Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies / 中国结合医学杂志

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.

Etiological analysis of 4 168 cases of acute pancreatitis in Inner Mongolia Autonomous Region, China / 中华消化杂志

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.

Analysis of the efficacy of relieving the postoperation pain by using mesh to stuture and fixate tissue during transabdominal preperitoneal hernioplasty in inguinal hernia patients / 国际外科学杂志

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.

Analysis of the efficacy of relieving the postoperation pain by using mesh to stuture and fixate tissue during transabdominal preperitoneal hernioplasty in inguinal hernia patients / 国际外科学杂志

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.

Discussion on the analytical method of sodium lactate in compound sodium lactate and glucose injection in chinese pharmacopoeia / 中国药学杂志

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.

Comparative study of iris location guided SBK and thin-flap LASlK for extremely high myopia / 国际眼科杂志(Guoji Yanke Zazhi)

?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.

Influence of excisional biopsy on detection rate of sentinel lymph node biopsy through methylene blue in breast cancer / 国际外科学杂志

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.

Diagnostic Value of Multichannel Intraluminal Impedance in Gastroesophageal Reflux Disease / 胃肠病学

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.

Laparoscopic and gasless laparoscopic sigmoid colon vaginoplasty in women with vaginal agenesis / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>In the past several decades we have seen multiple advances in the reconstruction for girls born with vaginal agenesis. This study aimed to evaluate the technical feasibility, anatomical and functional outcomes of one-stage laparoscopic and gasless laparoscopic vaginoplasty with sigmoid colon for the patients of vaginal agenesis (Mayer-Rokitansky-Kuster-Hauser syndrome).</p><p><b>METHODS</b>We did a retrospective review of a total of 150 women with Mayer-Rokitansky-Kuster-Hauser syndrome treated at Beijing Anzhen Hospital, Capital Medical University from March 2006 to August 2010. The patients were divided into the CO2 pneumoperitoneum laparoscopic group and the abdominal wall lift of gasless laparoscopic group. Sigmoid colon vaginoplasty approaches were performed in all of the patients. The surgical techniques, perioperative results, complications, anatomical and functional outcomes of vaginoplasty were recorded.</p><p><b>RESULTS</b>All procedures were performed successfully. Significant differences in the operative time and intraoperative blood loss existed in the laparoscopic vaginoplasty group compared with the gasless laparoscopic vaginoplasty group. The patients who underwent sigmoid colon vaginoplasty had good cosmetic results without the problem of excessive mucus production. The postoperative complications were minimal. During a mean follow-up of 15.6 months, no stenosis or shrinkage was encountered. The subjective sexual satisfaction rate with the surgical outcomes in all patients was 83.3%.</p><p><b>CONCLUSIONS</b>Laparoscopic or gasless laparoscopic vaginoplasty with sigmoid colon are effective and feasible approaches for women with congenital vaginal agenesis. The procedures have satisfactory anatomical and functional results.</p>

Clinical evaluation of selective laser trabeculoplasty for residual primary angle-closure glaucoma / 中华实验眼科杂志

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.

Principles of ethics review on traditional medicine and the practice of institute review board in China / 中国结合医学杂志

As one of the significant parts of medical science research in China, the research on Chinese medicine (CM) reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture. Therefore, in the practice of ethics review on CM research protocols, besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study, we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values. In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics, and then attempted to summarize the key points for the bioethics review to CM researches in China, so as to serve as reference for the bioethics review to traditional and alternative medicine researches.

Problems to pay attention to in taking patient-reported outcomes as clinical outcomes assessment / 中国中西医结合杂志

Patient-reported outcomes (PROs) provide clinical researchers with a good means to assess patient-based outcomes. Yet there are still some problems to pay attention to while using PROs as an effectiveness assessment index, including the selection of an appropriate scale of PRO, quality control in PRO data collection, and the interpretations and application ranges of the PRO results.

Effect of Tumor Necrosis Factor-α Antagonism in Asthma: a Meta-analysis of the Published Literature / 华中科技大学学报（医学）（英德文版）

It remains controversial whether tumor necrosis factor (TNF)-α antagonism is effective for asthma.This meta-analysis was performed to evaluate efficacy of TNF-α antagonism in treatment of patients with asthma.MEDLINE,EMBASE,LILACS,and CINAHL databases were searched for English-language studies published through January 3,2010.Randomized-controlled trials comparing TNF-α antagonism with control therapy were selected.For each report,data were extracted in relation to the outcomes analyzed:asthma exacerbation,asthma quality of life questionnaire scores,and forced expiratory volume in 1 second.Four assessable trials were identified including 641 patients with asthma.TNF-α antagonism therapy was superior to control therapy in preventing exacerbations in asthmatics [pooled odds ratio 0.52 (95％ confidence interval 0.29-0.88),P=0.02]; however,there was a nonsignificant reduction in asthma quality of life questionnaire scores [0.23 (0 to 0.47),P=0.05],forced expiratory volume in 1 second [0.03,(-0.14 to 0.10),P=0.74] when analyzed using standardized mean differences.TNF-α antagonism was superior to control chemotherapy in terms of asthma exacerbation,but not asthma quality of life questionnaire scores or forced expiratory volume in 1 second.

