The irrational use of Chinese patent medicines （CPM） is becoming more and more prominent， which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines， and promote its development， this paper introduced the concept of CPM guidelines， summarized the characteristics of the two development modes， namely “taking CPM as the key” and “taking disease/syndrome as the key”， and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems， three suggestions have been put forward to optimize the quality of CPM guidelines， which were clarifying the target users and scope of CPM guidelines， establishing an open and transparent mechanism of the personnel involvement and process steps， and formulating implementable and operable recommendations for the use of CPM.

The identification of clinical questions for clinical practice guidelines of Chinese patent medicine （CPM） is important for subsequent evidence retrieval， evaluation of evidence quality， formation of recommendations. This paper described a methodological proposal for the identification of clinical questions for CPM guidelines to highlight the characteristics of Chinese patent medicine and reflect its effect in specific stage of the disease. Considering four aspects， namely， the drug of Chinese patent medicine （D）， the specific disease stage （S）， comparison （C）， and specific outcome （O）， DSCO framework has been proposed to formulate the clinical questions. Multi-source information through scientific research， policy or standard documents， and clinical data are suggested for collecting clinical questions， and clear selection criteria should be set to finalize the clinical questions to be addressed by the guideline. In addition， the above process needs to be transparently and publicly reported in order to ensure the clarity and completeness of the guidelines.

Objective To evaluate the risk of bias and reporting quality in randomized controlled trials(RCTs)of the Chinese medicine injection for acute cerebral infarction in the last five years.Methods RCTs literature on Chinese medicine injection in the treatment of acute cerebral infarction was systematically searched in CNKI,Wanfang Data,VIP,China Biology Medicine Database(CBM),PubMed,Embase and Cochrane Library from April 20,2018 to April 20,2023.The risk of bias and reporting quality of included RCTs were evaluated using the Cochrane Risk of Bias Tool(ROB 1.0)and CONSORT-CHM Formulas 2017,respectively.Results A total of 4 301 articles were retrieved,and 408 RCTs were included according to inclusion and exclusion criteria.The ROB evaluation results showed that the the majority of studies were rated as having an unclear risk of bias due to the lack of reporting on allocation concealment,blind method,trial registration information,and funding sources.The evaluation results of CONSORT-CHM Formulas 2017 showed that the number of reported papers of 17 items was greater than or equal to 50%,and the number of reported papers of 25 items was less than 10%,and most of the RCTs did not show the characteristics of TCM syndrome differentiation and treatment.Conclusion The quality of Chinese medicine injection in the treatment of acute cerebral infarction RCTs is generally low.It is recommended that researchers refer to the methodology design of RCTs and international reporting standards,improve the trial design,standardize the trial report,and highlight the characteristics of TCM syndrome differentiation and treatment.

Objective:To investigate the efficacy of 125I seed implantation combined with programmed cell death 1 (PD-1) monoclonal antibody in the treatment of patients with stage Ⅳ non-small cell lung cancer. Methods:A retrospective analysis was performed on 106 patients with stage Ⅳ non-small cell lung cancer treated in Department of Radiology of the Sixth Medical Center of PLA General Hospital from February 2017 to January 2020. All patients were divided into the combination group, radiotherapy group and immunotherapy group according to treatment methods. Besides conventional chemotherapy in all three groups, 125I seed implantation combined with PD-1 monoclonal antibody therapy was given in the combination group, 125I seed implantation therapy was delivered in the radiotherapy, and PD-1 monoclonal antibody therapy was supplemented in the immunotherapy group, respectively. Differences in the general data, maximum tumor diameter, efficacy, progression-free survival (PFS) and safety among the three groups were analyzed. One-way ANOVA was used for comparison between groups, paired sample t-test was used for comparison before and after treatment. Kaplan-Meier method was used to calculate the survival rate, and log-rank test was used to compare the survival curve. Results:After treatment, the maximum tumor diameter in the three groups was decreased, and the data in the combination group was smaller than those in the radiotherapy and immunotherapy groups ( F=4.67, P=0.011). The objective response rate (ORR), disease control rate (DCR) and PFS rate in the combination group were higher than those in the radiotherapy and immunotherapy groups ( χ2=18.93, P<0.001; χ2=11.11, P=0.004; χ2=6.67, P=0.036), and the ORR in the immunoradiotherapy group was higher than that in the radiotherapy group ( χ2=4.23, P=0.040). There was no significant difference in the occurrence of adverse reactions among the three groups ( χ2=1.60, P=0.449). Conclusion:125I seed implantation combined with PD-1 monoclonal antibody may yield high efficacy in patients with stage Ⅳ non-small cell lung cancer, which can alleviate clinical symptoms and improve long-term survival rate with good safety.

