OBJECTIVE: To evaluate the efficacy and safety of Wuda Granule (WDG) on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery (ERAS)-based perioperative care. METHODS: A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned (1:1) to receive either WDG or placebo (10 g/bag) twice a day from postoperative days 1-3, combining with ERAS-based perioperative care. The primary outcome was time to first defecation. Secondary outcomes were time to first flatus, time to first tolerance of liquid or semi-liquid food, gastrointestinal-related symptoms and length of stay. Subgroup analysis of the primary outcome according to sex, age, tumor site, surgical time, histories of underlying disease or history of abdominal surgery was undertaken. Adverse events were observed and recorded. RESULTS: A total of 107 patients [53 in the WDG group and 54 in the placebo group; 61.7 ± 12.1 years; 50 males (46.7%)] were included in the intention-to-treat analysis. The patients in the WDG group had a significantly shorter time to first defecation and flatus [between-group difference -11.01 h (95% CI -20.75 to -1.28 h), P=0.012 for defecation; -5.41 h (-11.10 to 0.27 h), P=0.040 for flatus] than the placebo group. Moreover, the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group (P<0.05). Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male, or under 60 years old, or surgical time less than 3 h, or having no history of basic disease or no history of abdominal surgery. There were no serious adverse events. CONCLUSION The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery. (Registry No. ChiCTR2100046242).
Humans ; Laparoscopy/adverse effects* ; Male ; Female ; Middle Aged ; Double-Blind Method ; Recovery of Function ; Drugs, Chinese Herbal/adverse effects* ; Treatment Outcome ; Gastrointestinal Tract/physiopathology* ; Defecation ; Aged ; Intestines/physiopathology*

ObjectiveTo optimize the extraction and purification process of Gardeniae Fructus for industrial production， and to obtain the total iridoid and total crocin extracts. MethodOrthogonal test was used to optimize the water extraction process by taking contents of geniposide， genipin gentiobioside， gardenoside， crocin-1 and crocin-2 as indicators and the decocting time， decocting times and water amount as factors. The purification process was optimized by single factor test， and four different types of macroporous adsorption resins were screened. The process conditions such as resin type， maximum loading amount， water washing amount， ethanol concentration， ethanol dosage， and flow rate of sample loading were mainly investigated. In addition， the drying methods （vacuum drying and spray drying） of the extract were investigated， and a pilot scale-up verification test was carried out. ResultThe optimal water extraction process of Gardeniae Fructus was to add 15， 10 times the amount of water for decocting twice， 1 h each time. The optimal purification process was as follows：the water extract through SP825L macroporous resin column， the amount of crude drug-the amount of resin （1∶1.5）， the sample loading flow rate of 3 BV h^-1， adding 2 BV of water to remove impurities， adding 4 BV of 30% ethanol to obtain the iridoid part， then adding 3 BV of 70% ethanol to obtain the crocin part， collecting the ethanol lotion， and drying at 70 ℃. Under these conditions， the extraction amount of total iridoids was 590.75 mg·g^-1 with the transfer rate of 70.48%， and the yield of dry extract was 8.89%. The extraction amount of total crocins was 83.37 mg·g^-1 with the transfer rate of 22.20%， and the dry extract yield was 2.60%. ConclusionThe optimized extraction and purification process is stable and feasible with high extraction rate of active components， which is suitable for the industrial extraction and purification of active parts of Gardeniae Fructus.

OBJECTIVETo investigate Chinese medicine (CM) patterns and epidemiological characters of patients with influenza-like illness (ILI) syndromes in clinics in China.

METHODSA prospective multi-center observational epidemiology survey on the clinical CM patterns of ILI and its prevalence was conducted from September 2009 to April 2010. A unified survey questionnaire was developed for data collection of ILI symptoms and CM patterns. Totally 45 hospitals from 22 provinces, municipality cities and autonomous regions of China participated this study. The collected data were input by EPI-data v3.1 and analyzed by SPSS 18.0, which included descriptive analysis and Chi-square test for group comparison.

