Objective To compare the efficacy of intravitreal triamcinolone(IVTA) injection and IVTA combined with macular laser grid photocoagulation（MLGP）to treat macular edema.Methods Consecutive 89 patients （109 eyes）diagnosed with macular edema by examinations of ocular fundus and optical coherence tomography (OCT).The visual acuity was hand moving-0.8 (0.19plusmn;0.13)；the intraocular pressure（IOP）ranged from 7 mm Hg to 21 mm Hg（1 mm Hg=0.133 kPa）and the average IOP was 13.78 mm Hg.All the patients received OCT and microperimetry examinations，the central macular thickness was （570plusmn;182）mu;m；the average light sensitivity was （5.07plusmn;3.94） dB and the fixation percentage was 70.67% within 4 deg;area around the macular fovea. All the patients received IVTA treatment，39 patients（48 eyes）further received MLGP 1 month later (IVTAMLGP group). The remaining 50 patients (61 eyes) without MLGP treatment was the IVTA group. Best corrected visual acuity (BCVA),IOP,lens,OCT and microprimetry examinations before and after IVTA (1,3,6,12 months) were followed and analyzed.Results On the 12th months，the BCVA in IVTAMLGP and IVTA group was （0.41plusmn;0.20）、（0.24plusmn;0.19）respectively (P＜0.05)；the central macular thickness was （309plusmn;187） and （487plusmn;206） mu;m respectively（P＜0.05）；the mean light sensitivity of 4deg; central macular was （8.24plusmn;4.64）and（6.30plusmn;3.22）dB respectively（P＜0.05）；the fixation percentage was（87.01plusmn;19.70）% and（78.85plusmn;20.41）% respectively （P＜0.05）. During the followup recurrent macular edema was noticed in 28 eyes of IVTA group and 8 eyes of IVTAMLGP group.Conclusions IVTA combined with MLG was more effective than IVTA to cure macular edema.
ObjectiveTo evaluate the quality of protocols and reports on the core outcome set of traditional Chinese medicine (COS-TCM), and to provide some evidence for COS-TCM developers to carry out studies and improve the reporting quality and methodological quality during their studies. MethodsLiterature databases in Chinese and English were searched to collect COS-TCM protocols or study reports from inception to April 18, 2023. The Core Outcome Set-STAndards for Reporting (COS-STAR), Core Outcome Set-STAndards for Development (COS-STAD), and Core Outcome Set-STAndardised Protocol Items (COS-STAP) were used to evaluate their reporting and methodological quality. Additionally, the consistency of studies with both published protocols and results was evaluated. ResultsA total of 14 protocols and 14 reports (involving 23 COS-TCM studies) were included. The evaluation of COS-TCM protocols according to the COS-STAP found that the reporting rates of "Stakeholders" (71.4%) and "Missing data" (42.9%) were relatively low. For the reports of COS-TCM, the evaluation based on the COS-STAD found that the reporting rates of "the population (s) covered by the COS" (35.7%) and "care was taken to avoid ambiguity of language used in the list of outcomes" (28.6%) were relatively low. Based on the COS-STAR, the items with low reporting rates were "Protocol Deviation" (7.1%), "Participants" (21.4%), and "Conflicts of interest" (28.6%). Additionally, the consistency evaluation found that there were inconsistencies between protocols and their results, such as the types of research included in the systematic review, the methods of qualitative research, the way of holding consensus meetings, scoring methods, etc. Moreover, only one study reported protocol deviation and reasons for change. ConclusionCOS-TCM studies need to improve their methodological quality and report transparency. When developing COS-TCM, we should pay attention to the characteristics of TCM while basing on international standards. The quality evaluation guidelines and standards of reporting for COS-TCM study need to be developed in the future.
Objective To investigate the feasibility and safety of laparoscopic operation of gastric and gastroesophageal junction diseases. Methods Between May 2004 and June 2009, 59 patients with gastric and gastroesophageal diseases were treated laparoscopically. The operative methods and maneuvers were evaluated and perioperative interventions, complications and efficacy of patients were analyzed. Results All operations were successfully completed laparoscopically except for one patient with gastric cancer who required a conversion to open surgery. No short-term complications occurred in all cases. No port transplant metastasis occurred for the patients with gastric cancer after an average of 36 months (1-60 months) follow-up. One patient died of liver metastasis 12 months after operation. The 3-year survival rate was 93.3% (14/15). Conclusion Laparoscopic surgery of the gastric and gastroesophageal junction diseases is feasible and safe with minimal invasiveness, which is worth popularizing.
