2016年 · 第129卷第08期

While combined oral contraceptives (COCs) are commonly used to treat polycystic ovary syndrome (PCOS), comparative data regarding metabolic effects of different progestogens on this patient population are missing. This study aimed to compare the different effects of drospirenone (DRP)-containing COCs with cyproterone acetate (CPA)-containing COCs, combined with metformin and lifestyle modifications in women with PCOS and metabolic disorders.

Ninety-nine women with PCOS and a metabolic disorder between January 2011 and January 2013 were enrolled into this prospective randomized clinical trial. Participants were randomized into two groups such as DRP-containing COCs, and CPA-containing COCs. Participants took COCs cyclically for 6 months, combined with metformin administration (1.5 g/d) and lifestyle modifications (diet and exercise). Clinical measures and biochemical and hormone profiles were compared. Comparisons for continuous variables were evaluated with paired and unpaired Student’s t-tests. The Wilcoxon signed rank test was used when the data were not normally distributed. Analysis of covariance was used to control for age, body mass index (BMI), and baseline data of each analyzed parameter when compared between the two groups.

A total of 68 patients have completed the study. The combination regimen of COCs, metformin, and lifestyle modifications in these patients resulted in a significant decrease in BMI, acne, and hirsutism scores when compared to baseline levels in both groups (P < 0.05). Blood pressure (BP) was significantly different in the CPA group when compared to baseline (75.14 ± 6.77 mmHg vs. 80.70 ± 5.60 mmHg, P < 0.01), and after 6 months of treatment, only the change in systolic BP was significantly different between the two groups (4.00 [–6.00, 13.00] mmHg vs. –3.50 [–13.00, 9.00] mmHg, P = 0.009). Fasting glucose, fasting insulin, and homeostasis model assessment-insulin resistance decreased significantly in the DRP group (5.40 ± 0.41 mmol/L vs. 5.21 ± 0.32 mmol/L, P = 0.041; 13.90 [10.50, 18.40] μU/ml vs. 10.75 [8.60, 13.50] μU/ml, P = 0.020; 3.74 [2.85, 4.23] vs. 2.55 [1.92, 3.40], P = 0.008) but did not differ between the two groups. While individual lipid profiles increased in both groups, no statistically significant difference was observed.

DRP-containing COCs combined with metformin and lifestyle modifications could better control BP and correct carbohydrate metabolism in women with PCOS and metabolic disorders compared with CPA-containing COCs.

Chinese Clinical Trial Registry, ChiCTR-TRC-11001143; http://www.chictr.org.cn/showproj.aspx?proj=8395.

Knee osteoarthritis (KOA) is a chronic joint disease that manifests as knee pain as well as different degrees of lower limb swelling, stiffness, and movement disorders. The therapeutic goal is to alleviate or eliminate pain, correct deformities, improve or restore joint functions, and improve the quality of life. This study aimed to evaluate the efficacy and safety of Zhuanggu joint capsules combined with celecoxib and the benefit of treatment with Zhuanggu alone for KOA.

This multi-center, randomized, double-blind, double-dummy, parallel controlled trial, started from December 2011 to May 2014, was carried out in 6 cities, including Beijing, Shanghai, Chongqing, Changchun, Chengdu, and Nanjing. A total of 432 patients with KOA were divided into three groups (144 cases in each group). The groups were treated, respectively, with Zhuanggu joint capsules combined with celecoxib capsule simulants, Zhuanggu joint capsules combined with celecoxib capsules, and celecoxib capsules combined with Zhuanggu joint capsule simulants for 4 weeks consecutively. The improvement of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and the decreased rates in each dimension of WOMAC were evaluated before and after the treatment. Intergroup and intragroup comparisons of quantitative indices were performed. Statistically significant differences were evaluated with pairwise comparisons using Chi-square test (or Fisher’s exact test) and an inspection level of α = 0.0167.

