The clinical practice guidelines of traditional Chinese medicine （TCM） have problems such as limited clinical application and unclear implementation effects， which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice， this article proposes a model of combining TCM guidelines with real-world study， which includes 4 steps. Firstly， during the implementation process of the guidelines， a high-quality research database is established. Secondly， the recommendations in the guidelines are evaluated based on the established database in multiple dimensions， including applicability， effectiveness， safety， and cost-effectiveness， and thus their effectiveness in practical applications can be determined. Thirdly， based on the established database， core prescriptions are identified， and the targeted populations and medication plans are determined. That is， the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies， dosages， and duration on efficacy. Fourthly， the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions， improving their application in clinical practice. Moreover， this model can reduce research costs and improve research efficiency. When applying this model， researchers need to pay attention to the quality of real-world evidence， ensuring that it can truly reflect the situation in clinical practice. In addition， importance should be attached to the clinical application of guideline recommendations， ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally， full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion， the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.

As a supplement to randomized controlled trials， observational studies can provide evidence for the effectiveness of traditional Chinese medicine （TCM） treatment measures. They can also study influencing factors of diseases， etiology， and prognosis. However， there is a confounding effect due to the lack of randomization， which seriously affects the causal inference between the study factors and the outcome， resulting in confounding bias. Therefore， identifying and controlling confounding factors are key issues to be addressed in TCM observational studies. According to the causal network and the characteristics of TCM theory， confounding factors can be categorized into measured and unmeasured confounding factors. In addition， attention must be paid to identifying confounding factors and intermediate variables， as well as the interaction between confounding factors and study factors. For methods of controlling confounding factors， measured confounding factors can be controlled by stratification， multifactor analysis， propensity scores， and disease risk scores. Unmeasured and unknown confounding factors can be corrected using instrumental variable methods， difference-in-difference methods， and correction for underlying event rate ratios. Correcting and controlling confounding factors can ensure a balance between groups， and confounding bias can be reduced. In addition， methods such as sensitivity analysis and determination of interactions make the control of confounding factors more comprehensive. Due to the unique characteristics of TCM， observational studies of TCM face unique challenges in identifying and controlling confounding factors， including the ever-changing TCM treatment measures received by patients， the often-overlooked confounding effects in the four diagnostic information of TCM， and the lack of objective criteria for TCM evidence-based diagnosis. Some scholars have already conducted innovative explorations to address these issues， providing a methodological basis for conducting higher-quality TCM observational studies， so as to obtain more rigorous real-world evidence of TCM and gradually develop quality evaluation criteria for OS that are consistent with the characteristics of TCM.

The classification of traditional Chinese medicine （TCM） syndromes is one of the core technical elements in the industry standard of Specification of Diagnosis and Therapeutic Effect Evaluation of Diseases and Syndromes in TCM. In the past，when clinical standards for TCM were formulated，the determination of TCM syndrome classification relied heavily on textbooks and expert experience，lacking systematic research. This approach thus failed to reflect the advancement and scientificity of the standards，thereby affecting their implementation and application. This article reviewed the presentation forms and technical methods of TCM syndrome classification，including the two-tier syndrome classification model with primary and secondary symptoms，as well as the application of modern literature research，ancient literature research，Delphi method，in-depth expert interviews，consensus conferences，and real-world research. When syndrome classification standards are developed，it is necessary to build upon modern literature research，adopt a mixed approach combining qualitative research and quantitative analysis results，and reach expert consensus through consensus conferences. Through systematic research，the scientificity，applicability，and coordination of TCM syndrome classification standards can be enhanced，providing guidance for the standardization of TCM.