RESULTSA total of 5,967 ILI patients were included in the study. The proportion of the 18-34 aged group (56.2%) was the largest; students (41.0%) were more than other occupations. Majority of the patients had the wind-heat invading Lung (Fei) syndrome (76%), while in Southwest China mainly wind-heat invading Lung syndrome and wind-cold tightening the exterior syndrome occurred. The typical symptoms of ILI were ranked as fatigue (80.9%), cough (72.2%), sore throat (67.2%), muscular soreness (67.1%), headache (65.4%), aversion to cold (60.1%), thirst (55.1%) and nasal obstruction (48.1%).

CONCLUSIONSThe ILI patients in clinics were mainly teenagers and young adults. In regard to CM syndrome, wind-heat invading Lung syndrome prevailed in all regions except the Southwest China. The characteristics of CM syndrome of ILI patients may be relevant to age and region distribution.

Adolescent ; Adult ; Age Distribution ; Body Temperature ; China ; epidemiology ; Female ; Hospitals ; Humans ; Influenza, Human ; epidemiology ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Prevalence ; Seasons ; Sex Characteristics ; Syndrome ; Time Factors ; Young Adult

OBJECTIVETo explore the mechanisms of Chinese herbal medicine Sanqi Oral Liquid, composed of Astragalus membranaceus and Panpax notoginseng, in alleviating renal injury by observing its effect on the expressions of CD4(+), CD8(+) and CD68(+) cells in 5/6 nephrectomized rats with chronic renal failure.

METHODSA total of 102 SD rats were randomly divided into six groups: three treatment groups were administrated with high, medium and low dosage of Sanqi Oral Liquid respectively by gavage; a normal group, a 5/6 nephrectomized model group, and a group treated with coated aldehyde oxygenstarch were used as controls. Following oral administration of Sanqi Oral Liquid for 12 weeks, the general condition and renal pathological changes were observed, and the renal function, platelet count (PLT) and the expressions of CD4(+), CD8(+) and CD68(+) cells were determined for each group.

RESULTSThere were proliferation of mesangial matrix, renaltubularnecrosis and obvious tubulointerstitial fibrosis in the model group, and they were much milder in the treatment groups. Compared with the model group, the amounts of blood urea nitrogen (BUN), serum creatinine (Scr) and PLT in the treatment groups decreased (P<0.05 for all); and in the group administrated of medium dosage of Sanqi Oral Liquid, the expression of CD4(+) cells was up-regulated and those of CD8(+) and CD68(+) cells were down-regulated (P<0.05 for all), leading to an increased ratio of CD4(+)/CD8(+)(P<0.01).

CONCLUSIONSanqi Oral Liquid has a significant effect on regulating lymphocyte subsets, reducing the infiltration of macrophages in renal tissues and alleviating tubulointerstitial fibrosis, and this may be one of mechanisms of Sanqi Oral Liquid in delaying the progression of chronic kidney diseases.

Administration, Oral ; Animals ; Antigens, CD ; metabolism ; Antigens, Differentiation, Myelomonocytic ; metabolism ; Astragalus membranaceus ; chemistry ; CD4-Positive T-Lymphocytes ; drug effects ; pathology ; physiology ; CD8-Positive T-Lymphocytes ; drug effects ; pathology ; physiology ; Drug Evaluation, Preclinical ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; Kidney Failure, Chronic ; drug therapy ; immunology ; pathology ; surgery ; Lymphocyte Count ; Male ; Nephrectomy ; Panax notoginseng ; chemistry ; Rats ; Rats, Sprague-Dawley ; Solutions

OBJECTIVETo develop quality of life questionnaire of Chinese medicine for postoperative patients with colorectal cancer (QLQ-CMPPCC), thus comprehensively and objectively evaluating the clinical efficacy of Chinese medicine and pharmacy in treating postoperative patients with colorectal cancer (CC).

METHODSThe theoretical structure model of the questionnaire was addressed in combined with basic theories of Chinese medicine according to the principle of WHO quality of life (QOL). The primary questionnaire was developed using methods of structuralization policy making after we extensively retrieve various universal and specific questionnaires for CC cancer patients at home and abroad. The 205 CC patients were tested by questionnaire. The items were screened using experts grading method, item selection analysis, dispersion trends of standard deviation, t-test, correlation coefficient method, factor analysis,and Cronbach's alpha.

RESULTSThe QLQ-CMPPCC was developed containing four domains of physical, psychological, independence, and social functions, involving 20 aspects and 54 items. Of them, non-fistula patients answered 43 items and fistula patients answered 46 items. One item covered the general QOL evaluation.

