Randomized controlled trials (RCT) have long been considered the gold standard for assessing clinical efficacy. However, RCT are inappropriate for some diseases due to related ethical issues and costs, such as rare diseases that are seriously life-threatening but without adequate treatment. Using real world data (RWD) as external control for RCT could make recruitment less complicated and reduce time and cost. This paper introduces common application scenarios, data sources, study design, basic principles, and statistical methods of RWD as an external control based on the latest guidelines related to RWD and combined with our team's previous research experience. This study could provide references for scholars and sponsors who want to conduct RWD research.

Objective To summarize the factors and the corresponding treatments for patients with coronary heart disease (CHD) complicated by thrombocytopenia, and provide medical advises for clinical treatment. Methods Literatures and case reports were analyzed and summarized. Results Thrombocytopenia in patient with CHD could be mainly divided into two types, one group was induced by the antithrombotic therapies for CHD, and the other group was caused by some concurrent diseases or combined non-antithrombotic medications. There were different medical decisions and prognoses according to the causes in different groups. Conclusion The treatment strategies of CHD will be considered in the CHD patients with thrombocytopenia. Identifying thrombocytopenia by monitoring the platelet counts in early stage, finding out the causes quickly and providing proper treatments are the key for the prognosis of the patients.

" Day surgery hospital-community joint follow-up model " results newly from the deepening implementation of the hierarchical medical system policy. It is designed to follow up the patients discharged from hospital but not fully recovered in time to ensure the prevention of adverse events after surgery. It can also improve the quality and efficiency of follow-up, and ensure the safety and integrity of the whole day operation management. In this context, through a comparative study of 720 patients discharged from daytime surgery in the region, patients in the combined follow-up group were followed up by telephone on the 3rd day after the operation by nurses from the day surgery ward. On the 10th and 20th days after the operation, the family doctor from the community health service center will visit the patient at home and follow up the patient by telephone. One month later, the patient returned to the hospital for follow-up consultation. Follow-up results show day surgery hospital-community joint mode as a helpful aid in keeping track of the patients postoperative rehabilitation, reducing complications and handling in time, while improving the ambulatory surgery perioperative safety.

Objective: To explore experience of wound treatment of extremely severe mass burn patients involved in August 2nd Kunshan factory aluminum dust explosion accident. Methods: On August 2nd, 2014, 98 extremely severe burn mass patients involved in August 2nd Kunshan factory aluminum dust explosion accident were admitted to 20 hospitals in China. The patients with complete medical record were enrolled in the study and divided into microskin graft group with 56 patients and Meek skin graft group with 42 patients. Split-thickness skin in area of residual skin were resected to repair wounds of patients in microskin graft group and Meek skin graft group by microskin grafting and Meek miniature skin grafting, respectively. The residual wound size on 28 days post injury and wound infection after skin grafting of patients in the two groups, and position of donor site of all patients were retrospectively analyzed. Data were processed with t test and chi-square test. Results: The size of residual wound of patients in Meek skin graft group on 28 days post injury was (59±13)% total body surface area (TBSA), which was obviously smaller than that in microskin graft group [(70±14)%TBSA, t=4.379, P<0.05]. Twenty-nine patients in microskin graft group and 11 patients in Meek skin graft group suffered from obvious wound infection after skin grafting. Wounds of patients in two groups were repaired with residual skin around wound in head, trunk, groin, armpit, and uncommon donor sites of scrotum (4 patients), vola (10 patients), and toe or finger web (8 patients). Conclusions Meek skin graft is the first choice for wound repair of extremely severe burn mass patients, with faster wound healing, less wound infection. Uncommon donor sites of scrotum, vola, and toe or finger web can also be used for wound repair in case of lack of skin.

Objective:To observe the compatibility of Xiaoaiping injection and insulin for injection in glucose infusion. Methods:The changes in appearance, particles and pH of the mixture in 24h at ambient temperature were observed. The concentration of chloro-genic acid and insulin were determined by HPLC. Results:There were no obvious changes in appearance, pH, precipitation or turbidi-ty generation, and the contents of insulin and chlorogenic acid kept stable in 12 h. The number of insoluble particles was stable in 12 h, and then gradually increased in 24 h. Conclusion:Xiaoaiping injection and insulin in 5％ glucose infusion is stable in 12h under the testing conditions.