Four weeks after treatment, the total efficacies of Zhuanggu group, combination group, and celecoxib group were 65%, 80%, and 64%, respectively, with statistically significant differences among the three groups (P = 0.005). Intergroup pairwise comparisons showed that the total efficacy of the combination group was significantly higher than that of the Zhuanggu (P = 0.005) and celecoxib (P = 0.003) groups. The difference between the latter two groups was not statistically significant (P > 0.0167). Four weeks after discontinuation, the efficacies of the three groups were 78%, 95%, and 65%, respectively, with statistically significant differences (P < 0.0001). Intergroup pairwise comparisons revealed that the efficacy of the combination group was significantly better than that of the Zhuanggu and the celecoxib groups (P < 0.0001). The difference between the latter two groups was not statistically significant (P > 0.0167). The incidences of adverse events in Zhuanggu group, combination group, and celecoxib group were 8.5%, 8.5%, and 11.1%, respectively, with insignificant differences (P > 0.05).

Zhuanggu joint capsules alone or combined with celecoxib showed clinical efficacy in the treatment of KOA. The safety of Zhuanggu joint capsules alone or combined with celecoxib was acceptable.

Chinese Clinical Trial Registry, ChiCTR-IPR-15007267; http://www.medresman.org/uc/project/projectedit.aspx?proj=1364.

The risk of radial artery occlusion (RAO) needs particular attention in transradial intervention (TRI). Therefore, reducing vascular occlusion has an important clinical significance. The aim of this study was to determine the appropriate puncture site during TRI through comparing the occurrence of RAO between the different puncture sites to reduce the occurrence of RAO after TRI.

We prospectively assessed the occurrence of RAO in 606 consecutive patients undergoing TRI. Artery occlusion was evaluated with Doppler ultrasound in 2 days and 1 year after the intervention. Risk factors for RAO were evaluated using a multivariate model analysis.

Of the 606 patients, the RAO occurred in 56 patients. Compared with TRI at 2–5 cm away from the radius styloid process, the odds ratio (OR) for occlusion risk at 0 cm and 1 cm were 9.65 (P = 0.033) and 8.90 (P = 0.040), respectively. The RAO occurred in the ratio of the arterial diameter to the sheath diameter ≤1 (OR = 2.45, P = 0.004).

Distal puncture sites (0–1 cm away from the radius styloid process) can lead to a higher rate of RAO.

ClinicalTrials.gov, NCT01979627; https://clinicaltrials.gov/ct2/show/NCT01979627?term = NCT01979627 and rank = 1.

Porous-coated cups have been widely used in acetabular reconstruction after failed treatment of acetabular fractures, and good results have been reported with the use of these cups; however, the durability and functionality of modular trabecular metal (TM) acetabular components in acetabular reconstruction after failed treatment of acetabular fractures remain unclear. This study aimed to examine the radiographic and clinical outcomes associated with the use of modular TM acetabular components for failed treatment of acetabular fractures to assess the durability and functionality of these components in acetabular reconstruction after failed treatment of acetabular fractures.

A total of 41 patients (41 hips) underwent total hip arthroplasty (THA) using modular TM acetabular components for failed treatment of acetabular fractures at our hospital between January 2007 and December 2012. Among these patients, two were lost to follow-up. Therefore, 39 patients (39 hips) were finally included in this study. The Harris hip score before and after the surgery, satisfaction level of the patients, and radiographic results were assessed.

The mean Harris hip score increased from 34 (range, 8–52) before surgery to 91 (range, 22–100) at the latest follow-up examination (P < 0.001). The results were excellent for 28 hips, good for six, fair for three, and poor for two. Among the 39 patients, 25 (64%) and 10 (26%) were very satisfied and somewhat satisfied, respectively. All cups were found to be fully incorporated, and no evidence of cup migration or periacetabular osteolysis was noted.

Despite the technically demanding nature of the procedure, THA using modular TM acetabular components showed good durability and functionality and may be an effective reconstruction option for failed treatment of acetabular fractures.

