Objective To review and evaluate the global clinical research literatures about the surgical management for prostatic abscess in the past decade, so as to provide useful information for clinical practice. Methods Based on the principles of evidence-based medicine, and the methods of bibliometrics, the PubMed database was searched from January 1st 2000 to April 10th 2011. The literatures about prostatic abscess were screened according to the predefined inclusion and exclusion criteria, the quality was assessed, the valid data were extracted and then systematical evaluation was performed after the establishment of the database with OpenOffice.org 3.8 Calc. Results a) A total of 205 articles were found initially and 81 were finally included with the total 388 cases involved (on average, 4.79 cases per paper). The patients’ ages ranged from 10 days to 83 years old. Two studies were diagnostic tests, and all the other 79 were surgical intervention studies; b) There was no controlled clinical trail. A total of 16 studies involving more than 5 cases for each and 311 cases in all which were retrospective case analyses, all the other 65 were individual case reports; c) American scholars published 13 papers (16.5%), ranked as the first. American and European scientists published 36 papers (44.44%). Chinese scholars published quite fewer studies, of which only 2 were in English; d) The incidence increased in younger patients gradually. The pathogens included fungi and bacteria. Most bacteria were gram-positive cocci (such as Staphylococci), followed by gram-negative bacillus (such as Klebsiella). There were also some minority pathogens. The pathogens were complex and quite diverse in different districts. The predisposing factors included both regional and systematic conditions, with diabetes mellitus, hepatocirrhosis, manipulations of lower urinary tract and urinary tract infections as the common; e) The diagnostic procedures included evaluation on symptoms and signs, physical examination, identification of pathogens, and medical imaging examinations (TRUS, CT, MRI). The therapeutic options included routine managements, conservative antibiotic therapies and surgical drainages. The surgical routes were transcutaneous, transperineal, transrectal, and transurethral. The fine needle aspiration, indwelling catheter drainage, or incision and drainage were performed under the guidance of TRUS, EUS or CT through transperineal or transrectal routes. The TUR, TURP or TUIP drainages were performed through transurethral route. The failed cases of fine needle aspiration were then treated by transurethral or transperineal incision and drainages, and some patients were also treated by urinary diversion; f) The best surgical method could not be concluded for lack of controlled data; and g) Few cases died from severe complications, and the outcomes of the majority cases were good. Conclusion a) The literatures about prostatic abscess are abundant but of low quality, with all retrospective studies or individual case reports, and most are published by American and European scholars; b) The prostatic abscess affects all ages but tends to increase in the young. Most pathogens are the gram-positive cocci (such as Staphylococci) ranked as the top and followed by gram-negative bacillus (such as Klebsiella), and the pathogens are obviously diverse in different districts; c) The predisposing factors are commonly seen as diabetes mellitus, hepatocirrhosis, manipulations of lower urinary tract and urinary tract infections; ......
Objective To provide baseline data for further evidence-based evaluation and selection of essential medicine by analyzing the inpatient disease constitution in 8 pilot township health centers located in eastern, central and western China in 2010. Methods The analysis was performed to compare the similarities and differences of both systematic diseases and top 15 single diseases of inpatients in 8 pilot township health centers located in eastern, central and western China in 2010. The Microsoft Excel 2003 and SPSS 13.0 softwares were used for data classification and analysis, and the frequency and composition were used as describing statistical indicators. Results a) The top 5 systematic diseases were respiratory, digestive, circulatory, urinary tract and urogenital systems, as well as the trauma and toxicosis, with accumulative constituent ratio accounting for 71.0%-81.6%; b) The inpatients suffering from top 15 systematic diseases were 10 630, accounting for 61.10%. Each of the respiratory and digestive system contained 6 single diseases including 4 acute and 2 chronic ones, with inpatients accounting for 99.2% and 93.8%, respectively; the circulatory system contained 3 single diseases which were all chronic with inpatient ratio of 84.6%; and c) The chronic diseases were in majority within the top 15 single diseases, which were most commonly seen rather than acute diseases in the pilot township health centers in eastern and central China. The inpatients’ acute diseases were more often seen than chronic diseases in well-off and fundamental township health centers. Conclusion a) The top 5-6 systematic diseases are stable in the pilot township health centers in eastern, central and western China in 2010. The common single inpatient diseases are centralized, which benefits the selection and adjustment of essential medicine for the pilot township health centers in China; b) The capacity building of the western, fundamental and well-off township health centers to diagnose and treat inpatients suffering acute diseases should be promoted; c) The capacity building of the central and general township health centers to diagnose and manage inpatients suffering chronic diseases should be promoted; d) The capacity building of the eastern and well-off township health centers to provide outpatient service should be promoted. The function of the eastern township health centers needs further clarification and improvement; and e) More attention should be paid to diseases prevention, control and treatment for women, children, the elderly and the population with high burden of diseases.
