Objective To investigate the morbidity rate of hyperuricemia and its association with hypertriglyceridemia and hypertension in elderly people in Fujian Quanzhou.Methods A crosssectional population survey for hyperuricemia was performed in Fujian Quanzhou.Questionnaire and physical examination were conducted in 1358 subjects.The levels of serum UA and lipid-profile as well as blood pressure were measured.Results In the same aged group,the level of blood uric acid was significantly higher in male (371.7±83.6) μmol/L than in female (294.8±66.5) μmol/L (t=15.8,P＜0.01).Blood uric acid concentration was gradually increased with aging in the group at age 40-70 years,but was gradually decreased with aging in female group aged over 70 years (F=12.1,P＜0.01).The total morbidity rate of hyperuricemia was 18.6％.The incidence of hypertriglyceridemia or hypertension in female with hyperuricemia was higher than those with normouricemia (22.1％ vs.10.5％,59.1％ vs.26.2％,x2=16.3,65.0,all P＜0.01).The incidence of hypertension in male with hyperuricemia was higher than those with normouricemia (54.6％ vs.42.8％,x2=4.0,P＜0.05).Conclusions The morbidity rate of hyperuricemia in elderly people is higher in south China coast than other region of China.The incidence of hypertriglyceridemia and hypertension in people with hyperuricemia is significantly higher than those with normouricemia.

OBJECTIVETo assess the accuracy of immunological fecal occult blood test (iFOBT) for detection of colorectal cancer (CRC).

METHODSA total of 1 197 studies published before June 2014 were selected from PubMed and Embase and 17 of which were finally included in this meta-analysis. A bivariate mixed-effects models was used for overall value merging and heterogeneity testing. In addition to the overall sensitivity and specificity, the analyses were also performed among certain subgroups, including a "colonoscopy group" (all were referred for colonoscopy diagnosis regardless screening results) and a "follow-up group" (only the screening positive were referred and all were then followed up), a qualitative group and a quantitative group (classified by the way of iFOBT result reading).

RESULTSA total of 161 502 subjects aged from 48 to 63 years were included in the analysis. IFOBT had an overall integrated sensitivity of 0.85 (95% CI: 0.79-0.89) (heterogeneity test: Q = 59.67, P < 0.001) and an overall integrated specificity of 0.93 (95% CI: 0.92-0.94) (heterogeneity test: Q = 1 722.53, P < 0.001) for detection of CRC. In the subgroup analysis, it was found that in the "colonoscopy group" and in the "follow-up group", the sensitivity were 0.81 (95%CI: 0.73-0.87) and 0.88 (95% CI: 0.81-0.92), respectively; the specificity were 0.92 (95% CI: 0.89-0.93) and 0.95 (95% CI: 0.94-0.96), respectively. It was also found that in the qualitative group and the quantitative group, the sensitivity were 0.84 (95% CI: 0.76-0.90) and 0.86 (95% CI: 0.78-0.92), respectively; the specificity were 0.94 (95% CI: 0.91-0.96) and 0.93 (95% CI: 0.91-0.94), respectively.

CONCLUSIONIFOBT had high overall sensitivity and specificity for detecting colorectal cancer.

