Network Meta-analysis of oral Chinese patent medicine in treatment of acute cerebral infarction / 中国中药杂志

The efficacy of oral Chinese patent medicine in the treatment of acute cerebral infarction was systematically evaluated by network Meta-analysis. The literature search was conducted in three English databases(Medline, EMbase and Cochrane Library) and four Chinese databases(CNKI, VIP, WanFang and SinoMed) from inception to June 2018, and the randomized controlled trials of acute cerebral infarction were screened out according to the pre-set criteria. Two reviewers independently screened out the literature by using pre-specified eligibility criteria, and assessed the quality of included studies according to the risk of bias tool of Cochrane Handbook 5.1.0. Data analysis was conducted by using Stata 13.0 and WinBUGS 1.4.3 software. Finally, 52 RCT were included, involving 11 kinds of oral Chinese patent medicines. The results of the network Meta-analysis showed that in terms of the total effective rate, the order of efficacy was as follows: Naomaitai Capsules>Xiaoshuan Changrong Capsules>Angong Niuhuang Pills>Yangxue Qingnao Granules>Compound Danshen Dripping Pills>Naoxintong Capsules>Tongxinluo Capsules>Naoxueshu Oral Liquid>Zhuyu Tongmai Capsules>Yinxingye Tablets>Compound Danshen Tablets; in terms of neurological deficit scores, the order of efficacy was: Tongxinluo Capsules>Angong Niuhuang Pills>Compound Danshen Dripping Pills>Xiaoshuan Changrong Capsules>Yangxue Qingnao Granules>Zhuyu Tongmai Capsules>Naoxintong Capsules>Naoxueshu Oral Liquid; in terms of Barthel index score, the order of efficacy was: Xiaoshuan Changrong Capsules>Naomaitai Capsules>Naoxueshu Oral Liquid>Angong Niuhuang Pills>Tongxinluo Capsules>Zhuyu Tongmai Capsules. Although different oral Chinese patent medicines can improve these outcomes, the difference in efficacy ranking was relatively large. Because of the small number and low quality of research literature, the conclusion still needs to be proved by multi-center, large-sample, and double-blind randomized trials.

Meta-analysis on safety of Tripterygium Glycosides Tablets in treatment of rheumatoid arthritis / 中国中药杂志

To systematically evaluate the adverse drug reaction(ADR) of Tripterygium Glycosides Tablets(TGT) in the treatment of rheumatoid arthritis(RA). Four Chinese databases(CNKI, VIP, WanFang, SinoMed) and three English databases(Cochrane Library, EMbase, PubMed), from the time of database establishing to August 2019, were systematically retrieved to collect literature on the treatment of all types of RA with TG. Screening literature and extracting data according to inclusion and exclusion criteria. All studies were assessed by using internationally recognized methodological quality assessment tools or reporting quality evaluation criteria, with data being extracted and Meta-analyzed. There were 79 studies included, randomized controlled trials(RCT) containing TGT in the treatment group, non-randomized controlled trials(non-RCT), case series, case reports, and RCT containing TGT only in the control group were covered. There were in the control group; 765 ADR of 2 214 patients in 30 RCT(treatment group given TGT), 11 non-RCT and 7 case reports. The results of Meta-analysis of these 48 literatures showed that the overall incidence of ADRs was 0.23(95%CI[0.22,0.24]); ADR mainly occured in the reproductive, gastrointestinal, skin and accessories, blood, hepatobiliary system damage and the incidence of ADR in systems mentioned about respectively were 0.14(95%CI[0.12,0.17]),0.07(95%CI[0.06,0.08]),0.06(95%CI[0.04,0.07]),0.04(95%CI[0.03,0.05]),0.04(95%CI[0.03,0.05]). Further subgroup analysis results showed that the incidence of total ADR, especially the gastrointestinal, reproductive and cutaneous ADR of patients with treatment alone was higher than that in those paients with MTX or MTX+LEF therapy; The incidence of ADR, especially the gastrointestinal ADR, was also positively correlated with daily dose and course of treatment, while the incidence of different systems ADR was also correlated with different drug manufacturers, for instance, damage on the female reproductive system occurs most frequently in Hunan manufacture TGT administration, same as the damage on skin and accessories induced by TGT from Jiangsu manufacture. Above all, The clinical treatment of TGT for RA will cause multi-system ADR, with the highest incidence in the reproductive system, followed by the gastrointestinal system, which is closely related to the way of medication(monotherapy), daily dose, course of medication and drug manufacturer. Therefore, it is recommended that, in the treatment of RA, using TGT in combination, low dose or short-course medication, take measures to protect the reproductive system, stomach and liver, and paying attention to the drug manufacturer as well response of patients during administration should be valued to avoid ADRs to the maximum possibility.