Objective:To explore the efficacy and safety of FOLFOX4 regimen hepatic arterial infusion chemotherapy (HAIC) combined with 125I seed implantation or gamma knife in patients with primary liver cancer and type Ⅲ portal vein tumor thrombosis (PVTT). Methods:The clinical data of 116 patients with primary liver cancer and type Ⅲ PVTT from January 2016 to June 2018 in the Sixth Medical Center of PLA General Hospital were retrospectively analyzed. Among them, 56 patients were treated with FOLFOX4 regimen HAIC combined with 125I seed implantation in PVTT (observation group), and 56 patients were treated with FOLFOX4 regimen HAIC combined with gamma knife in PVTT (control group). The clinical efficacy, adverse reactions, liver function, tumor serum markers, quality of life and portal venous pressure were compared between 2 groups. The patients were followed up to June 2021, the progression-free survival (PFS) time, overall survival (OS) time and 1-, 3-year survival rate were recorded. Results:The objective response rate and disease control rate in observation group were significantly higher than those in control group: 21.43% (12/56) vs. 7.14% (4/56) and 50.00% (28/56) vs. 30.36% (17/56), and there were statistical differences ( P<0.05). The aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin, alpha fetoprotein (AFP), carcinoembryonic antigen (CEA) and tumor supplied group of factor (TSG) after treatment in observation group were significantly lower than those in control group: (58.24 ± 7.16) U/L vs. (67.81 ± 8.39) U/L, (56.39 ± 5.42) U/L vs. (62.87 ± 6.83) U/L, (21.21 ± 4.32) μmol/L vs. (25.88 ± 4.71) μmol/L, (32.98 ± 6.15) μg/L vs. (45.06 ± 7.24) μg/L, (2.39 ± 0.22) μg/L vs. (3.17 ± 0.26) μg/L and (57.81 ± 5.67) kU/L vs. (66.19 ± 5.45) kU/L, and there were statistical differences ( P<0.01). The quality of life questionnaire core-30 (QLQ-C30) score after treatment in observation group was significantly higher than that in control group: (68.13 ± 6.95) scores vs. (64.49 ± 6.73) scores, the portal venous pressure after treatment in observation group was significantly lower than that in control group: (31.85 ± 3.89) cmH 2O (1 cmH 2O = 0.098 kPa) vs. (35.37 ± 4.23) cmH 2O, and there were statistical differences ( P<0.01). There was no statistical difference in incidence of adverse reactions between 2 groups ( P>0.05). Two cases were lost in observation group and 3 cases in the control group; the PFS time and OS time in observation group were significantly longer than those in control group: (13.36 ± 2.85) months vs. (11.76 ± 2.60) months and (23.36 ± 4.37) months vs. (20.72 ± 3.96) months, and there were statistical differences ( P<0.01); the 1-year survival rate in observation group was significantly higher than that in control group: 70.37% (38/54) vs. 50.94% (27/53), and there was statistical difference ( P<0.05); there was no statistical difference in 3-year survival rate between 2 groups ( P>0.05). Conclusions:The anti-tumor effect and the improvement effect on liver function in patients with primary liver cancer and type Ⅲ PVTT treated with FOLFOX4 regimen HAIC combined with 125I seed implantation are better than combined gamma knife, and it has high safety and longer survival time.

Objective　: To investigate the protective effects of different types of lead collars on the thyroid during radio- therapy after breast-conserving surgery.  Methods: Forty breast cancer patients undergoing radiotherapy after breast-con- serving surgery were randomly divided into four groups to wear different lead collars for thyroid protection: control group (0 mm Pb), common material group (0.5 mm Pb), common material group (2 mm Pb), and new radiation-shielding material group (2 mm Pb). Radiation doses inside and outside lead collars were monitored. A questionnaire survey was conducted to acquire information on patient acceptance of the lead collars. Results: All the groups (except the control group) showed significant differences between scattered radiation doses inside and outside lead collars (P < 0.05). The scattered radiation was attenuated by 33.64% on average in the 2-mm new material group, which was significantly higher than in the other groups (P < 0.05). After radiotherapy, there was no significant change in the color and appearance of skin under lead collars in any group. All the patients were normal at the first thyroid ultrasound re-examination. The 2-mm new material lead collar was the most acceptable. Conclusion　 The lead collar made of the new radiation-shielding material has a good protective effect on the thyroid gland, and is easily accepted by patients, which can be promoted for application.

Congenital abnormalities of the kidney and urinary tract (CAKUT) are common congenital malformations identified by prenatal ultrasound. This review summarizes the fetal renal development, the mechanism of CAKUT, and the influence of the fetal environment on CAKUT. CAKUT can manifest as different degrees of renal disease, from transient hydronephrosis to severe bilateral renal dysplasia, a major risk factor for chronic and end-stage renal disease in childhood. Genetic factors and abnormal fetal environment can both contribute to CAKUT. Ultrasound screening is conducive to detect CAKUT but may miss some defects. Monogenic mutations identified in CAKUT can help us gain more insight into the molecular mechanisms of renal development.