Objective To assess the accuracy of immunological fecal occult blood test (iFOBT) for detection of colorectal cancer (CRC). Methods A total of 1 197 studies published before June 2014 were selected from PubMed and Embase and 17 of which were finally included in this meta-analysis. A bivariate mixed-effects models was used for overall value merging and heterogeneity testing. In addition to the overall sensitivity and specificity, the analyses were also performed among certain subgroups, including a“colonoscopy group”(all were referred for colonoscopy diagnosis regardless screening results) and a"follow-up group" (only the screening positive were referred and all were then followed up), a qualitative group and a quantitative group (classified by the way of iFOBT result reading). Results A total of 161 502 subjects aged from 48 to 63 years were included in the analysis. IFOBT had an overall integrated sensitivity of 0.85 (95%CI:0.79-0.89)(heterogeneity test:Q=59.67,P<0.001)and an overall integrated specificity of 0.93 (95%CI:0.92-0.94)(heterogeneity test:Q=1 722.53,P<0.001)for detection of CRC. In the subgroup analysis, it was found that in the"colonoscopy group"and in the"follow-up group", the sensitivity were 0.81 (95%CI: 0.73-0.87) and 0.88 (95%CI: 0.81-0.92), respectively; the specificity were 0.92 (95%CI: 0.89-0.93) and 0.95 (95%CI: 0.94-0.96), respectively. It was also found that in the qualitative group and the quantitative group, the sensitivity were 0.84 (95%CI:0.76-0.90) and 0.86 (95%CI:0.78-0.92), respectively;the specificity were 0.94 (95%CI: 0.91-0.96) and 0.93 (95%CI: 0.91-0.94), respectively. Conclusion IFOBT had high overall sensitivity and specificity for detecting colorectal cancer.

Objective To assess the accuracy of immunological fecal occult blood test (iFOBT) for detection of colorectal cancer (CRC). Methods A total of 1 197 studies published before June 2014 were selected from PubMed and Embase and 17 of which were finally included in this meta-analysis. A bivariate mixed-effects models was used for overall value merging and heterogeneity testing. In addition to the overall sensitivity and specificity, the analyses were also performed among certain subgroups, including a“colonoscopy group”(all were referred for colonoscopy diagnosis regardless screening results) and a"follow-up group" (only the screening positive were referred and all were then followed up), a qualitative group and a quantitative group (classified by the way of iFOBT result reading). Results A total of 161 502 subjects aged from 48 to 63 years were included in the analysis. IFOBT had an overall integrated sensitivity of 0.85 (95%CI:0.79-0.89)(heterogeneity test:Q=59.67,P<0.001)and an overall integrated specificity of 0.93 (95%CI:0.92-0.94)(heterogeneity test:Q=1 722.53,P<0.001)for detection of CRC. In the subgroup analysis, it was found that in the"colonoscopy group"and in the"follow-up group", the sensitivity were 0.81 (95%CI: 0.73-0.87) and 0.88 (95%CI: 0.81-0.92), respectively; the specificity were 0.92 (95%CI: 0.89-0.93) and 0.95 (95%CI: 0.94-0.96), respectively. It was also found that in the qualitative group and the quantitative group, the sensitivity were 0.84 (95%CI:0.76-0.90) and 0.86 (95%CI:0.78-0.92), respectively;the specificity were 0.94 (95%CI: 0.91-0.96) and 0.93 (95%CI: 0.91-0.94), respectively. Conclusion IFOBT had high overall sensitivity and specificity for detecting colorectal cancer.

Objective:To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021.Methods:Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison.Results:Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P＜0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions:Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.

Burden of colorectal cancer is rising in China. More attention and financial input have been paid to it by central government that colorectal cancer screening program has been carried out recently in many areas in China. Diversity of screening strategies and limited health resources render selecting the best strategy in a population-wide program a challenging task that economy was also required to be considered except safety and efficacy. To provide a reference for the subsequent further economic evaluation, here we reviewed the evidence available on the economic evaluation of colorectal cancer screening in China. Meanwhile, information related to screening strategies, participation and mid-term efficacy of screening, information and results on economic evaluation were extracted and summarized. Three of the four studies finally included evaluated strategies combining immunochemical fecel occult blood test (iFOBT) with high-risk factor questionnaire as initial screening, colonoscopy as diagnostic screening. There was a consensus regarding the efficacy and effectiveness of screening compared to no screening. Whereas the lack and poor comparability between studies, multi-perspective and multi-phase economic evaluation of colorectal cancer screening is needed, relying on current population-based screening program to conduct a comprehensive cost accounting.

