Objective To evaluate the efficacy and safety of Polyunsaturated phosphatidylcholine (PPC) for chronic hepatitis. Methods We searched EMBASE (1980May,2003), MEDLINE(1966May,2003), CBM (1979May,2003), The Cochrane Library Issue 2, 2003 and handsearched 8 related Chinese journals. Randomized controlled trials(RCT) comparing PPC versus placebo/no treatment for chronic hepatitis were included with no restrictions of blinding, language and publication. Two reviewers independently performed data extraction and assessed the quality . Data were entered and analyzed by RevMan 4.2 software supplied by the Cochrane Collaboration .Results Six high quality trials involving 568 patients were included. Four studies involving 451 patients showed the clinical effective rate of PPC for chronic hepatitis was 52.5% while the control group was 37.5% with statistical difference [RR1.81,95%CI(1.41,2.33),Z=4.69, Plt;0.00001].A meta-analysis involving three studies with 100 patients showed the PPC can statically improve histopathology of chronic hepatitis comparing with control group [RR 2.58,95%CI (1.61,4.15),Z=3.91,Plt;0.0001].No serious adverse events were reported.Conclusions PPC is a safe medicine used for treating chronic viral hepatitis and may relieve clinical symptoms and signs.At the same time ,it has positive effect on hepatic histopathology for patients .However ,more high quality clinical trials are required.
Objective To evaluate and select essential medicine for acute and chronic gastritis using evidence-based approaches 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) Five guidelines for acute gastritis and seven guidelines for chronic gastritis were included. The recommended included omeprazole, ranitidine and domperidone. (2) A result of three CCTs (n=315, low quality) indicated that omeprazole was superior to famotidine and ranitidine in alleviating symptoms of chronic gastritis such as pain or discomfort in the upper abdomen, regurgitation, a burning sensation in the heart, distention and fullness in the upper abdomen (71.2% vs. 47.3%, 94.4% vs. 84.3%, Plt;0.05). A result of one RCT (n=100, low quality) and two CCTs (n=213, low quality) indicated that in HP eradication rates, omeprazole triple therapy and the control intervention had no significant difference (OR=1.09, 95%CI 0.44 to 2.70, Pgt;0.05). A result of one RCT (n=100, low quality) indicated that omeprazole caused no adverse reaction. A result of five CCTs (n=528, low quality) indicated that adverse reaction of omeprazole included poor appetite (two cases), nausea and vomiting (four cases), headache or vertigo (one case) and increased transaminase (one case). Omeprazole cost eight yuan (tablet) or four yuan (capsule) daily. (3) HP eradication rates of ranitidine bismuth citrate was higher than the control group (OR=2.05, 95%CI 1.29 to 3.25, P=0.002). A result of 15 RCTs (n=3 638, high quality) indicated adverse reaction of ranitidine bismuth citrate mainly included symptoms in the digestive system. A result of one RCT (n=100, low quality) indicated ranitidine bismuth citrate and omeprazole triple therapy had no significant difference (Pgt;0.05) and ranitidine bismuth citrate caused no adverse reaction. Ranitidine cost 0.36 yuan (tablet), 0.40 yuan (capsule) or 2.7 to 5.4 yuan (injection) daily. (4) A result of two CCTs (n=133, low quality) indicated that compared with the control intervention, domperidone was more efficient without adverse reaction in improving indigestion, promoting gastric emptying effect, and alleviating pain and distention in the upper abdomen, belching and regurgitation. Domperidone cost 1 to 1.3 yuan daily. (5) All kinds of recommended medicines are listed and legalized in China Pharmacopoeia (2010) and CNF (2010). (6) In clinical setting, above-recommended medicines should be applied strictly according to the CNF (2010) and the National Clinical Prescription Guidelines for Essential Medicine. Conclusion For acute and chronic gastritis, indigestion and HP eradication: (1) We offer a b recommendation for omeprazole (immediate release tablet/capsule for oral use, 10 mg/tablet) which should be cautiously used in children, elderly people, and women during pregnancy or lactation. (2) We offer a b recommendation for ranitidine (immediate release tablet/capsule for oral use, 150 mg/tablet) which should be cautiously used in patients with severe insufficiency in the liver or kidney, women in the pregnancy or lactation, and children under eight years of age.