Objective To establish standards, methods and processes for evidence-based evaluation and selection of essential medicine that meet the needs of the 8 pilot township health centers in China. Methods A descriptive analysis was conducted to compare the similarities/differences and the advantages/disadvantages of the standards, methods and processes between the World Health Organization (WHO) essential medicines evaluation and selection, and the GRADE evidence quality and recommend intensity. In combination with the former outcomes of this series of study, the standards, methods and processes of evidence-based evaluation and selection of essential medicines in the domestic pilot township health centers were optimized, restructured and improved. Softwares such as GRADEprofiler were used to assess the quality of evidence. Results a) Localized standards, methods and processes for evidence-based evaluation and selection of essential medicine were established, and the evaluation tool was ascertained; and b) Disease and drug names, guidelines and searching processes for evaluation and selection of essential medicine were developed with standardized, systematic and transparent approaches. Conclusion a) Standards, methods and processes for searching, evaluating and recommending the best evidence are preliminarily established, through comparative analysis on the effectiveness, safety, cost-effectiveness and applicability of the candidate medicines for diagnosing, treating and preventing diseases in township health centers in China; b) Following the principle of “utilizing the best existing evidences and developing the urgently-needed but lacking evidence”, a good exploration was done for the localization, standardization and transparency of the standards, methods and processes of evidence-based evaluation and selection of essential medicine for pilot township health centers.
Objective To evaluate and select essential medicine for urolithiasis using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Three evidence-based guidelines were included. Based on WHOEML (2011), NEML (2009), CNF (2010) and the quantity and quality of evidence, we made a recommendation for diclofenac sodium, nifedipine, allopurinol and ibuprofen used in symptomatic treatment of urolithiasis. (3) Results of domestic studies (including four RCTs, n=566; two observational studies, n=96) indicated that calculus-removed rates of diclofenac sodium, nifedipine and allopurinol were 91.5%, 86.4%~93.3% and 86.4% respectively with significant differences. Diclofenac sodium daily cost 7.00 to 8.57 yuan, nifedipine 1.48 to 4.44 yuan, and allopurinol 0.24 to 0.82 yuan. Ibuprofen had a total efficiency of 94.5% with a significant difference for alleviating renal colic, which cost 0.11 yuan daily. Four recommended medicines with safety, clinical efficacy, high economical efficiency and applicability had been marketed with specifications and dosage forms corresponding to guidelines in China. Conclusion For urolithiasis: (1) We offer a b recommendation for diclofenac sodium (capsule/tablet, 50 mg×24, or 25 mg×24) which is contradicted in patients with gastrointestinal bleeding and in pregnant women or women with planned pregnancy. (2) We offer a weak recommendation for nifedipine (tablet/capsule, 10 mg×100 or 10 mg×60) which is contraindicated in dialysis-receiving patients with malignant hypertension and should be cautiously used in patients with irreversible renal failure. (3) We offer a weak recommend allopurinol (tablet, 100 mg×100) which is contraindicated in patients with allergic reaction, severe insufficiency of the liver or kidney, or significant lack of blood cells. (4) We offer a b recommendation for ibuprofen (tablet, 20 mg×20) which is contraindicated in patients with allergic reaction to aspirin.
