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Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently, a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12, 2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs, which will further develop the scientific integrity and quality of clinical studies.
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Objective:To investigate the etiology of acute pancreatitis (AP) in Inner Mongolia and its correlation with gender, age and severity of the disease.Methods:From January 2015 to December 2018, the clinical data of 4 168 patients with AP admitted to six large tertiary general hospitals in Inner Mongolia were retrospectively collected and the etiology of AP was summarized. The etiology of different gender, age and severity of AP was analyzed. Chi-square test and adjusted chi-square test were used for statistical analysis.Results:The etiology of 4 168 patients with AP included 2 060 cases (49.4%) of biliary diseases, 608 cases (14.6%) of hypertriglyceridemia, 579 cases (13.9%) of idiopathic causes, 399 cases (9.6%) of alcohol intake, 256 cases (6.1%) of overeating and 266 cases (6.4%) of other causes. The proporation of biliary AP in male patients was lower than that in female patients (39.2%, 917/2 340 vs. 62.5%, 1 143/1 828), however the proporations of hypertriglyceridemic AP, alcoholic AP, overeating AP and AP caused by other causes were all higher than those of female patients (17.4%, 406/2 340 vs. 11.1%, 202/1 828; 14.9%, 349/2 340 vs. 2.7%, 50/1 828; 7.6%, 178/2 340 vs. 4.3%, 78/1 828 and 7.1%, 165/2 340 vs. 5.5%, 101/1 828), and the differences were statistically significant ( χ2=223.645, 32.693, 175.859, 19.858, and 4.001, all P<0.05). The proporation of biliary AP in patients aged between 19 and 59 years was lower than that in patients aged less than 18 years and over 60 years (42.4%, 1 100/2 593 vs. 55.1%, 54/98 and 61.3%, 906/1 477), and the differences were statistically significant ( χ2=6.199 and 134.746, both P<0.016). The proporation of hypertriglyceridemic AP in patients aged over 60 years was lower than that in patients aged between 19 and 59 years and less than 18 years (6.9%, 102/1 477 vs. 18.9%, 491/2 593 and 15.3%, 15/98), and the differences were statistically significant ( χ2=109.403 and 9.430, both P<0.016). The proporation of idiopathic AP in patients aged between 19 and 59 years was higher than that of patients aged over 18 years (14.8%, 384/2 593 vs. 6.1%, 6/98), and the difference was statistically significant ( χ2=5.750, P<0.016). The proporation of alcoholic AP in patients aged between 19 and 59 years was higher than that of patients aged less than 18 years and over 60 years (11.7%, 303/2 593 vs. 1.0%, 1/98 and 6.4%, 95/1 477), the differences were statistically significant ( χ2=10.718 and 29.435, both P<0.016). And the proporation of other causes of AP of the patients aged less than 18 years was higher than those of patients aged between 19 and 59 years and over 60 years (14.3%, 14/98 vs. 5.9%, 152/2 593 and 6.8%, 100/1 477), and the differences were statistically significant ( χ2=0.559 and 0.959, P<0.016). Among the biliary causes, the proporation of moderate severe acute pancreatitis (MSAP) was higher than those of mild acute pancreatitis (MAP) and severe acute pancreatitis (SAP) (59.6%, 336/564 vs. 47.5%, 1 522/3 204 and 50.5%, 202/400), and the differences were statistically significant ( χ2=27.959 and 7.814, both P<0.016). In terms of hypertriglyceridemia and other causes, the proporation of MAP was the lowest (12.7%, 407/3 204 and 4.0%, 127/3 204), and the proporations were statistically significant compared with the proporation of MSAP and SAP (23.0%, 130/564; 12.2%, 69/564 and 17.8%, 71/400; 17.5%, 70/400; χ2=42.013, 7.874, 66.520 and 126.094, all P<0.016). The proporation of MSAP was the lowest among the idiopathic causes (0.7%, 4/564), and the difference was statistically significant compared with the proporation of MAP and SAP (16.6%, 533/3 204 and 10.5%, 42/400; χ2=99.540 and 49.369, both P<0.016). The proporation of SAP was lower than that of MAP, and the difference was statistically significant ( χ2=9.983, P<0.016). In alcoholic and overeating causes, the proporation of MAP was the highest (11.4%, 365/3 204, 7.8%, 250/3 204), and the differences were statistically significant compared with MSAP and SAP (3.5%, 20/564; 0.9%, 5/564; 3.5%, 14/400 and 0.2%, 1/400; χ2=32.182, 23.537, 36.358 and 31.307, all P<0.016). Conclusions:Consistent with reports in most areas of China, the etiology of AP in Inner Mongolia area is mainly biliary diseases and hypertriglyceridemia. Most of the patients with biliary acute pancreatitis are female, mostly in patients more than 60 years old and most of them are MSAP. Hyperlipidemic and alcoholic AP are more common in middle-aged and young male patients, and are mostly MSAP and SAP; while most of alcoholic AP is MAP.