CONCLUSIONSQLQ-CMPPCC showed Chinese medical features. It comprehensively reflected the connotation of QOL for postoperative CC patients. It could be taken as a tool for evaluating Chinese medical efficacy for postoperative CC patients.

Colorectal Neoplasms ; surgery ; Humans ; Medicine, Chinese Traditional ; methods ; Postoperative Period ; Quality of Life ; Surveys and Questionnaires ; Treatment Outcome

OBJECTIVETo assess the clinical efficacy of acupuncture and moxibustion on depression in view of the outcome indicators of the patient subjective reports.

METHODSOne hundred and sixty-three cases of depression being in compliance with the inclusive standards were randomized into a soothing-liver and regulating-mind group, an acupoint-shallow-puncturing group and a non-acupoint-shallow-puncturing group. In the soothing-liver and regulating-mind group, the conventional acupuncture was applied to the four-gate points [Hegu (LI 4) and Taichong (LR 3)], Baihui (GV 20) and Yintang (EX-HN 3), the direct moxibustion with moxa cone was applied to the four-flower points [Geshu (BL 17), Danshu (BL 19)]. Finally, the intradermal needling was used at Xinshu (BL 15) and Ganshu (BL 18). In the acupoint-shallow-puncturing group, the acupoints selected were same as those in the soothing-liver and regulating-mind group. But the needle insertion was shallower and the time of moxibustion was shorter. In the non-acupoint-shallow-puncturing group, the spots that were 10 mm lateral to those acupoints in the soothing-liver and regulating-mind group were selected. The operation was same as that in the acupoint-shallow-puncturing group. The treatment was given twice a week in three groups. Totally, 12 weeks of treatment were required. The score of symptom checklist 90 (SCL-90), the self-report symptom inventory was observed before treatment, 1 month and 3 months after treatment separately so as to assess the corresponding short-term, mid-term and long-term efficacies of the program of acupuncture and moxibustion for soothing the liver and regulating the mind.

RESULTSIn each time-point after treatment, for the scores of somatization, obsessive-compulsive symptom, interpersonal sensitivity, depression, anxiety, hostility, paranoid ideation, psychoticism and the other 8 dimensionalities, in comparison between the soothing-liver and regulating-mind group and the non-acupoint-shallow-puncturing group, the differences were significant statistically (all P < 0.05). For the scores of depression, anxiety and hostility, in comparison between the soothing-liver and regulating-mind group and the acupoint-shallow-puncturing group, the differences were significant statistically (all P < 0.05).

CONCLUSIONAcupuncture and moxibustion can improve the scores of SCL-90 scale for the patients with depression. The outcome indicators of the patient subjective reports can accurately assess the clinical efficacy.

Acupuncture Therapy ; Adolescent ; Adult ; Aged ; Depression ; psychology ; therapy ; Female ; Humans ; Male ; Middle Aged ; Moxibustion ; Self-Assessment ; Treatment Outcome ; Young Adult

BACKGROUNDVisfatin, a visceral fat-derived adipocytokine, plays a significant physiological function in lipid metabolism. However, the precise function of visfatin and its regulation by thyroid hormones are still unknown. This study observed the plasma visfatin concentrations in subjects with hyperthyroidism and hypothyroidism in vivo, and investigated the possible regulation mechanism between visfatin and tri-iodothyronine (T3) in vitro as a further interpretation.

METHODSThe experiment in vivo included clinical subjects (57 patients with thyroid dysfunction and 29 euthyroid healthy volunteers) and an animal model (24 Wistar rats). All subjects were divided into hyperthyroidism, hypothyroidism and euthyroidism groups, with plasma thyroid hormones, thyrotropin, visfatin and triglyceride concentrations determined. Visfatin mRNA expression in visceral fat and liver of rats was detected by quantitative real-time reverse transcription-polymerase chain reaction (RT-PCR). The experiment in vitro studied 3T3-L1 cells and visfatin mRNA expression under nine different T3 concentrations (0, 0.1, 0.25, 0.5, 1, 5, 10, 20, 100 nmol/L) using quantitative real-time RT-PCR.