Objective To evaluate and select essential medicine for middle-aged and elderly women with primary osteoporosis using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) 18 guidelines were included, 14 of which were evidence-based or based on expert consensus. Recommended medicines included bisphosphonates, calcitonin, estrogen, parathyroid hormone, selective estrogen receptor modulator, strontium and Chinese patent drug. (2) A result of one quasi-RCT (very low quality) indicated that caltrate D had a better effect on elderly women with primary osteoporosis than calcium gluconate in improving bone mineral density (BMD) (MD=0.04, 95%CI 0.02 to 0.06) and ameliorating bone ache ( RR=2.64, 95%CI 1.40 to 4.96). A few cases treated by caltrate D presented with adverse reaction such as gastrointestinal discomfort, poor appetite, constipation and nausea which disappeared later. Caltrate D (calcium carbonate D3) with good applicability cost 1.00 yuan daily. (3) A result of one RCT (low quality) indicated that alendronate had a better effect than caltrate D in improving L2-L4 BMD (MD=0.06, 95%CI 0.017 to 0.10) and ameliorating bone ache (RR=1.8, 95%CI 1.40 to 2.52). A result of two RCTs (moderate quality) indicated that alendronate plus calcium carbonate plus vitamin D6 had a better effect than calcium carbonate plus vitamin D in improving L2-L4 BMD (MD=0.05, 95%CI 0.02 to 0.08) and reducing blood alkaline phosphatase (MD=–31.9, 95%CI –54.99 to –8.81). There were slight adverse effects mainly including gastrointestinal reaction. Alendronate with fairly poor applicability cost 2.67 yuan daily. (4) A result of one RCT (moderate quality) indicated that after a 3-month treatment, Xian Ling Gu Bao Jiao Nang (name of a Chinese patent drug, abbreviated as XLGB) plus calcium preparation had a better effect than calcium preparation alone (MD=10, 95%CI 0.05 to 0.15). A result of one RCT (moderate quality) indicated that given for 3 to 6 months, XLGB plus calcium preparation was superior to calcium preparation alone in increasing the density of Ward’s triangle and the great femoral trochanter. A result of one RCT (low quality) indicated that XLGB plus calcitriol had a better effect than calcitriol alone in pain relief (RR=1.26, 95%CI 1.04 to 1.52). There were slight adverse effects mainly including reaction in the digestive system, the circulatory system and the skin. XLGB with good applicability cost 4.58 yuan daily. Conclusion We offer a weak recommendation for alendronate applied to middle-aged and elderly women with primary osteoporosis and pain and fracture caused by primary osteoporosis. We also offer a b recommendation for caltrate D and XLGB applied to middle-aged and elderly women with primary osteoporosis and pain and fracture caused by primary osteoporosis. In addition, we propose that the census on elder people with osteoporosis in rural areas should be carried out. More clinical and pharmacoeconomic studies of large-sample, high-quality on alendronate and its calcium preparation for adult osteoporosis are needed in China.
Objective To evaluate and select essential medicine for uterine neoplasms using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Six guidelines were included, three of which were evidence-based. (2) Retrieved guidelines related to nine medicines (of three classes) for uterine neoplasms and five adjuvant drugs (of three classes) used after relevant surgery. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guideline and the quantity and quality of evidence, we offered a b recommendation for medroxyprogesterone acetate, oxytocin, ergometrine and a weak recommendation for testosterone propionate, methyltestosterone, tamoxifen, mifepristone, tranexamic acid, leonurus heterophyllus used in the treatment of uterine neoplasms. We offered a recommendation against danazol and aromatase inhibitors. (4) We found relevant domestic literature on mifepristone, methyltestosterone, tamoxifen, oxytocin and leonurus heterophyllus. Mifepriston combined with methyltestosterone or tamoxifen was recommended to use as a conservative therapy for uterine neoplasms. Oxytocin,and leonurus heterophyllus were used to reduce bleeding after the surgery of uterine neoplasms. As to daily expense, mifepriston (25 mg/d) cost 13.0 to 27.5 yuan, methyltestosterone (5 mg/d) 0.074 yuan, tamoxifen (20 mg/d) 0.6 to 1.4 yuan, leonurus heterophyllus (injection, 1 mL) 15 yuan and oxytocin (injection, 20 U) 1.5 yuan. (5) Results of domestic studies indicated that mifepristone, mifepristone plus methyltestosterone, and mifepristone plus tamoxifen were proved to be safe and applicable for the treatment of uterine neoplasms. Oxytocin and leonurus heterophyllus are effective in preventing postoperative bleeding and the combination of two effectively and safely promoted uterine contraction. Conclusion (1) We offer a recommendation for three medication plans used in the treatment uterine neoplasms during perimenopause, including: a) Mifepristone (25 mg/ tablet, once daily); b) Mifepristone (25 mg/ tablet, once daily) plus methyltestosterone (5 mg/tablet, once daily); c) Mifepristone (25 mg/ tablet, once daily) plus tamoxifen (10 mg/tablet, twice daily). The three plans mentioned above should be used from first day of menstrual cycle, continuously for three months. (2) Adjuvant drugs such as oxytocin (injection, 1 to 2 mL) and leonurus heterophyllus (injection, 10 U) can be applied to reduce vaginal bleeding flow after the surgery of uterine neoplasms. (3) Personnel in elementary healthcare institution should stick to drug indication, carefully make follow-up, and dynamically monitor the change of uterine neoplasms and menstruation so as to adjust medication plan according to patients’ situation.