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Objective To study the efficacy of relieving the postoperation pain by using mesh to stuture and fixate tissue during transabdominal preperitoneal hernioplasty (TAPP) in inguinal hernia patients.Metholds A retrospective analysis of 156 patients with inguinal hernia who underwent TAPP in Nanhai Hospital Affiliated to Southern Medical University from January 2016 to January 2017 was conducted,they were males,the average age was 50.84 years and the age range was from 33 to 62 years.Patients were divided into sacral nail group (n =120) and absorbable line group (n =36) according to the different methods of fixation of the iliac crest.Among them,the patients in the sacral nail group were fixed with iliac screws,and the patients in the absorbable line group were sutured with absorbable sutures.Pain visual analog scale (VAS) was used to compare the extent of postoperative pain in both groups.After the operation,through the outpatient review and telephone follow-up for 1 year,observed the recurrence of inguinal hernia in both groups.Measurement data were expressed as mean ± standard deviation (Mean ±-SD),t-test was used for comparison between groups;the Chi-square test was used to compare the count data between the two groups.Results Among them,19 patients with moderate pain after operation in the nail group had an incidence of 15.8％.Two patients with moderate pain in the absorbable line group had an incidence of 5.6％.The difference between the two groups was statistically significant (x2 =2.511,P =0.013).The pain VAS of the patients in the sacral nail group was (3.08-± 1.36),and the absorbable line group was (2.50 ±0.91),the difference between the two groups was statistically significant (t =2.973,P =0.001).All patients had no recurrence after outpatient review and telephone follow-up for 1 year.Conclusion In TAPP,the application of absorbable suture fixed patch can effectively reduce postoperative pain.
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Objective@#To study the efficacy of relieving the postoperation pain by using mesh to stuture and fixate tissue during transabdominal preperitoneal hernioplasty (TAPP) in inguinal hernia patients.@*Metholds@#A retrospective analysis of 156 patients with inguinal hernia who underwent TAPP in Nanhai Hospital Affiliated to Southern Medical University from January 2016 to January 2017 was conducted, they were males, the average age was 50.84 years and the age range was from 33 to 62 years. Patients were divided into sacral nail group (n=120) and absorbable line group (n=36) according to the different methods of fixation of the iliac crest. Among them, the patients in the sacral nail group were fixed with iliac screws, and the patients in the absorbable line group were sutured with absorbable sutures. Pain visual analog scale (VAS) was used to compare the extent of postoperative pain in both groups. After the operation, through the outpatient review and telephone follow-up for 1 year, observed the recurrence of inguinal hernia in both groups. Measurement data were expressed as mean ± standard deviation (Mean±SD), t-test was used for comparison between groups; the Chi-square test was used to compare the count data between the two groups.@*Results@#Among them, 19 patients with moderate pain after operation in the nail group had an incidence of 15.8%. Two patients with moderate pain in the absorbable line group had an incidence of 5.6%. The difference between the two groups was statistically significant (χ2=2.511, P=0.013). The pain VAS of the patients in the sacral nail group was (3.08±1.36), and the absorbable line group was (2.50±0.91), the difference between the two groups was statistically significant (t=2.973, P=0.001). All patients had no recurrence after outpatient review and telephone follow-up for 1 year.@*Conclusion@#In TAPP, the application of absorbable suture fixed patch can effectively reduce postoperative pain.
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OBJECTIVE: To establish a RP-HPLC method for the determination of sodium lactate in compound sodium lactate and glucose injection and provide reference for revision of method recorded in Chinese Pharmacopoeia. METHODS: The separation was performed on a Shim-pack VP-ODS C18 analytical column (4.6 mm×250 mm, 5 μm), and the mobile phase was formic acid-dicyclo-hexylamine-water (1:1:998, V/V) at a flow rate of 1.0 mL·min-1. The detection wavelength was set at 210 nm and the column temperature was maintained at 40℃. The loading volume was 20 μL. The RP-HPLC method and the cation exchange resin method adopted by Chinese Pharmacopoeia were both used to determine the content of sodium lactate in compound sodium lactate and glucose injection, and the results were compared. RESULTS: The linear range of the RP-HPLC method was 0.51-6.07 mg·mL-1 (r=0.9999). The average recovery was 99.47% (RSD=0.75%, n=9). CONCLUSION: The established method of RP-HPLC can be used for the determination of sodium lactate in compound sodium lactate and glucose injection.