Chronic obstructive pulmonary disease (COPD) is characterized by progressive loss of lung function and local and systemic inflammation, in which CD8⁺ T-cells are believed to play a key role. Activated CD8⁺ T-cells differentiate into distinct subpopulations, including interferon-γ (IFN-γ)-producing Tc1 and interleukin (IL)-17-producing Tc17 cells. Recent evidence indicates that Tc17 cells exhibit considerable plasticity and may convert into IL-17/IFN-γ-double producing (Tc17/IFN-γ) cells when driven by inflammatory conditions. The aim of this study was to investigate the Tc17/IFN-γ subpopulation in peripheral blood of patients with COPD and to evaluate their potential roles in this disease.

Peripheral blood samples were collected from 15 never-smokers, 23 smokers with normal lung function, and 25 patients with COPD (Global Initiative for Chronic Obstructive Lung Disease 2–4). Proportions of the IL-17/IFN-γ-double expressing subpopulation were assessed using flow cytometry. Plasma concentrations of cytokines favoring Tc17/IFN-γ differentiation were measured by enzyme-linked immunosorbent assay.

Patients with COPD had higher proportions of Tc17 cells and Tc17/IFN-γ cells in the peripheral blood than smokers and never-smokers. The plasticity of Tc17 cells was higher than that of Th17 cells. The percentages of Tc17 cells and Tc17/IFN-γ cells showed negative correlations with forced expiratory volume in 1 s % predicted value (r = −0.418, P = 0.03; r = −0.596, P = 0.002, respectively). The plasma concentrations of IL-6, transforming growth factor-β1, and IL-12 were significantly higher in patients with COPD compared with smokers and never-smokers.

Peripheral Tc17 cells are increased and more likely to convert to Tc17/IFN-γ cells in COPD, suggesting that Tc17 cell plasticity may be involved in persistent inflammation of the disease.

Recently, the most common incision for kidney transplantation (KT) is an inverted J-shaped incision known as the "hockey-stick." However, demands for minimally invasive surgery in KT are increasing as in other various fields of surgery. Hence, we evaluated whether there is difference between minimal skin incision technique in kidney transplantation (MIKT) and conventional KT (CKT).

Between June 2006 and March 2013, a total of 452 living kidney transplant patients were enrolled. The MIKT group included 17 young unmarried women whose body mass index was <25 kg/m² and had no anatomic variation. The CKT group included 435 patients. The MIKT operation technique restricted to the 10 cm-sized skin incision in the lower right abdomen from laterally below the anterior superior iliac spine to the midline just above the pubis was performed. We compared the baseline clinical characteristics and postoperative results between two groups. For proper comparison, propensity score matching was implemented.

There was no difference in graft function, survival, and postoperative complication rate between MIKT and CKT groups (all P > 0.05). The 5-year graft survival was 92.3% and 85.7% in MIKT and CKT groups, respectively (P = 0.786).

Our results indicated that MIKT showed more favorable cosmetic results, and there were no statistical differences in various postoperative factors including graft function, survival, and complications compared with CKT. Hence, we suggested that MIKT is an appropriate method for selected patients in living KT.

Coronary artery lesions (CALs) are known to be the main complication in children with Kawasaki disease (KD). Instead of intravenous immunoglobulin (IVIG), corticosteroid therapy has been accepted to be used for children with KD who are unresponsive to IVIG. This study aimed to evaluate risk factors for CALs in children with KD.

We retrospectively reviewed the clinical records of 2331 children with KD from January 2005 to December 2014. To identify the independent risk factors for CALs, multivariable logistic regression models were constructed using significant variables identified from univariate logistic regression analysis.