Burden of colorectal cancer is rising in China. More attention and financial input have been paid to it by central government that colorectal cancer screening program has been carried out recently in many areas in China. Diversity of screening strategies and limited health resources render selecting the best strategy in a population-wide program a challenging task that economy was also required to be considered except safety and efficacy. To provide a reference for the subsequent further economic evaluation, here we reviewed the evidence available on the economic evaluation of colorectal cancer screening in China. Meanwhile, information related to screening strategies, participation and mid-term efficacy of screening, information and results on economic evaluation were extracted and summarized. Three of the four studies finally included evaluated strategies combining immunochemical fecel occult blood test (iFOBT) with high-risk factor questionnaire as initial screening, colonoscopy as diagnostic screening. There was a consensus regarding the efficacy and effectiveness of screening compared to no screening. Whereas the lack and poor comparability between studies, multi-perspective and multi-phase economic evaluation of colorectal cancer screening is needed, relying on current population-based screening program to conduct a comprehensive cost accounting.

Objective:To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021.Methods:Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison.Results:Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P＜0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions:Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.

Background and objective Lung cancer is the most common malignancy and screening can decrease the mortality. High quality screening guideline is necessary and important for effective work. Our study is to review and evalu-ate the basic characteristics and methodology quality of the current global lung cancer screening guidelines so as to provide useful information for domestic study in the future.Methods Electronic searches were done in English and Chinese databases including PubMed, the Cochrane Library, Web of Science, Embase, CNKI, CBM, Wanfang, and some cancer offcial websites. Articles were screened according to the predeifned inclusion and exclusion criteria by two researchers. hTe quality of guidelines was assessed by AGREE II.Results At last, a total of 11 guidelines with methodology were included. hTe guidelines were is-sued mainly by USA (81%). Canada and China developed one, respectively. As for quality, the average score in the “Scale and objective” of all guidelines was 80, the average score in the “Participants” was 52, the average score in the “rigorism” was 50, the average score in the “clarity” was 76, the average score in the “application” was 43 and the average score in the “independence”was 59. hTe highest average score was found in 2013 and 2015. Canada guideline had higher quality in six domains. 7 guidelines were evaluated as A level.Conclusion hTe number of clinical guidelines showed an increasing trend. Most guidelines were issued by developed countries with heavy burden. Multi-country contribution to one guideline was another trend. Evidence-based methodology was accepted globally in the guideline development.

Objective:To deliver understanding of the latest research progress on clinical trials and approval of dermatological drugs in China in 2020.Methods:A registration and information disclosure platform for drug clinical studies and a query system for domestic and imported drugs in the National Medical Products Administration of China were searched for registered clinical trials and approved dermatological drugs, respectively. The number and stages of clinical trials, indications and classification of involved products, and listed dermatological drugs in 2020 were summarized and depicted.Results:There were 157 dermatological drug trials registered in China in 2020, accounting for 6.16% of all the 2 548 clinical drug trials, including 127 (80.9%) initiated by Chinese pharmaceutical enterprises and 25 (15.9%) international multicenter trials. Among the 127 drug trials initiated by Chinese pharmaceutical enterprises, bioequivalence trials were mostly common, accounting for 55.9% (71/127) . Compared with global pharmaceutical enterprises, domestic pharmaceutical companies initiated significantly decreased proportions of international multicenter trials (1.9% [3/157] vs. 14.0% [22/157], P < 0.001) , but significantly increased proportions of phaseⅠclinical trials and bioequivalence trials (24.4% [31/127] vs. 10.0% [3/30], 55.9% [71/127] vs. 0, respectively, both P < 0.001) . Totally, 90 kinds of dermatological drug were involved in all the trials, psoriasis, atopic dermatitis and melanoma were the most common indications, and innovative drugs accounted for 53.3% (48/90) ; the proportion of innovative drugs was significantly lower in domestic pharmaceutical companies than in global pharmaceutical companies (43.2% [32/74] vs. 16/16, P < 0.001) . In addition, 28 dermatological drugs developed by 22 pharmaceutical companies were approved in China in 2020, of which 21 drugs were developed by domestic pharmaceutical companies. Conclusion:Clinical drug trials carried out by domestic pharmaceutical companies mostly focus on generic drugs, and it is still necessary for domestic pharmaceutical companies to further improve the innovation ability.