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?AlM:To compare the effect of iris location guided sub-bowman keratomileusis ( SBK ) and iris location guided thin - flap laser in situ keratomileusis ( LASlK ) for extremely high myopia treatment. ?METHODS:lris location guided SBK was performed in 64 eyes of 32 patients with extremely high myopia and 42 eyes of 84 patients were received iris location guided thin-flap LASlK. All the patients’ spherical refraction was-9. 00D ~ - 11. 00D and the age was 22 ~ 35 years. Uncorrected visual acuity ( UCVA) , refraction, split-lamp examination, topography examination, central corneal stroma thickness, thickness of central corneal flap, thickness of peripheral corneal flap and complication was examined in these patients and follow-up was 6mo. ?RESULTS:At 6mo after surgery, 93. 8% of the patients received iris location guided SBK and 92. 9% received iris location guided thin-flap LASlK achieved a UCVA better than 20/20. There was no significant difference between two groups. Refraction between ±0. 5D was 89. 1% of SBK group and 84. 5% of LASlK group. There was no significant difference. Corneal rear surface height of SBK was 0. 046±0. 012μm and LASlK was 0. 056±0. 015μm. Thickness of corneal stroma after surgery was 328. 6±14. 7μm in SBK group, while it was 301. 2±21. 6μm in LASlK group and there was significant difference ( t =3. 127, P=0. 001). BUT was 11. 38±4. 02s and 17. 81±4. 89s in SBK and LASlK group respectively, with no statistical difference. There was no serious complication in two groups.?CONCLUTlON:Both iris location guided SBK and thin-flap LASlK are effective for extremely high myopia, but SBK is safer and more predictive than thin-flap LASlK.
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Objective To study the influence of excisional biopsy on detection rate of sentinel lymph node biopsy through methylene blue in breast cancer.Methods A review of 76 patients with clinical stage T1-2N0M0 breast cancer who had a successful sentinel lymph node biopsy at the Affiliated Nanhai Hospital of Southern Medical University between July 2009 to July 2014 was analyzed.There were 37 patients received sentinel lymph node biopsy directly.And 39 patients received sentinel lymph node biopsy after a excisional biopsy to primary lesion.We compare the difference of detection rate of sentinel lymph node between the two groups.Results Seventy cases had been found sentinel lymph node successfully in a total of 76 patients and the detection rate is 92.1％.There were 34 cases had sentinel lymph node biopsy in successfully in group of excisional biopsy and the detection rate is 87.2％.There were 36 cases had sentinel lymph node biopsy in successfully in group of needle core biopsy and the detection rate is 97.3％.This difference,however,was not statistically significant between the two groups (P ＞ 0.05).Conclusions The influence of excisional biopsy on detection rate of sentinel lymph node biopsy through methylene blue in breast cancer is not significant.
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Multichannel intraluminal impedance( MII)is a new technique that monitors comprehensively the function of esophagus and the nature and composition of gastroesophageal reflux, and can be applied for the diagnosis of gastroesophageal reflux disease( GERD),especially suitable for the diagnosis of weakly acidic reflux,non-acid reflux, refractory GERD,and GERD with atypical symptoms. This article reviewed the study on MII and its clinical application in diagnosis of GERD.
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Background Selective laser trabeculoplasty(SLT)has been widely accepted for the treatment of open-angle glaucoma.However,there are few reports about its application in treating angle-closure glaucoma so far.Objective This study was to clinically evaluate the safety and efficacy of selective laser trabeculoplasty for primary angle-closure glaucoma with opened anterior angle follow-up surgery.Methods A case-observational design was adopted in this study.A total of 33 eyes from 23 angle-closure glaucomatous patients with opened 180° angle were enrolled.All the patients understood this trial and written informed consent was obtained prior to the medical treatment.The average preoperative intraocular pressure(IOP)and number of medication were(23.07±4.01)mmHg and 1.52±0.66,respectively.A frequency doubled Q-switched Nd:YAG laser was used to irradiate the trabecular meshwork with 70-80 laser spots over 180°.The same preoperative anti-glaucoma drugs were topically administered during the follow-up period.Visual acuity,IOP,slit lamp examination,gonioscopy and the coefficient of outflow facility were regularly assessed and performed after laser surgery.Results The IOP values of the 33 eyes were(18.78±4.87)mmHg,(18.83±3.95)mmHg,(19.78±4.48)mmHg,(19.63±3.68)mmHg,(19.11±3.36)mmHg,and(21.17±3.14)mmHg 1 day,l week,and 1,3,6,9 months after operation,showing significant decline in comparison with preoperation(P＜0.01).The mean drug uses were 1.63±0.85,1.23±1.01,1.25±0.98,1.21±1.02,1.22±0.86,and 1.69±0.53 at the same time point after operation,respectively,and significant differences were found 1 week,1,3,6 months in postoperation in comparison with preoperation(P =0.020,0.026,0.020,0.031).Ciliary congestion and aqueous flare naturally disappeared 1 week after surgery.The coefficients of outflow facility were 0.11±0.09 and 0.23±0.15,respectively at pretreatment and 3 months after SLT with a statistically significant difference (P=0.002).Conclusions Selective laser trabeculoplasty is effective and safe for angle-closure glaucoma.However,it is essential to have 1/2 circle of anterior chamber open for SLT in angle-closure glaucoma.