Objective To systematically evaluate the effects of albumin compared with crystalloids on fluid resuscitation for adults with severe sepsis and septic shock.Methods The six databases as follows:Cochrane Library,Pubmed,Embase,CNKI,VIP and Wanfang,were retrieved by computer,from their inception to November,2015.Randomized controlled trials(RCT) in the treatment of adult patients with severe sepsis and septic shock were included for quality assessment and Meta-analysis was performed by using RevMan5.3 software.Results A total of 4 RCTs involving 3 862 participants were included.No differences were found between albumin and crystalloids resuscitation with respect to 28-day mortality[RR=0.95,95%CI(0.86,1.05),P=0.33],90-day mortality[RR=0.95,95%CI(0.86,1.05),P=0.33],duration of stay in ICU,duration of hospital stay,duration of mechanical ventilation and renal replacement therapy.Conclusion In that meta-analysis,the effects of fluid resuscitation with albumin or crystalloids were not significantly different in adults with severe sepsis and septic shock.

Objective: To explore the relationship between glycemic control and visceral adiposity index (VAI) among type 2 diabetes mellitus (T2DM) patients.Methods: A community-based epidemiological field study for patients with T2DM aged ≥ 40 years was conducted in China.Every participant underwent physical examinations, biochemical tests of fasting glucose, glycosylated hemoglobin (HbA1c), total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) and so on, and a questionnaire, including anthropometric characteristics, lifestyle, disease history, family history, and medication use.Those participants with HbA1c ≥7.0% were classified as the poorly controlled in our analysis of relationship between glycemic control and VAI.Anthropometric characteristics, lifestyle, and biochemical indexes of the participants were compared among the groups of different VAI levels.Logistic models were applied in multiple analysis adjusting for possible confounders.Results: A total of 1 607 patients with T2DM were recruited in our analysis with a mean age of (59.4±8.1) years and an average T2DM duration of (7.0±6.4) years.Among them, 78.3% were on hypoglycemic therapy.The cutoff points of quartiles of VAI were calculated for the males and females, respectively.According to the ascending order of the quartiles of VAI, the participants were divided into four groups, i.e.Q1, Q2, Q3, and Q4.The poor glycemic control rate for these groups were 60.6%, 65.7%, 70.1%, and 71.0%, respectively (Trend χ2=12.20, P<0.001).After adjustment for age, gender, systolic blood pressure (SBP), diastolic blood pressure (DBP), LDL-C, smoking, cardio-cerebral vascular disease (CVD) history, hypoglycemic therapy, T2DM duration, and family history of diabetes, the Logistic regression models showed that the glycemic control rate was significantly associated with VAI levels among the patients with T2DM.Compared with the participants in group Q1, the ORs of poor glycemic control for those in groups Q2, Q3, and Q4 were 1.239 (95%CI 0.918 to 1.672), 1.513 (95%CI 1.117 to 2.050), and 1.535 (95%CI 1.128to 2.088), respectively (trend P=0.003).With each quartile increase in VAI, the OR of poor glycemic control was 1.162 (95%CI 1.054 to 1.282).Conclusion: The glycemic control among the patients with T2DM is significantly associated with VAI.High level of VAI is an indicator of poor glycemic control.