Objective To investigate the epidemiological features and antiviral response of patients with genotype 6 chronic hepatitis C (CHC) in Guangxi, China. Methods A total of 97 patients with genotype 6 CHC who were admitted to The First Affiliated Hospital of Guangxi Medical University from December 2012 to December 2020 were enrolled, among whom 62 patients were given antiviral therapy. The 62 patients receiving antiviral therapy were divided into interferon group with 22 patients and direct-acting antiviral agent (DAA) group with 40 patients. Related data were collected, including general demographic data, HCV RNA, liver function, routine blood test results, and renal function. The chi-square test was used for comparison of categorical data between groups. Results Among the 97 patients, there were 69 male patients (71.1%) and 28 female patients (28.9%), with a mean age of 41.97±10.12 years, and the patients aged 30-40 years accounted for 47.4% (46/97). Of all 97 patients, 95 (97.9%) had genotype 6a, 1 had genotype 6e, and 1 had genotype 6xa. Among the 65 patients with a definite route of infection, 41 (63.1%) had intravenous drug use, 14 had medical-related operations, 9 had blood transfusion, and 4 had sexual contact as the route of infection. For the interferon group, the rapid virologic response (RVR) rate at week 4 was 81.8% (18/22), the rate of undetectable virus at the time of drug withdrawal (Epoint) was 86.4% (19/22), the rate of sustained virologic response at 12 weeks after drug withdrawal (SVR12) was 81.8%, and the rate of sustained virological response at 24 weeks after drug withdrawal (SVR24) was 81.8%; 1 patient in this group experienced recurrence. All 40 patients in the DAA group were previously untreated patients (33 patients without liver cirrhosis and 7 patients with compensated liver cirrhosis), with an overall RVR rate of 87.5%(35/40), an Epoint rate of 100%, and an SVR12 rate of 100%, and there was no treatment failure or recurrence. Although different DAA regimens had different RVR rates, they all had a SVR12 rate of 100%. The patients with compensated liver cirrhosis and other diseases had a SVR12 rate of 100%. Conclusion Intravenous drug addiction is the main route of infection for patients with genotype 6 CHC in Guangxi, and CHC is more common in men, with genotype 6a as the main subtype. DAA treatment has a higher virologic response rate than interferon treatment, with an SVR12 rate of 100%. There is no significant difference in SVR12 rate between the patients with compensated liver cirrhosis and those without liver cirrhosis.

Objective:To compare the similarities and differences of clinical characteristics of human immunodeficiency virus (HIV)-negative and HIV-positive patients with talaromycosis marneffei (TSM).Methods:The clinical data of 175 inpatients diagnosed with TSM in First Affiliated Hospital of Guangxi Medical University from May 2012 to April 2019 were retrospectively analyzed. The patients were divided into HIV-positive group and HIV-negative group according to the results of HIV confirmation test. The clinical manifestations, laboratory examination indicators (white blood cell count, hemoglobin, albumin, CD4 + T lymphocyte count and C-reactive protein (CRP)) between the two groups were compared. Mann-Whitney U test and chi-square test were used for statistical analysis. Results:Among 175 TSM patients, 85 were HIV-positive and 90 were HIV-negative patients. The main clinical manifestations of fever and lymphadenopathy in the HIV-positive group and HIV-negative group were 71 (83.53%) cases and 73 (81.11%) cases, 50 (58.82%) cases and 47 (52.22%) cases, respectively, and there were both no statistical differences ( χ2=0.175 and 0.771, respectively, both P>0.05), while respiratory symptoms, weight loss and subcutaneous masses were 62 (72.94%) cases and 81 (90.00%) cases, 73 (85.88%) cases and 56 (62.22%) cases, one (1.18%) case and 16 (17.78%) cases, respectively, the differences were all statistically significant ( χ2=8.514, 12.630 and 13.737, respectively, all P<0.01). Hemoglobin in HIV-positive group and HIV-negative group were 90.50 (77.00, 113.95) g/L and 88.65 (72.85, 99.93) g/L, respectively. The difference was statistically significant ( Z=2.023, P=0.043). The ratios of albumin<30 g/L, CRP>10 mg/L in the two groups were 69.41%(59/85) and 60.00%(54/90), 94.37%(67/71) and 94.19%(81/86), respectively, and the differences were both not statistically significant ( χ2=1.693 and 0, respectively, both P>0.05). The ratios of cases with white blood cell counts >10×10 9/L and CD4 + T lymphocyte count<50/μL in the positive and negative groups were 3.53%(3/85) and 81.11%(73/90), 80.77%(63/78) and 1.75%(1/57), respectively, the differences were both statistically significant ( χ2=107.095 and 82.467, respectively, both P<0.01). Conclusions:In TSM patients, HIV-negative with subcutaneous masses, and increased white blood cell counts are common. Decreased body weight and CD4 + T lymphocyte count<50/μL in HIV-positive patients are more common than HIV-negative patients.

