ABSTRACT
Objective:To explore the efficacy and safety of Ganhai Weikang capsule (GWC) in the treatment of functional dyspepsia (FD).Methods:A randomized, double-blind, placebo-controlled parallel, multi-center, superiority clinical trial was conducted. From March 2018 to April 2020, totally 324 patients with dyspepsia symptoms, who were diagnosed as chronic non-atrophic gastritis by endoscopy and pathology and met the Rome Ⅳ diagnostic criteria for FD from 7 top hospitals were enrolled, including the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), Heilongjiang Hospital of Traditional Chinese Medicine, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Qilu Hospital of Shandong University, the First Affiliated Hospital of Zhejiang University, Beijing Hospital of Traditional Chinese Medicine of Capital Medical University and the Third Xiangya Hospital of Central South University. The patients were randomly divided into the GWC group and the placebo group according to the ratio of 1∶1. The patients of GWC group were given GWC and the patients of placebo group were given GWC capsule simulant. The patients of both groups orally took capsules before meals, 2.4 g each time and 3 times per day, and the course of treatment was 4 weeks. The main efficacy index was the total clinical effective rate after 4 weeks, and the secondary efficacy index was the changes of clinical symptom scores of upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety. The safety index included laboratory tests and adverse events. Chi-square test and Wilcoxon rank sum test were used for statistical analysis.Results:A total of 320 FD patients were enrolled in the full analysis set (FAS), which included 161 cases in GWC group and 159 cases in placebo group. A total of 298 cases were in the per-protocol set (PPS), 149 cases each in GWC group and placebo group. The results of FAS and PPS both showed that the total clinical effective rates of the GWC group were higher than those of the placebo group (84.5%, 136/161 vs. 44.0%, 70/159 and 83.9%, 125/149 vs. 46.3%, 69/149), and the differences were statistically significant ( χ2=57.07 and 46.32, both P<0.001). In addition, the differences of the total score of main symptoms and each symptom (upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety) before and after treatment of GWC group were all higher than those of the placebo group (FAS: 10 (7, 14) vs. 5 (3, 11); 3 (2, 4) vs. 2 (0, 3); 2 (0, 4) vs. 1 (0, 3); 3 (1, 4) vs. 2 (1, 3); 2 (0, 4) vs. 1 (0, 3). PPS: 10 (7, 13) vs. 5 (3, 11); 3 (2, 4) vs. 2 (0, 3); 2 (0, 4) vs. 1 (0, 2); 3 (1, 4) vs. 2 (1, 3); 2 (0, 4) vs.1 (0, 3)), and the differences were statistically significant (FAS: Z=5.80, 5.91, 3.19, 3.72 and 3.30; PPS: Z=5.14, 5.11, 2.86, 3.21 and 2.84; all P<0.01). The results of FAS and PPS indicated that the improvement rates of main symptoms and each symptom (upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety) of GWC group were all higher than those of the placebo group (FAS: 77.8% (54.6%, 91.3%) vs. 42.9% (28.6%, 61.5%); 100.0% (60.0%, 100.0%) vs. 50.0% (25.0%, 60.0%); 100.0% (50.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 71.4% (33.3%, 100.0%) vs. 41.4% (25.0%, 66.7%); 100.0% (50.0%, 100.0%) vs. 50.0% (20.0%, 100.0%). PPS: 77.8% (54.2%, 89.5%) vs. 44.0% (28.6%, 65.0%); 100.0% (60.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 100.0% (50.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 71.4% (33.3%, 100.0%) vs. 46.4% (25.0%, 66.7%); 100.0% (50.0%, 100.0%) vs. 50.0% (20.0%, 100.0%)), and the differences were statistically significant (FAS: Z=8.60, 7.72, 4.98, 4.24 and 5.61; PPS: Z=7.90, 7.03, 4.49, 3.88 and 4.83; all P<0.001). After 2 weeks of treatment, the differences of the total score of main symptoms and score of each symptom (upper abdominal pain, upper abdominal burning and early satiety) before and after treatment of GWC group were all higher than those of the placebo group (5.0 (3.0, 8.0) vs. 4.0 (2.0, 6.0); 2.0 (1.0, 2.0) vs. 2.0 (0.0, 2.0); 1.5 (0.0, 2.0) vs. 1.0 (0.0, 2.0); 1.5 (0.0, 2.0) vs. 1.0 (0.0, 2.0)), and the differences were statistically significant ( Z=2.95, 3.44, 2.43 and 2.79, all P<0.05). There was no significant difference in the incidence of adverse events between the GWC group and the placebo group (0.6%, 1/163 vs. 0, 0/159). Conclusion:The clinical total effective rate of GWC in the treatment of FD is superior to that of placebo and it has good safety.