Spinal cord injury-induced astrocyte migration and glial scar formation: Effects of magnetic stimulation frequency.

The effects of magnetic stimulation on spinal cord injury-induced migration of white matter astrocytes were studied using an established animal model. Ethidium bromide was injected into the dorsal spinal cord funiculus of adult Sprague-Dawley rats on the left side at T10-11. Animals then received 1.52 Tesla-pulsed magnetic stimulation for 5 min at different frequencies (0-20 Hz) for 14 consecutive days. Selected animals received the non-competitive MEK1/2 inhibitor U0126 (10 μM), prior to stimulation at 10 Hz. Lesion volumes were measured in hematoxylin/eosin-stained sections. Expression of glial fibrillary acidic protein (GFAP), microtubule associated protein-2 (MAP-2) and extra-cellular signal-regulated kinase1/2 (ERK1/2) near the epicenter of injury was examined by Western blotting with quantification using an image analysis system. Lesion volumes decreased and GFAP and p-ERK1/2 expression increased with increasing magnetic stimulation frequency (0-10 Hz). MAP-2 expression was not affected at any frequency. Pretreatment with U0126 reduced GFAP and ERK1/2 expression and increased lesion volumes in response to stimulation at 10 Hz. It is concluded that magnetic stimulation increases the migration of astrocytes to spinal cord lesions. Activation of the ERK1/2 signaling pathway is proposed to mediate astrocyte migration and glial scar formation in response to spinal cord injury.

The changes and significance of T lymphocytes and subsets before and after receiving highly active anti-retroviral therapy in children infected with HIV or AIDS patients / 中华预防医学杂志

<p><b>OBJECTIVE</b>To investigate the changes of the T lymphocytes and their subsets before and after receiving highly active anti-retroviral therapy (HAART) in children who were infected with HIV or AIDS patients.</p><p><b>METHODS</b>Ninety-nine children met the criteria were recruited. All of them had received HAART in Guangxi Center for Disease Control and Prevention from May 2006 to April 2009. Peripheral blood of 2 milliliter was collected before treatment (D0) and after 3, 6, 12, 18, 24, 30, and 36 months (M3, M6, M12, M18, M24, M30 and M36), respectively. Four-color fluorescence flow cytometry was used for the detection of the absolute numbers of CD3(+), CD4(+), CD8(+) T lymphocytes in peripheral blood. And then, the percentages of CD3(+), CD4(+), CD8(+) T lymphocytes in the CD45(+) cells and the ratio of CD4/CD8 were calculated.</p><p><b>RESULTS</b>Sixteen-five (65.66%) cases were treated with lamivudine (3TC)/zidovudine (AZT)/nevirapine (NVP), and 16 (16.16%), 8 (8.08%) and 10 (10.10%) cases were treated with 3TC/stavudine (D4T)/NVP, 3TC/AZT/efavirenz (EFV) and 3TC/AZT/lpv-rtv (LPV/r), respectively. The median of the ratio of CD4/CD8 were 0.39, 0.51, 0.61, 0.65, 0.70, 0.73 and 0.76 in M3, M6, M12, M18, M24, M30 and M36, respectively which were significantly higher than that in D0 (0.19) (Z values were -5.158, -7.375, -9.078, -8.853, -8.373, -5.845 and -5.844 respectively, P < 0.000). The median of CD4% were 16.92%, 22.70%, 25.54%, 26.66%, 27.99%, 30.36% and 29.30% respectively in M3, M6, M12, M18, M24, M30 and M36 respectively, which were also higher significantly than that in D0 (9.92%) (Z values were -5.268, -7.568, -9.496, -9.171, -8.760, -6.190 and -5.964 respectively, P < 0.000). In addition, the median of the absolute numbers of CD4(+)T lymphocytes in peripheral blood were 631, 813, 1050, 946, 1057, 1166 and 894 cells/mm(3) respectively in M3, M6, M12, M18, M24, M30 and M36, which were higher significantly than that of D0 (382 cells/mm(3)) (Z values were -3.318, -5.288, -6.661, -5.886, -5.801, -4.110 and -3.600 respectively, P < 0.000). However, the median of CD8% were 47.25%, 43.01%, 43.04%, 42.60%, 41.37%, 40.83% and 38.31% respectively in M3, M6, M12, M18, M24, M30 and M36, which were lower significantly than that of D0 (53.17%) (Z values were -3.082, -4.697, -5.282, -5.846, -5.757, -3.883 and -4.380 respectively, P < 0.001).</p><p><b>CONCLUSION</b>There is certain rules for the changes of T lymphocytes and their subsets, which may play important roles in the evaluation of the therapeutic effect and the clinical application guidance of HAART.</p>