Objective:To assess the feasibility of free-handed conical craniotomy and drainage guided by novel 16-slice mobile CT-assisted surface projection in patients with supratentorial intracerebral hemorrhage (sICH), and to evaluate the accuracy of catheter placement.Methods:Fifty-two sICH patients received free-handed conical craniotomy and drainage guided by novel 16-slice mobile CT-assisted surface projection in our hospital from January 2018 to December 2019 were chosen (free-handed conical craniotomy group); 30 sICH patients received frameless stereotactic puncture and drainage at the same time period were selected (stereotactic puncture group). The clinical data of these patients were retrospectively analyzed. The CT results were analyzed, and differences of relative error (RE) as the indicator of catheter placement accuracy were compared between the two groups.Results:Mobile CT was successfully performed in all patients from free-handed conical craniotomy group, and sufficient information was provided for surface projection in all patients. The percentages of patients with satisfactory results of catheter placement (RE<1) in the free-handed conical craniotomy group and stereotactic puncture group were 92.3% and 90.0%; one patients from the free-handed conical craniotomy group had repeated puncture. There was no significant difference in postoperative RE between the two groups (0.52±0.33 vs. 0.53±0.29, P>0.05). Subgroup analysis of different hematoma locations and volumes also showed no statistically significant difference in postoperative RE ( P>0.05). Conclusion:Free-handed conical craniotomy and drainage guided by novel 16-slice mobile CT-assisted surface projection is feasible in sICH patients, and the accuracy of catheter placement is similar with frameless stereotactic puncture and drainage.

Objective To establish a non-venous bypass orthotopic liver transplantation model in Bama miniature pigs with high repeatability and stability. Methods Twelve Bama miniature pigs were randomly divided into the donor group (n=6) and recipient group (n=6). Pigs underwent non-venous bypass orthotopic liver transplantation. The time of anhepatic phase during operation was shortened, blood pressure during anhepatic phase was stably maintained, and management of anesthesia and body fluid during operation were strengthened. The operation time, anhepatic phase and survival status of the recipients were observed and recorded. The intraoperative heart rate, mean arterial pressure (MAP) and changes in arterial blood gas analysis were monitored. The perioperative liver function was evaluated. Results Among 6 Bama miniature pigs, 1 died from transplantation failure intraoperatively. The operation time of the remaining 5 pigs was (247±27) min and the time of anhepatic phase was (46±4) min. Three animals survived for more than 2 weeks. Compared with the preanhepatic phase, the heart rate of the animals was significantly faster, MAP was considerably reduced to (46±6) mmHg, blood pH value, base excess (BE) and HCO₃^- level were all significantly decreased and serum level of K⁺ was significantly elevated during the anhepatic phase (all P < 0.05). In the neohepatic phase, MAP of Bama miniature pigs was significantly increased, heart rate was dramatically slower.Blood pH value, BE, HCO₃^- level were significantly increased and serum level of K⁺ was significantly declined (all P < 0.05). During abdominal closure, MAP, blood gas indexes and serum level of K⁺ were almost recovered to those in the preanhepatic phase. Compared with preoperative levels, the levels of alanine aminotransferase(ALT), aspartate aminotransferase(AST), lactate dehydrogenase(LDH)and alkaline phosphatase(ALP)were significantly increased after operation (all P < 0.05), the change in AST was the most obvious, and it gradually decreased at postoperative 2 d. The level of γ-gutamyl transferase(GGT) did not significantly elevated. The level of total bilirubin (TB) was evidently elevated at postoperative 5 d. Compared with the preoperative levels, the levels of total protein (TP) and albumin (ALB) were significantly decreased after operation (both P < 0.05), and began to gradually increase at postoperative 1 d. Conclusions The non-venous bypass orthotopic liver transplantation model of Bama miniature pig is convenient, with highly reproducible and survival rate, which can be utilized as a standardized liver transplantation model.

Objective To detect the mRNA expression levels of PI3KCB and AKT1 genes in the peripheral blood lymphocytes of acute and chronic schizophrenia patients in different stages,and to explore the relationship between them and the clinic symptoms.Methods Twenty-four cases of schizophrenia patients without medication for at least 1 month,19 chronic schizophrenia patients with long-term clozapine medication,and 20 normal controls were involved in the study.The mRNA expression of PI3KCB and AKT1 genes of all the subjects were measured by real-time qRT-PCR,and the positive and negative symptom scales (PANSS) of schizophrenia patients were also evaluated.Spearman's correlation was used to analyze the relationship between PI3KCB,AKT1 and PANSS score.Results The gene expression of PI3KCB in acute schizophrenia patients,chronic schizophrenia patients with clozapine medication and normal control were (0.79±0.04),(0.83±0.08) and (0.87±0.09) respectively,and the difference was significant among the three groups (F=8.77,P=0.001).The AKT1 gene expression levels were (0.80±0.03),(0.27±0.13)and (0.29±0.12) respectively,and the difference was also significant among the three groups (F=302.31,P＜0.01).The PI3KCB mRNA levels of acute schizophrenia patients were significantly lower than the levels in healthy controls (MD =0.09,P=0.002),and the AKT1 mRNA levels of acute schizophrenia patients were significantly higher than the levels in chronic schizophrenia patients (MD=0.53,P＜0.01) and healthy controls (MD =0.51,P＜ 0.01).In schizophrenia patients,no significant relationship was found between PI3KCB,AKT1 expression levels and PANSS scores.Conclusion The gene expression status of PI3K-AKT pathway is significantly different in different stages of acute and chronic schizophrenia and that is no significant relationship with clinic symptoms,and clozapine treatment may affect its gene expression levels.