Objective To evaluate and select essential medicine for herniated lumbar disc based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Six clinical guidelines on herniated lumbar disc were included, five of which were evidence-based. (2) In total, there were 35 medicines (of four classes) listed in the guidelines. (3) We offer a b recommendation for paracetamol and ibuprofen as essential medicine and a weak recommendation for aspirin, indometacin and diazepam according to WHOEML (2011), NEML (2009), CNF (2010), clinical guidelines and the quantity and quality of evidence. (4) Five recommended medicines have been marketed in China with the dosage forms and specifications corresponding to guidelines and their prices were affordable (0.31 to 3.38 yuan daily). (5) Results of domestic low-quality studies indicated that ibuprofen and aspirin were effective with efficiencies of 63% to 84.5%; however, both of which were less effective than other trial medicines (efficiencies: 88.60% to 95.2%). We didn’t find any efficacy or pharmacoeconomic evidence of other medicines in Chinese literature databases. Conclusion (1) Pharmacotherapy should focus on symptomatic treatment of herniated lumbar disc. (2) We offer a b recommendation for paracetamol and ibuprofen used in the treatment of herniated lumbar disc and a weak recommendation for aspirin, indometacin and diazepam. (3) There is lack of evidence and high-quality guidelines on pharmacotherapy of lumbar intervertebral disc in China, especially pharmacoeconomic evidence. (4) We propose that guidelines should be established in basis of evidence so as to effectively direct clinical treatment. The effect of medicine in clinical practice should be based on current evidence from inside and outside China.
Objective To evaluate and select essential medicine for diabetes mellitus based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Six guidelines were included, three of which were evidence-based and published from 2006 to 2011. (2) Five recommended medicines were included according to recommendations and evidence of WHOEML (2011), NEML (2009), CNF (2010) and other guidelines. They were metformin, glibenclamide, glipizide, rosiglitazone and pioglitazone. Domestic evidence of the first three drugs was evaluated. (3) The first three have been marketed with the specifications and dosage forms corresponding to guidelines in China. The FBG cost-effectiveness ratios of metformin with different dosage forms as immediate release compressed tablet, enteric-coated tablet and sustained release capsule were 3.37, 3.76 and 3.50 respectively. 2-hour BG cost-effectiveness ratios of metformin were 3.74, 4.00 and 3.71 respectively. The cost-effectiveness ratio of glibenclamide and glimepiride were 11.23 and 13.81 respectively. Conclusion We offer a recommendation for: (1) Metformin (immediate release tablet/capsule for oral use, 0.25 g), contraindicated in patients with renal insufficiency. (2) Glibenclamide (tablet, 2.5 mg; capsule, 1.75 mg) and glipizide (tablet, 2.5 or 5mg; dispersible tablet, 5 mg), contraindicated in children, women during pregnancy or lactation, patients in the perioperative period of major operation, patients after total pancreatectomy, and patients allergic or adversely reacted to sulfa drug. (3) Evidence-based and standardized primary healthcare guidelines as well as clinical and pharmacoeconomic studies on diabetes mellitus (large-scale, multi-centre, randomized and double-blinded) are needed to produce high-quality local evidence.
Objective To evaluate and select essential medicine for abortion using evidence-based approaches based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Four guidelines on medicine for abortion were included, two of which are based on evidence. (2) Included guidelines referred to eight essential medicines used in drug abortion and four antibiotics used after abortion surgery. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guideline and the quantity and quality of evidence, we offered a b recommendation for misoprostol, mifepristone, oxytocin except prostaglandins used in abortion. (4) Published literature on oxytocin, misoprostol and mifepristone were found. Oxytocin with the dosage form and specification corresponding to guidelines has been marketed in China. Oxytocin (in vial, 10 U∶1 mL) cost 1.5 yuan/injection. Mifepristone (tablet, 25 mg×1) cost 13.0 to 27.5 yuan/tablet. Misoprostol (0.2 mg×3) cost 2.8 to 3.7 yuan/ tablet. (5) Results of domestic studies indicated that mifepristone combined with misoprostol and oxytocin was safe, efficient, convenient and applicable to the treatment of abortion. Conclusion For abortion: (1) We make a recommendation for mifepristone plus misoprostol. Mifepristone (25 to 50 mg/tablet) is orally taken twice a day, continually for 2 to 3 days, the total dose of 150 mg for three days. Misoprostol (0.2 mg/ tablet) 0.6 mg is orally given on an empty stomach within 36 to 48 hours after the intake of mifepristone. (2) Oxytocin (5 to 10 U in vial) injected after delivering the placenta can reduce the volume and time of vaginal bleeding. In future, clinical study should be standardized in order to improve design and implementation quality.