The incidence of CALs was 36.0% (840 of 2331), including 625 (26.8%) coronary artery dilations and 215 (9.2%) coronary artery aneurysms (CAAs). Multivariable logistic regression analysis identified that male, incomplete KD, longer fever duration, and C-reactive protein (CRP) >100 mg/L were independent risk factors for coronary artery dilatations. On the other hand, male, incomplete KD, longer fever duration, prolonged days of illness at the initial treatment, corticosteroid therapy, sodium ≤133 mmol/L, and albumin <35 g/L were the independent risk factors for CAAs. In addition, corticosteroid therapy, prolonged days of illness at the initial treatment, and albumin <35 g/L were the independent risk factors for giant CAAs.

CALs might be associated with male sex, incomplete KD, longer fever duration, prolonged days of illness at the initial treatment, albumin <35 g/L, sodium ≤133 mmol/L, CRP >100 mg/L, and corticosteroid therapy. Corticosteroid therapy was an independent risk factor for CAAs and giant CAAs. Thus, corticosteroids should be used with caution in the treatment of KD with the risk for CALs.

The ultimate goal of hepatitis B treatment is hepatitis B surface antigen (HBsAg) seroclearance. Several factors have been suggested to be associated with the rate of HBsAg reduction in antiviral-naive or lamivudine therapy cohorts. However, there are few studies evaluating the factors during long-term entecavir (ETV) therapy. In the present study, we aimed to evaluate the factors to predict the outcome of ETV therapy for 7 years.

A total of 47 chronic hepatitis B (CHB) patients treated with ETV monotherapy were included in this study. Liver biochemistry, hepatitis B virus (HBV) serological markers, serum HBV DNA, and HBsAg titers were tested at baseline, 3 months, 6 months, and yearly from 1 to 7. The associations between factors and HBsAg reduction were assessed using multivariate tests with repeated measure analysis of variance.

At baseline, serum HBsAg levels showed a positive correlation with baseline HBV DNA levels (r = 0.625, P < 0.001). The mean HBsAg titers after ETV treatment were significantly lower than the baseline titers (P ranges from 0.025 to 0.000,000,6). The HBsAg reduction rate during the 1^st year was greater compared to after 1 year of treatment (P < 0.05). Multivariate test showed that hepatitis B e antigen (HBeAg) seroclearance and/or HBsAg reduction ≥0.5 log₁₀ IU/ml at 6 months had a high negative predictive value (96.77%) for HBsAg seroclearance (P = 0.002, P = 0.012, respectively).

The HBsAg reduction rate during the 1^st year was greater than that after 1 year of treatment. Further, HBeAg status and HBsAg levels at month 6 are the optimal factors for the early prediction of HBsAg seroclearance after long-term ETV therapy in CHB patients.

Pain is a common burden of disease globally; yet, it is not systematically investigated in China, especially in hospitalized patients. This study was aimed at clarifying the epidemiological characteristics of pain and related factors in hospitalized patients in Southwest China.

A cross-sectional study was conducted to investigate the prevalence, severity, and influencing factors of pain and modes of postoperative analgesia in hospitalized patients from 17 hospitals in Southwest China. A prevalidated questionnaire was employed to calibrate all of these items within 3 days from March 18, 2015 to March 20, 2015.

A total of 2293 patients were surveyed, the incidence of pain was 57.4% in all hospitalized patients at rest, of which 62.1% were with acute pain and 37.9% had persistent to chronic pain. Among surgical patients, 90.8% of them complained of acute postoperative pain at rest and 97.1% in motion. The incidence of acute postoperative moderate-to-severe pain was 28.8% at rest and 45.1% in motion. Surgical patients reported higher incidences of pain, especially acute and persistent pain compared with nonsurgical patients (P < 0.05). Postoperative pain occurred predominately at surgical sites (95.2%) as compared with nonsurgical sites (4.8%). Agedness, lower education level, surgery, and history of smoking were factors associated with increased duration and severity of postoperative pain and nonsurgical pain (P < 0.05).

