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OBJECTIVE@#To evaluate the efficacy and safety of topical delivery of modified Da-Cheng- Qi Decoction (, MDCQD) by low-frequency ultrasound sonophoresis (LFUS) in patients with refractory metastatic malignant bowel obstruction (MBO) using an objective performance criteria (OPC) design.@*METHODS@#Fifty patients with refractory metastatic MBO were enrolled in this open-label single-arm clinical trial. Alongside fasting, gastrointestinal decompression, glycerol enema, intravenous nutrition and antisecretory therapy, a 50 g dose of MDCQD (prepared as a hydrogel) was applied through topical delivery at the site of abodminal pain or Tianshu (S 25) using LFUS for 30 min, twice daily for 5 consecutive days. The overall outcome was the remission of intestinal obstruction, and improvement on abdominal pain, abdominal distention, nausea and vomiting scores. Indicators of safety evaluation included liver and renal function as well as blood coagulation indicators.@*RESULTS@#Among 50 patients, 5 patients (10%) showed complete remission of intestinal obstruction and 21 patients (42%) showed improvement of intestinal obstruction. The overall remission rate of bowel obstruction was 52%. The results of the symptom score, based on the severity and frequency of the episode, are as follows: 26 patients (52%) showed improvment on symptom scores, 20 patients (40%) did not respond to treatment, and 4 patients (8%) discontinued treatment due to intolerance. No serious adverse effects or abnormal changes on liver and renal function or blood coagulation were observed.@*CONCLUSION@#Topical delivery of MDCQD at 100 g/day using LFUS can improve the treatment response in patients with refractory metastatic MBO.
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Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Administração Cutânea , Medicamentos de Ervas Chinesas , Neoplasias Intestinais , Obstrução Intestinal , Tratamento Farmacológico , Terapia por Ultrassom , MétodosRESUMO
OBJECTIVE@#To investigate the effects of Da-Cheng-Qi Decoction (DCQD, ) combined with Lactobacillus acidophilus (LA) on the recovery of gastrointestinal (GI) function in traumatic brain-injured (TBI) mice.@*METHODS@#A total of 150 male C57BL/6 mice were randomly divided into sham-injury, normal saline (NS), DCQD (0.4 mL/day), LA (⩾1 × 10 cfu/day LA), DCQD+LA (LA administration at the same dosage after 4 h of feeding DCQD), and ½ DCQD+LA groups (LA administration at the same dosage after 4 h of feeding ½ DCQD dose) by a random number table, 5-8 mice in each group. The sever TBI model was constructed according to Feeney's enhanced gravitational forces of free falling. On days 1, 3, and 7 post-TBI, plasma diamine oxidase (DAO) and D-lactic acid levels were assessed by enzyme-linked immunosorbent assay (ELISA). Occludin expression in the intestinal epithelium was assessed by Western blot analysis. Transmission electron microscopy (TEM) was used to observe the morphological changes in the network structure of interstitial cells of Cajal (ICC) and change of enteric nervous system-ICC-smooth muscle cell (ENS-ICC-SMC). Immunofluorescence staining was used to detect changes in the network structure of the ICC.@*RESULTS@#Compared with the NS group, occludin expression in the DCQD+LA group significantly increased on Day 1, 3, and 7 post-TBI (P<0.05 or P<0.01). The concentration of DAO significantly decreased in the LA, DCQD, and DCQD+LA groups on Day 3 and 7, whilst the D-lactate concentrations in the LA and ½ DCQD+LA groups decreased on Day 1 and 3 post-injury (P<0.05 or P<0.01). The NS group experienced a great damage on the ENS-ICC-SMC network morphology and ICC network structure, and all treatment groups had some improvements, among which the DCQD+LA group presented relatively intact network morphology.@*CONCLUSIONS@#DCQD combined with LA treatment could effectively repair the intestinal mucosal barrier and improve GI motility in mice after TBI. The combination of DCQD and LA was more effective than their respective monotherapies.
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OBJECTIVE: To explore the effectiveness of electroacupuncture (EA) stimulation of Shu-and Mu-points of Lung and Large Intestine Meridians combined with administration of Da-Cheng-Qi Decoction (DCQD) in the treatment of inflammatory injury in rats with acute pancreatitis, so as to reveal their synergetic anti-inflammatory effect. METHODS: Forty male SD rats were randomly divided into five groups: normal control, model, DCQD, EA, EA+DCQD, with 8 rats in each group. All the rats except those in the normal group received a retrograde biliopancreatic duct injection of sodium Taurocholate (3.0%, 0.1 mL/100 g) to induce an acute pancreatitis model. Twenty-four hours after modeling, EA (4 Hz/50 Hz) was applied to bilateral Shu-points "Feishu" (BL 13) and "Dachangshu" (BL 25), and Mu-points "Zhongfu" (LU 1) and "Tianshu" (ST 25) for 20 min, once every 7 h, 3 times in total. Rats of the DCQD and EA+DCQD groups were given intra-gastric gavage of DCQD (1 mL/100 g) 24 h after modeling, and those of the other 3 groups were given intra-gastric gavage of same dosage of normal saline. The histopathological changes of the pancreas, lung and large intestine tissues were observed after H. E. staining and scored according to Schmidt's and colleagues' methods (the severity of edema, inflammation, hemorrhage, necrosis). The concentrations of interleukin-6 (IL-6) and IL-10 in the serum, and those of myeloperoxidase (MPO) and malonaldehyde (MDA) in the lung and large intestine tissues were detected by using double-antibody sandwich ELISA. RESULTS: After modeling, the histopathological scores of pancreas, lung and large intestine tissues, the concentrations of MPO and MDA in lung and large intestine, and the levels of IL-6 and IL-10 in serum were significantly increased in the model group compared with the normal control group (P0.05). CONCLUSION: EA and DCQD can relieve the inflammatory injury of the pancreas, lung and large intestine tissues in rats with acute pancreatitis, and EA combined with DCQD has a better synergetic effect in reducing oxidative stress level and inflammatory reaction.