BACKGROUND:During artificial knee replacement for al kinds of severe knee disease or conservative treatment for end-stage knee disease, Deluxe-PS knee prosthesis and PFC Sigma RP knee prosthesis have their advantages.
OBJECTIVE: To compare and analyze the matching of the Deluxe-PS and PFC Sigma RP knee prostheses with bone cross section.
METHODS:According to the use of the knee prosthesis, 87 gonarthritis patients undergoing bilateral knee replacement were divided into two groups. 46 cases in the test group received Deluxe-PS knee prosthesis replacement. 41 cases in the control group received PFC Sigma RP knee prosthesis replacement. Operation time and intraoperative blood loss were compared between the two groups. American Knee Society score, knee score of American Special Surgical Hospital and knee joint range of motion were used to evaluate knee joint function before replacement, 3 months after replacement and during final folow-up. Anteroposterior X-ray films were obtained after replacement to measure valgus angle and flexion angle of femoral prosthesis.
RESULTS AND CONCLUSION: (1) Operation time and intraoperative blood loss were significantly better in the test group than in the control group (P< 0.05). (2) No significant difference in American Knee Society score, knee score of American Special Surgical Hospital and knee joint motion was detected between the two groups before replacement and 3 months after replacement (P > 0.05). Above indexes were significantly improved in both groups at 3 months after replacement and during final follow-up (P < 0.05). (3) No significant difference in valgus angle and flexion angle of femoral prosthesis was identified between test and control groups during final follow-up (P > 0.05). (4) These findings indicate that effect of Deluxe-PS type artificial knee prosthesis was identical to that of PFC Sigma RP knee prosthesis in knee osteoarthritis patients receiving bilateral knee joint replacement. Deluxe-PS type artificial knee prosthesis can perfectly realize high-accuracy combination of the prosthesis and the bone cross section, and enhance the fusion suitability of the prosthesis and the bone surface. Deluxe-PS type artificial knee prosthesis has the advantage of operation. This advantage is possibly because Deluxe-PS type artificial knee prosthesis is more in line with the anatomical structure of the knee joint of Chinese.

Objective To evaluate the quality coherence of commercial Angelicae Dahuricae Radix (Baizhi) decoction pieces. Methods The samples of 12 batches of commercial decoction pieces, 1 batch of sulphur fumigated Baizhi, and 1 batch of naturally dried Baizhi were collected. HPLC method was used to determine the fingerprints and the contents of imperatorin and isoimperatorin by C18 column (4.6 mm×250 mm, 5 μm) with a gradient mobile phase of acetonitrile-water solution system at the flow rate of 1.0 mL/min. The column temperature was set at 35 ℃, and the max plot of detection wavelength was in 210-800 nm. Similarity calculation was used to analyze the data. Results The HPLC fingerprint analysis method was established with 12 common peaks. The similarities of 12 batches of commercial decoction pieces of Baizhi were 0.840-0.973. Their similarities compared with the sulphur fumigated Baizhi were 0.672-0.908. Compared with naturally dried Baizhi, the similarities of fingerprint were 0.536-0.684. The contents of imperatorin and isoimperatorin in 12 batches of commercial decoction pieces were 0.035%-0.140% and 0.028%-0.069%, respectively. Conclusion The quality of Baizhi decoction pieces was consistent. It can be speculated that Baizhi decoction pieces were processed with sulphur fumigation.

Objective:To evaluate the efficacy and safety of capecitabine or S-1 combined with oxaliplatin or cisplatin in the treat-ment of advanced gastric cancer. Methods:Six databases including Cochrane Library, Pubmed, Embase, CNKI, VIP and WanFang were retrieved. Randomized controlled trials ( RCT) in the treatment of advanced gastric cancer were involved for the quality assess-ment and Meta-analysis. Results:A total of 14 RCT involving 1 051 patients were included. There were no significant differences in the total effective rate, complete remission rate and partial remission rate between the two groups(P>0. 05). In the safety evaluation, the incidence of hand-foot syndrome was higher in capecitabine-based regimens than that in S-1-based regimens[RR=2. 59,95%CI (1. 61,4. 17),P<0. 000 1], while the incidence of stomatitis was lower in capecitabine-based regimens[RR=0. 64,95%CI(0. 50, 0. 82),P=0. 000 4]. The other adverse reactions such as nausea and vomiting, diarrhea,neuropathy,dysfunction of liver and kidney, anemia, leukopenia, neutropenia and thrombocytopenia exhibited no significant differences between the two groups(P>0. 05). Con-clusion:Capecitabine combined with oxaliplatin or cisplatin has similar efficacy with S-1 combined with oxaliplatin or cisplatin in the treatment of advanced gastric cancer, and the incidence of hand-foot syndrome is higher in capecitabine-based regimens and the inci-dence of stomatitis is higher in S-1-based regimens.