Objective To evaluate and select essential medicine for acute gastroenteritis using evidence-based approaches 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) Five guidelines were included, two of which were evidence-based. (2) Recommended medicines included eight antidiarrheals (of four classes) and three antemetics. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence, we offered a weak recommendation for ondansetron, metoclopramide, smectite, racecadotril and loperamide applied in the treatment of acute gastroenteritis. We made a recommendation against antibiotics, dexamethasone, kaolin-pectin, activated charcoal, attapulgite and bismuth subsalicylate. (4) Evidence from domestic studies: a result of 14 CCTs (n=1 635, low quality) indicated that in the significant efficiency and total efficiency, smectite (smecta) was superior to routine liquid infusion, norfloxacin, gentamicin or furaxone. Among these 14 CCTs, two CCTs reported smectite (smecta) caused nausea and vomiting (three cases); one CCT reported pain and distention in the abdomen (one case) and general discomfort (one case); and the rest reported no adverse reaction. A result of 10 CCTs (n=1 017, low quality) indicated that for acute diarrhea, racecadotril was superior to routine treatment in the significant efficiency (OR=2.55, 95%CI 1.64 to 3.94, Plt;0.01) and total efficiency (OR=4.32, 95%CI 2.96 to 6.30, Plt;0.01). A result of two CCTs (n=344, low quality) indicated that racecadotril was superior to smectite in the total efficiency in treating acute diarrhea. A result of two CCTs (n=1 056, low quality) indicated that racecadotril was superior to routine treatment in the total efficiency in treating acute adult diarrhea (OR=5.19, 95%CI 3.54 to 7.63, Plt;0.01). A result of two CCTs (n=182, low quality) reported children presented with nausea (two cases). A result of one CCT (n=947, low quality) reported adults presented with constipation (fifteen cases), anorexia (four cases), headache (nine cases) and abdominal pain (one case). Conclusion For acute gastroentitis, we offer a weak recommendation for smectite (powder, for oral use) used in adults (once 3 g, tid., mixed with warm water before intake), child under one year of age (3 g daily, bid.), and child above one year of age (once 3 g, qd. or bid.). Retention enema could be appiled to children with acute gastroenteritis. We also offer a weak recommendation for racecadotril (capsule) used in adults (one capsule, tid., taken continuously less than seven days). Due to the lack of evidence from clinical trials, we make a recommendation against racecadotril applied to women with pregnancy and lactation or children. In order to produce high-quality local evidence, we propose that (1) Further clinical studies should be standardized in diagnosis and criteria. (2) The design and implementation quality of clinical studies should be improved. (3) Original studies on pharmacoeconomic studies and drug applicability are needed.
ObjectiveTo investigate the value of morning blood pressure surge in the evaluation of atherosclerosis by the observation of the relationship between morning blood pressure surge and ambulatory arterial stiffness index. MethodsFrom May 2011 to March 2013, we followed up 300 hypertensive patients who received ambulatory blood pressure monitoring, and they were divide into elevated morning blood pressure surge group and non-elevated morning blood pressure surge group. The AASI value was recorded and compared between the two groups according to the grade of hypertension. ResultsMorning blood pressure surge was more common in patients with hypertension. Compared with patients in the non-elevated morning blood pressure surge group, ambulatory arterial stiffness index was significantly higher in patients in the elevated morning blood pressure surge group. ConclusionThere is a certain correlation between morning blood pressure surge and arterial stiffness, which is an important factor leading to a variety of target organ damage.
Objectives We conducted a literature review of 33 kinds of Traditional Chinese medicine injections (CMIs) on the national essential medicine list (2004 edition) of China in ADR articles to retrieve basic ADR information and research trends related to CMIs and to provide evidence for the research and development as well as the rational use of CMIs, particularly pharmacovigilance and risk management of CMIs. Methods We electronically searched Chinese Biomedical Literature Database (CBM, Jan. 1978-April 2009), the China National Knowledge Infrastructure Database (CNKI, Jan. 1979-April 2009), Chinese Science and Technology Periodical Database (VIP, Jan. 1989-April 2009) and the Traditional Chinese Medicine Database (Jan. 1984 April 2009). We also retrieved the websites of Ministry of Health and State Food and Drug Administration, to collect data about CMIs ADRs reports and regulations from “Newsletter of Adverse Drug Reactions” (Issue 1 to 22). Then we descriptively analyzed all the results on the year published, periodicals and types