RESUMO
To evaluate the efficacy and safety of Choudongning (CDN)capsule in children with Tourette's syndrome of spleen deficiency and phlegm accumulation through a randomized double-blind three-arm controlled phase â ¢ study in 588 patients from 8 hospitals. The included patients were randomly divided into test group, positive control group and placebo group at the ratio of 3â¶1â¶1. Patients in the test group orally took CDN capsules and simulated Tiapridal tablets; the patients in positive control group took Tiapridal tablets and simulated CDN capsules; whereas the patients in placebo group orally took the simulated agents of the above two drugs. The treatment course was 6 weeks for three groups. The global grading rates, YGTSS scores and its factor scores, the degree of social function damage, as well as traditional Chinese medicine syndrome efficacy were evaluated as the outcome measures on efficacy. The AEs/ADRs, vital signs and laboratory testing were observed as outcome measures on safety. The total effective rate of YGTSS was 75.92% in the test group, 72.65% in the positive control group, and 37.29% in the placebo group. Non inferiority test stands between the test group and the positive control group, and they were superior to placebo group in efficacy with statistical difference. Significant difference had also been found among the 3 groups in YGTSS tics score, motor tics score, vocal tics, degree of social function damage and traditional Chinese medicine syndrome efficacy. During the study, there were 5 (1.42%)ADRs in the test group, 10 (8.55%)in the positive control group and 3 (2.54%)in the placebo group. The incidence of ADRs in the test group was lower than that in the positive control group, with statistical difference. It is clear to say that CDN capsule can effectively treat the Tourette's syndrome of spleen deficiency and phlegm accumulation. Its efficacy is not inferior to the commonly used Tiapridal tablets, with even less adverse reactions, so it has clinical application value.
Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Síndrome de Tourette/tratamento farmacológico , Cápsulas , Criança , Método Duplo-Cego , Humanos , Medicina Tradicional Chinesa , Baço/fisiopatologia , Resultado do TratamentoRESUMO
OBJECTIVE: To verify the equivalence of hawthorn leaves standard decoction and formula granules. METHODS: In this experiment, liquid chromatograph mass spectrometer (LC-MS) was used to examine the chemical composition of hawthorn leaves standard decoction and formula granules, separately. In addition, oxidative stress test was used to explore the antioxidant capacity of them. RESULTS: 71 chemical components were identified by LC-MS. Among them, 64 and 56 compounds were identified in the standard decoction and formula granules, respectively. There were a total of 49 common components, with no significant difference in content. Oxidative stress test showed that hawthorn leaves standard decoction and formula granules had no obvious toxicity to human umbilical vein endothelial cells. Compared with the model group, the same dose of hawthorn leaves formula granule and standard decoction could inhibit the secretion of lactate dehydrogenase and malondialdehyde (P < 0.05), and increase the content of superoxide dismutase (P < 0.01), with no statistically significant difference. CONCLUSIONS: There is no significant difference in the main active ingredients between the standard decoction and the formula granules, and the antioxidant activity in vitro is equivalent, providing an important theoretical basis for the further development of hawthorn leaves formula granules.
RESUMO
OBJECTIVE: The study investigated the use of great curvature plication with duodenal-jejunal bypass (GCP-DJB) in a type 2 diabetic with obesity rat model. METHODS: Twenty-two Sprague-Dawley rats were given a high fat and sugar diet with subsequent intraperitoneal injection of a small dosage of streptozotocin (30 mg/kg) and randomly assigned to either GCP-DJB (n = 12) or Sham surgery (n = 10). Body weight, peripheral blood glucose, and fasting serum insulin were assayed, and insulin resistance index (IRI) was calculated, before and at 1, 2, 4, and 8 weeks after surgery. RESULTS: No differences were found in the preoperative characteristics of the two groups (P > 0.05). At week 1, the body weights decreased significantly, but there was no significant difference between the two groups (P > 0.05).The fasting blood glucose was significantly lower in the GCP-DJB than in the Sham group (P < 0.05), serum insulin levels were higher (P < 0.05), and IRI began to decline (P < 0.05). From 2 to 8 weeks, the body weight of Sham group gradually recovered and continued to rise, while the GCP-DJB group remained at a relatively lower state. Compared to the Sham group, the body weight, fasting blood glucose as well as IRI of GCP-DJB rats had significantly decreased (P < 0.05). But, the fasting insulin concentrations had significantly increased (P < 0.05). CONCLUSION: This novel GCP-DJB procedure established a stable animal model for the study of metabolic surgery to treat type 2 diabetes mellitus (T2DM).
Assuntos
Cirurgia Bariátrica/métodos , Diabetes Mellitus Experimental/cirurgia , Diabetes Mellitus Tipo 2/cirurgia , Animais , Glicemia/análise , Resistência à Insulina/fisiologia , Ratos , Ratos Sprague-DawleyRESUMO
OBJECTIVE: To evaluate the clinical value of transvaginal elastography (TVES) in diagnosing cervical malignancies by detecting changes of tissue stiffness. METHODS: One hundred and ten consecutive patients with cervical lesions were enrolled. Pathological results were used as the gold standards. TVES was employed to detect the stiffness changes of the cervix. Strain ratio was calculated and compared between the benign and malignant lesions. Depth of invasion into stromas of 56 cases of cervical cancers measured by TVES were recorded and compared with the pathological results. Interclass correlation coefficient (ICC) was used to analyze the reproducibility. RESULTS: Strain ratio of malignant lesions were much higher than that of the benign lesions (8.19±5.66 vs. 2.81±2.24, P<0.01). Area under the curve (AUC) was 0.905 with a 95% CI (0.835-0.976). The best cut-off point of strain ratio value was 4.53. Specificity and sensitivity for the best cut-off point were 0.788 and 0.897, respectively. Mean depth of the 56 malignant lesions was 17.8±7.4mm measured by TVES (range 5.4-43.1mm) and 11.5±8.8mm measured by pathological samples (range 3.7-38.4mm). ICC of the 2 methods were 0.87 (95% CI 0.863-0.947) and 0.931 (95% CI 0.902-0.952) for the 2 observers. CONCLUSIONS: TVES was a useful technique in confirming the diagnoses of cervical cancer and in estimating the infiltrating region. When the strain ratio of a cervical lesion was higher than 4.53, it is confidential to be diagnosed as malignant.