ABSTRACT
Objective:To investigate the clinical efficacy of Jinghua Weikang capsule combined with Bifidobacterium for curing patients featured by spleen-stomach damp-heat syndrome and Helicobacter pylori (Hp) infection with low DOB values.Methods:To enroll 130 cases who were admitted to the Digestion Center of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University from March 2019 to March 2020. According to the treaatment protocols, the quadruple therapy group and dual therapy group, each had 65 patients. The quadruple therapy group had two different treatment protocols, 34 cases with Rabeprazole sodium enteric-coated tablet, Bismuth potassium citrate capsule, Amoxicillin capsule, and Clarithromycin, the other one had 31 cases with Rabeprazole sodium enteric-coated tablet, Bismuth potassium citrate capsule, Amoxicillin capsule, and Levofloxacin tablets. The Dual therapy group was treated with Jinghua Weikang capsule combined with Bifidobacterium. As for quadruple therapy group, 14 days was a course of treatment, while28 days was a course of treatment for dual therapy group. The two groups were treated for one course, respectively. The TCM syndromes were scored before and after treatment. After 4-weeks long drug withdrawal, all cases were reexamined via 13C-UBT. The Hp eradication rate, efficacy evaluation and adverse reactions were compared between both groups.Results:The eradication rate was 90.8% (59/65) in quadruple therapy group and 78.5% (51/65) in dual therapy group. There was no statistical difference between two groups ( χ２=3.78, P=0.052). As for quadruple therapy group, the eradication rate was 91.2% (31/34) in Protocol One and 90.3% (28/31) in Protocol Two. There was no statistical difference between two protocols ( χ２=0.01, P=0.906). After treatment, the TCM syndrome score of quadruple therapy group [(7.02±0.89) vs. (6.51±0.85), Z=-3.01], was significantly higher than that of dual therapy group ( P<0.01). The total effective rate was 93.9% (61/65) in dual therapy group and 78.5% (51/65) in quadruple therapy group. There was statistically significantly difference between two groups ( χ２=6.45, P=0.011). The adverse reactions was 24.6% (16/65) in quadruple therapy group and 6.2% (4/65) in dual therapy group. There was statistically significantly difference in two groups ( χ２=8.51, P=0.004). Conclusions:The Jinghua Weikang capsule combined with Bifidobacterium had curative effects on Hp infected patients with low DOB values. It could improve TCM Syndromes with little adverse reactions.
ABSTRACT
OBJECTIVE@#To investigate the effects of Weikang Capsule (, WKC) on aspirin-related gastric and small intestinal mucosal injury by magnetically controlled capsule endoscopy (MCCE).@*METHODS@#Patients taking enteric-coated aspirin aged 40-75 years were enrolled in Beijing Anzhen Hospital, Capital Medical University from January 2019 to December 2019. The patients continued taking aspirin Tablet (100 mg per day) and underwent MCCE before and after 1-month combined treatment with WKC (0.9 g per time orally, 3 times per day). The gastrointestinal symptom score, gastric Lanza score, the duodenal, jejunal and ileal mucosal injury scores were used to evaluate the gastrointestinal injury before and after treatment. Adverse events including nausea, vomiting, abdominal pain, abdominal distension, abdominal discomfort, dizziness, or headache during MCCE and combined treatment were observed and recorded.@*RESULTS@#Twenty-two patients (male/female, 13/9) taking enteric-coated aspirin aged 59.5 ± 11.3 years with a duration of aspirin use of 28.0 (1.0, 48.0) months were recruited. Compared with pre-treatment, the gastrointestinal symptom rating scale scores, gastric Lanza scores, and duodenal mucosal injury scores were significantly reduced after 1-month WKC treatment (P<0.05), and jejunal and ileal mucosal injury scores showed no obvious change. No adverse events occurred during the trial.@*CONCLUSIONS@#WKC can alleviate gastrointestinal symptoms, as well as gastric and duodenal mucosal injuries, in patients taking enteric-coated aspirin; it does not aggravate jejunal or ileal mucosal injury, which may be an effective alternative for these patients (Clinical trial registry No. ChiCTR1900025451).