of study design of included ADR literatures, the major CMIs as well as the regulations about their ADRs. Results (1) There were 5 405 citations found in total and 2160 were removed because of duplication. After screening the title, abstract and full text of the selected papers, 1 010 studies finally met the eligible criteria. (2) The total and cumulative amount of research articles published about CMIs ADRs significantly increases over time. (3) The included 1,010 articles were scattered among 297 periodicals. A total of 55 journals on pharmaceutical medicine, containing 399 articles, accounted for 39.50% of total; 64 journals on traditional Chinese medicine and pharmaceutical medicine, containing only 197 articles, amounted for 19.50% of total. Only 22 periodicals were included on the core journals of the Beijing University List (2008 edition) (8.94% of the total journals in the list), which published 129 articles (12.77% of the total articles published). (4) We categorized the articles included into eight categories based on their content and study methodology. There were: 348 case reports and 254 case series which accounted for 34.46% and 25.15% of the total articles, 119 overviews (11.78%), 116 randomized controlled trials (11.49%), 78 cross-sectional studies (7.72%), 61 ADR literature analyses (6.04%), and 28 non-randomized controlled clinical studies (2.77%). (5) In the three of top ten journals, "Adverse Drug Reactions Journal", "China Medical Herald", and "Chinese Pharmaceuticals" published literature accounted for 5.84%, 3.76% and 2.67% of the total respectively. (6) The reports of ADRs to Shuanghuanglian, Qingkailing and Yuxingcao injections were the most in all reports for CMIs (All the three injections had more than 200 articles, accounting for 41.95% of the total). The Ministry of Health and the State Food and Drug Administration took measures to supervise them. (7) The four kinds of CMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) among the top 5 reported ADR literatures were removed from the market or were suspended for sale. The varieties and numbers of reports for CMIs ADRs have relationship with the supervision to them. Conclusions (1) Articles published on CMIs ADRs increased year by year, but overall the research is of low quality and is scattered in a large number of sources. (2) It is very urgent to create a clear standard to grade ADRs of CMIs for the risk management. (3) It is necessary to enforce safety re-evaluation work for CMIs and to promote the clinical rational use.
Objective To evaluate and select essential medicine for bone fracture 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) 17 guidelines were included, six of which were evidence-based or based on expert consensus. We found that for fracture, global guidelines recommended surgical treatment and analgesics, while domestic guidelines recommended Chinese patent drugs. (2) A result of one RCT (low quality) indicated that Shang Ke Jie Gu Pian (name of a Chinese patent drug) shortened the clinical recovery time of fracture (MD=–4.2, 95%CI –5.25 to –3.14). A result of one RCT indicated that Shang Ke Jiu Ji Pian had a higher total clinical efficiency compared with San Qi Pian (name of a Chinese patent drug) (RR=1.28, 95%CI 1.11 to 1.47). A result of one RCT (low quality) indicated that Shang Ke Jiu Ji Pian (name of a Chinese patent drug) had a better effect than Shenyang Hong Yao Pian (name of a Chinese patent drug) in promoting the growth of osteotylus (RR=1.48, 95%CI 1.27 to 1.73) and also it had a higher clinical recovery rate (RR=1.62, 95%CI 1.37 to 1.9) compared to Shenyang Hong Yao Pian. A result of one RCT (moderate quality) indicated that Shang Ke Jiu Ji Pian was slightly better than Die Da Wan (name of Chinese patent drug) in regard to the recovery score of fracture (MD=0.25, 95%CI 0.026 to 0.47). A result of one RCT (low quality) indicated that compared to fracture reduction alone Shang Ke Jiu Ji Pian efficiently relieved pain (MD=–25.9, 95% –32.6 to –19.19) and shortened pain time (MD=–38.6, 95% –41.44 to –35.77). A result of one quasi-RCT (low quality) indicated that Shang Ke Jiu Ji Pian had a higher efficiency in relieving pain than benorylate (RR=1.13, 95%CI 1.04 to 1.23). A result of one RCT (low quality) indicated that Shang Ke Jiu Ji Pian had a higher efficiency than Shenyang Hong Yao Pian in relieving pain and swelling (RR=2.4, 95%CI 1.88 to 3.02). A result of one RCT (moderate quality) indicated that Shang Ke Jiu Ji Pian was superior to Die Da Wan in relieving pain and swelling (MD=–0.4, 95%CI –0.60 to –0.2). A result of two RCT (n=198) indicated that Shang Ke Jie Gu Pian caused no adverse reaction. With good applicability, Shang Ke Jie Gu Pian (taken with warm water or rice wine) cost 7.47 yuan daily. Conclusion (1) We offer a b recommendation for Shang Ke Jie Gu Pian and Jie Gu Qi Li Pian used in the treatment of adult fracture. (2) We should carry out more large-sample and controlled trials and improve outcome indicator in order to produce high-quality local evidence.