ObjectiveTo evaluate the clinical efficacy and safety of directional atherectomy (DA) combined with drug-coated balloon (DCB) for the treatment of femoropopliteal artery lesions. MethodsA retrospective analysis was performed on data from patients with femoropopliteal artery lesions treated with DA combined with paclitaxel DCB from January 2021 to November 2022 in the TALENT study (NCT04675632). Observational metrics included intraoperative bailout stenting rate, maximum DCB diameter, 12-month freedom from clinically-driven target limb revascularization (CD-TLR), incidence of major adverse events (MAEs), and changes in Rutherford category and vascular-related quality of life score. ResultsThis study enrolled 189 limbs from 184 patients. The age was (71.0±9.4) years, and 69.0% (127/184) were male. Comorbidities were common, including diabetes mellitus [71.2% (131/184)] and coronary artery disease [34.2% ( 63/184)], with 32.6% (60/184) having a history of smoking. The lesions had a length of (181.2±119.6) mm, with chronic total occlusion accounting for 63.0% (119/189). In terms of clinical severity, 47.1% (89/189) were classified as Rutherford category 3, and 52.9% (100/189) presented with chronic limb-threatening ischemia (Rutherford categories 4–6). According to Trans-Atlantic Inter-Society Consensus Ⅱ classification, 52.9% (100/189) were type A+B, and 47.1% (89/189) were type C+D; 18.0%(34/189) of the lesions exhibited severe calcification. The technical success rate of DA combined with DCB treatment was 96.8%(183/189), with a bailout stent implantation rate of 4.2% (8/189). The maximum DCB diameter used was (5.1±0.6) mm. At the 12-month follow-up, the cumulative freedom from CD-TLR rate was 96.1% [95%CI (92.6%, 98.2%)], and the cumulative freedom from MAEs rate was 89.2% [95%CI (84.0%, 92.9%)]. Both the postoperative Rutherford category and quality of life score showed significant improvement compared to baseline [1.81±1.39 versus 3.89±1.22, MD (95%CI)=?2.08 (?2.29, ?1.87), P<0.001; (5.51±1.09) points versus (2.90±1.05) points, MD (95%CI)=2.61 (2.46, 2.76), P<0.001]. ConclusionDA combined with paclitaxel DCB for the treatment of femoropopliteal artery lesions effectively achieves lumen enlargement, reduces the need for intraoperative bailout stenting, and demonstrates favorable 12-month clinical outcomes, representing a feasible vessel preparation strategy.
Objective To developapatient-reported outcomes scale of chronic obstructive pulmonary disease used for Chinese, thus offering tools for clinical efficacy assessment. Methods According to the development standard of International Patient-Reported Outcomes, the item pool was established and the preliminary scale was prepared. Then, 100 patients with chronic obstructive pulmonary disease and 50 healthy subjects were face-to-face interviewed with preliminary scale by well-trained investigators.Those copies were collected, surveys were analyzed and items were selected with 5 methods including measure of discrete tendency method, factor analysis, correlation coefficient method, Cronbach’s alpha coefficient method and item response Theory. Finally, the final scale was gained. Results The eventual scale contains 4 areas(physiological dimain, psychological dimension, social dimension, treatment), 11 dimensions(specific symptoms, general symptoms, individual, anxiety, depression, disease cognization, disease influence on social pctivity, social support, compliance, drug adverse reaction, satisfactory), and 52 items. Conclusion The ultimate scale coincides with the theoretical framework and reflects the connotation of the quality of life of patients with chronic obstructive pulmonary disease.
ObjectiveTo evaluate the clinical and cosmetic outcome of patients with early breast cancer underwent oncoplastic techniques in breast conserving surgery. MethodsClinical data of 59 patients with early stage breast cancer who underwent oncoplastic techniques in the breast conserving surgery were analyzed retrospectively from January 2007 to March 2011. Cosmetic outcome score and patient satisfaction questionnaire were also assessed. ResultsThe age of the patients was (53.5±9.8) years (range, 32 to 77 years). The diameter of tumors was (1.6±0.7) cm (range, 0.5 to 4.0 cm). The foci located at upper quadrant in 38, lower quadrant in 17, central area in 4. During operation, single incision approach was used in 25 patients, two incisions approach in 34 patients. A variety of methods were used to repair breast defects including mammary gland direct suture in 9 patients, mammary gland pedicle flaps in 35, local flaps or adipofascial flap in 9, latissimus dorsi myocutaneous flaps in 2, and reduction mammaplasty with “J” or double ring incision in 4. The mean followup period was 30 months (range, 3 to 53 months), no local recurrence was detected. However, bone metastases was found in one patient on 14 months after operation. Fifty-three patients (89.8%) had good to excellent aesthetic results with cosmetic outcome score ≥26. Patient satisfaction questionnaire showed that 40 patients (67.8%) were excellent, 14 (23.7%) good, 3 (5.1%) fair, and 2 (3.4%) poor. ConclusionOncoplastic techniques in the breast conservative therapy for early stage breast cancer is a safe and effective procedure, with highly satisfactory cosmetic outcomes in the majority of patients.
