1.Systematic Review and Trial Sequential Analysis of Efficacy and Safety of Salvianolate Combined with Western Medicine on Diabetes Mellitus and Associated Chronic Microvascular Complications
Yuanyuan YUE ; Yanshuo SHI ; Yuehong YUE ; Yingguang SUN
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(5):1297-1311
Objective To systematically evaluate the CIinical indexes of western medicine combined with salvianolate in patients affected with diabetes and chronic microvascular complications.Methods Relevant RCTs in China National Knowledge(CNKI),Wanfang Date,Chinese Scientific Journal Database(VIP),PubMed and other databases were searched by computer,and the search time was limited from the foundation of each database to December,2023.Rev Man 5.3 and Stata 15.0 software were used for meta analysis,and TSA 0.9.5.10 Beta software was used for trial sequential analysis(TSA).Results A total of 33 RCTs(2690 patients)were finally involved.The meta-analysis results showed that compared with western medicine,combined with alvianolate could significantly improve the Clinical total effective rate,decrease fasting and postprandial blood glucose,improve vascellum endothelial function{ET-1[MD=-82.46,95%CI(-122.25,-42.67),P<0.05]、NO[MD=11.50,95%CI(7.22,15.78),P<0.05]},lower oxidative stress{SOD[MD=13.18,95%CI(10.26,16.11),P<0.05]、MDA[SMD=-1.43,95%CI(-1.94,-0.92),P<0.05]、Hcy[MD=-6.85,95%CI(-10.58,-3.12),P<0.05]},reduce inflammatory markers{hs-CRP[MD=-3.77,95%CI(-4.90,-2.64),P<0.05]、sICAM-1[MD=-212.59,95%CI(-289.48,-135.70),P<0.05]、IL-6[MD=-14.14,95%CI(-17.73,-10.54),P<0.05]},improve renal function{Scr[MD=-18.69,95%CI(-28.34,-9.03),P<0.05]、BUN[MD=-1.30,95%CI(-1.92,-0.67),P<0.05]、UAER[MD=-37.75,95%CI(-49.40,-26.10),P<0.05].There was no statistical difference in the incidence of adverse reactions between the two groups(P>0.05).TSA further affirmed salvianolate had beneficial effect on serum ET-1、SOD、IL-6、Scr and BUN.Conclusion Compared with the conventional therapy of western medicine,the combined medication of salvianolate and chemical medicine achieves much better Clinical effects on diabetes and chronic microvascular complications.Considering the limitations of the included studies,more large sample and high-quality randomized controlled trials are needed to prove our conclusions.
2.Systematic Review and Trial Sequential Analysis of Efficacy and Safety of Salvianolate Combined with Western Medicine on Diabetes Mellitus and Associated Chronic Microvascular Complications
Yuanyuan YUE ; Yanshuo SHI ; Yuehong YUE ; Yingguang SUN
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(5):1297-1311
Objective To systematically evaluate the CIinical indexes of western medicine combined with salvianolate in patients affected with diabetes and chronic microvascular complications.Methods Relevant RCTs in China National Knowledge(CNKI),Wanfang Date,Chinese Scientific Journal Database(VIP),PubMed and other databases were searched by computer,and the search time was limited from the foundation of each database to December,2023.Rev Man 5.3 and Stata 15.0 software were used for meta analysis,and TSA 0.9.5.10 Beta software was used for trial sequential analysis(TSA).Results A total of 33 RCTs(2690 patients)were finally involved.The meta-analysis results showed that compared with western medicine,combined with alvianolate could significantly improve the Clinical total effective rate,decrease fasting and postprandial blood glucose,improve vascellum endothelial function{ET-1[MD=-82.46,95%CI(-122.25,-42.67),P<0.05]、NO[MD=11.50,95%CI(7.22,15.78),P<0.05]},lower oxidative stress{SOD[MD=13.18,95%CI(10.26,16.11),P<0.05]、MDA[SMD=-1.43,95%CI(-1.94,-0.92),P<0.05]、Hcy[MD=-6.85,95%CI(-10.58,-3.12),P<0.05]},reduce inflammatory markers{hs-CRP[MD=-3.77,95%CI(-4.90,-2.64),P<0.05]、sICAM-1[MD=-212.59,95%CI(-289.48,-135.70),P<0.05]、IL-6[MD=-14.14,95%CI(-17.73,-10.54),P<0.05]},improve renal function{Scr[MD=-18.69,95%CI(-28.34,-9.03),P<0.05]、BUN[MD=-1.30,95%CI(-1.92,-0.67),P<0.05]、UAER[MD=-37.75,95%CI(-49.40,-26.10),P<0.05].There was no statistical difference in the incidence of adverse reactions between the two groups(P>0.05).TSA further affirmed salvianolate had beneficial effect on serum ET-1、SOD、IL-6、Scr and BUN.Conclusion Compared with the conventional therapy of western medicine,the combined medication of salvianolate and chemical medicine achieves much better Clinical effects on diabetes and chronic microvascular complications.Considering the limitations of the included studies,more large sample and high-quality randomized controlled trials are needed to prove our conclusions.