Pain is a common burden of disease in China, of which surgical pain constituted an important component. Surgical patients complained more severe pain than those who did not undergo surgery. Postoperative analgesia still needs to be improved to control pain after surgery. Patients’ perception might influence the efficacy of pain management, which should be implemented with a multidisciplinary approach.

Few studies have addressed whether abnormalities in the lenticular nucleus (LN) are characteristic transcranial sonography (TCS) echo features in patients with primary dystonia. This study aimed to explore alterations in the basal ganglia in different forms of primary focal dystonia.

A cross-sectional observational study was performed between December 2013 and December 2014 in 80 patients with different forms of primary focal dystonia and 55 neurologically normal control subjects. TCS was performed in patients and control subjects. Multiple comparisons of multiple rates were used to compare LN hyperechogenicity ratios between control and patient groups.

Thirteen individuals were excluded due to poor temporal bone windows, and two subjects were excluded due to disagreement in evaluation by sonologists. Totally, 70 patients (cervical dystonia, n = 30; blepharospasm, n = 30; oromandibular dystonia, n = 10) and 50 normal controls were included in the final analysis. LN hyperechogenicity was observed in 51% (36/70) of patients with primary focal dystonia, compared with 12% (6/50) of controls (P < 0.001). Substantia nigra hyperechogenicity did not differ between the two groups. LN hyperechogenicity was observed in 73% (22/30) of patients with cervical dystonia, a greater prevalence than in patients with blepharospasm (33%, 10/30, P = 0.002) and oromandibular dystonia (40%, 4/10, P = 0.126). LN hyperechogenicity was more frequently observed in patients with cervical dystonia compared with controls (73% vs. 12%, P < 0.001); however, no significant difference was detected in patients with blepharospasm (33% vs. 12%, P = 0.021) or oromandibular dystonia (40% vs. 12%, P = 0.088).

LN hyperechogenicity is more frequently observed in patients with primary focal dystonia than in controls. It does not appear to be a characteristic TCS echo feature in patients with blepharospasm or oromandibular dystonia.

Clopidogrel low response (CLR) is an independent risk factor of adverse outcomes in patients undergoing percutaneous coronary intervention (PCI), and intensified antiplatelet treatments (IAT) guided by platelet function assays might overcome laboratory CLR. However, whether IAT improves clinical outcomes is controversial.

Relevant trials were identified in PubMed, the Cochrane Library, and the Chinese Medical Journal Network databases from their establishment to September 9, 2014. Trials were screened using predefined inclusion criteria. Conventional meta-analysis and cumulative meta-analysis were performed using the Review Manager 5.0 and STATA 12.0 software programs.

Thirteen randomized controlled trials involving 5111 patients with CLR were recruited. During a follow-up period of 1–12 months, the incidences of cardiovascular (CV) death, nonfatal myocardial infarction (MI), and stent thrombosis were significantly lower in the IAT arm than in the conventional antiplatelet treatment arm (relative risk [RR] = 0.45, 95% confidence interval [CI]: 0.36–0.57, P < 0.000,01), whereas bleeding was similar between the two arms (RR = 1.05, 95% CI: 0.86–1.27, P = 0.65).

IAT guided by platelet function assays reduces the risk of CV death, nonfatal MI, and stent thrombosis (ST) without an increased risk of bleeding in patients undergoing PCI and with CLR.

Helicobacter pylori (H. pylori) eradication remains a challenge with increasing antibiotic resistance. Hybrid therapy has attracted widespread attention because of initial report with good efficacy and safety. However, many issues on hybrid therapy are still unclear such as the eradication efficacy, safety, compliance, influencing factors, correlation with antibiotic resistance, and comparison with other regimens. Therefore, a comprehensive review on the evidence of hybrid therapy for H. pylori infection was conducted.

The data used in this review were mainly from PubMed articles published in English up to September 30, 2015, searching by the terms of "Helicobacter pylori" or "H. pylori", and "hybrid" .

Clinical research articles were selected mainly according to their level of relevance to this topic.