ObjectiveTo investigate the clinical settings, antibiotic susceptibilities, management and outcomes of streptococcal endophthalmitis. MethodsA retrospective observational case series study. Fifty six eyes of 56 patients diagnosed with streptococcal endophthalmitis in Eye & ENT Hospital, Fudan University from 2012 to 2022 were collected. The treatment followed the general principles of relevant guidelines, including pars plana vitrectomy (PPV), vitreous injection of antibiotics (IVI), vitreous injection of glucocorticoids and systemic application of antibiotics. The follow-up time was (11.9±17.0) months. Patients' clinical characteristics, pathogenic distribution and antibiotic susceptibilities, treatment and outcomes in their medical records were retrospectively collected and analyzed. ResultsAll 56 patients had monocular onset, including 39 (69.6%, 39/56) males and 17 (30.4%, 17/56) females, 26 (46.4%, 26/56) with left eyes involved and 30 (53.6%, 30/56) with right eyes involved. Their average age was (25.0±24.4) years. Ocular trauma was the leading cause of streptococcal endophthalmitis (73.2%, 41/56), followed by ophthalmic surgery (23.2%, 13/56) and endogenous infection (3.6%, 2/56). The streptococcal species included Streptococcus viridans (50.0%, 28/56), Streptococcus pneumoniae (18/56, 32.1%) and β-hemolytic Streptococcus (17.9%, 10/56). The susceptibility rates of Streptococcus to penicillin, cefatriaxone, vancomycin and levofloxacin were 66.0%, 57.1%, 94.1% and 92.4%, respectively. Patients received PPV+IVI and IVI as initial treatment were 49 eyes (87.5%, 49/56) and 7 eyes (12.5%, 7/56), respectively. Vitreous injection of glucocorticoids were performed in 17 eyes (30.4%, 17/56); and systemic antibiotics were applied in 52 cases (92.9%, 52/56). At the final follow-up, 47 eyes were recorded with visual acuity. Twenty (35.7%, 20/56) had best corrected visual acuity (BCVA)≥0.05 and 27 (48.2%, 27/56) had BCVA ＜0.05, of which 1 (1.8%, 1/56) had an eyeball enucleation. The etiology of endophthalmitis, streptococcal species, initial treatment with PPV, vitreous injection of glucocorticoids, and systemic antibiotics did not significantly affect patients' visual outcomes (P＞0.05). Timely visit to the hospital after the onset of symptoms (≤3 days) was significantly associated with achieving a final BCVA above 0.05 (P=0.025). ConclusionsOcular trauma was the primary cause of streptococcal endophthalmitis. Streptococcus viridans is the most common pathogenic bacterium. Streptococci had high susceptibility to vancomycin, but patients' visual outcomes were poor.
Objective To analyse the consistency of perioperative self-reported pain scores of lung cancer patients with clinical records to provide a basis for optimal pain management. MethodsThe patients with lung cancer who underwent surgical treatment in the Department of Thoracic Surgery, Sichuan Cancer Hospital from November 2017 to January 2020 were selected. They were divided into two groups based on the source of pain data. The self-report group used a questionnaire in which patients self-reported their pain scores, and the pain scores for the clinical record group were extracted from the electronic medical record system. Kappa test was used to compare the concordance of pain scores between the two groups preoperatively, on postoperative 1-6 days and on the day of discharge. McNemar's paired χ2 test was used to compare the differences in pain intensity levels between the two groups. Binary logistic multi-factor regression was used to analyse the factors influencing the concordance of severe pain (7-10 points) between the two groups. Results Totally 354 patients were collected, including 191 males and 163 females, with an average age of 55.64±10.34 years. The median postoperative hospital stay was 6 days. The consistency of pain scores between the two groups was poor (Kappa=–0.035 to 0.262, P<0.05), and the distribution of pain levels at each time point was inconsistent and statistically significant (P<0.001). The percentage of inconsistent severe pain assessment ranged from 0.28% to 35.56%, with the highest percentage of inconsistent severe pain assessment on postoperative day 1 (35.56%). Single-port thoracoscopic surgical access was an influencing factor for inconsistent assessment of severe pain on postoperative day 3 (OR=2.571, P=0.005). Conclusion Self-reported perioperative pain scores of lung cancer patients are poorly aligned with clinical records. Clinical measures are needed to improve the accuracy of patient pain data reporting by choosing the correct assessment method, increasing education, and developing effective quality control measures.