ABSTRACT
Objective To compare the effects of Jinghua Weikang capsule and bismuth potassium citrate in the treatment of Helicobacter pylori (Hp) infection.Methods From July 2016 to April 2018,124 patients who were diagnosed as Hp positive by gastrointestinal urease test and 13C breath test at the First Affiliated Hospital of He'nan University were randomly divided into group A (63 cases) and group B (61 cases) according to the digital table. Group A received bismuth potassium citrate +standard triple therapy ,treatment for 14 days.Group B was given Jinghua Weikang capsule +standard triple therapy,treatment for 14 days.One month after treatment ,the treatment effect of the two regimens was recorded.Results The total effective rates of group A and group B after one course of treatment were 88.89%(56／63) and 93.44%(57／61),respectively,the difference was no statistically significant between the two groups(χ2 ＝0.795,P＝0.373).The Hp eradication rates of group A and group B were 84.13%(53／63) and 95.08%(58／61),respectively,the difference was statistically significant (χ2 ＝3.963,P＝0.047).The proportions of patients with improved symptoms within 7 days in group A and group B were 68.25%(43／63) and 83.61%(51／61),respectively,the difference was statistically significant (χ2 ＝3.983,P＝0.046).The incidences of adverse reactions in group A and group B were 14.29%(9／63) and 3.28%(2／61),respectively,the difference was statistically significant(χ2 ＝4.645,P ＝0.031).Conclusion Compared with bismuth potassium citrate , Jinghua Weikang capsule has similar clinical effect after one course of treatment ,higher Hp eradication rate ,lower incidence of adverse reactions,faster symptom improvement ,and the satisfaction and compliance of patients are higher.
ABSTRACT
Objective@#To evaluate the clinical effect of Jinghua Weikang capsule in treating peptic ulcer with intermingled heat and cold syndrome.@*Methods@#From January 2016 to December 2018, 90 patients of peptic ulcer with intermingled heat and cold syndrome in Changzhou Hospital of Traditional Chinese Medicine were divided into two groups by the random digital table method, with 45 cases in each group.The control group was treated with rabeprazole capsule, and the observation group were treated with rabeprazole capsule and Jinghua Weikang capsule.The gastroscopic performance, the main individual symptoms and TCM syndrome between the two groups were compared.@*Results@#The gastroscopic performance[42 cases(93.3%) were clinical cured, 1 case(2.2%) was significantly improved, 1 case(2.2%) was improved], TCM syndrome effect[38 cases(84.4%) were clinical cured, 4 cases(8.9%) were significantly improved, 2 cases(4.4%) were improved] in the observation group were significantly better than those in the control group[the gastroscopic performance: 35 cases(77.8%) were clinical cured, 5 cases(11.1%) were significantly improved, 3 cases(6.7%) were improved], TCM syndrome effect: 28 cases(62.2%) were clinical cured, 6 cases(13.3%) were significantly improved, 8 cases(17.8%) were improved](Z=-2.040, -2.463, all P<0.05). The improvement of TCM symptoms of epigastric pain which could be relieved by warmth and pressure, dry mouth with bitter taste, cool limbs were significantly better than those in the control group(χ2=6.154, 6.056, 7.174, all P<0.05).@*Conclusion@#Jinghua Weikang capsule can accelerate the repair of gastric mucous of patients with intermingled heat and cold syndrome, improve clinical syndrome, especially these symptoms: stomacha which can be relieved by warmth and pressure, dry mouth with bitter taste, cool limbs.
ABSTRACT
Objective@#To compare the effects of Jinghua Weikang capsule and bismuth potassium citrate in the treatment of Helicobacter pylori(Hp) infection.@*Methods@#From July 2016 to April 2018, 124 patients who were diagnosed as Hp positive by gastrointestinal urease test and 13C breath test at the First Affiliated Hospital of He'nan University were randomly divided into group A(63 cases) and group B(61 cases) according to the digital table.Group A received bismuth potassium citrate + standard triple therapy, treatment for 14 days.Group B was given Jinghua Weikang capsule+ standard triple therapy, treatment for 14 days.One month after treatment, the treatment effect of the two regimens was recorded.@*Results@#The total effective rates of group A and group B after one course of treatment were 88.89%(56/63) and 93.44%(57/61), respectively, the difference was no statistically significant between the two groups(χ2=0.795, P=0.373). The Hp eradication rates of group A and group B were 84.13%(53/63) and 95.08%(58/61), respectively, the difference was statistically significant(χ2=3.963, P=0.047). The proportions of patients with improved symptoms within 7 days in group A and group B were 68.25%(43/63) and 83.61%(51/61), respectively, the difference was statistically significant(χ2=3.983, P=0.046). The incidences of adverse reactions in group A and group B were 14.29%(9/63) and 3.28%(2/61), respectively, the difference was statistically significant(χ2=4.645, P=0.031).@*Conclusion@#Compared with bismuth potassium citrate, Jinghua Weikang capsule has similar clinical effect after one course of treatment, higher Hp eradication rate, lower incidence of adverse reactions, faster symptom improvement, and the satisfaction and compliance of patients are higher.