Systematic review of Kudiezi injection drug safety / 中国中药杂志

To systematically evaluate the safety of Kudiezi injection. Databases such as Cochrane library, Medline, EMbase, Web of Science, Clinical Trials, CBM, CNKI, VIP, Wanfang and Chinese Clinical Trial Register were searched to collect the literature on all the study types of Kudiezi injection. Two researchers screened literature, assessed quality and extracted data according to inclusion and exclusion criteria. All studies were assessed by using internationally recognized methodological quality assessment tools or reporting quality evaluation criteria; Meta-analysis of adverse drug reaction/adverse events (ADR/AE) of Kudiezi injection was performed by using Stata 12.0 software. There were 411 clinical studies included, out of which 315 studies were analyzed finally. 18 072 patients in total used kudiezi injection, and there were 330 cases with ADRs and 13 cases with AEs. The most common ADR related system was the central and peripheral nervous system, with a weighted incidence of 2.9% [95%CI(0.022, 0.036)]. From the current evidence, the overall safety of Kudiezi injection was acceptable. Although data could be collected from all kinds of published reports, there are lack of mechanism experiments or observational studies with large samples of Kudiezi injection. Therefore, it is necessary to carry out further research on the safety of Kudiezi injection. Meanwhile, off label use of Kudiezi injection is common, so it is urgent for relevant governmental departments to formulate drug use specifications and provide better guidance for clinical drug use.

Shenshuaining capsules as adjuvant treatment for chronic renal failure： systematic review and Meta-analysis of randomized controlled trials / 中国中药杂志

Chronic renal failure(CRF) is one of the common diseases. Shenshuaining capsule (SSN) can be used to treat patients with CRF, and many randomized control trials(RCTs) have been conducted to investigate its efficacy. The current review aims to systematically evaluate the efficacy and safety of SSN as an adjuvant treatment for patients with CRF. Eleven English and Chinese electronic databases (up to October 2015), were searched to identify RCTs on SSN for CRF. Two reviewers independently extracted the data and assessed the quality of included studies by using Cochrane Handbook 5.1.Meta-analysis was carried out by using Revman 5.3 software. If the Meta-analysis was not suitable for some outcomes, only descriptive analysis would be conducted.429 related articles were identified and finally a total of 25 RCTs (1 937 patients including 1 059 patients of treatment group and 878 patients of control group) were included. The SSN treatment group was more effective than the control group in terms of clinical efficiency, blood urea nitrogen(BUN), serum creatinine(Scr) and creatinine clearance(Ccr). However, the efficacy of SSN on increasing hemoglobin (Hb) could not be determined. No serious adverse drug events or reactions were reported. SSN capsules have certain efficacy and safety in the adjuvant treatment for chronic renal failure. However, due to the generally low methodological quality of the included studies, this review can not provide high-quality evidence to prove the clinical efficacy of this drug. More well-designed and large-scale multi-center randomized controlled trials should be conducted in the future for verification.

Systematic review on safety of Xinyuan capsules / 中国中药杂志

To systematically review the adverse drug reactions/adverse events(ADRs/AEs) of Xinyuan capsules in clinical application. A systematic literature search was performed in the databases of the Cochrane Library, Medline, EMBASE, the Web of Science, Clinical trials, CNKI, VIP, WanFang Data and CBM. The literature was screened and data was extracted according to the inclusion and exclusion criteria. Because of the substantial heterogeneity among different studies, we assessed them only with descriptive analysis by study type, disease diagnosis, and ADRs/AEs conditions. All included studies were assessed by using the internationally recognized report quality evaluation standard or methodological quality assessment tools. A total of 42 studies involving 3 671 patients were included finally. Two thouand four hundred and thirty-mine patients of them took Xinyuan capsules, and 1 242 patients did not take Xinyuan capsules. No serious ADRs occurred in all patients. One patient died as AE during the research. Sixteen patients of the 2 439 patients taking Xinyuan capsules (alone or in combination) had ADRs, including 7 patients with polytherapy of Xinyuan capsules and 9 patients with monotherapy. The most common ADRs were in gastrointestinal tract, mainly including thirst, nausea, vomiting and abdominal pain, etc. The ADRs included 10 gastrointestinal tract ADRs, 3 renal ADRs and 1 ADR respective in skin system, respiratory system and cardiovascular system. Xinyuan capsules was generally safe in clinical application. The reports on the study of Xinyuan capsules were dispersed in various clinical studies, the study on drug safety still should be strengthened in the future. Further mechanism studies or clinical observation studies of the drug safety shall be conducted to better guide clinical application in the future.