Objective:To investigate the incidence and determinants of vaccine hesitancy towards national immunization program in China and understand the current status of parents' hesitancy to different vaccines used in national immunization program.Methods:A cross-sectional survey was conducted in Beijing, Sichuan and Gansu. The methods of proportional probability sampling and convenience sampling were used to select the eligible study subjects for questionnaire surveys.Results:A total of 3 592 parents were enrolled in the study, in whom 38.22% fully accepted all the vaccines, 59.35% agreed to let their children to receive all the vaccines but showed slight concern, and 2.42% had hesitancy to the vaccines. The vaccine with the most hesitancy was polio vaccine (0.89%), followed by diphtheria pertussis tetanus vaccine (0.70%) and hepatitis A vaccine (0.64%). The dominant reason for vaccine hesitancy was the risk-benefit perception of vaccination (31.03%), followed by the low awareness of the parents (21.84%) and the inconvenience caused by distance and time (21.84%).Conclusions:The incidence of vaccine hesitancy towards national immunization program was low in parents in China, but over 50% of the parents showed concern to the vaccines. It is essential to improve the service quality of national immunization program and strengthen the health education about the vaccination to reduce the incidence of vaccine hesitancy in parents.

Objective:To evaluate the reliability and validity of Chinese version of Glasgow antipsychotics side-effect scale (GASS).Methods:Totally 200 patients diagnosed as schizophrenia following the criteria of DSM-IV were enrolled in the study.Cronbach’s α was used to investigate the internal consistency of GASS.Exploring factor analysis was used to examine the construct validity.Pearson correlation analysis between GASS and TESS and CGI sub-scale of side effect were conducted to evaluate the criterion validity.Based on clinical criteria, the sensitivity and specificity and ROC curve was calculated so as to establish the cut-off point of the scale and test discrimination validity.Results:For reliability, Cronbach’s α ws 0.926, indicating that GASS had a good internal consistency.Four main factors were extracted by exploratory factor analysis which were extrapyramidal side effect factor, genitourinary side effect factor, anticholinergic side effect factor, over sedation and cardiovascular side effect factor.For validity, exploring analysis demonstrated that nineteen item of the scale has relatively higher factor load on the principal factor (0.531-0.972), suggesting that the scale had a good construct validity.The total score of the GASS was positively correlated with that of TESS and CGI subscale of side effects( r=0.90, P<0.05; r=0.87, P<0.05). The cut-off point of experimental validity of GASS for mild antipsychotics side effects was determined as ≥1.With this cut-off point, GASS had both high sensitivity (96.3%) and high specificity (70.7%), area under curve (AUC) were 0.78.The cut-off point of GASS for moderate antipsychotics side effects was determined as ≥20, with the sensitivity and specificity of GASS were 86.3% and 84.7%, AUC were 0.92.When the cut-off point of GASS for severe antipsychotics side effects was determined as ≥41, GASS had both high sensitivity (92.1 %) and high specificity (96.3 %), AUC were 0.96. Conclusion:GASS has good reliability and validity and can reflect the side effects of antipsychotics, and it can be adopted as a useful instrument to evaluate the severity of side effects of antipsychotics.

Objective:This study intended to explore the current sexual and childbearing stigma, experienced by chronic hepatitis B patients in China, and to develop related preventive strategies.Methods:We used a self-made questionnaire to investigate the sexual and childbearing stigma suffered by chronic hepatitis B patients in four provinces of China. Analysis of variance and chi-square test were used to compare the differences on sexual and childbearing stigma indexes between different demographic variables.Results:We surveyed 797 chronic hepatitis B patients in four provinces. Among them, 4.15 % (28/675) of the patients were persuaded not to give birth to children, and 4.67 % (10/210) of patients were told to stop pregnancy, by their medical care takers or by members from the family planning institutions. 3.62 % (25/690) and 3.48 % (24/690) of the patients were not able to enjoy the family planning or reproductive health services as they were stigmatized,suffered, as having HBV infection. Among the male chronic hepatitis B patients, the under 30 years group suffered less sexual and childbearing stigma than those who were aged 31- ( P=0.011) or 51 and above year-olds ( P=0.009). Among female chronic hepatitis B patients, the 31- year-olds group suffered less sexual and childbearing stigma than those under 30 years group but higher than those aged 41- ( P=0.001) or 51 and above ones ( P<0.001). Patients with knowledge on route of sexual transmission for HBV, were more likely to practice less related sexual behaviors than those without such knowledge ( P=0.022). Patients who were aware or not that condoms could reduce the risk of HBV infection did not show statistically significant difference on sex behaviors ( P=0.612). Conclusions:Chronic hepatitis B patients did suffer from sexual and childbearing related stigma, with women aged 31-40 years old the most. It is necessary to advocate on the advantage of condom use for prevention of HBV transmission among pregnant women, both horizontally and vertically. Strategies on protection the rights of patients with hepatitis B should be developed and strengthened.