OBJECTIVE: To discuss the effects of single dose of cisplatin on renal interstitial fibrosis indicators in rats dynamically. METHODS: 72 SD rats were randomly divided into normal group and cisplatin group, with 36 rats in each group. Normal group and cisplatin group were given equal volume of normal saline and cisplatin 5 mg/kg intraperitoneally on the first day, respectively. Each 6 rats were sacrificed on 8th, 14th, 30th, 50th, 60th, 90th day. The serum levels of blood urea nitrogen (BUN) and creatinine (Cr) were determined, and the degree of renal tubulointerstitial injury and relative area of renal tubulointerstitial fibrosis were evaluated. The expression of α-smooth muscle actin (α-SMA), type Ⅰ collagen (Col Ⅰ) and transforming growth factor β1 (TGF-β1) were determined in renal tissue. RESULTS: Compared with normal group, the serum levels of BUN and Cr, renal tubulointerstitial injury indexes, relative area of renal tubulointerstitial fibrosis, and the expression of α-SMA, Col Ⅰ and TGF-β1 in renal tissue were increased significantly (P<0. 05 or P<0. 01). In cisplatin group, within the 8th-90th days, serum level of BUN in rats had no significant change; serum level of Cr, renal tubulointerstitial injury indexes, renal tubulointerstitial fibrosis, the expression of a-SMA, Col Ⅰ and TGF-β1 in renal tissue increased first and then decreased. CONCLUSIONS: A single dose of clinical dose of cisplatin can induce renal interstitial fibrosis in rats, and its mechanism may be related to the expression of TGF-β1 in renal tissue.

OBJECTIVE:To investigate the effects of Shenfukang capsules on clinical efficacy and renal function indexes of patients with renal insufficiency. METHODS:Totally 100 inpatients with renal insufficiency treated by Shenfukang cap-sules in the First Affiliated Hospital of Guangxi Medical University during Feb. to Mar. 2015 were analyzed retrospectively in respects of general information of patients,therapy plan,renal function indexs before and after treatment and clinical effica-cy. The relationship of clinical efficacy with age and duration was also analyzed. RESULTS:There were 33 cases of acute re-nal insufficiency and 67 cases of chronic renal insufficiency. The route of administration of Shenfukang capsules was oral ad-ministration(97 cases,97.00%),the main dosage was 6 capsule/d(36 cases,36.00%),and treatment duration were 0-<7 days(39 cases)and 7-<15 days(49 cases). After treatment,the average serum creatinine concentration was lower than be-fore treatment,while mean GFR and Ccr were higher than before treatment,with statistical significance(P<0.05). The total response rate was 72.00%,and response rate of patients with acute renal insufficiency was 87.88% and significantly higher than 64.18% of patients with chronic renal insufficiency,with statistical significance(P<0.05). Among patients with ≤60 years old,the total response rate of patients with acute renal insufficiency was significantly higher than that of patients with chronic renal insufficiency,with statistical significance(P<0.05);among patients elder than 60 years old,there was no statistical significance in therapeutic efficacy between acute renal insufficiency and chronic renal insufficiency(P>0.05);among patients with chronic renal insufficiency,the total response rate of patients elder than 60 years old was significantly better than that of patients with ≤60 years old,with statistical significance (P<0.05). With the extension of treatment duration,the total response rate of patients with acute renal insufficiency was on the rise,and that of patients with chron-ic renal insufficiency increased first and then decreased. No obvious ADR was found during treatment. CONCLUSIONS:Shenfu-kang capsules can improve renal function in patients with renal insufficiency,and has definite curative effect on acute and chronic renal insufficiency with good security. The clinical efficacy may be related to age and treatment course.