Synthetic evaluation of the clinical effect of the Shengmai capsule for treatment of chronic congestive heart failure using analytic hierarchy process / 南方医科大学学报

<p><b>OBJECTIVE</b>To explore the approaches and techniques for synthetic evaluation of the clinical therapeutic effect of new Chinese herbal medicine in clinical trials.</p><p><b>METHODS</b>In a double-blind, randomized, and placebo-controlled clinical trail, analytic hierarchy process (AHP) was applied to evaluate the clinical therapeutic effect of Shengmai capsule in the treatment of chronic congestive heart failure.</p><p><b>RESULTS</b>Shengmai capsule produced positive therapeutic effect on chronic congestive heart failure.</p><p><b>CONCLUSION</b>A feasible method is established for evaluating and grading the clinical therapeutic effect of Chinese herbal medicine.</p>

A prospective comparative study of three treatment options in patients with malignant gastric outlet obstruction / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To evaluate outcomes after different treatment options including endoscopic stent placement, surgical bypass, and percutaneous gastrostomy for malignant gastric outlet obstruction (GOO).</p><p><b>METHODS</b>Thirty-nine patients with GOO secondary to unresectable primary or metastatic cancer were treated with endoscopic stent placement (group 1, n=13), surgical bypass (group 2, n=21), or percutaneous gastrostomy (group 3, n=5). QLQ-STO22 form was used to assess quality of life (QOL) at baseline, 1 month, and 3 months following intervention.</p><p><b>RESULTS</b>Overall median survival time was 68 days. Median survival time in group 1 and group 2 was 85 and 72 days respectively, longer than that in group 3 (48 days, P<0.05). Fourteen patients (7 cases in group 1 and 7 cases in group 2) completed all three QOL surveys. All the patients in group 1 had significant improvement in dysphagia, dietary restrictions, dry mouth, and reflux (P<0.05). In group 2, dysphagia and dietary restrictions were significantly improved (P<0.05), while there were no significant improvements in dry mouth, reflux and pain (all P>0.05).</p><p><b>CONCLUSION</b>Although the prognosis of malignant GOO is poor, endoscopic stent placement and surgical bypass may improve QOL of patients and therefore are reasonable alternatives for palliation.</p>

Comparison of pragmatic clinical trials and explanatory clinical trials / 中国中西医结合杂志

Clinical trials are often designed as either pragmatic or explanatory. The pragmatic clinical trials are generally used for measuring the effectiveness of a treatment in common clinical practice, while the explanatory trial for measuring the efficacy of a treatment under ideal conditions. Since the methods concerning pragmatic clinical trials are less introduced in China, its archetypal features, advantages and limitations were introduced in this paper. And a current study of pragmatic clinical trials on using acpuncture for treatment of low back pain carried out in German was taken as an example to illustrate the practical methods concretely. The key steps of the design were presented in detail, and reasonable suggestions about the problems often encountered in the trial, as well as how to balance the internal and external validity, outcome measurement, etc., were offered.

Eighty-six cases of laparoscopic vaginoplasty using an ileal segment / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The surgical management of the absence of the vagina is a complex problem and constitutes a significant technical challenge. As the laparoscopy has been an important tool for the treatment of uterovaginal anomalies, we evaluated the feasibility of laparoscopic vaginoplasty using an ileal segment retrospectively.</p><p><b>METHODS</b>Totally 86 patients who underwent laparoscopic vaginoplasty using an ileal segment in Beijing Anzhen Hospital during February 2004 to July 2007 were enrolled in this study. Of the 86 patients, 70 (81.4%) underwent primary operations and 16 (18.6%) secondary operations. Nineteen (22.1%) patients underwent total laparoscopic vaginoplasty and 67 (77.9%) patients underwent laparoscope-assisted vaginoplasty. The operation time, cost of hospitalization, and hospital duration were compared between the two laparoscopic groups. The Student's t test and the Mann-Whitney test were used to examine the differences.</p><p><b>RESULTS</b>All the surgeries were successfully completed with no any intraoperative complication. There were three major surgical complications in the postoperative period: one case of intra-abdominal hemorrhage, one case of meatal stenosis, and one case of intestinal obstruction. The mean follow-up period of this series was 18 months. Seventy-eight patients were satisfied with their sexual lives after the surgeries except 5 women complaining of vaginal stenosis and 3 with no sexual partner during the follow-up. Significant differences were obtained between total laparoscopic and laparoscope-assisted vaginoplasty groups, such as the operation time, cost of hospitalization, and hospital duration (P < 0.01). There were no significant differences in sexual function between the two groups.</p><p><b>CONCLUSIONS</b>The laparoscopic vaginoplasty using an ileal segment is satisfactory for cosmetic, functional, and anatomic results. Vaginoplasty with an ileal segment, performed by either total laparoscopic or laparoscope-assisted techniques, has a high success rate for a functional vagina.</p>