In this paper,the management process of Chinese-Western medicine compound preparation is briefly reviewed.the existing problems were analyzed from the perspective of registration supervision and quality control.It is pointed out that there are still some types of management in the registration of supervision,such as the weak basic research,approval number of multiple pecifications,not uniform name,and not standardized specification.In the area of quality control,correlation analysis between the lack of key items (such as related substances,uniformity of contents,and dissolution test items) and the hidden dangers in medical security of preparations was performed.To explore the need for reevaluation,and put forward some suggestions for improvement in order to provide a useful reference for the scientific supervision of Chinese-Western medicine compound preparation.

Objective To compare efficacy of two intensive therapies:continuous subcutaneous insulin infusion(CSⅡ) and multiple subcutaneous insulin infusion (MSⅡ) for treatment of type 2 diabetes mellitus.Methods 60 patients with type 2 diabetes mellitus were randomly divided into 2 groups. Patients in CSⅡ group were treated by insulin (Novolin R) through a infusion pump. Patients in MSⅡ group were treated by Novolin R before meals (3 times a day) and Novolin N at bedtime. Blood glucose was monitored the whole day before and after treatment. Time required for blood glucose to reach the standard level, insulin dosage and hypoglycemia incidence were compared between the 2 groups before and after treatment. Results Both of the 2 therapeutic methods effectively controlled blood glucose (P＜0.05). However, the 2 groups had significant difference in terms of the time required for blood glucose to reach the standard level ( 3.6 ± 1.2 d vs. 9.4 ± 3.2 d, P ＜ 0. 01 ), daily insulin consumption (35.2 ± 8.5 u vs. 43.2 ± 10. 1 u, P ＜0. 01 ) and hypoglycemia incidence (2. 1% vs.9.7%, P ＜0.01 ). Conclusions CSⅡ and MSⅡ are effective for treatment of type 2 diabetes mellitus. CSⅡ is superior to MSⅡ due to its advantages of quick response, safety, and less insulin consumption.

Objective To investigate clinical characteristics,quality of life,and psychological factors in functional dyspepsia (FD) patients with weight loss.Methods A multi-center and prospective investigation was conducted (Clinical trial registration number:ChiCTR-TRC-12001968) which recruited 1341 consecutive FD outpatients from three Guangdong hospitals according to Rome Ⅲ criteria between June and September in 2012.Of these,1057 patients with complete information were divided into group A as having weight loss more than 5％ (n =207) and group B as having weight loss less than 5％ (n =850).Nepean Dyspepsia Index-symptom checklist,appetite,Hamilton Rating Scale of Anxiety/Depression (HAMA/HAMD),Pittsburgh Sleep Quality Index (PSQI),Nepean Dyspepsia Index-quality of life,direct medical costs were used to compare the differences between the two groups.Results There were no significant differences in total scores of NDI-symptom checklist,the severity or bothersome items between two groups (t =-1.301、-0.918、0.138,P =0.193、0.359、0.890),but significant differences were observed in the frequence item and the rating of appetite as poor or very poor between two groups (t =-2.122,P =0.035 ;x2 =35.448,P =0.000 ;x2 =35.274,P =0.000).Significant differences were observed in the incidence of anxiety and depression and total scores of PSQI between the two groups (x2 =73.939,P =0.000;x2 =47.046,P =0.000 ; t =-4.904,P =0.000).Subscales scores of NDI-quality of life in group B were all significantly higher than those in group A (t =5.348、2.569、5.809、4.704,P =0.000、0.010、0.000、0.000).There were significant differences in the frequency of care-seeking and direct medical costs between the two groups (t =-4.860、-3.011,P =0.000、0.003).The frequency of gastroscopic examinations in group A was slightly higher than that in group B (t =-1.505,P =0.133).Conclusion FD patients with weight loss is not rare,and most of them have psychological disorders,loss of appetite and sleep disturbance.Moreover,care-seeking are more frequent,direct medical costs are more expensive,and impairment as assessed by NDI-QOL is more severe.Therefore,we should pay more attention to FD with weight loss in clinical setting.