Rapid development of recently emerging precision medicine techniques represented by gene therapy has brought hope for the treatment of rare blinding eye diseases such as inherited retinal diseases (IRDs) for which there was no effective treatment previously. Although the globally growth of clinical trials for IRDs has increased rapidly over the past decade, due to the highly genetic and clinical phenotypic heterogeneity, as well as limited data on epidemiology and natural history of the disease, along with severe loss of vision function of majority patients for which the established measurements may not be appropriate, such studies lack standard outcome measurements and endpoints to asses clinical meaningful effectiveness, posing great challenges in terms of study design and evaluation of treatment efficacy, as well as clinical practice application. At present, there is no systematic nor standardized guidance on safety measures, clinical outcomes and endpoints of visual function for clinical trial design in IRDs. Therefore, in order to standardize the validated evaluation of IRDs clinical efficacy outcome measurements and endpoints, the Fundus Disease Group of Chinese Medical Association Ophthalmology Branch and Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch organized domestic experts to put forward consensus and recommendations on standardizing outcome measurements and endpoints for clinical study design in IRDs, aiming to advance the study design of IRDs natural history research and clinical trials and to effectively evaluate disease progression and intervention efficacy. Along with the development of medical science and clinical trials, relevant content will be improved and updated accordingly.
Objective To evaluate the effectiveness of tendon insertion medialized repair in treatment of large-to-massive rotator cuff tears (L/MRCT). Methods The clinical and imaging data of 46 L/MRCT patients who underwent arthroscopic insertion medialized repair between October 2015 and June 2019 were retrospectively analyzed. There were 26 males and 20 females with an average age of 57.7 years (range, 40-75 years). There were 20 cases of large rotator cuff tears and 26 cases of massive rotator cuff tears. Preoperative imaging evaluation included fatty infiltration (Goutallier grade), tendon retraction (modified Patte grade), supraspinatus tangent sign, acromiohumeral distance (AHD), and postoperative medializaiton length and tendon integrity. The clinical outcome was evaluated by visual analogue scale (VAS) score, American Society for Shoulder and Elbow Surgery (ASES) score, shoulder range of motion (including anteflexion and elevation, lateral external, and internal rotation) and anteflexion and elevation muscle strength before and after operation. The patients were divided into two groups (the intact tendon group and the re-teared group) according to the integrity of the tendon after operation. According to the medializaiton length, the patients were divided into group A (medialization length ≤10 mm) and group B (medialization length >10 mm). The clinical function and imaging indexes of the patients were compared. Results All patients were followed up 24-56 months, with an average of 31.8 months. At 1 year after operation, MRI showed that the medializaiton length of supraspinatus tendon was 5-15 mm, with an average of 10.26 mm, 33 cases in group A and 13 cases in group B. Eleven cases (23.91%) had re-teared, including 5 cases (45.45%) of Sugaya type Ⅳ and 6 cases (54.55%) of Sugaya type Ⅴ. At last follow-up, the VAS score, ASES score, shoulder anteflexion and elevation range of motion, lateral external rotation range of motion, and anteflexion and elevation muscle strength significantly improved when compared with those before operation (P<0.05); there was no significant difference in internal rotation range of motion between pre- and post-operation (P>0.05). The Goutallier grade and modified Patte grade of supraspinatus muscle in the re-teared group were significantly higher than those in the intact tendon group, and the AHD was significantly lower than that in the intact tendon group (P<0.05). There was no significant difference in other baseline data between the two groups (P>0.05). Except that the ASES score of the intact tendon group was significantly higher than that of the re-teared group (P<0.05), there was no significant difference in the other postoperative clinical functional indicators between the two groups (P>0.05). There was no significant difference in the incidence of re-tear, VAS score, ASES score, range of motion of shoulder joint, and anteflexion and elevation muscle strength between group A and group B (P>0.05). ConclusionTendon insertion medialized repair may be useful in cases with L/MRCT, and shows good postoperative shoulder function. Neither tendon integrity nor medialization length shows apparent correlations with postoperative shoulder function.