The results were as follows: The static adsorption capacity of AB-8 type resin was 104. 65 mg/g, the static elution ratio were 95.9% , the dynamic adsorption capacity of AB-8 type resin was 96.5 mg/g, the recovery rate was more than 91.24% and the purity was more than 90%. AB-8 type resin was the best for separating and purificating Macleaya cordata in total alkaloids. The optimum conditions is: the eluant is 90% alcohol and 2-3 times as the volume of the resin, the volume of the resin is 10.4 times of total alkaloids in sample, concentration of total alkaloids of sample is 21.57 mg/ml and current velocity of 2-3 ml/min, pH value of sample is 7-8.

[Effect of strengthening Pi and activating blood circulation therapy on serum levels of adrenocorticotrophic hormone and vascular endothelial growth factor in rheumatoid arthritis patients].

OBJECTIVE: To observe the effect of strengthening Pi and activating blood circulation therapy (SPAB) on serum levels of adrenocorticotrophic hormone (ACTH) and vascular endothelial growth factor (VEGF) in rheumatoid arthritis (RA) patients. METHODS: Seventy RA patients were randomly assigned to 3 groups. The 30 in the Chinese medicine (CM) group were treated with SPAB; the 20 in the Western medicine (WM) group were treated with indomethacin and methopterin; and the 20 in the CM-WM group were treated with the combination of the therapy in the above two groups, and the course of treatment was 3 months for all. Serum levels of ACTH and VEGF were determined before and after treatment. RESULTS: The total effective rate in the CM group was 80.0%, WM group 85.0% and CM-WM group 95.0%, the last one showed the best efficacy (P<0.05). Serum level of ACTH increased and level of VEGF decreased after treatment in all groups (P<0.05 or P<0.01), but the increment/decrement in the CM-WM group was higher than that in the other two groups (P<0.01), while comparison between that in the CW group and WM group showed insignificant difference. CONCLUSION: SPAB therapy has the effect in alleviating the condition of RA, similar to that of Western medicine, it can increase the serum level of ACTH and decrease the serum level of VEGF remarkably in RA patients.

[Study on extraction technics and variety trends of the flavonoids in Sarcandrae glabra].

OBJECTIVE: To study on extraction technics and variety trends of the flavonoids in Sarcandrae glabra. METHOD: By using S. glabra in Guizhou as materials and the experiment of L9 (3(4)) by ethanol as extracting way, The variety trends of the flavonoids from S. glabra are studied under the optimum extracting conditions during different raw stored times, different gathering season, different S. glabra position. RESULT: The flavonoid's contains was more low when the raw material was stored more long and descended average 24.74% annually. The flavonoid's contains had the tallest in 10-12 month by gathering indifferent season. The flavonoids contains were the tallest in the leaf of S. glabra in Guizhou than in the root and stem, and the contains were the lowest in stem. CONCLUSION: The optimum conditions of extracting flavonoids from S. glabra are obtained when the condition is 60% of density of ethanol at 10 times of volume, 80 degrees C of extracting temperature, 3 h of extracting hours, 3 times of extracting number of times in 10-12 month, in the leaf, the raw material was stored more shortest, the flavonoid's contains had the tallest.

[Separation and purification of flavonoids from chrysanthemum indicum with macroporous resin].

OBJECTIVE: A method for separation and purification of flavonoids from C. indicum with macroporous resin was studied. METHOD: By using C. indicum in Guizhou as the materials and with the content and recovery rate of flavonoids as indexes, the static and dynamic adsorption tests were employed to investigated effects and affective factors of separation and purification of flavonoids from C. indicum with macroporous resin. RESULT: Results show that the static adsorption capacity of AB-8 type resin was 114.65 mg x g(-1), the static elution ratio were 94.9%, the dynamic adsorption capacity of AB-8 type resin was 94.5 mg x g(-1), the recovery rate was more than 92.6% and the purity of flavonoids was more than 90%. AB-8 type resin is the best for separating and purificating C. indicum in flavonoids. CONCLUSION: The optimum conditions is AB-8 type macroporous resin, 70% alcohol as the eluant and 2 to approximately 3 times volume of the resin as the eluant volume, the ratio of flavonoids to the volume of the resin as 1:10.6, concentration of flavonoids of sample as 19.8 mg x mL(-1) and current velocity as 2 to approximately 3 mL x min(-1), pH value of sample as 4 to approximately 5. [Key words]' macroporous resin; Chrysanthemum indicum; flavonoids; separation; purification

[Correlations between diagnostic information and therapeutic efficacy in rheumatoid arthritis analyzed with decision tree model].

OBJECTIVE: To explore the correlations between diagnostic information and therapeutic efficacy in rheumatoid arthritis (RA) with decision tree model analysis. METHODS: Three hundred and ninety seven patients came from 9 clinical centers were randomly divided into the Western medicine (WM) group (n=194) treated with non-steroidal anti-inflammatory drugs and slow-acting antirheumatic drug and the Chinese medicine (CM) group (n=203) with basic therapy and syndrome-differentiation dependant TCM treatment. TCM and WM diagnostic information were collected. The ACR 20 was used for efficacy evaluation and the information of patients before treatment was analyzed by SAS 8.2 statistical package. Through single-factor exploratory analysis, odds ratio of efficacy and variable was calculated taken P < 0.2 as the including criteria for data mining analysis with decision tree model. All data were classified into the training set (75%) and verifying set (25%) with efficacy as the variable for layering to make further verification of the data-mining analysis. RESULTS: Twenty variables were included in the CM group and 26 in the WM group in the data-mining model. In the former, 9 variables were positively correlated to the efficacy, including degree of arthralgia, tenderness and morning stiffness, number of swollen joint, and joint with tenderness, levels of IgM, rheumatoid factor (RF), C-reactive protein (CRP), and total assessment from doctor; and disease duration and degree of nocturnal polyuria were negatively correlated to that. While in the latter, 8 were positively correlated to the efficacy, including erythrocyte sedimentation rate (ESR), sour and weak waist and knees, white fur in tongue, joint ache and stiffness, swollen joint, and total assessment from doctor and patient, and red tongue with yellow fur and leucocyte count negatively correlated to it. Data mining with decision tree analysis revealed that different combinations of morning stiffness, slight red tongue, joint tenderness and nocturnal polyuria in the CM group, and those of white fur in tongue, CRP level, leucocyte count and morning stiffness in the WM group showed different efficacy, which were also verified in the randomly chosen verifying set. CONCLUSION: To analyze the correlations between diagnostic information and therapeutic efficacy with decision tree analysis is conformed to the theory of TCM in applying treatment according to syndrome differentiation individually, thus it would contribute to elevate the accuracy of therapy.