RESULTSClinical subjects and animal models showed elevated plasma visfatin concentrations in the hyperthyroidism group (20.466 ng/ml (15.263, 26.795 ng/ml) and (1209.164±165.292) ng/L) and hypothyroidism group (12.457 ng/ml (11.115, 15.454 ng/ml) and (1205.425±109.200) ng/L) compared to euthyroidism group (6.891 ng/ml (5.888, 8.803 ng/ml) and (926.650±54.002) ng/L, P<0.001). For animal models, visfatin mRNA expression in visceral fat in the hyperthyroidism and hypothyroidism groups increased about 3.33-fold and 1.98-fold compared to the euthyroidism group (P<0.001), which was positively correlated with plasma visfatin concentrations (r=0.713, P<0.001). However, no significant group difference (P>0.05) and correlation (r=0.121, P=0.572) was found in the liver. T3 induced a remarkable increase of visfatin mRNA expression in 3T3-L1 cells at low concentrations (0-0.5 nmol/L T3) followed by a sharp decrease at higher concentrations (0.5-100 nmol/L T3), with an inflection point at 0.5 nmol/L T3.

CONCLUSIONElevated circulating visfatin levels in subjects with hyperthyroidism and hypothyroidism are possibly due to an increase of visfatin mRNA expression in visceral fat, and a nonlinear regulation mechanism on visfatin mRNA expression under various T3 concentrations might be involved.

3T3-L1 Cells ; Adult ; Animals ; Female ; Humans ; Hyperthyroidism ; blood ; genetics ; metabolism ; Hypothyroidism ; blood ; genetics ; metabolism ; Male ; Mice ; Middle Aged ; Nicotinamide Phosphoribosyltransferase ; genetics ; metabolism ; Reverse Transcriptase Polymerase Chain Reaction ; Triiodothyronine ; blood

To compare the efficacy and safety of Lamivudine (LAM) plus Adefovir dipivoxil (ADV) combination therapy and Entecavir (ETV) monotherapy for chronic hepatitis B patients. 120 patients with chronic hepatitis B managed in a single-centre clinical practice (median 96 weeks) were split into 2 cohorts, one was treated with de-novo combination Lamivudine (100 mg/day) plus Adefovir (10 mg/day) (LAM+ADV), the other with Entecavir (0.5 mg/day) monotherapy. Serum levels of ALT, creatinine, HBsAg, HBeAg and HBV viral load, together with genotypic resistence were analyzed at 0, 12, 24, 48, 96 weeks, respectively. HBV DNA was determined by real-time PCR. HBsAg and HBeAg were assessed by chemiluminescence. Serum levels of ALT and creatinine were detected by automatic biochemical analyzer. HBV genotypic resistence was tested by direct sequencing. (1) At the time point of 96 weeks, a total of 99 patients (51 cases in combination therapy cohort and 48 case in monotherapy cohort) were compared. The baseline characteristics as for HBV viral load, median age, serum levels of ALT and creatinine were compatible between combination therapy cohort and monotherapy cohort. (2) The rates of HBV DNA values is less than 300 copies/ml and HBV DNA values is less than 1000 copies/ml had no significant difference between LAM + ADV and ETV cohorts by the 12 and 24 weeks (P more than 0.05). (3) At the time point of 48 weeks, the rates of HBV DNA is less than 1000 copies/ml, HBeAg seroconversion, and ALT normalization were similar in both cohorts, though the rate of HBV DNA values is less than 300 copies/ml was obviously higher in combination therapy cohort than that of monotherapy cohort (90.7% vs 76%, P values is less than 0.05). (4) At the time point of 96 weeks, the rates of HBV DNA values is less than 300 copies/ml (96.1% vs 79.2%), HBV DNA values is less than 1000 copies/ml (98% vs 87.5%) and the HBeAg seroconversion (41.7% vs 16.7%) were markedly higher in combination therapy cohort than those of monotherapy cohort statistically (P values is less than 0.05 for all). The mean values of decreases for HBV viral loads and HBsAg levels were smilar in both cohorts at 48 and 96 weeks. (5) Elevated serum creatinine not be found in both cohorts at the end of treatment. (6) No virological breakthrough occurred in combination therapy cohort at the end of treatment. Four patients in monotherapy cohort were found with virological breakthrough at 96 weeks and three cases among were confirmed to be of variants associated with ETV resistance (rtL180M + T184L + M204V). Present study suggests that Lamivudine plus Adefovir dipivoxil de-novo combination therapy was more efficacious than Entecavir monotherapy for CHB patients and the tolerance is compatible.