Totally, 1871 patients of 12 studies received hybrid therapy. The eradication rates were 77.6–97.4% in intention-to-treat and 82.6–99.1% in per-protocol analyses. Compliance was 93.3–100.0%, overall adverse effects rate was 14.5–67.5%, and discontinued medication rate due to adverse effects was 0–6.7%. H. pylori culture and sensitivity test were performed only in 13.3% patients. Pooled analysis showed that the eradication rates with dual clarithromycin and metronidazole susceptible, isolated metronidazole or clarithromycin resistance, and dual clarithromycin and metronidazole resistance were 98.5%, 97.6%, 92.9%, and 80.0%, respectively. Overall, the efficacy, compliance, and safety of hybrid therapy were similar with sequential or concomitant therapy. However, hybrid therapy might be superior to sequential therapy in Asians.

Hybrid therapy showed wide differences in the efficacy but consistently good compliance and safety across different regions. Dual clarithromycin and metronidazole resistance were the key factor to efficacy. Hybrid therapy was similar to sequential or concomitant therapy in the efficacy, safety, and compliance.

Coronary malperfusion associated with aortic dissection is relatively rare, which has been reported at 5.7%–11.3%,^[1]but when it occurs, it is fatal to the patient. Despite improved therapeutic techniques for aortic dissection over the years, surgical treatment for the uncommon condition of aortic dissection with coronary malperfusion is still premature. Prompt coronary revascularization and concomitant surgical repair of the aorta are essential for dealing with this problem. To date, the surgical management for this condition relies on various techniques, which include coronary artery bypass grafting (CABG) and repair coronary vessels.^[1,2]However, the optimal surgical strategy for coronary revascularization is still debated. In this study, we reviewed our experience with aortic dissection involving the coronary artery in 36 patients, which evolved over a 14-year period, aiming to provide alternative options in the face of this scenario.

To the Editor: A 71-year-old male was admitted to Department of Urology, The 3^rdXiangya Hospital, Central South University on June 26, 2014, because of lateral distending pain in the left back in recent 3 months. The patient’s past medical history included retroperitoneoscopic left pelvilithotomy at 6 years ago. Physical examination showed left costovertebral angle tenderness when slightly tapped at left kidney region (affected area). In addition, plain core of pelvic calculus was white strip funicular substance, which strongly attached to the pelvic mucosa and could not be removed by flexible ureterorenoscopy. The patient then was admitted for percutaneous nephroscopy with the guidance of B ultrasound. First, removing calculus at subrenal calyx out and then locating foreign body at renal pelvis [Figure 1e]. Thereafter, the foreign body at pelvis was removed using alligator plier. Finally, double-J tube and X-ray of the kidney, ureter, and bladder (KUB) and abdominopelvic computed tomography scan showed multiple left renal stones with hydronephrosis [Figure 1a-1d]. After meticulous preoperative preparation, the patient, stayed at lithotomy position under general anesthesia, was admitted for flexible ureterorenoscopy with holmium laser lithotripsy. Unexpectedly, two stones were found at the left ureteral pelvis and subrenal calyx, respectively. The fistula were indwelled. After checkingin vitro, the foreign body was Hem-o-lok clip [Figure 1f]. After the operation, the patient recovered uneventfully. KUB re-examination showed no residual stones in the left kidney [Figure 1g].

To the Editor: A 43-year-old woman, having a renal cell carcinoma (RCC) treated with radical nephrectomy 15 months ago in West China Hospital, was consulted to our gynecology outpatient clinic for a 3-month history of vaginal bleeding in March 2008. Before the clinic, blood transfusion was given to the patient at a local hospital due to heavy vaginal bleeding.

To the Editor: Clinical trial participants have a right to know the results from the trials that they enable.^[1]European and North American research, however, shows that trial results are rarely shared with participants.^[2]Given the increase in industry-sponsored trials in China, we conducted the first investigation into Chinese consumer views about sharing the clinical trial results with participants.