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Objective: Patients and doctors often have questions about the equivalence of traditional and machinery decoctions. In this article, using Da-cheng-qi Decoction (DCQD) as a model of formula, traditional decoction (TD), machinery decoction under high pressure (MDHP), and machinery decoction under normal pressure (MDNP) were compared. Methods: For chemical components, HPLC fingerprints were established and evaluated using AHP combined with CRITIC weighing method; For animals' effects, the experiments of small intestinal propulsion were conducted; For clinical effects, a randomized clinical trial (RCT) was designed and performed. Results: Although there were some differences between TD and MDNP in chemical ingredients, there was no significant difference in animal experiments and clinical trials (P > 0.05). Conclusion: The traditional and machinery decoctions of DCQD could be used bioequivalently.
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Objective To investigate the effect of Da-Cheng-Qi decoction on enteric functional disturbance in rats with acute experimental pancreatitis and its potential mechanism. Methods Seventy-two SD rats were randomly divided into sham operation group, acute pancreatitis (AP) group and Da-Cheng-Qi decoction treated group with 24 each. The AP model was induced by retrograde injection of sodium taurocholate (0.1 ml/100 g) into bitiopancreatic duet. Before modeling, the rats in treatment group received Da-Cheng-Qi decoction (2 g/100 g), and the rats in other two groups received 0.9% NaCl solution. The rats were sacrificed at 3, 6 and 12 hours with 8 each, and the blood samples were taken for detecting the level of amylase and the contents of 5-hydroxytryptamine (5-HT) by enzyme-linked immunosorbent assay. The colonic tissues 10 cm apart from trans-ligament incluing jejunum, terminal ileum and sigmoid colon were collected for examining the expressions of 5-HT_3 and 5-HT_4mRNA and proteins by RT-PCR and Western blotting respectively. Results ① The levels of serum amylase and 5-HT in AP group and treatment group were significantly higher than those in sham operation group (P<0. 01), but they were lower in treatment group than in AP group at each time points (P<0. 05). The level of 5-HT was increased in the initial stage and then decreased gradually both in AP group and treatment group. ③ The expressions of 5-HT_3 and 5-HT_4 mRNA and proteins were significantly decreased in the jejunum, terminal ileum and sigmoid colon in AP group compared with sham operation group (P<0. 01). Whereas the expressions of 5-HT_3 mRNA and protein,but not 5-HT_4, were increased in the treatment group in comparison with AP group (P<0.05). Conclusions The level of 5-HT is significantly increased in acute pancreatitis, but its receptors (5-HT_3 and 5-HT_4) are decreased, which may induce enteric functional disturbance. The Da-Cheng-Qi decoction may improve enteric dynamic failure by increasing the expression of 5-HT_4 and may be a choice for treatment of acute pancreatitis with enteric dynamic failure
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Objective To investigate the therapeutic effect of Da-Cheng-Qi Decoction on gut dysfunction in patients with severe acute pancreatitis (SAP). Methods Forty-eight SAP patients complicated with gut dysfunction were randomly divided into two groups according to the number of admission, which were treatment group and control group. The therapy in t reatment group was Da-Cheng-Qi Decoction infusion through gastric tube (one paste/day, b. i. d), however the therapy of control group was normal saline infusion through gastric tube (the amount was the same as the former, b. i. d), and other management in the two groups was similar. The first passage of gas by anus and defecation after treatment was observed. Serum amylase, C-reactive protein (CRP), tumor necrosis factor (TNF)-α, interleukin (IL)-6 were examined before and one week after treatment;complications and mortality were compared between the two groups. Results The first passage of gas by anus and defecation in the treatment group was ( 12.3 ± 5.7 ) h and ( 24.8 ± 11.2 ) h, respectively, and shorter than ( 22. 1 ± 9.7 ) h and 46.2 ± 17.4) h of control group ( P <0.01) ;the numerical values of serum amylase, CRP, TNF-α and IL-6 one week after treatment were ( 120.3 ± 35.8 ) U/L, ( 10.8 ±2.0) ng/ml, (36.3 ± 5.8) U/L and (4.8 ± 1.0) U/L, which were significantly decreased when compared with the values before treatment, and these values were significantly lower than (267.2 ± 78.9 )U/L, ( 19.5 ± 2.7 ) ng/ml, (80.1 ± 9.0) U/L, ( 10.5 ± 1.2 ) U/L of the control group ( P < 0.05 ). The total complications and mortality of treatment group was 12.5% and 4.4%, respectively, which were significantly lower than those in the control group (37.5% and 25%, P <0.05). Conclusions Treatment with Da-Cheng-Qi Decoction in SAPpatients complicated with gut dysfunction was effective to reverse gut dysfunction and reduce total complications and mortality.