ABSTRACT
Objective To observe the effects of Jinghua Weikang Capsule on NF-κB p65 expression in gastric mucosa of Helicobacter pylori (Hp) infected mice;To discuss its mechanism of action. Methods Totally 44 SPF KM mice were randomly divided into blank group, model group, triple therapy group and Jinghua Weikang group. Except for the blank group, Hp infected model was set up by short term immunosuppression combined with peroral infection. The treatment strategies were triple therapy group with lansoprazole, metronidazole and clarithromycin for 1 week, Jinghua Weikang group with Jinghua Weikang volatile oil for 4 weeks, model group with sterile water for 4 weeks, and blank group free of any treatments. All the subjects were sacrificed in the 4th week after the treatment. NF-κB p65 was detected through real-time PCR and immunohistochemical method. Results The relative quantitative expressions of NF-κB p65 mRNA were 3.27±0.53 in blank group, 2.18±0.50 in control group, 4.19±1.21 in triple therapy group, and 7.70±1.41 in Jinghua Weikang group (χ2=86.303, P<0.001). Compared with model group, the expressions of NF-κB p65 mRNA of other three groups increased statistically differently (P=0.004), and there was also statistical difference between triple therapy and Jinghua Weikang group. Through immunohistochemical tests, the values of NF-κB p65 mean optical density of nucleus were 25.18± 7.42 in blank group, 31.17±2.98 in model group, 30.06±4.69 in triple therapy group, and 26.94±5.19 in Jinghua Weikang group (χ2=10.960, P=0.012). The values of NF-κB p65 mean optical density of cytoplasm had no statistical difference (F=1.922, P=0.134), and the nucleus/cytoplasm values were 0.23±0.06 in blank group, 0.28±0.03 in model group, 0.26±0.04 in triple therapy group, and 0.24±0.04 in Jinghua Weikang group (χ2=14.527, P=0.002). The statistical analysis of the nucleus/cytoplasm values showed significance between blank and model group (P=0.002), while triple therapy group was still equal to model group (P=0.420). Jinghua Weikang group was lower than model group (P=0.022) and equal to blank group (P=0.750). Conclusion Jinghua Weikang Capsule can effectively reduce the expression of NF-κB p65 in protein level in Hp infected mice.
ABSTRACT
Objective To establish a HPLC method for determining the contents of Magnolol and Honokiol in Weikang Capsule.Methods Stationary phase was Hypersil ODS C_(18)(4.6mm?100mm,5?m),mobile phase was methanol-water(70:30),with detection wavelength 294 nm,flow rate 1.0mL/min and column temperature 30℃.Results There was good linearity in range of 0.0534～1.068?g(r=0.9998,n=6)for Magnolol.The average recoveries of Magnolol was 99.08%,RSD was 0.57%.There was good linearity in range of 0.09～1.80?g(r=0.9998,n=6)for Honokiol.The average recoveries of Honokiol was 98.95%,RSD was 0.69%.Conclusion This method is simple,fast and accurate for the quality control of the preparation.
ABSTRACT
OBJECTIVE:To establish an HPLC method for the determination of the concentration of tetrahydropalmatine in Puyuan weikang capsule. METHODS: The HPLC separation was performed on Venusil XBP-C18 chromatographic column (150 mm?6.0 mm, 5 ?m) with mobile phase consisted of methanol-0.1% phosphoric acid solution(60∶40, with pH adjusted to 6.0 using triethylamine) with a flow rate of 1 mL?min-1. The detective wavelength was set at 280 nm and the column temperature was set at 25 ℃. RESULTS: The linear range of tetrahydropalmatine was 2.5～100 ?g?mL-1 (r=0.999 6) and the recovery rate was 94.33%(RSD=1.11%,n=6). CONCLUSION: The method developed in the study was proved to be simple, rapid and accurate, and applicable for the quality control of Puyuan weikang capsule.
ABSTRACT
OBJECTIVE:To prepare Weikang capsule and establish its quality standard METHODS:Weikang capsule was prepared with gentamycin sulfate,vitamin B1,vitamin B2,vitamin B6 and vitamin B12 A polarimetry was established for determining the content of gentamycin sulfate in Weikang capsule RESULTS:There was a good linearity between optical rotations and concentrations of gentamycin sulfate from 2 000IU/ml to 12 000IU/ml with a regression equation of ?=0 00 767+1 77 003C,r=0 9 999 The average recovery rate of gentamycin sulfate in Weikang capsule was 100 1%,RSD was 0 79%(n=6) The results of polarimetry and microbioassay were nearly equivalent CONCLUSION:The preparation process of Weikang capsule is simple,and polarimetry for determination of the content of gentamycin sulfate in Weikang capsule wes rapid and reliable