ICS/LABA聯合治療的提出和推廣，是近十年來哮喘治療領域的一個革命性進展。然而，從LABA問世之初，圍繞LABA的爭議就始終沒有平息過。在2010年2月18日，FDA再次發出關于LABA安全性的公告。美國FDA申明LABA絕不應當（should never）單獨用于治療兒童或成人哮喘。制造商須在這類藥物產品的標簽上加入這一警示，同時采取其他步驟以減少這類藥物的過度使用。這些藥物包括單獨的LABA制劑，如施立穩（Serevent，沙美特羅）和 Foradil（福莫特羅），也包括和ICS的復合制劑如Advair（沙美特羅/氟替卡松）及信必可（布地奈德/福莫特羅）。FDA要求產品標簽反映以下信息：●如果沒有使用其他哮喘控制性藥物，如ICS，則不應當使 用LABA。LABA只能與其他控制性藥物聯合使用，不應當單獨使用。只有對那些其他哮喘控制性藥物不能取得充分控制的患者，才能夠長期使用 LABA。●使用LABA治療應當采用取得哮喘癥狀控制的最短的療程，一旦哮喘取得控制，只要有可能就應當停用。患者應當用其他的控制性藥物維持。●需要使用LABA和ICS治療的兒童和青少年患者，應當使用一種既含有ICS也含有LABA的復合制劑，以保證治療的依從性。
Objective To investigate the efficacy on clinical condition assessment and the safety of ultrasound-guided osteofascial chamber puncture manometry in evaluating the pressure of the osteofascial chamber in patients with venomous snake bites. Methods Patients with venomous snake bites admitted to the Department of Emergency Medicine of West China Hospital of Sichuan University between April 2021 and January 2023 were prospectively included, and their basic information, physiological indicators (heart rate, blood pressure), laboratory examination indicators, physical signs, treatment methods and prognosis were collected. The patients whose extremal pressure was measured by osteofascial chamber puncture under ultrasound guidance were selected as the manometry group. Patients who were bitten by venomous snakes at the same time without puncture pressure measurement were randomly selected as the control group at a ratio of 1∶1. The bleeding, infection, nerve injury, length of hospital stay and long-term prognosis of the two groups were compared to explore the safety of ultrasound-guided osteofascial chamber puncture manometry. The correlation between the pressure measured in the manometry group and creatine kinase (a representative index of acute poisoning severity score) was analyzed to explore the efficacy of ultrasound-guided osteofascial chamber puncture manometry in evaluating the disease. Results There was no significant difference between the manometry group and the control group in new or aggravated infection, bleeding, nerve injury (such as numbness and anesthesia), hospital treatment time, final detumescence time of the affected limb, or final adverse prognosis (P>0.05). There was a positive correlation between the measured pressure and creatine kinase (rs=0.286, P=0.002). Conclusions The higher pressure measured by ultrasound-guided osteofascial chamber puncture manometry is, the more serious the poisoning condition may be. In addition, ultrasound-guided osteofascial chamber puncture manometry does not prolong the hospital time of patients or the final swelling reduction time of the affected limb, and does not increase the incidence of bleeding, infection, nerve damage or eventual adverse prognosis events. It has clinical practicability and feasibility.
The incidence of myopia is increasing year by year and the trend of younger age is obvious. The situation of myopia prevention and control is very serious. The sclera is the target organ for the development of myopia. When myopia occurs and develops, the ultrastructure of the sclera tissue will undergo pathological changes, resulting in a decrease in its tensile strength, then progressive axial growth and posterior sclera expansion. Scleral collagen cross-linking can effectively increase the hardness and tensile strength of scleral tissue, which may have great potential in the prevention and control of myopia, especially pathological myopia. At present, the effectiveness of scleral collagen cross-linking technology in the prevention and treatment of pathological myopia researches are still in the stage of animal experiments, and there are a lot of controversies on the safety. The development of any new technology to ensure safety is the primary condition. A comprehensive understanding of the safety of scleral collagen crosslinking in the prevention and control of myopia can provide more basis and guidance for the further study of scleral collagen crosslinking.
ObjectiveTo observe effect and safety of interstitial chemotherapy with 5-fluorouracil sustained release agent in radical operation of colorectal cancer. MethodsOne hundred and sixty patients with colorectal cancer from October 2011 to December 2013 were randomly divided into observation group and control group according to an incomplete random method, 78 cases of them were in the observation group and 82 cases of them were in the control group. All the patients were performed radical resection of colorectal cancer. The abdominal cavity and pelvic cavity were washed after surgery. 5-fluorouracil sustained release agent was implanted in the observation group patients for interstitial chemotherapy, the implant site was at the tumor resection area and the mesenteric artery. Routine chemotherapy was performed in these two groups after operation. The postoperative complications were observed. The postoperative local recurrence rate, liver metastasis rate, and 24-month survival rate were recorded. ResultsThe rates of abdominal complications and toxic effects had no significant differences between these two groups (P > 0.05). The rates of 12-month and 24-month local recurrence and the rate of liver metastasis in the observation group were significant lower than those in the control group[1.3% (1/78) versus 8.5% (7/82), x2=8.934, P=0.023; 5.2% (4/78) versus 23.2% (19/82), x2=14.834, P=0.004; 10.3% (8/78) versus 18.3% (15/82), x2=12.034, P=0.016]. The rate of 24-month survival in the observation group was significant higher than that in the control group[94.9% (74/78) versus 84.1% (69/82), x2=11.465, P=0.010]. ConclusionThe good safety of interstitial chemotherapy with 5-fluorouracil sustained release agent could effectively decrease local recurrence rate and liver metastasis rate of colorectal cancer after radical operation and improve survival time of patients.