Objective To explore the depression and anxiety status of patients with refractory irritable bowel syndrome (IBS)and its subtypes.Methods In this large sample,multi-center,prospective survey(Registration number in Chinese Clinical Trial Registry:ChiCTR-TRC-12001969),the patients who conformed to the Rome Ⅲ criteria for IBS were recruited from the department of gastroenterology of three hospitals in Guangdong province from June 2012 to September 2012.And 100 healthy subjects from the examination center of hospitals were recruited at the same time.The 17-item Hamilton Depression Rating Scale(HAMD) and the 14-item Hamilton Anxiety Rating Scale(HAMA) were used to analyze the depression and anxiety,respectively.Results 9802 patients were collected from department of gastroenterology,and a total of 1128 (11.5 ％) patients were diagnosed as IBS.601 of questionnaires were collected,including 142 (23.6％) of refractory IBS and 459 (76.4％) of non-refractory IBS.The incidences of depression,anxiety,depression and anxiety and the HAMD,HAMA scores were higher in refractory IBS group than those in the non-refractory IBS and control group,((66.2％ vs 23.3％ vs 9.0％),P＜0.05 ;(65.5％ vs 28.5％ vs 10.0％),P＜0.05;(58.5％ vs 17.9％ vs 5.0％),P＜0.05;(9.77 ±5.16)vs(5.48 ±4.03)vs(1.66±2.50),P＜0.05;(9.75 ±5.08)vs(5.91 ±3.80)vs(2.26 ±2.68),P＜0.05).And the incidences of moderate-severe depression and moderate-severe anxiety were higher in refractory IBS group than those in the non-refractory IBS and control group ((8.5％ vs 1.3％ vs 0),P＜0.05; (15.5％ vs 3.7％ vs 0),P＜0.05).The incidences of depression,anxiety,depression and anxiety and the HAMD scores were not obviously different among IBS-D,IBS-C,IBS-M and IBS-U subtypes of refractory IBS (P ＞ 0.05).However,the HAMA scores of IBS-D and IBS-M were higher than that of IBS-U((10.10 ± 5.03) vs(7.55 ± 3.22),P ＜ 0.05 ; (12.08 ±6.89) vs (7.55 ± 3.22),P ＜ 0.05).Conclusion The high incidences of depression,anxiety and depression and anxiety,and the serious degrees of depression and anxiety existed in the patients with refractory IBS.And these are the important causes for refractoriness in these patients.

Objective To explore the eating behaviors associated with refractory functional dyspepsia (RFD).Methods In this multicenter,prospective trial,1341 new outpatients with functional dyspepsia (FD) from three Guangdong hospitals who had been diagnosed according to the Rome Ⅲ criteria were enrolled from May to September in 2012.One hundred healthy volunteers were also enrolled as controls.A questionnaire was used to obtain data,and logistic regression analysis was used for analysis.Results ①RFD was diagnosed in 24.4％ of the FD patients.②Unhealthy eating behaviors were significantly greater in patients with RFD and non-RFD than in the normal controls.Patients with RFD skipped meals more often,ate extra meals,and preferred sweets and gasproducing foods (P ＜ 0.05).③A comparison among the non-RFD subtypes,showed that those with epigastric pain syndrome had a greater preference for spicy foods (47.5 ％ vs 35.7 ％,P ＜ 0.05),and those with postprandial distress syndrome had a greater preference for sweets(50.0％ vs 36.4％,P ＜ 0.05) and gas-producing foods (14.9％ vs 7.1％,P＜0.05).Those with both subtypes skipped more meals (30.1％ vs 17.0％,P ＜ 0.05),and ate extra meals (15.0％ vs 6.5％,P＜0.05).④Logistic regression analysis showed that meal skipping(95％ CI,1.177 ～2.272; P=0.003),eating extra meals (95％ CI,1.015 ～2.604; P =0.043),and a preference for sweets (95 ％ CI,1.040 ～ 1.757 ; P =0.024) and gas-producing foods (95 ％ CI,1.022 ～ 2.306 ; P =0.039) were risk factors for RFD.Conclusion Unhealthy eating behaviors,especially,meal skipping,eating extra meals,preferring sweets and gas-producing foods correlate with RFD and these behaviors may be the key reasons for the refractory characteristic of RFD.