3.Severe gastrointestinal hemorrhage due to concomitant use of bevacizumab and camrelizumab
Yuesong YIN ; Yanshuo SHI ; Yupei WU ; Lien HE ; Xiaofei XU ; Xiaoyan FAN
Adverse Drug Reactions Journal 2024;26(11):702-704
A 67-year-old male patient with intrahepatic bile duct carcinoma was treated with oxaliplatin (hepatic artery perfusion)+gemcitabine (hepatic artery perfusion)+camrelizumab (intravenous infusion)+apatinib (oral). Platelet count (PLT) decline (49×10 9/L) was observed after 2 months (apatinib had been discontinued by himself), which was improved after platelet elevating therapy. Due to multiple tumor metastases, bevacizumab (hepatic arterial perfusion, once per 30 days) was added. Before bevacizumab treatment, PLT and coagulation function of the patient were basically no abnormalities. After 2 cycles of treatments, the PLT was 101×10 9/L and prothrombin time was 14.1 s. Considering the high risk of bleeding in interventional therapy, oxaliplatin and gemcitabine were discontinued, and bevacizumab administration was changed to intravenous infusion. PLT and coagulation function were not improved. Six days after the 5th dose of bevacizumab, the patient had intermittent hematemesis twice (about 300 ml). Laboratory tests showed PLT 75×10 9/L and prothrombin time 15.8 s. The patient was diagnosed with digestive tract hemorrhage. Fasting and water restriction was performed, and gastric acid suppression, hemostasis, parenteral nutrition, etc. were given. The patient had no hematemesis but intermittent black stool. Gastroscopy indicated duodenal ulcer accompanied by bleeding. Rabeprazole and sucralfate were added. Fasting was stopped and liquid diet was given. The next day, the patient had blood in the stool, and the bleeding of the lower digestive tract was judged to be related to camrelizumab and bevacizumab. The bleeding symptoms were slightly improved after treatments with arterial embolization hemostasis and type A cryopprecipitation coagulation factor, etc. Later, the patient had repeated bleeding condition, and finally died despite of rescue efforts.
4.Severe gastrointestinal hemorrhage due to concomitant use of bevacizumab and camrelizumab
Yuesong YIN ; Yanshuo SHI ; Yupei WU ; Lien HE ; Xiaofei XU ; Xiaoyan FAN
Adverse Drug Reactions Journal 2024;26(11):702-704
A 67-year-old male patient with intrahepatic bile duct carcinoma was treated with oxaliplatin (hepatic artery perfusion)+gemcitabine (hepatic artery perfusion)+camrelizumab (intravenous infusion)+apatinib (oral). Platelet count (PLT) decline (49×10 9/L) was observed after 2 months (apatinib had been discontinued by himself), which was improved after platelet elevating therapy. Due to multiple tumor metastases, bevacizumab (hepatic arterial perfusion, once per 30 days) was added. Before bevacizumab treatment, PLT and coagulation function of the patient were basically no abnormalities. After 2 cycles of treatments, the PLT was 101×10 9/L and prothrombin time was 14.1 s. Considering the high risk of bleeding in interventional therapy, oxaliplatin and gemcitabine were discontinued, and bevacizumab administration was changed to intravenous infusion. PLT and coagulation function were not improved. Six days after the 5th dose of bevacizumab, the patient had intermittent hematemesis twice (about 300 ml). Laboratory tests showed PLT 75×10 9/L and prothrombin time 15.8 s. The patient was diagnosed with digestive tract hemorrhage. Fasting and water restriction was performed, and gastric acid suppression, hemostasis, parenteral nutrition, etc. were given. The patient had no hematemesis but intermittent black stool. Gastroscopy indicated duodenal ulcer accompanied by bleeding. Rabeprazole and sucralfate were added. Fasting was stopped and liquid diet was given. The next day, the patient had blood in the stool, and the bleeding of the lower digestive tract was judged to be related to camrelizumab and bevacizumab. The bleeding symptoms were slightly improved after treatments with arterial embolization hemostasis and type A cryopprecipitation coagulation factor, etc. Later, the patient had repeated bleeding condition, and finally died despite of rescue efforts.

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