目的：探討丙泊酚、芬太尼用于纖支鏡檢查的安全性。方法：60例纖支鏡檢查患者分為丙泊酚組和對照組。丙泊酚組采用芬太尼1～15 μg/kg,丙泊酚1～2 mg/kg靜脈麻醉，觀察檢查前、纖支鏡進入聲門后5分鐘、檢查后的HR、BP、RR 、SpO2變化及兩組病例術中、術后的反應。結果：丙泊酚組檢查中HR、BP較對照組平穩(P＜0.01), RR、SpO2變化與對照組比較無明顯統計學差異(P＞0.05)，丙泊酚組檢查中、檢查后不良反應少，蘇醒快，患者滿意。結論：丙泊酚、芬太尼用于纖支鏡檢查，減少了患者的恐懼與痛苦，提供了良好的檢查條件，同時也是安全可行的。
ObjectiveTo evaluate the effects and safety of statins in patients with acute respiratory distress syndrome (ARDS). MethodsLiteratures in English and Chinese concerning randomized controlled trials (RCTs) on statins in ARDS patients were retrieved by electronic and manual search. All related data were extracted. Meta-analysis was conducted using the statistical software RevMan 5.3 on the basis of strict quality evaluation. ResultsFive RCTs involving 1489 ARDS patients were included, with 709 patients in the statins group and 780 patients in the placebo control group. Compared with the control group, statins did not improve the survival of ARDS patients[risk ratio (RR) 1.01, 95% confidence interval (CI) 0.86 to 1.18, P=0.91), while the improvement of oxygenation[mean difference (MD) 3.92, 95%CI-14.10 to 21.94, P=0.67], ventilator-free days (MD 0.65, 95%CI-0.20 to 1.50, P=0.13) and non-pulmonary organ failure-free days (MD 1.20, 95%CI-1.46 to 3.87, P=0.38) exhibited no differences between the statins group and the control group. However statins were associated with significant elevation of creatine kinase (MD 6.92, 95%CI 5.77 to 8.07, P < 0.000 01). ConclusionThis study demonstrates that statins can not improve outcomes of ARDS patients, and the safety of statins still needs further evaluation.
ObjectiveTo systematically review the efficacy and safety of capecitabine combined with irinotecan (CAPIRI) versus capecitabine combined with oxaliplatin (CAPOX) for patients with advanced/metastatic colorectal cancer.MethodsPubMed, EMbase, The Cochrane Library, VIP, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) on CAPIRI versus CAPOX for patients with advanced/metastatic colorectal cancer from inception to August 2018. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 12 RCTs involving 1 049 patients were included. The results of meta-analysis showed that: there were no significant differences in complete response (CR), partial response (PR), stable disease (SD), progression disease (PD), overall respond rate (ORR), median progression-free survival (mPFS), and median overall survival (mOS) between two groups (P>0.05). However, CARIRI group was lower on the disease control rate (RR=0.93, 95%CI 0.86 to 1.00, P=0.04) than CAPOX group. Incidence of diarrhea was higher in CAPIRI group (RR=1.83, 95%CI 1.37 to 2.45, P<0.000 1). However, the incidence rate of peripheral neurotoxicity in CAPOX group was higher (RR=0.13, 95%CI 0.05 to 0.35, P<0.000 1). There were no significant differences between two groups in the incidence rates of nausea and vomiting, hand-foot syndrome, anemia, thrombocytopenia, leukocytopenia and alopecia (P>0.05).ConclusionsCurrent evidence shows that two groups are equivalent in terms of curative effects. CAPIRI has a higher incidence rate of diarrhea, while CAPOX has a higher risk of peripheral neurotoxicity. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Objective To systematically evaluate the effectiveness and safety of China-made omeprazole in treating acute non-variceal upper gastrointestinal bleeding. Methods Such databases as PubMed, MEDLINE, Springer, The Cochrane Library, CNKI, VIP, CBM and WanFang data were searched to collect the randomized controlled trials (RCTs) about China-made omeprazole in treating acute non-variceal upper gastrointestinal bleeding, and the references of included studies were also retrieved. The retrieval time was from inception to December 2012. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the quality, and then the meta-analysis was conducted by using RevMan 5.1 software. Results A total of 11 RCTs were included. Among all 1 075 patients, 544 were in the treatment group, while the other 531 were in the control group. The results of meta-analysis showed that, there were no significant differences in the total effective rate (OR=0.68, 95%CI 0.35 to 1.33, P=0.26) and safety (RR=1.33, 95%CI 0.45 to 3.91, P=0.96) between the China-made omeprazole and imported omeprazole. Conclusion China-made omeprazole is effective and safe in treating acute non-variceal upper gastrointestinal bleeding in comparison with the imported omeprazole.
Objective To assess the potential of ciprofloxacin to induce arthropathy in children and provide evidence for clinical practice. Methods We searched MEDLINE(1985- March 2006), The Cochrane Library (Issue 1,2006), EMBASE(1985 to March 2006) and CBMdisk(1990 to March 2006) for randomized controlled trials (RCTs) involving the safety of ciprofloxacin in pediatrics. We assessed the methodological quality of the studies identified. RevMan 4.2 was used for meta-analysis. Results Seven RCTs met the inclusion criteria. Compared with the control group, the combined rate of arthralgia did not increase compared to ciprofloxacin. The relative risk was 0.98, 95% confidence interval 0.65 to 1.48. No studies reported joint pathology and cartilage lesions on radiographic imaging, ultrasound or magnetic resonance imaging in the pediatric population. Conclusion Based on the results of the review and the meta-analysis, there is no evidence that using ciprofloxacin in the pediatric population is associated with clinical arthropathy. Further well-designed clinical studies should be performed to assess the long-term consequences of the use of ciprofloxacin in children.