OBJECTIVETo study the distribution laws of the Chinese medicine syndrome patterns and its correlated symptoms in patients with polycystic ovarian syndrome (PCOS), and the possible correlation between Chinese medicine syndrome patterns and PCOS associated parameters, thus to provide a guidance for selecting proper indices in curative effectiveness assessment.

METHODSUsing clinical epidemiological methods and mathematical statistics, the Chinese medicine syndrome patterns were studied in 228 PCOS patients. The distribution features of Chinese medicine syndrome patterns were summarized.

RESULTSShen-deficiency blood-stasis syndrome was the most frequently seen in PCOS patients, followed by Pi-deficiency phlegm-dampness syndrome, Pi-Shen yang-deficiency syndrome, and Shen-yin deficiency syndrome. Positive correlation existed between serum levels of follicle stimulating hormone (FSH) and Pi-Shen yang-deficiency syndrome. Positive correlation existed between fasting blood sugar (FBS), waist to hip ratio (WHR), body mass index (BMI), fasting insulin (FIN), and Hirsutism score and Pi-deficiency phlegm-dampness syndrome. Positive correlation existed between serum levels of prolactin (PRL), estradiol (E2 ) and qi stagnancy and blood stasis syndrome. Positive correlation existed between serum progesterone (PRG) level, FSH, FIN, BMI, acne score and Gan stagnancy and blood heat syndrome. Positive correlation existed between luteinizing hormone (LH) and Shen-deficiency blood-stasis syndrome. Besides, LH/FSH >3 was possibly more frequently seen in Pi-deficiency phlegm-dampness syndrome and Pi-Shen yang-deficiency syndrome. Family heritability could be seen in each syndrome patterns. Among them, female heritability was more often seen in Shen-deficiency blood-stasis syndrome, while male heritability was more often seen in Shen-yin deficiency syndrome.

CONCLUSIONSShen-deficiency blood-stasis syndrome, Pi-deficiency phlegm-dampness syndrome, Pi-Shen yang-deficiency syndrome, and Shen-yin deficiency syndrome were most frequently seen in PCOS patients. The sex hormones (including 6 items), FBS, FIN, WHR and BMI, etc. were correlated with each Chinese medicine syndrome pattern to various extents, which could be taken as reference in Chinese medicine syndrome differentiation.

Adult ; Body Mass Index ; Female ; Humans ; Medicine, Chinese Traditional ; Polycystic Ovary Syndrome ; diagnosis

OBJECTIVETo analyze the effectiveness of Chinese medicine and integrated Chinese and Western medicine for influenza A (H1N1) in the fever clinics and its relevant expenditure.

METHODSA prospective survey on the clinical epidemic observation and follow-up was conducted from July 2009 to October 2009 with a self-developed questionnaire whose contents including the clinical data of the confirmed 149 H1N1 cases and their relevant therapeutic expenditure. The patients were assigned to the Chinese medicine group (22 cases treated by Chinese medicine alone) and integrative medicine group (124 cases treated by both Chinese medicine and Western medicine). The data were processed with descriptive analysis, t test and χ (2), and sum-rank test.

RESULTSThe proportion of clinical recovery of Chinese medicine group (81.8%) was higher than that of integrative medicine group (54.8%) with statistical significance (P=0.02). The average fever durations in both groups were 3.5 to 4 days, showing no significant difference (P=0.86). In the comparisons of average cost of Chinese herbs, drugs, therapies, and total cost, those of the Chinese medicine group were lower than those in the integrative group (P=0.01, P=0.00, P=0.00, P=0.00).

CONCLUSIONSThe H1N1 patients in the fever clinic who received Chinese medicine treatment had a higher clinical recovery proportion than those who received integrated Chinese and Western medicine treatment with lower medical cost. However, due to small sample size of the Chinese medicine group in the study, the conclusion needs further confirmation by studies with large sample size.

Adult ; Costs and Cost Analysis ; Female ; Fever ; economics ; therapy ; virology ; Health Expenditures ; Hospitals ; Humans ; Influenza A Virus, H1N1 Subtype ; physiology ; Influenza, Human ; economics ; therapy ; virology ; Integrative Medicine ; economics ; Male ; Medicine, Chinese Traditional ; economics ; Time Factors ; Treatment Outcome