Objective To investigate the characteristics of blood pressure and coronary artery impairment in patients with essential hypertension (EH) combining coronary heart disease (CHD). Methods A total of 358 patients with EH combining CHD and other 144 patients with CHD were measured with ambulatory blood pressure monitoring (ABPM), and the parameters of ambulatory blood pressure were analyzed. All the patients underwent coronary angiography. The severity of coronary artery stenosis was evaluated in accordance with the number of impaired arteries. Results Compared to the patients with simplex CHD, those with EH combining CHD had much heavier artery stenosis and more diffuse lesions, with significant differences (χ2=6.03, P=0.019). The 24h systolic blood pressure (SBP), day SBP, night SBP, 24h pulse pressure (PP), day PP and night PP were higher in the patients with EH combining CHD compared to those of the patients with simplex CHD (The t values were 2.580, 2.045, 2.675, 2.037, 2.601, and 1.995, respectively, while the P values were 0.015, 0.037, 0.009, 0.041, 0.017, and 0.047, respectively). Conclusion Compared to the patients with simplex CHD, the patients with EH combining CHD suffer from much severe coronary artery impairment, so a good controlling of blood pressure is advisable to improve the coronary artery impairment for the patients with EH combining CHD.
Objective To evaluate and select essential medicine for children with fever and adult gastrointestinal flu caused by common cold using evidence-based approaches 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) 12 guidelines were included, 11 of which were evidence-based or based on expert consensus. We offered a recommendation for medicines used in the treatment including analgesics and antipyretics, decongestants, antihistamines, cough-relieving drug, phlegm-removing drug and drug for gastrointestinal symptoms. (2) A result of four RCTs (very low quality) indicated that in the treatment of children with cold, ibuprofen suspension had an antipyretic effect similar to paracetamol solution (for oral use) with a pooled result of 6-hour efficiency in relieving fever (RR 1.48, 95%CI 0.66 to 3.30, P=0.34). The major adverse effects of ibuprofen suspension included gastrointestinal reaction and profuse sweats (RR=1.23, 95%CI 0.72 to 2.11, P=0.45). With good applicability, ibuprofen suspension (for oral use with no need to be supervised) cost 1.93 yuan daily. (3) A result of three RCTs (low quality) indicated that after given for 30 minutes and one hour, paracetamol solution (suppository) was fairly superior to ibuprofen suspension in lowering the high temperature caused by fever (given for 30 min: MD= –0.16°C, 95%CI –0.21 to –0.11, Plt;0.01; given for one hour: MD= –0.19°C, 95%CI –0.28 to 0.10, Plt;0.01). As to adverse reaction, paracetamol solution (suppository) mainly included anal irritation, skin rashes and profuse sweats, which had a comparative result of incidence with ibuprofen suspension (RR=1.84, 95%CI 0.62 to 5.44, P=0.27). For children with fever, paracetamol solution (suppository) cost 0.90 yuan daily. With good applicability, paracetamol solution (suppository) was administered via the anus. Conclusion (1) We offer a b recommendation for ibuprofen suspension (2 g/100 mL) or acetaminophen (0.1 g/suppository) as symptomatic treatment used in children with fever, pain and discomfort caused by common cold, and for Huo Xiang Zheng Qi Jiao Nang (0.3 g/ capsule) used in adults with gastrointestinal flu. We also offer a weak recommendation for acetylcysteine (injection, 300 mg/mL, 10 mL/ampoule) used in patients with paracetamol poisoning. (2) In order to produce high-quality local evidence, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on ibuprofen suspension and acetaminophen suppository in the treatment of children with fever, pain and discomfort caused by common cold should be further carried out. Besides, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on Chinese patent drugs of Huo Xiang Zheng Qi used in chidren and Huo Xiang Zheng Qi Jiao Nang used in adults should further carried out. Moreover, we suggest that epidemiological investigation as well as clinical and pharmacoeconomic studies of acetylcysteine injection for paracetamol poisoning should be carried out and the instructions of acetylcysteine injection should be added in the guidelines of essential medicine in China. Finally, further studies on evidence of oxymetazoline, dextromethorphan and other Chinese patent drugs with the effect of relieving cough and treating cold should be carried out.
ObjectiveTo build the list of appropriate dosage forms and specifications of essential medicines for children which is subsistent abroad and absent in China. MethodsBased on the authoritative data and expert consultation, we established the selection methodology which included the standard of essential medicine for children, the standard of appropriate dosage for children, the standard of appropriate specifications for children, the standard of urgent classification, the standard of urgent level. ResultsThe list of appropriate dosage forms and specifications included 61 medicines which included 20 dosage forms and 112 specifications. 112 specifications included 27 specifications which belong to level Ⅱ, and 85 specifications which belong to level Ⅲ. ConclusionThe established list can be included by the green channel.